Submission for OMB Review; 30-Day Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (NCI), 32965-32966 [2014-13411]
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Federal Register / Vol. 79, No. 110 / Monday, June 9, 2014 / Notices
(including the use of containment bags)
for these devices.
On July 11, 2014, during the afternoon
session, the committee will also be
asked to discuss the regulatory
classification of laparoscopic power
morcellator devices when used to cut
and extract tissue during gynecologic
laparoscopic procedures and to assist
FDA in determining the appropriate
level of regulatory control necessary for
this device type, including discussion of
class II (special controls) or
reclassification to class III (subject to
premarket approval application (PMA)).
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.
The Center for Devices and
Radiological Health (CDRH) plans to
provide a live webcast of the July 10 and
11, 2014, meeting of the Obstetrics and
Gynecology Devices Panel of the
Medical Devices Advisory Committee.
While CDRH is working to make
webcasts available to the public for all
advisory committee meetings held at the
White Oak campus, there are instances
where the webcast transmission is not
successful; staff will work to reestablish
the transmission as soon as possible.
The link for the webcast is available at:
https://colaboration.fda.gov/obgyd/, or
further information regarding the
webcast, including the Web address for
the webcast, will be made available at
least 2 days in advance of the meeting
at the following Web site: https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/
MedicalDevices/
MedicalDevicesAdvisoryCommittee/
ObstetricsandGynecologyDevices/
default.htm. Select the link for 2014
Meeting Materials.
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 June 24, 2014. Oral
presentations from the public will be
scheduled between approximately 9
a.m. and 10 a.m. for both days of this
meeting. Those individuals interested in
making formal oral presentations should
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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 June 16, 2014. 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 June 19, 2014.
FDA will work with the
manufacturers of laparoscopic
morcellators and containment bags who
wish to make presentations to ensure
that adequate time, separate from the
approximate time slots for the general
open public hearing session, is
provided. Manufacturers interested in
making formal presentations to the
committee should notify the contact
person on or before June 18, 2014.
Manufacturers with common interests
are urged to coordinate their oral
presentations.
FDA is opening a docket for public
comment on this document. The docket
number is FDA–2014–N–0736. The
docket will close on August 11, 2014.
Interested persons are encouraged to use
the docket to submit electronic or
written comments regarding this
meeting. Submit electronic comments to
https://www.regulations.gov. Comments
received on or before July 1, 2014, will
be provided to the committee for their
consideration. Comments received after
July 1, 2014, will be taken into
consideration by the Agency.
Submit written comments to the
Division of Dockets Management, Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852. It
is only necessary to send one set of
comments. Comments are to be
identified with the docket number
found in brackets in the heading of this
document. Received comments may be
seen in the Divisions 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.
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
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32965
require special accommodations due to
a disability, please contact AnnMarie
Williams, at Annmarie.Williams@
fda.hhs.gov, or 301–796–5966, 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: June 3, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–13290 Filed 6–6–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; Generic Clearance
for the Collection of Qualitative
Feedback on Agency Service Delivery
(NCI)
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH), has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on March 18, 2014,
Vol. #79, page 15133 and allowed 60days for public comment. No public
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment. The
National Cancer Institute (NCI),
National Institutes of Health, may not
conduct or sponsor, and the respondent
is not required to respond to, an
information collection that has been
extended, revised, or implemented on or
after October 1, 1995, unless it displays
a currently valid OMB control number.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: NIH Desk Officer.
SUMMARY:
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32966
Federal Register / Vol. 79, No. 110 / Monday, June 9, 2014 / Notices
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments or request more
information on the proposed project
contact: Vivian Horovitch-Kelley, Office
of Management Policy and Compliance,
National Cancer Institute, 9609 Medical
Center Drive, Bethesda, MD 20892–9760
or call non-toll-free number 240–276–
6850 or Email your request including
your address to: horovitchkellv@
mail.nih.gov. Formal requests for
additional plans and instruments must
be requested in writing.
and expectations, provide an early
warning of issues with service, or focus
attention on areas where
communication, training or changes in
operations might improve delivery of
products or services. It will also allow
feedback to contribute directly to the
improvement of program management.
Feedback collected under this generic
clearance will provide useful
information but it will not yield data
that can be generalized to the overall
population.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated burden hours are 8,750.
Proposed Collection: Generic
Clearance for the Collection of
Qualitative Feedback on Agency Service
Delivery (NCI), 0925–0642, Expiration
Date 9/31/2014, Extension, National
Cancer Institute (NCI), National
Institutes of Health (NIH).
Need and Use of Information
Collection: There are no changes being
requested for this submission. The
information collection activity will
garner qualitative customer and
stakeholder feedback in an efficient,
timely manner, in accordance with the
Administration’s commitment to
improving service delivery. This generic
will provide information about the
National Cancer Institute’s customer or
stakeholder perceptions, experiences
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of collection
Surveys ............................................................................................................
In-Depth Interviews (IDIs) or Small Discussion Groups ..................................
Focus Groups ..................................................................................................
Website or Software Usability Tests ................................................................
Dated: May 27, 2014.
