Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act, 68787-68788 [2012-27881]
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Federal Register / Vol. 77, No. 222 / Friday, November 16, 2012 / Notices
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or email
your request, including your address,
phone number, OMB number, and CMS
document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received by the OMB desk officer at
the address below, no later than 5 p.m.
on December 17, 2012. OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
Number: (202) 395–6974, Email:
OIRA_submission@omb.eop.gov.
Dated: November 9, 2012.
Martique Jones,
Director, Regulations Development Group,
Division B, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2012–27841 Filed 11–15–12; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0164]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Draft Guidance for
Industry on Safety Labeling Changes;
Implementation of the Federal Food,
Drug, and Cosmetic Act
AGENCY:
Food and Drug Administration,
HHS.
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
SUMMARY:
68787
Act. FDA plans to request safety
labeling changes by sending a
notification letter to the application
holder. Under section 505(o)(4)(B) of the
FD&C Act (21 U.S.C. 355(o)(4)(B)), the
application holder must respond to
FDA’s notification by submitting a
labeling supplement or notifying FDA
that the applicant does not believe the
labeling change is warranted and
submitting a statement detailing the
reasons why the application holder does
not believe a change is warranted (a
rebuttal statement).
The submission of rebuttal statements
may result in the collection of
information that is not already approved
by OMB. Based on FDA’s experience
thus far with safety labeling changes
requirements under section 505(o)(4) of
the FD&C Act, FDA estimates that
approximately six application holders
will elect to submit approximately one
rebuttal statement each year and that
each rebuttal statement will take
approximately 6 hours to prepare.
In addition, in the draft guidance, the
Agency states that new labeling
prepared in response to a safety labeling
change notification should be available
on the application holder’s Web site
within 10 calendar days of approval,
which may result in the collection of
information that is not already approved
by OMB. FDA estimates that
approximately 197 application holders
will post new labeling one time each
year in response to a safety labeling
change notification and that the posting
of the labeling will take approximately
4 hours to prepare.
In the Federal Register of April 13,
2011 (76 FR 20686), FDA published a
60-day notice requesting public
comment on the draft version of this
guidance. None of the comments we
received pertained to the information
collection provisions.
FDA estimates the burden of the
collections of information that have not
already been approved by OMB is as
follows:
the Paperwork Reduction Act of 1995
(the PRA).
DATES: Fax written comments on the
collection of information by December
17, 2012.
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–NEW and
title ‘‘Draft Guidance for Industry on
Safety Labeling Changes;
Implementation of Section 505(o)(4) of
the Federal Food, Drug, and Cosmetic
Act.’’ Also include the FDA docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
7726, Ila.Mizrachi@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.
Draft Guidance for Industry on Safety
Labeling Changes; Implementation of
Section 505(o)(4) of the Federal Food,
Drug, and Cosmetic Act—(OMB Control
Number 0910-New)
This draft guidance provides
information on the implementation of
section 901 of the Food and Drug
Administration Amendments Act of
2007, which authorizes FDA to require
certain drug and biological product
application holders to make safety
related labeling changes based upon
new safety information that becomes
available after the drug or biological
product is approved under the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) or the Public Health Service
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
6
1
6
6
36
mstockstill on DSK4VPTVN1PROD with NOTICES
Rebuttal statement ...........................................
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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15:43 Nov 15, 2012
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68788
Federal Register / Vol. 77, No. 222 / Friday, November 16, 2012 / Notices
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Type of submission
Number of
respondents
Annual frequency
per disclosure
Total annual
disclosures
Hours per
disclosure
Total hours
Post approved labeling on application holder’s
Web site .......................................................
197
1
197
4
788
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
This draft guidance also refers to
previously approved collections of
information. Specifically, the draft
guidance describes: Labeling
supplements for new drug applications,
abbreviated new drug applications, and
biologics license applications submitted
under 21 CFR 314.70, 314.71, 314.97,
and 601.12, and the content and format
of prescription drug labeling submitted
under 21 CFR 201.56 and 201.57. These
collections of information are subject to
review by OMB under the PRA and are
approved under OMB control numbers
0910–0001, 0910–0338, and 0910–0572.
Section V of the draft guidance refers to
the guidance entitled ‘‘Formal Dispute
Resolution: Appeals Above the Division
Level,’’ which describes collections of
information approved under OMB
control number 0910–0430.
Dated: November 9, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–27881 Filed 11–15–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Neurological Devices Panel of the
Medical Devices Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public. This meeting is being
rescheduled due to the postponement of
the November 1, 2012, meeting due to
unanticipated weather conditions
caused by hurricane Sandy.
Name of Committee: Neurological
Devices Panel of the Medical Devices
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
VerDate Mar<15>2010
15:43 Nov 15, 2012
Jkt 229001
Date and Time: The meeting will be
held on December 10, 2012, from 8 a.m.
to 6 p.m.
Location: Hilton Washington DC
North/Gaithersburg, 620 Perry Pkwy.,
Grand Ballroom, Gaithersburg, MD
20877. The hotel’s telephone number is
301–977–8900.
Contact Person: Natasha Facey, Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm.
1544, Silver Spring, MD 20993–0002,
301–796–5290,
Natasha.Facey@fda.hhs.gov or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: On December 10, 2012, the
committee will discuss current
knowledge about the safety and
effectiveness of the CoAxia NeuroFlo
Catheter device for the intended use of
diverting cardiac output to the cerebral
vasculature via partial occlusion of the
descending aorta, including in patients
with acute ischemic stroke within 14
hours of symptom onset.
