
[Federal Register Volume 79, Number 108 (Thursday, June 5, 2014)]
[Notices]
[Pages 32552-32554]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-13037]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0627]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; General 
Administrative Procedures: Citizen Petitions; Petition for 
Reconsideration or Stay of Action; Advisory Opinions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July 7, 
2014.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0183. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

General Administrative Procedures: Citizen Petitions; Petition for 
Reconsideration or Stay of Action; Advisory Opinions--(OMB Control 
Number 0910-0183)--Extension

    The Administrative Procedures Act (5 U.S.C. 553(e)), provides that 
every Agency shall give an interested person the right to petition for 
issuance, amendment, or repeal of a rule. Section 10.30 (21 CFR 10.30) 
sets forth the format and procedures by which an interested person may 
submit to FDA, in accordance with Sec.  10.20 (21 CFR 10.20) 
(Submission of documents to Division of Dockets Management), a citizen 
petition requesting the Commissioner of Food and Drugs (the 
Commissioner) to issue, amend, or revoke a regulation or order, or to 
take or refrain from taking any other form of administrative action.
    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. Respondents are individuals or households, State or 
local governments, not-for-profit institutions, or groups.
    Section 10.33 (21 CFR 10.33) issued under section 701(a) of the 
Federal,

[[Page 32553]]

Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 371(a)), sets 
forth the format and procedures by which an interested person may 
request reconsideration of part or all of a decision of the 
Commissioner on a petition submitted under 21 CFR 10.25 (Initiation of 
administrative proceedings). A petition for reconsideration must 
contain a full statement in a well-organized format of the factual and 
legal grounds upon which the petition 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. The respondent must submit a petition no later 
than 30 days after the decision involved. However, the Commissioner 
may, for good cause, permit a petition to be filed after 30 days. 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. FDA uses the information provided in 
the request to determine whether to grant the petition for 
reconsideration. Respondents to this collection of information are 
individuals of households, State or local governments, not-for-profit 
institutions, and businesses or other for-profit institutions who are 
requesting from the Commissioner of FDA a reconsideration of a matter.
    Section 10.35 (21 CFR 10.35), issued under section 701(a) of the 
FD&C Act, sets forth the format and procedures by which an interested 
person may request, in accordance with Sec.  10.20 (Submission of 
documents to Division of Dockets Management), the Commissioner to stay 
the effective date of any administrative action.
    Such a petition must do the following: (1) Identify the decision 
involved; (2) state the action requested, including the length of time 
for which a stay is requested; and (3) include a statement of the 
factual and legal grounds on which the interested person relies in 
seeking the stay. FDA uses the information provided in the request to 
determine whether to grant the petition for stay of action.
    Respondents to this information collection are interested persons 
who choose to file a petition for an administrative stay of action.
    Section 10.85 (21 CFR 10.85), issued under section 701(a) of the 
FD&C Act sets forth the format and procedures by which an interested 
person may request, in accordance with Sec.  10.20 (Submission of 
documents to Division of Dockets Management), an advisory opinion from 
the Commissioner on a matter of general applicability. An advisory 
opinion represents the formal position of FDA on a matter of general 
applicability. When making a request, the petitioner must provide a 
concise statement of the issues and questions on which an opinion is 
requested, and a full statement of the facts and legal points relevant 
to the request.
    Respondents to this collection of information are interested 
persons seeking an advisory opinion from the Commissioner on the 
Agency's formal position for matters of general applicability.
    In the Federal Register of March 20, 2014 (79 FR 15594), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR Section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
10.30...........................             207               1             207              24           4,968
10.33...........................               4               1               4              10              40
10.35...........................               5               1               5              10              50
10.85...........................               4               1               4              16              64
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           5,122
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The burden estimates for this collection of information are based 
on Agency records.
    On December 19, 2013, FDA published a technical amendment (78 FR 
76748) announcing that the Agency 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.
    The Agency still allows for non-electronic submissions; however, 
electronic submissions of a citizen petition to a specific electronic 
docket presents a simpler and more 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

[[Page 32554]]

communication, quicker interaction between citizen petitioners and FDA, 
and easier access to FDA to seek input through the citizen petition 
process.

    Dated: May 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13037 Filed 6-4-14; 8:45 am]
BILLING CODE 4160-01-P


