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Notes

21 C.F.R. §§ 10.25–10.40

6 sections in range

§10.25. Initiation of administrative proceedings.

21 C.F.R. § 10.25

An administrative proceeding may be initiated in the following three ways:
(a)
An interested person may petition the Commissioner to issue, amend, or revoke a regulation or order, or to take or refrain from taking any other form of administrative action. A petition must be either:
(1)
In the form specified in other applicable FDA regulations, e.g., the form for a color additive petition in § 71.1, for a food additive petition in § 171.1 or § 571.1, for a new drug application in § 314.50, for a request to establish or amend an import tolerance in § 510.205, for a new animal drug application in § 514.1, or
(2)
in the form for a citizen petition in § 10.30.
(b)
The Commissioner may initiate a proceeding to issue, amend, or revoke a regulation or order or take or refrain from taking any other form of administrative action. FDA has primary jurisdiction to make the initial determination on issues within its statutory mandate, and will request a court to dismiss, or to hold in abeyance its determination of or refer to the agency for administrative determination, any issue which has not previously been determined by the agency or which, if it has previously been determined, the agency concluded should be reconsidered and subject to a new administrative determination. The Commissioner may utilize any of the procedures established in this part in reviewing and making a determination on any matter initiated under this paragraph.
(c)
The Commissioner will institute a proceeding to determine whether to issue, amend, or revoke a regulation or order, or take or refrain from taking any other form of administrative action whenever any court, on its own initiative, holds in abeyance or refers any matter to the agency for an administrative determination and the Commissioner concludes that an administrative determination is feasible within agency priorities and resources.
Notes, amendments, and revision history

Amendments

[44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9034, Mar. 3, 1989; 86 FR 52409, Sept. 21, 2021]

Authority

Authority: 5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b, 264.

Source

Source: 44 FR 22323, Apr. 13, 1979, unless otherwise noted.

Amendments

[44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9034, Mar. 3, 1989; 86 FR 52409, Sept. 21, 2021]

§10.30. Citizen petition.

21 C.F.R. § 10.30

(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) of this section and § 10.20 and delivered to this address: Dockets Management Staff, Department of Health and Human Services, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit two copies (original and redacted version) for confidential petitions. Otherwise, only one copy is necessary.
(3)
Petition format. A petition submitted under paragraphs (b)(1) or (b)(2) of this section must be in accordance with § 10.20 and in the following format:
(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 Dockets Management Staff, stamped with the date of filing, and assigned a unique docket number. The unique docket number identifies the docket file established by the Dockets Management Staff 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 Dockets Management Staff will promptly notify the petitioner of the filing and unique docket number of the petition.
(d)
An interested person may submit comments to the Dockets Management Staff 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.
(e)
(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.
(2)
Except as provided in paragraphs (e)(4) and (5) of this section, the Commissioner shall furnish a response to each petitioner within 180 days of receipt of the petition. The response will either:
(i)
Approve the petition, in which case the Commissioner shall concurrently take appropriate action (e.g., publication of a Federal Register notice) implementing the approval;
(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.
(5)
The Commissioner intends to furnish a response to each petitioner within 150 days of receipt of a petition subject to section 505(q) of the Federal Food, Drug, and Cosmetic Act.
(f)
If a petition filed under paragraph (c) of this section requests the Commissioner to issue, amend, or revoke a regulation, § 10.40 or § 10.50 also apply.
(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.
(h)
In reviewing a petition the Commissioner may use the following procedures:
(1)
Conferences, meetings, discussions, and correspondence under § 10.65.
(2)
A hearing under parts 12, 13, 14, 15, or 16.
(3)
A <I>Federal Register</I> notice requesting information and views.
(4)
A proposal to issue, amend, or revoke a regulation, in accordance with § 10.40 or § 12.20.
(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—
(1)
The petition, including all information on which it relies, filed by the Dockets Management Staff.
(2)
All comments received on the petition, including all information submitted as a part of the comments.
(3)
If the petition resulted in a proposal to issue, amend, or revoke a regulation, all of the documents specified in § 10.40(g).
(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 Dockets Management Staff as part of the record supporting the decision.
(6)
All documents filed with the Dockets Management Staff under § 10.65(h).
(7)
If a petition for reconsideration or for a stay of action is filed under paragraph (j) of this section, the administrative record specified in § 10.33(k) or § 10.35(h).
(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 Dockets Management Staff 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;
(2)
The date the petition was filed by the Dockets Management Staff;
(3)
The name of the petitioner;
(4)
The subject matter involved; and
(5)
The disposition of the petition.
Notes, amendments, and revision history