The CoAxia NeuroFlo Catheter is a 7F
multilumen device with two balloons
mounted near the distal tip. The
proximal end has a multiport manifold
that provides access for the guidewire,
monitoring of blood pressure, and
independent inflation of the individual
balloons. The device is placed in the
descending aorta. On March 30, 2005, a
humanitarian device exemption
application for the CoAxia NeuroFlo
Catheter was approved for the following
indication for use: The CoAxia
NeuroFlo Catheter is intended for the
treatment of cerebral ischemia resulting
from symptomatic vasospasm following
aneurismal subarachnoid hemorrhage,
PO 00000
Frm 00058
Fmt 4703
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secured by either surgical or
endovascular intervention for patients
who have failed maximal medical
management.
Of note, the CoAxia NeuroFlo
Catheter is identical in design to the
CoAxia FloControl, which is currently
cleared for the following general
indications for use:
1. The CoAxia FloControl Catheter is
intended for use in selectively stopping
or controlling flow in the peripheral
vasculature (K023914).
2. The CoAxia FloControl Catheter is
intended for use in selectively stopping
or controlling flow in the peripheral
vasculature, which includes the
descending aorta (K090970).
CoAxia has submitted a de novo
application for the NeuroFlo for the
following indication: The CoAxia
NeuroFlo Catheter is intended for use in
diversion of cardiac output via partial
occlusion of the descending aorta,
including patients with acute ischemic
stroke within 14 hours of symptom
onset. The CoAxia NeuroFlo Catheter is
also intended for use in selectively
stopping or controlling blood flow in
the peripheral vasculature, which
includes the descending aorta.
FDA is convening this committee to
seek expert scientific and clinical
opinion on the risks and benefits of this
device based on the available premarket
and postmarket data. In particular, the
committee will be asked to discuss the
safety and effectiveness data from the
‘‘Safety and Efficacy of NeuroFlo
Technology in Ischemic Stroke’’
(SENTIS) clinical trial as they relate to
the proposed indications for use.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
E:\FR\FM\16NON1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 222 (Friday, November 16, 2012)]
[Notices]
[Pages 68787-68788]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27881]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0164]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Draft Guidance for
Industry on Safety Labeling Changes; Implementation 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 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 (the PRA).
DATES: Fax written comments on the collection of information by
December 17, 2012.
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-NEW and
title ``Draft Guidance for Industry on Safety Labeling Changes;
Implementation of Section 505(o)(4) of the Federal Food, Drug, and
Cosmetic Act.'' Also include the FDA docket number found in brackets in
the heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-7726, Ila.Mizrachi@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.
Draft Guidance for Industry on Safety Labeling Changes; Implementation
of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act--(OMB
Control Number 0910-New)
This draft guidance provides information on the implementation of
section 901 of the Food and Drug Administration Amendments Act of 2007,
which authorizes FDA to require certain drug and biological product
application holders to make safety related labeling changes based upon
new safety information that becomes available after the drug or
biological product is approved under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) or the Public Health Service Act. FDA plans
to request safety labeling changes by sending a notification letter to
the application holder. Under section 505(o)(4)(B) of the FD&C Act (21
U.S.C. 355(o)(4)(B)), the application holder must respond to FDA's
notification by submitting a labeling supplement or notifying FDA that
the applicant does not believe the labeling change is warranted and
submitting a statement detailing the reasons why the application holder
does not believe a change is warranted (a rebuttal statement).
The submission of rebuttal statements may result in the collection
of information that is not already approved by OMB. Based on FDA's
experience thus far with safety labeling changes requirements under
section 505(o)(4) of the FD&C Act, FDA estimates that approximately six
application holders will elect to submit approximately one rebuttal
statement each year and that each rebuttal statement will take
approximately 6 hours to prepare.
In addition, in the draft guidance, the Agency states that new
labeling prepared in response to a safety labeling change notification
should be available on the application holder's Web site within 10
calendar days of approval, which may result in the collection of
information that is not already approved by OMB. FDA estimates that
approximately 197 application holders will post new labeling one time
each year in response to a safety labeling change notification and that
the posting of the labeling will take approximately 4 hours to prepare.
In the Federal Register of April 13, 2011 (76 FR 20686), FDA
published a 60-day notice requesting public comment on the draft
version of this guidance. None of the comments we received pertained to
the information collection provisions.
FDA estimates the burden of the collections of information that
have not already been approved by OMB is as follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Rebuttal statement....................................... 6 1 6 6 36
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 68788]]
Table 2--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Annual frequency Total annual Hours per
Type of submission respondents per disclosure disclosures disclosure Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Post approved labeling on application holder's Web site.. 197 1 197 4 788
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
This draft guidance also refers to previously approved collections
of information. Specifically, the draft guidance describes: Labeling
supplements for new drug applications, abbreviated new drug
applications, and biologics license applications submitted under 21 CFR
314.70, 314.71, 314.97, and 601.12, and the content and format of
prescription drug labeling submitted under 21 CFR 201.56 and 201.57.
These collections of information are subject to review by OMB under the
PRA and are approved under OMB control numbers 0910-0001, 0910-0338,
and 0910-0572. Section V of the draft guidance refers to the guidance
entitled ``Formal Dispute Resolution: Appeals Above the Division
Level,'' which describes collections of information approved under OMB
control number 0910-0430.
Dated: November 9, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-27881 Filed 11-15-12; 8:45 am]
BILLING CODE 4160-01-P
