Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act, 60288-60290 [2013-23886]
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60288
Federal Register / Vol. 78, No. 190 / Tuesday, October 1, 2013 / Notices
developmental stage. Respondents will
be asked to give their reaction to the
messages in either individual or group
settings.
Third, as evaluative research, it will
allow FDA to ascertain the effectiveness
of the messages and the distribution
method of these messages in achieving
the objectives of the message campaign.
Evaluation of campaigns is a vital link
in continuous improvement of
communications at FDA.
FDA estimates the burden of this
collection of information based on prior
experience with the various types of
data collection methods described
above:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 U.S.C.
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Section 393(d)(2)(D) ............................................................
9,280
1
9,280
0.2935
(17 min.)
2,724
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–23791 Filed 9–30–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0008]
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Guidance for
Industry on Citizen Petitions and
Petitions for Stay of Action Subject to
Section 505(q) of the Federal Food,
Drug, and Cosmetic Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 information collection in the
guidance on citizen petitions and
petitions for stay of action subject to of
the Federal Food, Drug, and Cosmetic
Act (FD&C Act).
DATES: Submit either electronic or
written comments on the collection of
information by December 2, 2013.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
emcdonald on DSK67QTVN1PROD with NOTICES
SUMMARY:
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14:45 Sep 30, 2013
Jkt 232001
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)
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Sfmt 4703
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.
Guidance for Industry on Citizen
Petitions and Petitions for Stay of
Action Subject to Section 505(q) of the
Federal Food, Drug, and Cosmetic
Act—(OMB Control Number 0910–
0679)—Extension
In the Federal Register of June 8,
2011(76 FR 33309), FDA announced the
availability of a guidance for industry
entitled ‘‘Citizen Petitions and Petitions
for Stay of Action Subject to Section
505(q) of the Federal Food, Drug, and
Cosmetic Act.’’ The guidance provides
information regarding FDA’s current
thinking on interpreting section 914 of
Title IX of the Food and Drug
Administration Amendments Act
(FDAAA) (Pub. L. 110–85). Section 914
of FDAAA added new section 505(q) to
the FD&C Act (21 U.S.C. 355(q)) and
governs certain citizen petitions and
petitions for stay of agency action that
request that FDA take any form of action
related to a pending application
submitted under section 505(b)(2) or
505(j) (U.S.C. 355(b)(2) or U.S.C. 355(j))
of the FD&C Act. The guidance
describes FDA’s interpretation of
section 505(q) of the FD&C Act
regarding how the Agency will
determine if: (1) The provisions of
section 505(q) addressing the treatment
of citizen petitions and petitions for stay
of agency action (collectively, petitions)
apply to a particular petition and (2) a
petition would delay approval of a
pending abbreviated new drug
application (ANDA) or a section
505(b)(2) application. The guidance also
describes how FDA will interpret the
provisions of section 505(q) requiring
that: (1) A petition includes a
certification and (2) supplemental
information or comments to a petition
E:\FR\FM\01OCN1.SGM
01OCN1
emcdonald on DSK67QTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 190 / Tuesday, October 1, 2013 / Notices
include a verification. Finally, the
guidance addresses the relationship
between the review of petitions and
pending ANDAs and section 505(b)(2)
applications for which the Agency has
not yet made a decision on
approvability.
The Food and Drug Administration
Safety and Innovation Act (FDASIA)
was signed into law on July 9, 2012
(Pub. L. 112–144, 126 Stat. 993). Section
1135 of FDASIA amended section
505(q) of the FD&C Act in two ways.
First, it shortened FDA’s deadline from
180 days to 150 days for responding to
petitions subject to section 505(q) of the
FD&C Act. Second, it expanded the
scope of section 505(q) of the FD&C Act
to include certain petitions concerning
applications submitted under section
351(k) of the Public Health Service Act
(42 U.S.C. 262), the abbreviated
pathway for the approval of biosimilar
biological products. Accordingly, we are
now including submissions pertaining
to biosimilar biological product
applications in the information
collection burden estimates below.
Section 505(q)(1)(H) of the FD&C Act
requires that citizen petitions and
petitions for stay of agency action that
are subject to section 505(q) include a
certification to be considered for review
by FDA. Section 505(q)(1)(I) of the
FD&C Act requires that supplemental
information or comments to such citizen
petitions and petitions for stay of agency
action include a verification to be
accepted for review by FDA. The
guidance sets forth the criteria the
Agency will use in determining if the
provisions of section 505(q) of the FD&C
Act apply to a particular citizen petition
or petition for stay of agency action. The
guidance states that one of the criteria
for a citizen petition or petition for stay
of agency action to be subject to section
505(q) of the FD&C Act is that a related
ANDA or section 505(b)(2) application
is pending at the time the citizen
petition or petition for stay is submitted.