Amendments

[44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 50 FR 16656, Apr. 26, 1985; 54 FR 9034, Mar. 3, 1989; 57 FR 17980, Apr. 28, 1992; 59 FR 14364, Mar. 28, 1994; 62 FR 40592, July 29, 1997; 66 FR 6467, Jan. 22, 2001; 66 FR 12848, Mar. 1, 2001; 78 FR 76749, Dec. 19, 2013; 81 FR 78505, Nov. 8, 2016; 88 FR 45064, July 14, 2023]

Authority

Authority: 5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b, 264.

Source

Source: 44 FR 22323, Apr. 13, 1979, unless otherwise noted.

Amendments

[44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 50 FR 16656, Apr. 26, 1985; 54 FR 9034, Mar. 3, 1989; 57 FR 17980, Apr. 28, 1992; 59 FR 14364, Mar. 28, 1994; 62 FR 40592, July 29, 1997; 66 FR 6467, Jan. 22, 2001; 66 FR 12848, Mar. 1, 2001; 78 FR 76749, Dec. 19, 2013; 81 FR 78505, Nov. 8, 2016; 88 FR 45064, July 14, 2023]

§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.

21 C.F.R. § 10.31

(a)
Applicability. This section applies to a citizen petition or petition for stay of action that meets all of the following criteria:
(1)
The petition requests that the Commissioner take any form of action that could, if taken, delay approval of an abbreviated new drug application submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act, a new drug application submitted through the pathway described by section 505(b)(2) of the Federal, Food, Drug and Cosmetic Act, or a biologics license application submitted under section 351(k) of the Public Health Service Act.
(2)
The petition is submitted on or after September 27, 2007.
(3)
The petition is submitted in writing and under § 10.30 (for citizen petitions) or § 10.35 (for petitions for stay of action).
(b)
Date of submission. A petition subject to this section and submitted in accordance with § 10.20, § 10.30, § 10.31, or § 10.35 is regarded as submitted on the date on which the petition is received by the Dockets Management Staff.
(c)
Certification.
(1)
FDA will not consider for review a petition that is subject to this section unless the petition is in writing and contains the following certification:
(2)
The certification in paragraph (c)(1) of this section must contain one or more specific dates (month, day, and year) in the first blank space provided. If different categories of information become known at different times, the certification must contain each estimated relevant date. The information associated with a particular date must be identified.
(d)
Verification.
(1)
FDA will not accept for review any supplemental information or comments on a petition that is subject to this section unless the supplemental information or comments are in writing and contain the following verification:
(2)
The verification in paragraph (d)(1) of this section must contain one or more specific dates (month, day, and year) in the first blank space provided. If different categories of information become known at different times, the verification must contain each estimated relevant date. The information associated with a particular date must be identified.
Notes, amendments, and revision history

Amendments

[81 FR 78506, Nov. 8, 2016]

Authority

Authority: 5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b, 264.

Source

Source: 44 FR 22323, Apr. 13, 1979, unless otherwise noted.

Amendments

[81 FR 78506, Nov. 8, 2016]

§10.33. Administrative reconsideration of action.

