§10.30. Citizen petition. — Inbound Citations

FDA will consider modifying the requirements of this subpart applicable to a food or type of entity, or exempting a food or type of entity from the requirements of this subpart, on our own initiative or in response to a citizen petition submitted under § 10.30 of this chapter by any interested party.

In addition to meeting the requirements on the content and format of a citizen petition in § 10.30 of this chapter, a petition requesting modified requirements or an exemption from the requirements of this subpart must:

(a) In general, the procedures set forth in § 10.30 of this chapter govern FDA's response to a petition requesting modified requirements or an exemption. An interested person may submit comments on such a petition in accordance with § 10.30(d) of this chapter.

(b) A citizen petition requesting a waiver for a type of entity submitted under § 10.30 of this chapter by any person subject to the requirements of this subpart.

In addition to meeting the requirements on the content and format of a citizen petition in § 10.30 of this chapter, a petition requesting a waiver for a type of entity must:

(a) In general, the procedures set forth in § 10.30 of this chapter govern FDA's response to a petition requesting a waiver. An interested person may submit comments on such a petition in accordance with § 10.30(d) of this chapter.

We will consider whether to waive a requirement of this subpart on our own initiative or on the petition submitted under § 10.30 of this chapter by any person who is subject to the requirements of this subpart with respect to any class of persons, vehicles, food, or nonfood products.

In addition to the requirements set forth in § 10.30 of this chapter, the Statement of Grounds in a petition requesting a waiver must:

(a) In general, the procedures set forth in § 10.30 of this chapter govern our response to a petition requesting a waiver.

We may deny a petition requesting a waiver if the petition does not provide the information required under § 1.918 (including the requirements of § 10.30 of this chapter), or if we determine that the waiver could result in the transportation of food under conditions that would be unsafe for human or animal health, or that the waiver could be contrary to the public interest.

(2) in the form for a citizen petition in § 10.30.

(3) The petition is submitted in writing and under § 10.30 (for citizen petitions) or § 10.35 (for petitions for stay of action).

(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:

(i) The name of the agency;

(a) This section applies to court review of final administrative action taken by the Commissioner, including action taken under §§ 10.25 through 10.40 and § 16.1(b), except action subject to § 10.50 and part 12.

(ii) If no form is specified, by a petition under § 10.30.

(3) By a petition under § 10.30.

(2) Must be submitted in the form of a citizen petition under § 10.30 before publication of a notice of hearing under § 12.35 or a denial of hearing under § 12.28; and

(b) The petition will be in the form specified in § 10.30 except that the heading will be “Request to Participate in Forma Pauperis, Docket No. ____.” Filing and service requirements for the petition are described in paragraph (c) of this section, whether or not the petition is granted. The petition must demonstrate that either: (1) The person is indigent and a strong public interest justifies participation, or (2) the person's participation is in the public interest because it can be considered of primary benefit to the general public.

(2) A request for establishment of a color additive advisory committee is to be made in accordance with § 10.30. The Commissioner may deny any petition if inadequate grounds are stated for establishing a color additive advisory committee. A request for establishment of a color additive advisory committee may not rest on mere allegations or denials, but must set forth specific facts showing that there is a genuine and substantial issue of fact that requires scientific judgment and justifies a hearing before a color additive advisory committee. When it conclusively appears from the request for a color additive advisory committee that the matter is premature or that it does not involve an issue arising under section 721(b)(5)(B) of the FD&C Act or that there is no genuine and substantial issue of fact requiring scientific judgment, or for any other reason a color additive advisory committee is not justified, the Commissioner may deny the establishment of a color additive advisory committee.

(d) The Commissioner may waive or refund such fees in whole or in part when, in the Commissioner's judgment, such action will promote the public interest. Any person who believes that payment of these fees will be a hardship may petition the Commissioner under § 10.30 to waive or refund the fees.

Any interested person may request, under § 10.30, that a specific matter relating to a particular human prescription drug be submitted to an appropriate advisory committee for a hearing and review and recommendations. The request must demonstrate the importance of the matter and the reasons why it should be submitted for a hearing at that time. The Commissioner may grant or deny the request.

(a) If the person objects to any action, including a failure to act, other than denial of access to an advisory committee document, the person shall submit a petition in the form and in accordance with the requirements of § 10.30. The provisions of § 10.45 relating to exhaustion of administrative remedies are applicable.