Because petitioners or commenters may
not be aware of the existence of a
pending ANDA or section 505(b)(2)
application, the guidance recommends
that all petitioners challenging the
approvability of a possible ANDA or
section 505(b)(2) application include the
certification required in section
505(q)(1)(H) of the FD&C Act and that
petitioners and commenters submitting
supplements or comments, respectively,
to a citizen petition or petition for stay
of action challenging the approvability
of a possible ANDA or section 505(b)(2)
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Jkt 232001
application include the verification
required in section 505(q)(1)(I) of the
FD&C Act. The guidance also
recommends that if a petitioner submits
a citizen petition or petition for stay of
agency action that is missing the
required certification but is otherwise
within the scope of section 505(q) of the
FD&C Act and the petitioner would like
FDA to review the citizen petition or
petition for stay of agency action, the
petitioner should submit a letter
withdrawing the deficient petition and
submit a new petition that contains the
required certification.
FDA currently has OMB approval for
the collection of information entitled
‘‘General Administrative Procedures:
Citizen Petitions; Petition for
Reconsideration or Stay of Action;
Advisory Opinions’’ (OMB control
number 0910–0183). This collection of
information includes, among other
things: (1) The format and procedures
by which an interested person may
submit to FDA, in accordance with
§ 10.20 (21 CFR 10.20), a citizen petition
requesting the Commissioner of Food
and Drugs (Commissioner) to issue,
amend, or revoke a regulation or order,
or to take or refrain from taking any
other form of administrative action
(§ 10.30(b) (21 CFR 10.30(b))); (2) the
submission of written comments on a
filed citizen petition (§ 10.30(d)); (3) the
submission of a supplement or
amendment to or a letter to withdraw a
filed citizen petition (§ 10.30(g)); (4) the
format and procedures by which an
interested person may request, in
accordance with § 10.20, the
Commissioner to stay the effective date
of any administrative action (§ 10.35(b)
(21 CFR 10.35(b))); and (5) the
submission of written comments on a
filed petition for administrative stay of
action (§ 10.35(c)). This information
collection includes citizen petitions,
petitions for administrative stay of
action, comments to petitions,
supplements to citizen petitions, and
letters to withdraw a citizen petition, as
described previously in this document,
which are subject to section 505(q) of
the FD&C Act and described in the
guidance.
We are requesting OMB approval for
the following collection of information
submitted to FDA under section 505(q)
of the FD&C Act and the guidance:
1. The certification required under
section 505(q)(1)(H) of the FD&C Act for
citizen petitions that are subject to
section 505(q) and/or that are
challenging the approvability of a
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60289
possible ANDA, section 505(b)(2)
application, or biosimilar biological
product application. Although the
submission of a certification for citizen
petitions is approved under OMB
control number 0910–0183, the
certification would be broadened under
section 505(q) of the FD&C Act and the
guidance.
2. The certification required under
section 505(q)(1)(H) of the FD&C Act for
petitions for stay of agency action that
are subject to section 505(q) and/or that
are challenging the approvability of a
possible ANDA, section 505(b)(2)
application, or biosimilar biological
product application.
3. The verification required under
section 505(q)(1)(I) of the FD&C Act for
comments to citizen petitions.
4. The verification required under
section 505(q)(1)(I) of the FD&C Act for
comments to petitions for stay of agency
action.
5. The verification required under
section 505(q)(1)(I) of the FD&C Act for
supplements to citizen petitions.
6. Supplements to petitions for stay of
agency action.
7. The verification required under
section 505(q)(1)(I) of the FD&C Act for
supplements to petitions for stay of
agency action.
8. The letter submitted by a petitioner
withdrawing a deficient petition for stay
of agency action that is missing the
required certification but is otherwise
within the scope of section 505(q) of the
FD&C Act.
Section 505(q)(1)(B) and (C) of the
FD&C Act and the guidance state that if
FDA determines that a delay in approval
of an ANDA, section 505(b)(2)
application, or biosimilar biological
product application is necessary based
on a petition subject to section 505(q),
the applicant may submit to the petition
docket clarifications or additional data
to allow FDA to review the petition
promptly. This information collection is
not included in this analysis because it
is approved under OMB control number
0910–0001.