21 C.F.R. § 10.33

(a)
The Commissioner may at any time reconsider a matter, on the Commissioner's own initiative or on the petition of an interested person.
(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.
(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:
(1)
The petition demonstrates that relevant information or views contained in the administrative record were not previously or not adequately considered.
(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 Dockets Management Staff. 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 Dockets Management Staff.
(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.
(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).
(k)
The record of the administrative proceeding consists of the following—
(1)
The record of the original petition specified in § 10.30(i).
(2)
The petition for reconsideration, 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 (f) 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 <I>Federal Register</I> notices or other documents resulting from the petition.
(6)
All documents filed with the Dockets Management Staff under § 10.65(h).
(7)
If the Commissioner reconsiders the matter, the administrative record relating to reconsideration specified in § 10.30(i).
Notes, amendments, and revision history

Amendments

[44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 59 FR 14364, Mar. 28, 1994; 66 FR 6467, Jan. 22, 2001; 66 FR 12848, Mar. 1, 2001]

Authority

Authority: 5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b, 264.

Source

Source: 44 FR 22323, Apr. 13, 1979, unless otherwise noted.

Amendments

[44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 59 FR 14364, Mar. 28, 1994; 66 FR 6467, Jan. 22, 2001; 66 FR 12848, Mar. 1, 2001]

§10.35. Administrative stay of action.

21 C.F.R. § 10.35

(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.
(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 <I>Federal Register</I> 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.
Notes, amendments, and revision history

Amendments

[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]

Authority

Authority: 5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b, 264.

Source

Source: 44 FR 22323, Apr. 13, 1979, unless otherwise noted.

Amendments

[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]

§10.40. Promulgation of regulations for the efficient enforcement of the law.