(1) If the person objects to past action, the person shall submit the petition within 30 days after the action objected to. If the Commissioner determines that there was noncompliance with any provision of this subpart or of the Federal Advisory Committee Act, the Commissioner will grant any appropriate relief and take appropriate steps to prevent its future recurrence.

(2) If the person objects to proposed future action, the Commissioner will expedite the review of the petition and make a reasonable effort to render a decision before the action concerned in the petition.

(3) If the person objects to action that is imminent or occurring and which could not reasonably have been anticipated, e.g., the closing of a portion of a meeting which is made known for the first time on the day of the meeting, the matter may be handled by an oral petition in lieu of a written petition.

(p) Issuance, amendment, or revocation of a regulation in response to a reference amount petition as described in § 101.12(h) of this chapter, a nutrient content claim petition as described in § 101.69 of this chapter, a health claim petition as described in § 101.70 of this chapter, or a petition pertaining to the label declaration of ingredients as described in § 10.30 of this chapter.

(b) The petition shall be filed in accordance with § 10.20, under the docket number of the Federal Register notice of the agency's regulatory review period determination, and shall be in the format specified in § 10.30. The petition shall contain the information specified in § 10.30 and any additional information required by this subpart. If any provision of § 10.20 or § 10.30 is inconsistent with any provision of this part, FDA will consider the petition in accordance with this part.

(3) The petition does not contain the information required by § 10.30;

(c) The written proposal should be sent to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday. The proposal should be clearly identified as a request for a temporary exemption for purposes of conducting authorized food labeling experiments and submitted as a citizen petition under § 10.30 of this chapter.

(C) Submit a petition, under 21 CFR 10.30, to request an alternative means of compliance. The petition must provide scientific data or other information for why the amount of added sugars in a serving of the product is likely to have a significant reduction in added sugars compared to the amount added prior to non-enzymatic browning and/or fermentation. A significant reduction would be where reduction in added sugars after non-enzymatic browning and/or fermentation may be significant enough to impact the label declaration for added sugars by an amount that exceeds the reasonable deficiency acceptable within good manufacturing practice under paragraph (g)(6) of this section. In addition, the scientific data or other information must include the reason that the manufacturer is unable to determine a reasonable approximation of the amount of added sugars in a serving of their finished product and a description of the process that they used to come to that conclusion.

(3) The manufacturer of an eligible infant formula may, not later than November 12, 2015, submit a petition to the Food and Drug Administration under § 10.30 of this chapter that:

(i) Demonstrates that such formula fulfills one or more of the criteria in paragraph (i)(1) of this section; or

(ii) Demonstrates that such formula fulfills one or more of the criteria in paragraph (i)(2) of this section.

(ii) You may submit a petition, under 21 CFR 10.30, to request an exemption from the testing requirements in paragraph (a)(1)(i) of this section. The petition must set forth the scientific rationale, and must be accompanied by the supporting data and information, for proposed alternative testing that will demonstrate that there is no material diminution of assurance, compared to the assurance provided by 100 percent identity testing, of the identity of the dietary ingredient before use when the dietary ingredient is obtained from one or more suppliers identified in the petition. If FDA grants the petition, you must conduct the tests and examinations for the dietary ingredient, otherwise required under § 111.75(a)(1)(i), under the terms specified by FDA when the petition is granted; and

To request a variance from one or more requirements of this part, the competent authority (i.e., the regulatory authority for food safety) for a State, tribe, or a foreign country must submit a petition under § 10.30 of this chapter.

In addition to the requirements set forth in § 10.30 of this chapter, the Statement of Grounds in a petition requesting a variance must:

(a) In general, the procedures set forth in § 10.30 of this chapter govern our response to a petition requesting a variance.

(a) A State, tribe, or a foreign country that believes that a variance requested by a petition submitted by another State, tribe, or foreign country should also apply to similarly situated persons in its jurisdiction may request that the variance be applied to its similarly situated persons by submitting comments in accordance with § 10.30 of this chapter. These comments must include the information required in § 112.173. If FDA determines that these comments should instead be treated as a separate request for a variance, FDA will notify the State, tribe, or foreign country that submitted these comments that a separate request must be submitted in accordance with §§ 112.172 and 112.173.

We may deny a variance request if it does not provide the information required under § 112.173 (including the requirements of § 10.30 of this chapter), or if we determine that the variance is not reasonably likely to ensure that the produce is not adulterated under section 402 of the Federal Food, Drug and Cosmetic Act and to provide the same level of public health protection as the requirements of this part.

