Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 71983-71984 [2011-29890]
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Federal Register / Vol. 76, No. 224 / Monday, November 21, 2011 / Notices
MD 20993–0002, (301) 796–6218, email:
raquel.peat@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of August 8,
2011, FDA published a notice
announcing a public meeting for the
‘‘Advancing Regulatory Science for
Highly Multiplexed Microbiology/
Medical Countermeasure Devices,’’ and
opening of a public docket to seek input
and comments from interested
stakeholders to discuss the concept
paper 1 for FDA’s proposed evaluation
approach for assessing the performance
of highly multiplexed microbiology/
MCM devices, including the following
topics:
1. Clinical Application of Highly
Multiplexed Microbiology Devices: Their
clinical application and public health/
clinical needs; inclusion of MCMrelated pathogens that are expected to
be rarely present in the tested
specimens; the composition of clinically
relevant panels of pathogens; the
interpretation of the test results taking
into consideration the possible
detection of microorganisms that are not
clinically relevant, and what is known
and unknown about co-infections.
2. Device Evaluation: How to evaluate
the analytical and clinical performance
of highly multiplexed microbiology
devices; approaches to device validation
when positive specimens are not easily
available, which is the case for many
MCM pathogens; the sufficiency,
feasibility, and practicality of the
proposed FDA evaluation approach to
establish device performance.
3. Reference Databases: Quality
criteria for establishing the accuracy of
reference databases; methods for
curating, maintaining, and updating
these databases; what is the current
practice for creating and maintaining
reference databases.
In the Federal Register notice of
August 8, 2011, interested persons were
originally given until September 13,
2011, to submit comments.
emcdonald on DSK5VPTVN1PROD with NOTICES
II. Request for Comments
Following publication of the August
8, 2011, Federal Register notice and
posting of the concept paper, FDA
received requests to allow interested
persons additional time to comment.
The Agency has considered the requests
and is reopening the comment period
until December 21, 2011.
1 This concept paper may be found at https://www.
fda.gov/MedicalDevices/NewsEvents/Workshops
Conferences/ucm267410.htm.
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16:00 Nov 18, 2011
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III. How To Submit 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. In addition,
when responding to specific questions
as outlined in Section I of this
document, please identify the question
you are addressing. Received comments
may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: November 15, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–29937 Filed 11–18–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Gastroenterology and Urology Devices
Panel of the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
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.
Name of Committee: Gastroenterology
and Urology 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.
Date and Time: The meeting will be
held on January 11, 2012, from 8 a.m.
to 6 p.m.
Location: Hilton Washington DC
North/Gaithersburg, salons A, B, C, and
D, 620 Perry Pkwy., Gaithersburg, MD
20877. The hotel’s telephone number is
(301) 977–8900.
Contact Person: Avena Russell, Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm.
1535, Silver Spring, MD 20993–0002,
Avena.Russell@fda.hhs.gov, (301) 796–
3805, or FDA Advisory Committee
Information Line, 1–(800) 741–8138
(301) 443–0572 in the Washington, DC
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
71983
area), and follow the prompts to the
desired center or product area. Please
call the Information Line for up-to-date
information on this meeting. 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 and call the
appropriate advisory committee hot
line/phone line to learn about possible
modifications before coming to the
meeting.
Agenda: On January 11, 2012, the
committee will discuss, make
recommendations, and vote on
information related to the premarket
approval application, sponsored by
Torax Medical, Inc., for the LINX Reflux
Management System, a sterile, single
use, surgically placed device used to
treat the symptoms associated with
gastroesophageal reflux disease.
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 December 30, 2011.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making 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
December 22, 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 December 23, 2011.
E:\FR\FM\21NON1.SGM
21NON1
71984
Federal Register / Vol. 76, No. 224 / Monday, November 21, 2011 / Notices
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact James Clark,
at James.Clark@fda.hhs.gov or (301)
796–5293, at least 7 days in advance of
the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
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: November 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–29890 Filed 11–18–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, email
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer at (301) 443–
0165.
The following request has been
submitted to the Office of Management
and Budget for review under the
Paperwork Reduction Act of 1995.