Based on FDA’s knowledge of citizen
petitions and petitions for stay of agency
action subject to section 505(q) of the
FD&C Act that have been submitted to
FDA, as well as the Agency’s familiarity
with the time needed to prepare a
supplement, a certification, and a
verification, FDA estimates the burden
of this collection of information as
follows:
E:\FR\FM\01OCN1.SGM
01OCN1
60290
Federal Register / Vol. 78, No. 190 / Tuesday, October 1, 2013 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses
per respondent
Number of
respondents
Activity
Average
burden per
response
Total annual
responses
Total hours
Certification for citizen petitions (505(q)(1)(H)) ..............
Certification for petitions for stay of agency action
(505(q)(1)(H)).
Verification for comments to citizen petitions
(505(q)(1)(I)).
Verification for comments to petitions for stay of agency action (505(q)(1)(I)).
Verification for supplements to citizen petitions
(505(q)(1)(I)).
Supplements to petitions for stay of agency action .......
Verification for supplements to petitions for stay of
agency action (505(q)(1)(I)).
Letter withdrawing a petition for stay of agency action ..
26
1
1.15
1
32
1
0.5 (30 min.) ...
0.5 (30 min.) ...
16
.5
9
1.33
12
0.5 (30 min.) ...
6.0
1
1
1
0.5 (30 min.) ...
.5
7
1.43
10
0.5 (30 min.) ...
5.0
1
1
1
1
1
1
6 ......................
0.5 (30 min.) ...
6
0.5
1
1
1
0.5 (30 min.) ...
0.5
Total Hours ..............................................................
........................
........................
.........................
1 There
[FR Doc. 2013–23886 Filed 9–30–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0271]
Availability of Masked and Deidentified Non-Summary Safety and
Efficacy Data; Reopening of Comment
Period
Food and Drug Administration,
HHS.
ACTION:
Notice; reopening of comment
period.
The Food and Drug
Administration (FDA) is reopening the
comment period for the notice entitled
‘‘Availability of Masked and Deidentified Non-Summary Safety and
Efficacy Data; Request for Comments,’’
which appeared in the Federal Register
of June 4, 2013 (78 FR 33421). The
Agency is reopening the comment
period in response to requests for
additional time and to allow interested
persons more time to submit comments.
DATES: Submit either electronic or
written comments by October 31, 2013
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
comments 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
SUMMARY:
emcdonald on DSK67QTVN1PROD with NOTICES
35
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 26, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
AGENCY:
..........................
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14:45 Sep 30, 2013
Jkt 232001
docket number found in brackets at the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Nancy B. Sager, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., HILL–3110, Silver
Spring, MD 20993, 301–796–3603, FAX:
301–431–6351, Nancy.sager@
fda.hhs.gov; Stephen Ripley, Center for
Biologics Evaluation and Research
(HFM–17), Food and Drug
Administration, 1401 Rockville Pike,
Suite 200N, Rockville, MD 20852–1448,
301–827–6210; or Aaliyah EavesLeanos, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5435, 301–796–
2948, FAX: 301–847–8510,
Aaliyah.Eaves-Leanos@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 4, 2013
(78 FR 33421), FDA published a request
for public comments from interested
persons on the proposed availability of
de-identified and masked data derived
from medical product applications. In
that notice, FDA requested comments by
August 5, 2013, on the following topics:
(1) What factors should be considered in
masking study data (e.g., data fields
from regulatory submissions to remove
or modify, number of different products
to pool within a product class); (2) what
limitations, if any, should there be on
the Agency’s ability to make available
the masked data as described
previously; (3) are there any additional
factors FDA should consider in deidentifying data in addition to FDA’s
requirement to remove any names and
other information (e.g., birth date, death
date, local geographic information,
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contact information) that would identify
patients or research subjects before
disclosing information; (4) would
regulatory changes facilitate
implementation of such a proposal, and
if so, what changes would be most
useful; and (5) which situations do you
believe disclosing masked data would
be most useful to advance public
health?
The comment period was 60 days, but
the Agency has received requests for an
additional 30 days for submitting
comments. Each request conveyed
concern that the 60-day comment period
did not allow sufficient time to develop
a meaningful or thoughtful response.
FDA has considered the requests and
will reopen the comment period for an
additional 30 days, thus extending the
comment period to October 31, 2013.
The Agency believes that an additional
30 days allows adequate time for
interested persons to submit comments
without significantly delaying the
Agency’s consideration of these
important issues.