(d) The Food and Drug Administration will grant an exemption from paragraph (a) of this section where appropriate upon petition under the provisions of § 10.30 of this chapter. Decisions with respect to requests for exemptions shall be maintained in a permanent file for public review by the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

(d) A manufacturer or packer may request an exemption from the packaging and labeling requirements of this section. A request for an exemption is required to be submitted in the form of a citizen petition under § 10.30 of this chapter and should be clearly identified on the envelope as a “Request for Exemption from the Tamper-Evident Packaging Rule.” The petition is required to contain the following:

(1) The name of the drug product or, if the petition seeks an exemption for a drug class, the name of the drug class, and a list of products within that class.

(2) The reasons that the drug product's compliance with the tamper-evident packaging or labeling requirements of this section is unnecessary or cannot be achieved.

(3) A description of alternative steps that are available, or that the petitioner has already taken, to reduce the likelihood that the product or drug class will be the subject of malicious adulteration.

(a) An abbreviated new drug application that refers to, or a petition under section 505(j)(2)(C) of the act and § 314.93 that relies on, a listed drug that has been voluntarily withdrawn from sale in the United States must be accompanied by a petition seeking a determination whether the listed drug was withdrawn for safety or effectiveness reasons. The petition must be submitted under §§ 10.25(a) and 10.30 of this chapter and must contain all evidence available to the petitioner concerning the reasons for the withdrawal from sale.

(14) For an ANDA submitted pursuant to an approved petition under § 10.30 of this chapter and § 314.93, an NDA subsequently has been approved for the change described in the approved petition.

(3) When a person petitions for such a determination under §§ 10.25(a) and 10.30 of this chapter.

If FDA determines after approval that the requirements established in § 314.520, § 314.530, or § 314.550 are no longer necessary for the safe and effective use of a drug product, it will so notify the applicant. Ordinarily, for drug products approved under § 314.510, these requirements will no longer apply when FDA determines that the required postmarketing study verifies and describes the drug product's clinical benefit and the drug product would be appropriate for approval under traditional procedures. For drug products approved under § 314.520, the restrictions would no longer apply when FDA determines that safe use of the drug product can be assured through appropriate labeling. FDA also retains the discretion to remove specific postapproval requirements upon review of a petition submitted by the sponsor in accordance with § 10.30.

If FDA determines after approval under this subpart that the requirements established in §§ 314.610(b)(2), 314.620, and 314.630 are no longer necessary for the safe and effective use of a drug product, FDA will so notify the applicant. Ordinarily, for drug products approved under § 314.610, these requirements will no longer apply when FDA determines that the postmarketing study verifies and describes the drug product's clinical benefit. For drug products approved under § 314.610, the restrictions would no longer apply when FDA determines that safe use of the drug product can be ensured through appropriate labeling. FDA also retains the discretion to remove specific postapproval requirements upon review of a petition submitted by the sponsor in accordance with § 10.30 of this chapter.

(3) Drug products that have been declared suitable for an abbreviated new drug application submission by FDA through the petition procedures set forth under § 10.30 of this chapter and § 314.93.

(c) To obtain permission to submit an ANDA for a change described in paragraph (b) of this section, a person must submit and obtain approval of a petition requesting the change. A person seeking permission to request such a change from a reference listed drug shall submit a petition in accordance with § 10.20 of this chapter and in the format specified in § 10.30 of this chapter. The petition shall contain the information specified in § 10.30 of this chapter and any additional information required by this section. If any provision of § 10.20 or § 10.30 of this chapter is inconsistent with any provision of this section, the provisions of this section apply.

(i) For an ANDA based on an approved petition under § 10.30 of this chapter and § 314.93, the reference listed drug must be the same as the listed drug referenced in the approved petition.

(e) The Food and Drug Administration will grant an exemption from paragraphs (b), (c), and (d) of this section where appropriate, upon petition under the provisions of § 10.30 of this chapter. Appropriate cause, such as a specific solubility or manufacturing problem, must be adequately documented in the petition. Decisions with respect to requests for exemption shall be maintained in a permanent file for public review by the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

