Prescription Drug User Fee Act IV Information Technology Plan, 58020-58021 [2011-23923]
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Federal Register / Vol. 76, No. 181 / Monday, September 19, 2011 / Notices
up-to-date information on this meeting.
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previously announced advisory
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published quickly enough to provide
timely notice. Therefore, you should
always check the Agency’s Web site and
call the appropriate advisory committee
hot line/phone line to learn about
possible modifications before coming to
the meeting.
Agenda: On October 26, 2011, the
committee will discuss, make
recommendations, and vote on
information related to the premarket
approval application sponsored by
AtriCure, Inc., for the AtriCure Synergy
Ablation System to be used for the
treatment of atrial fibrillation in patients
who are undergoing open concomitant
cardiac surgery. The AtriCure Synergy
Ablation System consists of the
following:
• The AtriCure Isolator Synergy
Handpieces (models OLL2 and OSL2),
which resemble surgical clamps,
include a syringe-type grip handle/
actuator, connected by a cylindrical
shaft to a pair of grasping jaws with
electrodes on each jaw. The electrodes
deliver radiofrequency (RF) energy to
the tissue grasped by the jaws.
• The Ablation and Sensing Unit is
an RF generator used to power the
Isolator Synergy Handpieces.
• The Isolator Switch Matrix is an
accessory interface module allowing the
Isolator Synergy Handpieces to connect
to the RF generator.
On October 27, 2011, the committee
will discuss, make recommendations,
and vote on information related to the
premarket approval application for the
Medtronic Ablation Frontiers Cardiac
Ablation System sponsored by
Medtronic, Inc. The Medtronic Ablation
Frontiers Cardiac Ablation System is a
catheter-based device developed for the
treatment of atrial fibrillation. The
system consists of the following:
• The Pulmonary Vein Ablation
Catheter, which is designed to create
lesions in the left atrium via five pairs
of electrodes to isolate the pulmonary
veins. It has a deflectable distal end and
bidirectional steering to aid in
positioning the catheter appropriately.
• The Multi-Array Septal Catheter,
which is designed to create lesions on
the septal wall of the left atrium via six
pairs of electrodes. It is not steerable
and is intended to be used in a
transseptal approach.
• The Multi-Array Ablation Catheter,
which is designed to create ‘‘X’’-like
lesions in the left and/or right atrium
via four pairs of electrodes. It has a
deflectable distal segment and
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bidirectional steering within a single
plane.
• The GENius Multi-Channel RF
Ablation Generator.
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 link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before October 19, 2011.
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be scheduled between approximately 1
p.m. and 2 p.m. on October 26 and 27.
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formal oral presentations should notify
the contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before October 11, 2011. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
October 13, 2011.
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AdvisoryCommittees/
AboutAdvisoryCommittees/
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ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: September 13, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–23875 Filed 9–16–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0352]
Prescription Drug User Fee Act IV
Information Technology Plan
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of an updated information
technology (IT) plan entitled ‘‘PDUFA
IV Information Technology Plan’’
(updated plan) to achieve the objectives
defined in the Prescription Drug User
Fee Act (PDUFA) Performance Goals.
This plan is intended to provide
regulated industry and other
stakeholders with information on FDA’s
vision and plan for improving the
automation of business processes and
maintaining information systems that
support the process for the review of
human drug applications. The FDA is
publishing the updated plan for
comment to allow the public to provide
feedback as the Agency moves towards
a fully electronic standards-based
submission and review environment.
DATES: Submit electronic or written
comments on the updated plan by
November 3, 2011.
ADDRESSES: You may submit comments,
identified by Docket No. FDA–2008–N–
0352, by any of the following methods:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written submissions in the
following ways:
• Fax: 301–827–6870.
• Mail/Hand delivery/Courier (for
paper, disk, or CD–ROM submissions):
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Federal Register / Vol. 76, No. 181 / Monday, September 19, 2011 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
Instructions: All submissions received
must include the Agency name and
Docket No. FDA–2008–N–0352. All
comments received may be posted
without change to https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘Comments’’ heading
of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Alfred Kempski, Office of the PDUFA
Business Program Manager, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 1127,
Silver Spring, MD 20993–0002, 301–
796–1999.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
an updated IT plan entitled ‘‘PDUFA IV
Information Technology Plan.’’ This
plan will meet one of the performance
goals agreed to under the 2007
reauthorization of PDUFA IV (Title I of
the Food and Drug Administration
Amendments Act of 2007 (Pub. L. 110–
85)). Under section XIV of the PDUFA
Performance Goals, FDA agreed to
develop, periodically update, and
publish for comment an IT plan for
achieving the objectives defined in
section XIV, Information Technology
Goals, of the PDUFA Performance Goals
(see https://www.fda.gov/ForIndustry/
UserFees/PrescriptionDrugUserFee/
ucm119243.htm). This plan is intended
to provide regulated industry and other
stakeholders with information on FDA’s
vision and plan for improving the
automation of business processes and
maintaining information systems that
support the process for the review of
human drug applications, to achieve the
objectives defined in section XIV of the
PDUFA Performance Goals. The
objectives of the PDUFA IV IT Goals are
to move FDA towards the long-term goal
of an automated standards-based
information technology environment for
the exchange, review, and management
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of information supporting the process
for the review of human drug
applications throughout the product life
cycle.
