
[Federal Register Volume 79, Number 54 (Thursday, March 20, 2014)]
[Notices]
[Pages 15594-15596]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-06132]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
Comment Request; General Administrative Procedures: Citizen Petitions; 
Petition for Reconsideration or Stay of Action; Advisory Opinions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 15595]]

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the reporting requirements 
contained in existing FDA regulations regarding the general 
administrative procedures for a person to petition the Commissioner of 
Food and Drugs (the Commissioner) to issue, amend, or revoke a rule; to 
file a petition for an administrative reconsideration or an 
administrative stay of action; and to request an advisory opinion from 
the Commissioner.

DATES: Submit either electronic or written comments on the collection 
of information by May 19, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 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, 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.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 15596]]



                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
         21 CFR Section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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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
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    Total.......................  ..............  ..............  ..............  ..............           5,122
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\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 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, and easier 
access to FDA to seek input through the citizen petition process.

    Dated: March 14, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-06132 Filed 3-19-14; 8:45 am]
BILLING CODE 4160-01-P