II. How To Submit Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
E:\FR\FM\01OCN1.SGM
01OCN1
]]>Agencies
[Federal Register Volume 78, Number 190 (Tuesday, October 1, 2013)]
[Notices]
[Pages 60288-60290]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-23886]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0008]
Agency Information Collection Activities: Proposed Collection;
Comment Request; Guidance for Industry on Citizen Petitions and
Petitions for Stay of Action Subject to Section 505(q) of the Federal
Food, Drug, and Cosmetic Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 information collection in
the guidance on citizen petitions and petitions for stay of action
subject to of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
DATES: Submit either electronic or written comments on the collection
of information by December 2, 2013.
ADDRESSES: Submit electronic comments on the collection of information
to https://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.
Guidance for Industry on Citizen Petitions and Petitions for Stay of
Action Subject to Section 505(q) of the Federal Food, Drug, and
Cosmetic Act--(OMB Control Number 0910-0679)--Extension
In the Federal Register of June 8, 2011(76 FR 33309), FDA announced
the availability of a guidance for industry entitled ``Citizen
Petitions and Petitions for Stay of Action Subject to Section 505(q) of
the Federal Food, Drug, and Cosmetic Act.'' The guidance provides
information regarding FDA's current thinking on interpreting section
914 of Title IX of the Food and Drug Administration Amendments Act
(FDAAA) (Pub. L. 110-85). Section 914 of FDAAA added new section 505(q)
to the FD&C Act (21 U.S.C. 355(q)) and governs certain citizen
petitions and petitions for stay of agency action that request that FDA
take any form of action related to a pending application submitted
under section 505(b)(2) or 505(j) (U.S.C. 355(b)(2) or U.S.C. 355(j))
of the FD&C Act. The guidance describes FDA's interpretation of section
505(q) of the FD&C Act regarding how the Agency will determine if: (1)
The provisions of section 505(q) addressing the treatment of citizen
petitions and petitions for stay of agency action (collectively,
petitions) apply to a particular petition and (2) a petition would
delay approval of a pending abbreviated new drug application (ANDA) or
a section 505(b)(2) application. The guidance also describes how FDA
will interpret the provisions of section 505(q) requiring that: (1) A
petition includes a certification and (2) supplemental information or
comments to a petition
[[Page 60289]]
include a verification. Finally, the guidance addresses the
relationship between the review of petitions and pending ANDAs and
section 505(b)(2) applications for which the Agency has not yet made a
decision on approvability.
The Food and Drug Administration Safety and Innovation Act (FDASIA)
was signed into law on July 9, 2012 (Pub. L. 112-144, 126 Stat. 993).
Section 1135 of FDASIA amended section 505(q) of the FD&C Act in two
ways. First, it shortened FDA's deadline from 180 days to 150 days for
responding to petitions subject to section 505(q) of the FD&C Act.
Second, it expanded the scope of section 505(q) of the FD&C Act to
include certain petitions concerning applications submitted under
section 351(k) of the Public Health Service Act (42 U.S.C. 262), the
abbreviated pathway for the approval of biosimilar biological products.
Accordingly, we are now including submissions pertaining to biosimilar
biological product applications in the information collection burden
estimates below.
Section 505(q)(1)(H) of the FD&C Act requires that citizen
petitions and petitions for stay of agency action that are subject to
section 505(q) include a certification to be considered for review by
FDA. Section 505(q)(1)(I) of the FD&C Act requires that supplemental
information or comments to such citizen petitions and petitions for
stay of agency action include a verification to be accepted for review
by FDA. The guidance sets forth the criteria the Agency will use in
determining if the provisions of section 505(q) of the FD&C Act apply
to a particular citizen petition or petition for stay of agency action.
The guidance states that one of the criteria for a citizen petition or
petition for stay of agency action to be subject to section 505(q) of
the FD&C Act is that a related ANDA or section 505(b)(2) application is
pending at the time the citizen petition or petition for stay is
submitted. Because petitioners or commenters may not be aware of the
existence of a pending ANDA or section 505(b)(2) application, the
guidance recommends that all petitioners challenging the approvability
of a possible ANDA or section 505(b)(2) application include the
certification required in section 505(q)(1)(H) of the FD&C Act and that
petitioners and commenters submitting supplements or comments,
respectively, to a citizen petition or petition for stay of action
challenging the approvability of a possible ANDA or section 505(b)(2)
application include the verification required in section 505(q)(1)(I)
of the FD&C Act. The guidance also recommends that if a petitioner
submits a citizen petition or petition for stay of agency action that
is missing the required certification but is otherwise within the scope
of section 505(q) of the FD&C Act and the petitioner would like FDA to
review the citizen petition or petition for stay of agency action, the
petitioner should submit a letter withdrawing the deficient petition
and submit a new petition that contains the required certification.