In the Federal Register of June 30,
2008 (73 FR 36880), FDA issued a notice
announcing the availability of an earlier
version of the IT plan entitled
‘‘Prescription Drug User Fee Act
(PDUFA) IV Information Technology
Plan’’ (June 2008 plan). This updated
plan revises the June 2008 plan; it
communicates the progress and strategic
changes for key initiatives that illustrate
the accomplishment of near-term
objectives and describes FDA’s strategy
for meeting the long-term goal of a fully
electronic submission and review
environment. The sections that have
been revised are identified in the
Revision Index (after the Table of
Contents) in the updated plan.
FDA conducts an annual IT
assessment to measure performance
against the IT plan. The 2010 Annual IT
Assessment is available at https://
www.fda.gov/ForIndustry/UserFees/
PrescriptionDrugUserFee/
ucm183308.htm.
II. Electronic Access
Persons with access to the Internet
may obtain the updated plan at https://
www.regulations.gov.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed 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.
Dated: September 12, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–23923 Filed 9–16–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer at (301) 443–
0165.
Comments are invited on: (a) The
proposed collection of information for
the proper performance of the functions
of the Agency; (b) the accuracy of the
Agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
Proposed Project: Health Professions
Student Loan (HPSL) Program and
Nursing Student Loan (NSL) Program
Administrative Requirements
(Regulations and Policy) (OMB No.
0915–0047)—[Extension]
The regulations for the Health
Professions Student Loan (HPSL)
Program and Nursing Student Loan
(NSL) Program contain a number of
reporting and recordkeeping
requirements for schools and loan
applicants. The requirements are
essential for assuring that borrowers are
aware of rights and responsibilities,
know the history and status of each loan
account in order to pursue aggressive
collection efforts to reduce default rates,
and that they maintain adequate records
for audit and assessment purposes.
Schools are free to use improved
information technology to manage the
information required by the regulations.
The estimated total burden is 49,489
hours. The annualized burden estimates
are as follows:
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
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]]>Agencies
[Federal Register Volume 76, Number 181 (Monday, September 19, 2011)]
[Notices]
[Pages 58020-58021]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23923]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0352]
Prescription Drug User Fee Act IV Information Technology Plan
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of an updated information technology (IT) plan entitled
``PDUFA IV Information Technology Plan'' (updated plan) to achieve the
objectives defined in the Prescription Drug User Fee Act (PDUFA)
Performance Goals. This plan is intended to provide regulated industry
and other stakeholders with information on FDA's vision and plan for
improving the automation of business processes and maintaining
information systems that support the process for the review of human
drug applications. The FDA is publishing the updated plan for comment
to allow the public to provide feedback as the Agency moves towards a
fully electronic standards-based submission and review environment.
DATES: Submit electronic or written comments on the updated plan by
November 3, 2011.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2008-
N-0352, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
Fax: 301-827-6870.
Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions):
[[Page 58021]]
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Agency name
and Docket No. FDA-2008-N-0352. All comments received may be posted
without change to https://www.regulations.gov, including any personal
information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Alfred Kempski, Office of the PDUFA
Business Program Manager, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 1127, Silver Spring, MD 20993-0002, 301-
796-1999.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of an updated IT plan entitled
``PDUFA IV Information Technology Plan.'' This plan will meet one of
the performance goals agreed to under the 2007 reauthorization of PDUFA
IV (Title I of the Food and Drug Administration Amendments Act of 2007
(Pub. L. 110-85)). Under section XIV of the PDUFA Performance Goals,
FDA agreed to develop, periodically update, and publish for comment an
IT plan for achieving the objectives defined in section XIV,
Information Technology Goals, of the PDUFA Performance Goals (see
https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119243.htm). This plan is intended to provide regulated industry and
other stakeholders with information on FDA's vision and plan for
improving the automation of business processes and maintaining
information systems that support the process for the review of human
drug applications, to achieve the objectives defined in section XIV of
the PDUFA Performance Goals. The objectives of the PDUFA IV IT Goals
are to move FDA towards the long-term goal of an automated standards-
based information technology environment for the exchange, review, and
management of information supporting the process for the review of
human drug applications throughout the product life cycle.
In the Federal Register of June 30, 2008 (73 FR 36880), FDA issued
a notice announcing the availability of an earlier version of the IT
plan entitled ``Prescription Drug User Fee Act (PDUFA) IV Information
Technology Plan'' (June 2008 plan). This updated plan revises the June
2008 plan; it communicates the progress and strategic changes for key
initiatives that illustrate the accomplishment of near-term objectives
and describes FDA's strategy for meeting the long-term goal of a fully
electronic submission and review environment. The sections that have
been revised are identified in the Revision Index (after the Table of
Contents) in the updated plan.
FDA conducts an annual IT assessment to measure performance against
the IT plan. The 2010 Annual IT Assessment is available at https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm183308.htm.
II. Electronic Access
Persons with access to the Internet may obtain the updated plan at
https://www.regulations.gov.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed 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.
Dated: September 12, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-23923 Filed 9-16-11; 8:45 am]
BILLING CODE 4160-01-P