Karla Bailey,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2014–13411 Filed 6–6–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
ehiers on DSK2VPTVN1PROD with NOTICES
National Library of Medicine; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App), notice is
hereby given of the meetings.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable materials,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Biomedical Library
and Informatics Review Committee.
Date: November 6–7, 2014.
Time: November 6, 2014, 8 a.m. to 6 p.m.
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Number of
responses per
respondent
1000
500
2000
3000
Agenda: To review and evaluate grant
applications.
Place: National Library of Medicine,
Building 38, 2nd Floor, Board Room, 8600
Rockville Pike, Bethesda, MD 20892.
Time: November 7, 2014, 8 a.m. to 2 p.m.
Agenda: To review and evaluate grant
applications.
Contact Person: Arthur A. Petrosian, Ph.D.,
Chief Scientific Review Officer, Division of
Extramural Programs, National Library of
Medicine, 6705 Rockledge Drive, Suite 301,
Bethesda, MD 20892–7968, 301–496–4253,
petrosia@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.879, Medical Library
Assistance, National Institutes of Health,
HHS)
Dated: June 3, 2014.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–13328 Filed 6–6–14; 8:45 am]
BILLING CODE 4140–01–P
Average
burden per
response
(in hours)
1
1
1
1
Total burden
hours
30/60
90/60
90/60
90/60
500
750
3,000
4,500
Institutes of Health, Building 31, C
Wing, 6th Floor, 31 Center Drive,
Conference Room 10, Bethesda, MD
20892 which was published in the
Federal Register on May 7, 2014, 79 FR
26259.
The meeting notice is being amended
to cancel the Subcommittee meeting on
Planning and Budget on June 22, 2014.
The meeting notice is also being
amended to change the following open
and closed session times of the Joint
Board meeting. On June 23, 2014, the
open session will be from 8:30 a.m. to
6 p.m. On June 24, 2014, the open
session will be from 8:30 a.m. to 10:45
a.m. and the closed session will be from
10:45 a.m. to 12 p.m. The meeting is
partially closed to the public.
Dated: June 3, 2014.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–13330 Filed 6–6–14; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4140–01–P
National Institutes of Health
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Cancer Institute; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Cancer
Advisory Board and NCI Board of
Scientific Advisors, June 22, 2014, 4
p.m. to June 24, 2014, 12 p.m., National
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National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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]]>Agencies
[Federal Register Volume 79, Number 110 (Monday, June 9, 2014)]
[Notices]
[Pages 32965-32966]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-13411]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request; Generic
Clearance for the Collection of Qualitative Feedback on Agency Service
Delivery (NCI)
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institutes of Health (NIH), has
submitted to the Office of Management and Budget (OMB) a request for
review and approval of the information collection listed below. This
proposed information collection was previously published in the Federal
Register on March 18, 2014, Vol. 79, page 15133 and allowed
60-days for public comment. No public comments were received. The
purpose of this notice is to allow an additional 30 days for public
comment. The National Cancer Institute (NCI), National Institutes of
Health, may not conduct or sponsor, and the respondent is not required
to respond to, an information collection that has been extended,
revised, or implemented on or after October 1, 1995, unless it displays
a currently valid OMB control number.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974,
Attention: NIH Desk Officer.
[[Page 32966]]
Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30-days
of the date of this publication.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments or request more information on the
proposed project contact: Vivian Horovitch-Kelley, Office of Management
Policy and Compliance, National Cancer Institute, 9609 Medical Center
Drive, Bethesda, MD 20892-9760 or call non-toll-free number 240-276-
6850 or Email your request including your address to:
horovitchkellv@mail.nih.gov. Formal requests for additional plans and
instruments must be requested in writing.
Proposed Collection: Generic Clearance for the Collection of
Qualitative Feedback on Agency Service Delivery (NCI), 0925-0642,
Expiration Date 9/31/2014, Extension, National Cancer Institute (NCI),
National Institutes of Health (NIH).
Need and Use of Information Collection: There are no changes being
requested for this submission. The information collection activity will
garner qualitative customer and stakeholder feedback in an efficient,
timely manner, in accordance with the Administration's commitment to
improving service delivery. This generic will provide information about
the National Cancer Institute's customer or stakeholder perceptions,
experiences and expectations, provide an early warning of issues with
service, or focus attention on areas where communication, training or
changes in operations might improve delivery of products or services.
It will also allow feedback to contribute directly to the improvement
of program management. Feedback collected under this generic clearance
will provide useful information but it will not yield data that can be
generalized to the overall population.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated burden hours are
8,750.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Type of collection respondents responses per response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Surveys......................................... 1000 1 30/60 500
In-Depth Interviews (IDIs) or Small Discussion 500 1 90/60 750
Groups.........................................
Focus Groups.................................... 2000 1 90/60 3,000
Website or Software Usability Tests............. 3000 1 90/60 4,500
----------------------------------------------------------------------------------------------------------------
Dated: May 27, 2014.
Karla Bailey,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2014-13411 Filed 6-6-14; 8:45 am]
BILLING CODE 4140-01-P
