|
(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 in the following form:
(Date)________________________________________
Division of Dockets Management, Food and Drug Administration, Department of
Health and Human Services, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Citizen Petition
The undersigned submits this petition under ___ (relevant statutory sections,
if known) of the ___ (Federal Food, Drug, and Cosmetic Act or the Public Health
Service Act or any other statutory provision for which authority has been
delegated to the Commissioner of Food and Drugs under 21 CFR 5.10) to request
the Commissioner of Food and Drugs to ___ (issue, amend, or revoke a regulation
or order or take or refrain from taking any other form of administrative
action).
A. Action requested
((1) If the petition requests the Commissioner to issue, amend, or revoke a
regulation, the exact wording of the existing regulation (if any) and the
proposed regulation or amendment requested.)
((2) If the petition requests the Commissioner to issue, amend, or revoke an
order, a copy of the exact wording of the citation to the existing order (if
any) and the exact wording requested for the proposed order.)
((3) If the petition requests the Commissioner to take or refrain from taking
any other form of administrative action, the specific action or relief
requested.)
B. Statement of grounds
(A full statement, in a well organized format, of the factual and legal
grounds on which the petitioner relies, including all relevant information and
views on which the petitioner relies, as well as representative information
known to the petitioner which is unfavorable to the petitioner`s position.)
C. Environmental impact
(A) Claim for categorical exclusion under §§ 25.30, 25.31,
25.32, 25.33, or § 25.34 of this chapter or an environmental
assessment under § 25.40 of this chapter.)
D. Economic impact
(The following information is to be submitted only when requested by the
Commissioner following review of the petition: A statement of the effect of
requested action on: (1) Cost (and price) increases to industry, government, and
consumers; (2) productivity of wage earners, businesses, or government; (3)
competition; (4) supplies of important materials, products, or services; (5)
employment; and (6) energy supply or demand.)
E. Certification
The undersigned certifies, that, to the best knowledge and belief of the
undersigned, this petition includes all information and views on which the
petition relies, and that it includes representative data and information known
to the petitioner which are unfavorable to the petition.
(Signature)________________________________________
(Name of petitioner)________________________________________
(Mailing address)________________________________________
(Telephone number)________________________________________
(c) A petition which appears to meet the requirements of paragraph (b) of
this section and § 10.20 will be filed by the Division of Dockets
Management, stamped with the date of filing, and assigned a docket number. The
docket number identifies the file established by the Division of Dockets
Management for all submissions relating to the petition, as provided in this
part. Subsequent submissions relating to the matter must refer to the docket
number and will be filed in the docket file. Related petitions may be filed
together and given the same docket number. The Division of Dockets Management
will promptly notify the petitioner in writing of the filing and docket number
of a petition.
(d) An interested person may submit written comments to the Division of
Dockets Management on a filed petition, which comments become part of the docket
file. The comments are to specify the docket number of the petition and 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 paragraph (e)(4) 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; or
(iii) 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.
The petitioner is to be notified in writing of the Commissioner`s decision. The
decision will be placed in the public docket file in the office of the Division
of Dockets Management 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.
(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 in writing
without agency approval and without prejudice to resubmission at anytime until
the Commissioner rules on the petition, unless the petition has been referred
for a hearing under parts 12, 13, 14, or 15. 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 Federal Register 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
Division of Dockets Management.
(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 Division of Dockets Management
as part of the record supporting the decision.
(6) All documents filed with the Division of Dockets Management 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 Division of Dockets Management will maintain a chronological list of
each petition filed under this section and § 10.85, but not of
petitions submitted elsewhere in the agency under § 10.25(a)(1),
showing:
(1) The docket number;
(2) The date the petition was filed by the Division of Dockets Management;
(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]
| 