(i) The Commissioner may propose on the Commissioner's own initiative to amend or repeal any monograph established pursuant to this section. Any interested person may petition the Commissioner for such proposal pursuant to § 10.30 of this chapter. The Commissioner may deny the petition if the Commissioner finds a lack of safety or effectiveness employing the standards in paragraph (a)(4) of this section (in which case the appeal provisions of paragraph (a)(11) of this section shall apply), or the Commissioner may publish a proposed amendment or repeal in the Federal Register if the Commissioner finds general recognition of safety and effectiveness employing the standards in paragraph (a)(4) of this section. Any interested person may, within 90 days after publication of the proposed order in the Federal Register, file with the Dockets Management Staff, Food and Drug Administration, written comments in triplicate. Comments may be accompanied by a memorandum or brief in support thereof. All comments may be reviewed in the Dockets Management Staff between the hours of 9 a.m. and 4 p.m., Monday through Friday. After reviewing the comments, the Commissioner shall publish a final order amending the monograph established under the provisions of paragraph (a)(9) of this section or withdraw the proposal if comments opposing the amendment are persuasive. A new drug application may be submitted in lieu of, or in addition to, a petition under this paragraph.

The formulation or mode of administration of certain products may require a modification of the United States Pharmacopeia 23/National Formulary 18 acid neutralizing capacity test. Any proposed modification and the data to support it shall be submitted as a petition under the rules established in § 10.30 of this chapter. All information submitted will be subject to the disclosure rules in part 20 of this chapter.

(4) The labeling states the warning “When using this product [in bold type] [bullet] may cause marked drowsiness.” The word “marked” may be deleted from the warning upon petition under the provisions of § 10.30 of this chapter provided adequate data are submitted to demonstrate that the combination product does not cause a significant increase in drowsiness as compared with each active ingredient when tested alone. The petition and the data it contains will be maintained in a permanent file for public review in the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

The formulation or mode of administration of certain products may require modification of the testing procedures in this subpart. In addition, alternative methods (including automated or in vitro procedures) employing the same basic procedures as those described in this subpart may be used. Any proposed modification or alternative procedure shall be submitted as a petition in accord with § 10.30 of this chapter. The petition should contain data to support the modification or data demonstrating that an alternative procedure provides results of equivalent accuracy. All information submitted will be subject to the disclosure rules in part 20 of this chapter.

(c) Alternative testing procedures may be used. Any proposed modification or alternative testing procedures shall be submitted as a petition in accord with § 10.30 of this chapter. The petition should contain data to support the modification or data demonstrating that an alternative testing procedure provides results of equivalent accuracy. All information submitted will be subjected to the disclosure rules in part 20 of this chapter.

The Commissioner of Food and Drugs, either on his own initiative or on behalf of any interested person who has submitted a petition, may issue a proposal to establish, revoke, or amend a regulation under this part. Any such petition shall include an adequate factual basis to support the petition, shall be in the form set forth in § 10.30 of this chapter, and will be published in the Federal Register for comment if it contains reasonable grounds for the proposed regulation.

(c) A petition for revocation must be submitted in the form specified in § 10.30 of this chapter.

If FDA determines after approval that the requirements established in § 601.42, § 601.43, or § 601.45 are no longer necessary for the safe and effective use of a biological product, it will so notify the applicant. Ordinarily, for biological products approved under § 601.41, these requirements will no longer apply when FDA determines that the required postmarketing study verifies and describes the biological product's clinical benefit and the biological product would be appropriate for approval under traditional procedures. For biological products approved under § 601.42, the restrictions would no longer apply when FDA determines that safe use of the biological product can be assured through appropriate labeling. FDA also retains the discretion to remove specific postapproval requirements upon review of a petition submitted by the sponsor in accordance with § 10.30.

If FDA determines after approval under this subpart that the requirements established in §§ 601.91(b)(2), 601.92, and 601.93 are no longer necessary for the safe and effective use of a biological product, FDA will so notify the applicant. Ordinarily, for biological products approved under § 601.91, these requirements will no longer apply when FDA determines that the postmarketing study verifies and describes the biological product's clinical benefit. For biological products approved under § 601.91, the restrictions would no longer apply when FDA determines that safe use of the biological product can be ensured through appropriate labeling. FDA also retains the discretion to remove specific postapproval requirements upon review of a petition submitted by the sponsor in accordance with § 10.30 of this chapter.

(d) A manufacturer or packer may request an exemption from the packaging and labeling requirements of this section. A request for an exemption is required to be submitted in the form of a citizen petition under § 10.30 of this chapter and should be clearly identified on the envelope as a “Request for Exemption from Tamper-resistant Rule.” The petition is required to contain the following:

(2) The reasons that the product's compliance with the tamper-resistant packaging or labeling requirements of this section is unnecessary or cannot be achieved.

(3) A description of alternative steps that are available, or that the petitioner has already taken, to reduce the likelihood that the product will be the subject of malicious adulteration.