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 49,487
hours. The burden estimates are as
follows:
RECORDKEEPING REQUIREMENTS
Number of
record-keepers
Regulatory/section requirements
Hours per year
Total burden
hours
HPSL Program:
57.206(b)(2), Documentation of Cost of Attendance .............................................
57.208(a), Promissory Note ...................................................................................
57.210(b)(1)(i), Documentation of Entrance Interview ...........................................
57.210(b)(1)(ii), Documentation of Exit Interview ...................................................
57.215(a) & (d), Program Records .........................................................................
57.215(b), Student Records ...................................................................................
57.215(c), Repayment Records .............................................................................
435
435
435
* 477
* 477
* 477
* 477
1.17
1.25
1.25
0.33
10
10
18.75
509
544
544
157
4,770
4,770
8,944
HPSL Subtotal .................................................................................................
............................
..............................
20,238
NSL Program:
57.306(b)(2)(ii), Documentation of Cost of Attendance .........................................
57.308(a), Promissory Note ...................................................................................
57.310(b)(1)(i), Documentation of Entrance Interview ...........................................
57.310(b)(1)(ii), Documentation of Exit Interview ...................................................
57.315(a)(1) & (a)(4), Program Records ................................................................
57.315(a)(2), Student Records ...............................................................................
57.215(b)(3), Repayment Records .........................................................................
304
304
304
* 486
* 486
* 486
* 486
0.3
0.5
0.5
0.17
5
1
2.51
91
152
152
83
2,430
486
1,220
NSL Subtotal ...................................................................................................
............................
..............................
4,614
* Includes active and closing schools.
HPSL data include active and closing Loans for Disadvantaged Students (LDS) program schools.
emcdonald on DSK5VPTVN1PROD with NOTICES
REPORTING REQUIREMENTS
Number of
respondents
Regulatory/Section requirements
HPSL:
57.206(a)(2), Student Financial Aid Transcript ........
57.208(c), Loan Information Disclosure ...................
57.210(b)(1)(i), Entrance Interview ...........................
57.210(b)(1)(ii), Exit Interview ..................................
57.210(b)(1)(iii), Notification of Repayment ..............
VerDate Mar<15>2010
16:00 Nov 18, 2011
Jkt 226001
PO 00000
Frm 00053
Responses per
respondent
4,600
435
435
* 477
* 477
Fmt 4703
1
68.73
68.73
12
30.83
Sfmt 4703
Total annual
responses
4,600
29,898
29,898
5,724
14,706
E:\FR\FM\21NON1.SGM
21NON1
Hours per
response
0.25
0.0833
0.167
0.5
0.167
Total burden
hours
1,150
2,490
4,993
2,862
2,456
]]>Agencies
[Federal Register Volume 76, Number 224 (Monday, November 21, 2011)]
[Notices]
[Pages 71983-71984]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-29890]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Gastroenterology and Urology Devices Panel of the Medical Devices
Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
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.
Name of Committee: Gastroenterology and Urology 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.
Date and Time: The meeting will be held on January 11, 2012, from 8
a.m. to 6 p.m.
Location: Hilton Washington DC North/Gaithersburg, salons A, B, C,
and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone
number is (301) 977-8900.
Contact Person: Avena Russell, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 1535, Silver Spring, MD 20993-0002, Avena.Russell@fda.hhs.gov,
(301) 796-3805, or FDA Advisory Committee Information Line, 1-(800)
741-8138 (301) 443-0572 in the Washington, DC area), and follow the
prompts to the desired center or product area. Please call the
Information Line for up-to-date information on this meeting. 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 and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
Agenda: On January 11, 2012, the committee will discuss, make
recommendations, and vote on information related to the premarket
approval application, sponsored by Torax Medical, Inc., for the LINX
Reflux Management System, a sterile, single use, surgically placed
device used to treat the symptoms associated with gastroesophageal
reflux disease.
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
December 30, 2011. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those individuals interested in
making 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 December 22, 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 December 23, 2011.
[[Page 71984]]
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact James Clark, at
James.Clark@fda.hhs.gov or (301) 796-5293, at least 7 days in advance
of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/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: November 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-29890 Filed 11-18-11; 8:45 am]
BILLING CODE 4160-01-P
