Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Citizen Petitions and Petitions for Stay of Action Subject to the Federal Food, Drug, and Cosmetic Act, 13656-13658 [2014-05190]
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13656
Federal Register / Vol. 79, No. 47 / Tuesday, March 11, 2014 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Information Comparison with
Insurance Data
OMB No.: 0970–0342
Description: The Deficit Reduction
Act of 2005 amended Section 452 of the
Social Security Act (the Act) to
authorize the Secretary, through the
Federal Parent Locator Service (FPLS),
to conduct comparisons of information
concerning individuals owing past-due
child support with information
maintained by insurers (or their agents)
concerning insurance claims,
settlements, awards, and payments.
Public Law 109–171, § 7306.
The insurer may choose to conduct
the data comparison by either of the
following methods. Under the first
method, an insurer or the insurer’s agent
will submit to OCSE information
concerning claims, settlements, awards,
and payments. OCSE will then compare
that information with information
pertaining to individuals owing pastdue support.
Under the second method, OCSE will
send to the insurer or the insurer’s agent
a file containing information pertaining
to individuals owing past-due support.
The insurer or the insurer’s agent will
compare that information with
information pertaining to claims,
settlements, awards, and payments. The
insurer will then send the information
resulting from the comparison to OCSE.
On a daily basis, OCSE will send the
results of a comparison to the state
agencies responsible for collecting child
support from the individuals by
transmitting the Insurance Match
Response Record. The results of the
comparison will be used by the State
agencies to collect from the insurance
proceeds past-due child support owed
by the individuals.
This information collection is
authorized by: (1) 42 U.S.C. 652(a)(9)
which requires the federal Office of
Child Support Enforcement (OCSE) to
operate the FPLS established by 42
U.S.C. 653(a)(1); 42 U.S.C. 652(l) (to be
redesignated (m)) which authorizes
OCSE, through the FPLS to compare
information concerning individuals
owing past-due support with
information maintained by insurers (or
their agents) concerning insurance
claims, settlements, awards, and
payments, and to furnish information
resulting from the data matches to the
state child support agencies responsible
for collecting child support from the
individuals.
Respondents: Insurers or their agents,
including the U.S. Department of Labor
and state agencies administering
workers’ compensation programs, and
the Insurance Services Office (ISO).
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden
hours per
response
Total
burden hours
Insurance Match File .......................................................................................
22
12
0.50
132
emcdonald on DSK67QTVN1PROD with NOTICES
Estimated Total Annual Burden Hours: 132.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
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collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2014–05195 Filed 3–10–14; 8:45 am]
BILLING CODE 4184–01–P
ACTION:
Notice.
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 April 10,
2014.
SUMMARY:
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 0910–0679. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0008]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on Citizen Petitions and
Petitions for Stay of Action Subject to
the Federal Food, Drug, and Cosmetic
Act
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00047
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FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
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Federal Register / Vol. 79, No. 47 / Tuesday, March 11, 2014 / Notices
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
emcdonald on DSK67QTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
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) (21 U.S.C. 355(b)(2) or 21 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
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
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Jkt 232001
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 in this
document.
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
PO 00000
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13657
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
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.
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Federal Register / Vol. 79, No. 47 / Tuesday, March 11, 2014 / Notices
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.
In the Federal Register of October 1,
2013 (78 FR 60288), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received that pertained to the
information collection analysis.
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:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Activity
Total
annual
responses
Average
burden per
response
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
1.15
32
0.5 (30 min.)
16
1
9
1
1.33
1
12
0.5 (30 min.)
0.5 (30 min.)
0.5
6
1
1
1
0.5 (30 min.)
0.5
7
1
1.43
1
10
1
0.5 (30 min.)
6
5
6
1
1
1
1
1
1
0.5 (30 min.)
0.5 (30 min.)
0.5
0.5
Total Hours ...................................................................
........................
35
........................
........................
........................
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
treatment of chronic fatigue syndrome/
myalgic encephalomyelitis (CFS/ME).
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by May 12, 2014.
DATES:
[FR Doc. 2014–05190 Filed 3–10–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Draft Guidance for Industry on Chronic
Fatigue Syndrome/Myalgic
Encephalomyelitis: Developing Drug
Products for Treatment; Availability
AGENCY:
Food and Drug Administration,
HHS.
emcdonald on DSK67QTVN1PROD with NOTICES
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Chronic Fatigue
Syndrome/Myalgic Encephalomyelitis:
Developing Drug Products for
Treatment.’’ The purpose of this draft
guidance is to assist sponsors in the
development of drug products for the
SUMMARY:
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Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance 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.
ADDRESSES:
[Docket No. FDA–2014–D–0264]
PO 00000
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FOR FURTHER INFORMATION CONTACT:
Janet Maynard, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 3185,
Silver Spring, MD 20993–0002, 301–
796–2300.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Chronic Fatigue Syndrome/Myalgic
Encephalomyelitis: Developing Drug
Products for Treatment.’’ The purpose of
this draft guidance is to assist sponsors
in the development of drug products for
the treatment of CFS/ME.
Currently, there are no approved
therapies indicated to treat CFS/ME.
The lack of approved therapies
indicated for the treatment of CFS/ME
represents a public health concern. To
foster drug development in CFS/ME,
this draft guidance outlines the
following key issues in drug
development in CFS/ME:
• The case definitions or criteria for
CFS/ME that could be used to define a
patient population in the context of
drug development
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]]>Agencies
[Federal Register Volume 79, Number 47 (Tuesday, March 11, 2014)]
[Notices]
[Pages 13656-13658]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-05190]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0008]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
on Citizen Petitions and Petitions for Stay of Action Subject to the
Federal Food, Drug, and Cosmetic Act
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 April
10, 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 0910-0679.
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, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, PRAStaff@fda.hhs.gov.
[[Page 13657]]
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.
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) (21 U.S.C. 355(b)(2) or 21 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 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 in this document.
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.
[[Page 13658]]
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.
In the Federal Register of October 1, 2013 (78 FR 60288), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received that pertained to
the information collection analysis.
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:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average
Activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Certification for citizen petitions (505(q)(1)(H))...................... 26 1.15 32 0.5 (30 min.) 16
Certification for petitions for stay of agency action (505(q)(1)(H)).... 1 1 1 0.5 (30 min.) 0.5
Verification for comments to citizen petitions (505(q)(1)(I))........... 9 1.33 12 0.5 (30 min.) 6
Verification for comments to petitions for stay of agency action 1 1 1 0.5 (30 min.) 0.5
(505(q)(1)(I)).........................................................
Verification for supplements to citizen petitions (505(q)(1)(I))........ 7 1.43 10 0.5 (30 min.) 5
Supplements to petitions for stay of agency action...................... 1 1 1 6 6
Verification for supplements to petitions for stay of agency action 1 1 1 0.5 (30 min.) 0.5
(505(q)(1)(I)).........................................................
Letter withdrawing a petition for stay of agency action................. 1 1 1 0.5 (30 min.) 0.5
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Total Hours......................................................... .............. 35 .............. .............. ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-05190 Filed 3-10-14; 8:45 am]
BILLING CODE 4160-01-P
