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specify when a final response may be (1) The petition, including all inforfurnished.

mation on which it relies, filed by the (3) The Commissioner may grant or Dockets Management Branch. deny such a petition, in whole or in (2) All comments received on the pepart, and may grant such other relief tition, including all information subor take other action as the petition mitted as a part of the comments. warrants. The petitioner is to be noti- (3) If the petition resulted in a profied in writing of the Commissioner's posal to issue, amend, or revoke a regudecision. The decision will be placed in lation, all of the documents specified the public docket file in the office of in 8 10.40(g). the Dockets Management Branch and (4) The record, consisting of any may also be in the form of a notice transcripts, minutes of meetings, republished in the FEDERAL REGISTER. ports, FEDERAL REGISTER notices, and

(4) The Commissioner shall furnish a other documents resulting from the opresponse to each petitioner within 90 tional procedures specified in paradays of receipt of a petition filed under graph (h) of this section, except a transection 505(j)(2)(C) of the act. The re- script of a closed portion of a public adsponse will either approve dis- visory committee meeting. approve the petition. Agency action on (5) The Commissioner's decision on a petition shall be governed by $314.93 the petition, including all information of this chapter.

identified or filed by the Commissioner (f) If a petition filed under paragraph with the Dockets Management Branch (c) of this section requests the Com

as part of the record supporting the demissioner to issue, amend, or revoke a

cision. regulation, $ 10.40 or $10.50 also apply.

(6) All documents filed with the (8) A petitioner may supplement,

Dockets Management Branch under amend, or withdraw a petition in writ

$10.65(h). ing without agency approval and with- (7) If a petition for reconsideration or out prejudice to resubmission at any

for a stay of action is filed under paratime until the Commissioner rules on

graph (j) of this section, the administhe petition, unless the petition has

trative record specified in § 10.33(k) or been referred for a hearing under parts

$10.35(h). 12, 13, 14, or 15. After a ruling or refer

(j) The administrative record speciral, a petition may be supplemented,

fied in paragraph (i) of this section is amended, or withdrawn only with the

the exclusive record for the Commisapproval of the Commissioner. The

sioner's decision. The record of the adCommissioner may approve with

ministrative proceeding closes on the drawal, with without prejudice

date of the Commissioner's decision against resubmission of the petition.

unless some other date is specified. (h) In reviewing a petition the Com

Thereafter any interested person may missioner may use the following proce

submit a petition for reconsideration dures:

under $10.33 or a petition for stay of ac(1) Conferences,

tion under $10.35. A person who wishes meetings, discus

to rely upon information or views not sions, and correspondence under $10.65.

included in the administrative record (2) A hearing under parts 12, 13, 14, 15,

shall submit them to the Commissioner or 16.

with a new petition to modify the deci(3) A FEDERAL REGISTER notice re

sion in accordance with this section. questing information and views.

(k) This section does not apply to the (4) A proposal to issue, amend, or re- referral of a matter to a United States voke a regulation, in accordance with

attorney for the initiation of court en$10.40 or $ 12.20.

forcement action and related (5) Any other specific public proce- respondence, or to requests, suggesdure established in this chapter and ex- tions, and recommendations made inpressly applicable to the matter.

formally in routine correspondence re(i) The record of the administrative ceived by FDA. Routine correspondproceeding consists of the following: ence does not constitute a petition

or

cor

A. Decision involved

(A concise statement of the decision of the Commissioner which the petitioner wishes to have reconsidered.)

B. Action requested (The decision which the petitioner requests the Commissioner to make upon reconsideration of the matter.)

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.

(1) The Dockets Management Branch 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 Branch;

(3) The name of the petitioner; (4) The subject matter involved; and

(5) The disposition of the petition. [44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 50 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)

$ 10.33 Administrative reconsideration

of action. (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. Statement of grounds (A full statement, in a well-organized format, of the factual and legal grounds upon which the petitioner relies. The grounds must demonstrate that relevant information and views contained in the administrative record were not previously or not adequately considered by the Commissioner.

(No new information or views may be included in a petition for reconsideration.) (Signature) (Name of petitioner) (Mailing address) (Telephone number)

(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

(Date)

Dockets Management Branch, Food and Drug Administration, Department of Health and Human Services, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.

PETITION FOR RECONSIDERATION

[Docket No.) The undersigned submits this petition for reconsideration of the decision of the Commissioner of Food and Drugs in Docket No.

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 Branch. 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 Branch.

(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 Branch.

(3) All comments received on the petition, including all information submitted as a part of the comments.

(4) The Commissioner's decision on the petition under paragraph (f) of this section, including all information identified or filed by the Commissioner with the Dockets Management Branch as part of the record supporting the decision.

(5) Any FEDERAL REGISTER notices or other documents resulting from the petition.

(6) All documents filed with the Dockets Management Branch under $ 10.65(h).

(7) If the Commissioner reconsiders the matter, the administrative record relating to reconsideration specified in $10.30(i). [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.

(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 no later than 30 days after the date of the decision involved. The Commissioner may, for good cause, permit a petition to be filed after 30 days. In the case of a decision published in the FEDERAL REGISTER, the day of publication is the date of decision.

(Date)

Dockets Management Branch, Food and Drug Administration, Department of Health and Human Services, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.

PETITION FOR STAY OF ACTION

The undersigned submits this petition requesting that the Commissioner of Food and Drugs stay the effective date of the following matter.

A. Decision involved (The specific administrative action being taken by the Commissioner for which a stay is requested, including the docket number or other citation to the action involved.)

B. Action requested (The length of time for which the stay is requested, which may be for a specific or indefinite time period.)

C. Statement of grounds (A full statement, in a well-organized format, of the factual and legal grounds upon which the petitioner relies for the stay.) (Signature) (Name of petitioner) (Mailing address) (Telephone number)

(c) A petition for stay of action relating to a petition submitted under $ 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 pe

tition. 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 Branch. A determination to grant a stay will be published in the FEDERAL REGISTER if the Commissioner's original decision was so published. Any other determination to grant or to deny a stay may also be published in the FEDERAL REGISTER.

(g) A petition for a stay of action submitted later than 30 days after the date of the decision involved will be denied as untimely unless the Commissioner permits the petition to be filed after 30 days. A petition for a stay of action is considered submitted on the day it is received by the Dockets Management Branch.

(h) The record of the administrative proceeding consists of the following:

(1) The record of the proceeding to which the petition for stay of action is directed

(2) The petition for stay of action, including all information on which it relies, filed by the Dockets Management Branch.

(3) All comments received on the petition, including all information submitted as a part of the comments.

(4) The Commissioner's decision on the petition under paragraph (e) of this section, including all information identified or filed by the Commissioner with the Dockets Management Branch as part of the record supporting the decision.

(5) Any FEDERAL REGISTER notices or other documents resulting from the petition.

(6) All documents filed with the Dockets Management Branch under $ 10.65(h).

(44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 54 FR 9034, Mar. 3, 1989; 59 FR 14364, Mar. 28, 1994; 66 FR 6468, Jan. 22, 2001; 66 FR 12848, Mar. 1, 2001)

§ 10.40 Promulgation of regulations for

the efficient enforcement of the

law. (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 Branch), 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 Branch 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 Branch 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

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