(d) A manufacturer or packer may request an exemption from the packaging and labeling requirements of this section. A request for an exemption is required to be submitted in the form of a citizen petition under § 10.30 of this chapter and should be clearly identified on the envelope as a “Request for Exemption from Tamper-resistant Rule.” A petition for an exemption from a requirement of this section is required to contain the same kind of information about the product as is specified for OTC drugs in § 211.132(d) of this chapter.

(i) The manufacturer presents evidence, in the form of a citizen petition submitted in accordance with the requirements of § 10.30 of this chapter, demonstrating that the alternative test method will yield results that are equivalent to the results yielded by the test method specified in this section; and

(i) Any affected person may request an exemption or variance from the requirements of this section by submitting a citizen petition in accordance with § 10.30 of this chapter.

(1) A manufacturer subject to any requirement under section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act, including any requirements under this part, may petition for an exemption or variance from such requirement in accordance with section 520(f)(2) of the Federal Food, Drug, and Cosmetic Act. Petitions for an exemption or variance shall be submitted in accordance with the procedures set forth in § 10.30 of this chapter.

(b) A request for an exemption or variance shall be submitted in the form of a petition under § 10.30 of this chapter and shall comply with the requirements set out therein, except that a response shall be issued in 90 days. The Director or Deputy Directors, CDRH, or the Director or Principal Deputy Director of the Office of Product Evaluation and Quality, CDRH, shall issue responses to requests under this section. The petition shall also contain the following:

(1) The name of the device and device class and representative labeling showing the intended use(s) of the device;

(2) The reasons that compliance with the tracking requirements of this part is unnecessary;

(3) A complete description of alternative steps that are available, or that the petitioner has already taken, to ensure that an effective tracking system is in place; and

(2) Be submitted in accordance with the requirements of § 10.30.

(2) Requested by an interested person, in the form of a citizen petition in accordance with § 10.30 of this chapter, which is made within the period provided for comment on the proposed regulation and which demonstrates good cause for referral.

(h) Upon petition of any interested person submitted in accordance with § 10.30 of this chapter, or as a matter of discretion, the Commissioner may institute proceedings to amend or revoke a regulation that made a device a banned device if the Commissioner finds that the conditions that constituted the basis for the regulation banning the device are no longer applicable. When appropriate, the procedures in this section will be employed in such proceedings.

(a) A request for an exemption or variance shall be submitted in the form of a petition under § 10.30 of this chapter and shall comply with the requirements set out therein. The petition shall also contain the following:

(1) The name of the device, the class in which the device has been classified, and representative labeling showing the intended uses(s) of the device;

(2) The reasons why compliance with the performance standard is unnecessary or unfeasible;

(3) A complete description of alternative steps that are available, or that the petitioner has already taken, to ensure that a patient will not be inadvertently connected to hazardous voltages via an unprotected patient cable or electrode lead wire for intended use with the device; and

(2) Petitions for which acknowledgment of receipt of filing is provided by regulation or by customary practice, e.g., § 10.30(c) relating to a citizen petition.

(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.

(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.

(b) A request for an advisory opinion is to be submitted in accordance with § 10.20, is subject to the provisions of § 10.30 (c) through (l), and must be in the following form:

(a) In general, the procedures set forth in § 10.30 of this chapter govern FDA's response to a petition requesting modified requirements or an exemption. An interested person may submit comments on such a petition in accordance with § 10.30(d) of this chapter.

(a) In general, the procedures set forth in § 10.30 of this chapter govern FDA's response to a petition requesting a waiver. An interested person may submit comments on such a petition in accordance with § 10.30(d) of this chapter.

(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.

(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.

(b) A request for an advisory opinion is to be submitted in accordance with § 10.20, is subject to the provisions of § 10.30 (c) through (l), and must be in the following form:

(4) Any interested person may submit written comments to the Dockets Management Staff on a filed petition as provided in § 10.30(d) of this chapter.

(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.

(b) A request for an advisory opinion is to be submitted in accordance with § 10.20, is subject to the provisions of § 10.30 (c) through (l), and must be in the following form:

(c) An exemption or variance is not effective until the Director or Deputy Directors, CDRH, or the Director or Principal Deputy Director of the Office of Product Evaluation and Quality, CDRH, approves the request under § 10.30(e)(2)(i) of this chapter.

(b) An exemption or variance is not effective until the agency approves the request under § 10.30(e)(2)(i) of this chapter.