21 C.F.R. § 10.40

(a)
The Commissioner may propose and promulgate regulations for the efficient enforcement of the laws administered by FDA whenever it is necessary or appropriate to do so. The issuance, amendment, or revocation of a regulation may be initiated in any of the ways specified in § 10.25.
(1)
This section applies to any regulation: (i) Not subject to § 10.50 and part 12, or (ii) if it is subject to § 10.50 and part 12, to the extent that those provisions make this section applicable.
(2)
A regulation proposed by an interested person in a petition submitted under § 10.25(a) will be published in the Federal Register as a proposal if:
(i)
The petition contains facts demonstrating reasonable grounds for the proposal; and
(ii)
The petition substantially shows that the proposal is in the public interest and will promote the objectives of the act and the agency.
(3)
Two or more alternative proposed regulations may be published on the same subject to obtain comment on the different alternatives.
(4)
A regulation proposed by an interested person in a petition submitted under § 10.25(a) may be published together with the Commissioner's preliminary views on the proposal and any alternative proposal.
(b)
Except as provided in paragraph (e) of this section, each regulation must be the subject of a notice of proposed rulemaking published in the Federal Register. (1) The notice will contain:
(i)
The name of the agency;
(ii)
The nature of the action, e.g., proposed rule, or notice;
(iii)
A summary in the first paragraph describing the substance of the document in easily understandable terms;
(iv)
Relevant dates, e.g., comment closing date, and proposed effective date(s);
(v)
The name, business address, and phone number of an agency contact person who can provide further information to the public about the notice;
(vi)
An address for submitting written comments;
(vii)
Supplementary information about the notice in the form of a preamble that summarizes the proposal and the facts and policy underlying it, includes references to all information on which the Commissioner relies for the proposal (copies or a full list of which are a part of the docket file on the matter in the office of the Dockets Management Staff), and cites the authority under which the regulation is proposed;
(viii)
Either the terms or substance of the proposed regulation or a description of the subjects and issues involved;
(ix)
A reference to the existence or lack of need for an environmental impact statement under § 25.52 of this chapter; and
(x)
The docket number of the matter, which identifies the docket file established by the Dockets Management Staff for all relevant submissions.
(2)
The proposal will provide 60 days for comment, although the Commissioner may shorten or lengthen this time period for good cause. In no event is the time for comment to be less than 10 days.
(3)
After publication of the proposed rule, any interested person may request the Commissioner to extend the comment period for an additional specified period by submitting a written request to the Dockets Management Staff stating the grounds for the request. The request is submitted under § 10.35 but should be headed “REQUEST FOR EXTENSION OF COMMENT PERIOD.”
(i)
A request must discuss the reason comments could not feasibly be submitted within the time permitted, or that important new information will shortly be available, or that sound public policy otherwise supports an extension of the time for comment. The Commissioner may grant or deny the request or may grant an extension for a time period different from that requested. An extension may be limited to specific persons who have made and justified the request, but will ordinarily apply to all interested persons.
(ii)
A comment time extension of 30 days or longer will be published in the Federal Register and will be applicable to all interested persons. A comment time extension of less than 30 days will be the subject either of a letter or memorandum filed with the Dockets Management Staff or of a notice published in the Federal Register.
(4)
A notice of proposed rulemaking will request that four copies of all comments be submitted to the Dockets Management Staff, except that individuals may submit single copies. Comments will be stamped with the date of receipt and will be numbered chronologically.
(5)
Persons submitting comments critical of a proposed regulation are encouraged to include their preferred alternative wording.
(c)
After the time for comment on a proposed regulation has expired, the Commissioner will review the entire administrative record on the matter, including all comments and, in a notice published in the Federal Register, will terminate the proceeding, issue a new proposal, or promulgate a final regulation.
(1)
The quality and persuasiveness of the comments will be the basis for the Commissioner's decision. The number or length of comments will not ordinarily be a significant factor in the decision unless the number of comments is material where the degree of public interest is a legitimate factor for consideration.
(2)
The decision of the Commissioner on the matter will be based solely upon the administrative record.
(3)
A final regulation published in the Federal Register will have a preamble stating: (i) The name of the agency, (ii) the nature of the action e.g., final rule, notice, (iii) a summary first paragraph describing the substance of the document in easily understandable terms, (iv) relevant dates, e.g., the rule's effective date and comment closing date, if an opportunity for comment is provided, (v) the name, business address, and phone number of an agency contact person who can provide further information to the public about the notice, (vi) an address for the submission of written comments when they are permitted, (vii) supplementary information about the regulation in the body of the preamble that contains references to prior notices relating to the same matter and a summary of each type of comment submitted on the proposal and the Commissioner's conclusions with respect to each. The preamble is to contain a thorough and comprehensible explanation of the reasons for the Commissioner's decision on each issue.
