[Federal Register Volume 78, Number 244 (Thursday, December 19, 2013)]
[Rules and Regulations]
[Pages 76748-76750]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-30150]



Food and Drug Administration

21 CFR Part 10

[Docket No. FDA 2013-S-0610]

Citizen Petition Submission; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.


SUMMARY: The Food and Drug Administration (FDA) is modernizing its 
administrative regulations regarding submission of citizen petitions to 
explicitly provide for electronic submission. The current regulation 
does not recognize electronic methods for submitting citizen petitions; 
thus, this action will enable efficiency and ease in the filing of 
citizen petitions.

DATES: This final rule is effective December 19, 2013.

FOR FURTHER INFORMATION CONTACT: Lisa M. Helmanis, Office of Policy, 
Regulations Policy Management Staff, Food and Drug Administration, 
10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-9135.

SUPPLEMENTARY INFORMATION: FDA is updating its administrative 
regulations in 21 CFR part 10 to include an electronic method for 
citizen petition submissions and to remove references only to written 
documents. The Agency still allows for non-electronic submissions, 
however, electronic submissions of a citizen petition to a specific 
electronic docket presents a simpler and straightforward approach. FDA 
has created a single docket on http://www.regulations.gov, the U.S. 
Government's consolidated docket Web site for Federal Agencies, for the 
initial electronic submission of all citizen petitions. The FDA 
Electronic Method for Submission of Citizen Petitions Docket, Docket 
No. FDA 2013-S-0610, allows the petitioner to create an electronic 
submission through http://www.regulations.gov and provides an 
alternative to the current system of submission for citizen petitions. 
Electronic submissions through http://www.regulations.gov will provide 
the submitter with an immediate record of the time of submission. FDA's 
Division of Dockets Management (DDM) (http://www.fda.gov/RegulatoryInformation/Dockets/default.htm) will continue to inform the 
submitter of formal filing; however, tracking will be more easily 
accomplished through electronic submission.
    DDM will receive the electronically submitted citizen petition 
through the Federal Dockets Management System, the Agency component of 
http://www.regulations.gov. Subsequently, DDM will review the 
electronic submission and when it accepts the citizen petition for 
filing, DDM will assign a docket number to that petition, different 
from the FDA electronic submission docket number. This unique docket 
number from DDM identifies the docket for that particular citizen 
petition for all future filings and submissions related only to that 
citizen petition. Subsequent submissions associated with that citizen 
petition will refer to the assigned unique docket number. The advantage 
to this change is that it ensures efficiency and ease in communication, 
quicker interaction between citizen petitioners and FDA,

[[Page 76749]]

and easier access to FDA to seek input through the citizen petition 
    Publication of this document constitutes final action under the 
Administrative Procedure Act (5 U.S.C. 553). FDA has determined that 
good cause exists to dispense with prior notice and public comment 
under 5 U.S.C. 553(b)(3)(B) since such notice and comment are 
unnecessary because this amendment to the regulation provides only 
technical and grammatical corrections, modernizes the administrative 
process to add a simple and electronic method, ensures clarity in the 
Agency's regulations, and updates obsolete information.

List of Subjects in 21 CFR Part 10

    Administrative practice and procedure, News media.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
10 is amended as follows:


1. The authority citation for 21 CFR part 10 continues to read as 

    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, 236b, 264.

2. Amend Sec.  10.30 by revising paragraphs (b), (c), (d), (e)(3), and 
(g) to read as follows:

Sec.  10.30  Citizen petition.

* * * * *
    (b) A petition (including any attachments) must 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 Sec.  10.20 through http://www.regulations.gov at 
Docket No. FDA 2013-S-0610. It is only necessary to submit one copy.
    (2) Mail, delivery services, or other non-electronic submissions. A 
petition (including any attachments), that is not electronically 
submitted under paragraph (b)(1) of this section, must be submitted in 
accordance with paragraph (b)(3) and Sec.  10.20 and delivered to this 
address: Division of Dockets Management, Department of Health and Human 
Services, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852.
    It is only necessary to submit two copies.
    (3) Petition format. A petition submitted under paragraphs (b)(1) 
or (b)(2) of this section must be in accordance with Sec.  10.20 and in 
the following format:

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) 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 Sec. Sec.  25.30, 25.31, 
25.32, 25.33, or Sec.  25.34 of this chapter or an environmental 
assessment under Sec.  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 


(Name of petitioner)---------------------------------------------------

(Mailing address)------------------------------------------------------

(Telephone number)-----------------------------------------------------
    (c) A petition which appears to meet the requirements of paragraph 
(b)(3) of this section and Sec.  10.20 will be filed by the Division of 
Dockets Management with the date of filing and assigned a unique docket 
number. The unique docket number identifies the docket file established 
by the Division of Dockets Management for all submissions relating to 
the petition, as provided in this part. Subsequent submissions relating 
to the matter must refer to the assigned docket number assigned in this 
paragraph and will be filed in the established docket file. Related 
petitions may be filed together and given the same docket number. The 
Division of Dockets Management will promptly notify the petitioner of 
the filing and unique docket number of the petition.
    (d) An interested person may submit comments to the Division of 
Dockets Management on a filed petition, which comments become part of 
the docket file. The comments are to specify the docket number of the 
petition and 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) * * *
    (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 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.
* * * * *
    (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

[[Page 76750]]

approval of the Commissioner. The Commissioner may approve withdrawal, 
with or without prejudice against resubmission of the petition.
* * * * *

    Dated: December 13, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-30150 Filed 12-18-13; 8:45 am]