FDA currently has OMB approval for the collection of information
entitled ``General Administrative Procedures: Citizen Petitions;
Petition for Reconsideration or Stay of Action; Advisory Opinions''
(OMB control number 0910-0183). This collection of information
includes, among other things: (1) The format and procedures by which an
interested person may submit to FDA, in accordance with Sec. 10.20 (21
CFR 10.20), a citizen petition requesting the Commissioner of Food and
Drugs (Commissioner) to issue, amend, or revoke a regulation or order,
or to take or refrain from taking any other form of administrative
action (Sec. 10.30(b) (21 CFR 10.30(b))); (2) the submission of
written comments on a filed citizen petition (Sec. 10.30(d)); (3) the
submission of a supplement or amendment to or a letter to withdraw a
filed citizen petition (Sec. 10.30(g)); (4) the format and procedures
by which an interested person may request, in accordance with Sec.
10.20, the Commissioner to stay the effective date of any
administrative action (Sec. 10.35(b) (21 CFR 10.35(b))); and (5) the
submission of written comments on a filed petition for administrative
stay of action (Sec. 10.35(c)). This information collection includes
citizen petitions, petitions for administrative stay of action,
comments to petitions, supplements to citizen petitions, and letters to
withdraw a citizen petition, as described previously in this document,
which are subject to section 505(q) of the FD&C Act and described in
the guidance.
We are requesting OMB approval for the following collection of
information submitted to FDA under section 505(q) of the FD&C Act and
the guidance:
1. The certification required under section 505(q)(1)(H) of the
FD&C Act for citizen petitions that are subject to section 505(q) and/
or that are challenging the approvability of a possible ANDA, section
505(b)(2) application, or biosimilar biological product application.
Although the submission of a certification for citizen petitions is
approved under OMB control number 0910-0183, the certification would be
broadened under section 505(q) of the FD&C Act and the guidance.
2. The certification required under section 505(q)(1)(H) of the
FD&C Act for petitions for stay of agency action that are subject to
section 505(q) and/or that are challenging the approvability of a
possible ANDA, section 505(b)(2) application, or biosimilar biological
product application.
3. The verification required under section 505(q)(1)(I) of the FD&C
Act for comments to citizen petitions.
4. The verification required under section 505(q)(1)(I) of the FD&C
Act for comments to petitions for stay of agency action.
5. The verification required under section 505(q)(1)(I) of the FD&C
Act for supplements to citizen petitions.
6. Supplements to petitions for stay of agency action.
7. The verification required under section 505(q)(1)(I) of the FD&C
Act for supplements to petitions for stay of agency action.
8. The letter submitted by a petitioner withdrawing a deficient
petition for stay of agency action that is missing the required
certification but is otherwise within the scope of section 505(q) of
the FD&C Act.
Section 505(q)(1)(B) and (C) of the FD&C Act and the guidance state
that if FDA determines that a delay in approval of an ANDA, section
505(b)(2) application, or biosimilar biological product application is
necessary based on a petition subject to section 505(q), the applicant
may submit to the petition docket clarifications or additional data to
allow FDA to review the petition promptly. This information collection
is not included in this analysis because it is approved under OMB
control number 0910-0001.
Based on FDA's knowledge of citizen petitions and petitions for
stay of agency action subject to section 505(q) of the FD&C Act that
have been submitted to FDA, as well as the Agency's familiarity with
the time needed to prepare a supplement, a certification, and a
verification, FDA estimates the burden of this collection of
information as follows:
[[Page 60290]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Certification for citizen petitions 26 1.15 32 0.5 (30 min.)........................ 16
(505(q)(1)(H)).
Certification for petitions for stay of agency 1 1 1 0.5 (30 min.)........................ .5
action (505(q)(1)(H)).
Verification for comments to citizen petitions 9 1.33 12 0.5 (30 min.)........................ 6.0
(505(q)(1)(I)).
Verification for comments to petitions for stay 1 1 1 0.5 (30 min.)........................ .5
of agency action (505(q)(1)(I)).
Verification for supplements to citizen 7 1.43 10 0.5 (30 min.)........................ 5.0
petitions (505(q)(1)(I)).
Supplements to petitions for stay of agency 1 1 1 6.................................... 6
action.
Verification for supplements to petitions for 1 1 1 0.5 (30 min.)........................ 0.5
stay of agency action (505(q)(1)(I)).
Letter withdrawing a petition for stay of agency 1 1 1 0.5 (30 min.)........................ 0.5
action.
-------------------------------------------------------------------------------------------------------
Total Hours................................. .............. .............. .............. ..................................... 35
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 26, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-23886 Filed 9-30-13; 8:45 am]
BILLING CODE 4160-01-P