(4)
The effective date of a final regulation may not be less than 30 days after the date of publication in the Federal Register, except for:
(i)
A regulation that grants an exemption or relieves a restriction; or
(ii)
A regulation for which the Commissioner finds, and states in the notice good cause for an earlier effective date.
(d)
The provisions for notice and comment in paragraphs (b) and (c) of this section apply only to the extent required by the Administrative Procedure Act (5 U.S.C. 551, 552, and 553). As a matter of discretion, however, the Commissioner may voluntarily follow those provisions in circumstances in which they are not required by the Administrative Procedure Act.
(e)
The requirements of notice and public procedure in paragraph (b) of this section do not apply in the following situations:
(1)
When the Commissioner determines for good cause that they are impracticable, unnecessary, or contrary to the public interest. In these cases, the notice promulgating the regulation will state the reasons for the determination, and provide an opportunity for comment to determine whether the regulation should subsequently be modified or revoked. A subsequent notice based on those comments may, but need not, provide additional opportunity for public comment.
(2)
Food additive and color additive petitions, which are subject to the provisions of § 12.20(b)(2).
(3)
New animal drug regulations, which are promulgated under section 512(i) of the act.
(f)
In addition to the notice and public procedure required under paragraph (b) of this section, the Commissioner may also subject a proposed or final regulation, before or after publication in the Federal Register, to the following additional procedures:
(1)
Conferences, meetings, discussions, and correspondence under § 10.65.
(2)
A hearing under parts 12, 13, 14, or 15.
(3)
A notice published in the Federal Register requesting information and views before the Commissioner determines whether to propose a regulation.
(4)
A draft of a proposed regulation placed on public display in the office of the Dockets Management Staff. If this procedure is used, the Commissioner shall publish an appropriate notice in the Federal Register stating that the document is available and specifying the time within which comments on the draft proposal may be submitted orally or in writing.
(5)
A revised proposal published in the Federal Register, which proposal is subject to all the provisions in this section relating to proposed regulations.
(6)
A tentative final regulation or tentative revised final regulation placed on public display in the office of the Dockets Management Staff and, if deemed desirable by the Commissioner, published in the Federal Register. If the tentative regulation is placed on display only, the Commissioner shall publish an appropriate notice in the Federal Register stating that the document is available and specifying the time within which comments may be submitted orally or in writing on the tentative final regulation. The Commissioner shall mail a copy of the tentative final regulation and the Federal Register notice to each person who submitted comments on the proposed regulation if one has been published.
(7)
A final regulation published in the Federal Register that provides an opportunity for the submission of further comments, in accordance with paragraph (e)(1) of this section.
(8)
Any other public procedure established in this chapter and expressly applicable to the matter.
(g)
The record of the administrative proceeding consists of all of the following—
(1)
If the regulation was initiated by a petition, the administrative record specified in § 10.30(i).
(2)
If a petition for reconsideration or for a stay of action is filed, the administrative record specified in §§ 10.33(k) and 10.35(h).
(3)
The proposed rule published in the Federal Register, including all information identified or filed by the Commissioner with the Dockets Management Staff on the proposal.
(4)
All comments received on the proposal, including all information submitted as a part of the comments.
(5)
The notice promulgating the final regulation, including all information identified or filed by the Commissioner with the Dockets Management Staff as part of the administrative record of the final regulation.
(6)
The transcripts, minutes of meetings, reports, Federal Register notices, and other documents resulting from the procedures specified in paragraph (f) of this section, but not the transcript of a closed portion of a public advisory committee meeting.
(7)
All documents submitted to the Dockets Management Staff under § 10.65(h).
(h)
The record of the administrative proceeding closes on the date of publication of the final regulation in the Federal Register 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 it to the Commissioner with a new petition to modify the final regulation.
(i)
The Dockets Management Staff shall maintain a chronological list of all regulations proposed and promulgated under this section and § 10.50 (which list will not include regulations resulting from petitions filed and assigned a docket number under § 10.30) showing—
(1)
The docket number (for a petition submitted directly to a center, the list also includes the number or other designation assigned by the center, e.g., the number assigned to a food additive petition);
(2)
The name of the petitioner, if any;
(3)
The subject matter involved; and
(4)
The disposition of the petition.
Notes, amendments, and revision history

Amendments

[44 FR 22323, Apr. 13, 1979, as amended at 52 FR 36401, Sept. 29, 1987; 54 FR 9034, Mar. 3, 1989; 56 FR 13758, Apr. 4, 1991; 62 FR 40592, July 29, 1997; 66 FR 6468, Jan. 22, 2001; 66 FR 12848, Mar. 1, 2001]

Authority

Authority: 5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b, 264.

Source

Source: 44 FR 22323, Apr. 13, 1979, unless otherwise noted.

Amendments

[44 FR 22323, Apr. 13, 1979, as amended at 52 FR 36401, Sept. 29, 1987; 54 FR 9034, Mar. 3, 1989; 56 FR 13758, Apr. 4, 1991; 62 FR 40592, July 29, 1997; 66 FR 6468, Jan. 22, 2001; 66 FR 12848, Mar. 1, 2001]