[Federal Register Volume 79, Number 54 (Thursday, March 20, 2014)]
[Notices]
[Pages 15594-15596]
From the Federal Register Online via the Government Publishing 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, [email protected].
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]
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