(c) Under § 10.30(e)(3) of this chapter, we will respond to the petitioner in writing, as follows:

(1) If we grant the petition either in whole or in part, we will publish a notice in the Federal Register setting forth any modified requirements or exemptions and the reasons for them.

(2) If we deny the petition (including a partial denial), our written response to the petitioner will explain the reasons for the denial.

(c) Under § 10.30(e)(3) of this chapter, we will respond to the petitioner in writing, as follows:

(1) If we grant the petition either in whole or in part, we will publish a notice in the Federal Register setting forth any requirements we have waived and the reasons for the waiver.

(2) If we deny the petition (including a partial denial), our written response to the petitioner will explain the reasons for the denial.

(c) Under § 10.30(e)(3) of this chapter, we will respond to the petitioner in writing.

(1) If we grant the petition, either in whole or in part, we will publish a notice in the Federal Register setting forth any waiver and the reasons for such waiver.

(2) If we deny the petition (including partial denials), our written response to the petitioner will explain the reason(s) for the denial.

(c) Under § 10.30(e)(3) of this chapter, we will respond to the petitioner in writing and will also make public a notice on FDA's Web site announcing our decision to either grant or deny the petition.

(1) If we grant the petition, either in whole or in part, we will specify the persons to whom the variance applies and the provision(s) of this part to which the variance applies.

(2) If we deny the petition (including partial denials), our written response to the petitioner and our public notice announcing our decision to deny the petition will explain the reason(s) for the denial.

(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).

(b) A request for an advisory opinion is to be submitted in accordance with § 10.20, is subject to the provisions of § 10.30 (c) through (l), and must be in the following form:

(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).

(b) A request for an advisory opinion is to be submitted in accordance with § 10.20, is subject to the provisions of § 10.30 (c) through (l), and must be in the following form:

(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).

(b) A request for an advisory opinion is to be submitted in accordance with § 10.20, is subject to the provisions of § 10.30 (c) through (l), and must be in the following form:

(c) The Commissioner may use an optional procedure specified in § 10.30(h) to consider issuing, amending, or revoking an order.

(c) In making the determination in paragraph (a) of this section, the Commissioner may use any of the optional procedures specified in § 10.30(h) or in other applicable regulations, e.g., §§ 314.200, 514.200, and 601.7(a).

(b) Under § 10.30(h)(3) of this chapter, FDA will publish a notice in the Federal Register requesting information and views on a submitted petition, including information and views from persons who could be affected by the modified requirements or exemption if we granted the petition.

(b) Under § 10.30(h)(3) of this chapter, FDA will publish a notice in the Federal Register requesting information and views on a submitted petition requesting a waiver for a type of entity, including information and views from persons who could be affected by the waiver if we granted the petition.

(b) Under § 10.30(h)(3) of this chapter, we will publish a notice in the Federal Register, requesting information and views on a filed petition, including information and views from persons who could be affected by the waiver if the petition were to be granted.

(b) Under § 10.30(h)(3) of this chapter, we will publish a notice in the Federal Register, requesting information and views on a filed petition, including information and views from persons who could be affected by the variance if the petition were to be granted (e.g., because their farm is covered by the petition or as a person similarly situated to persons covered by the petition).

(1) The record of the original petition specified in § 10.30(i).

(1) If the regulation was initiated by a petition, the administrative record specified in § 10.30(i).

(f) The Commissioner shall take the position in an action for judicial review under 5 U.S.C. 701 et seq., whether or not it includes a request for a declaratory judgment under 28 U.S.C. 2201, or in any other case in which the validity of administrative action is properly challenged, that the validity of the action must be determined solely on the basis of the administrative record specified in §§ 10.30(i), 10.33(k), 10.35(h), 10.40(g), and 16.80(a) or the administrative record applicable to any decision or action under the regulations referenced in § 16.1(b), and that additional information or views may not be considered. An interested 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 action under § 10.25(a).

(b) A request for an advisory opinion is to be submitted in accordance with § 10.20, is subject to the provisions of § 10.30 (c) through (l), and must be in the following form:

(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).

(b) A request for an advisory opinion is to be submitted in accordance with § 10.20, is subject to the provisions of § 10.30 (c) through (l), and must be in the following form:

(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).

(b) A request for an advisory opinion is to be submitted in accordance with § 10.20, is subject to the provisions of § 10.30 (c) through (l), and must be in the following form:

(b) A request for an advisory opinion is to be submitted in accordance with § 10.20, is subject to the provisions of § 10.30 (c) through (l), and must be in the following form: