Agency Information Collection Activities: Proposed Collection: Public Comment Request, 7130-7131 [2016-02571]
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Federal Register / Vol. 81, No. 27 / Wednesday, February 10, 2016 / Notices
Æ barriers to broader biomarker data
aggregation, dissemination, and
application; and
Æ possible strategies to address these
barriers.
Registration: Registration is free and
available on a first-come, first-served
basis. Persons interested in attending
this public workshop must register
online by 4 p.m. (EST), February 22,
2016. Early registration is recommended
because facilities are limited and,
therefore, FDA may limit the number of
participants from each organization. If
time and space permits, onsite
registration on the day of the public
workshop will be provided beginning at
7 a.m.
If you need special accommodations
due to a disability, please contact Susan
Monahan, Office of Communication and
Education, Center for Devices and
Radiological Health, Food and Drug
Administration, 301–796–5661, email:
susan.monahan@fda.hhs.gov no later
than February 16, 2016.
To register for the public workshop,
please visit FDA’s Medical Devices
News & Events—Workshops &
Conferences calendar at https://
www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm. (Select this meeting/public
workshop from the posted events list.)
Please provide complete contact
information for each attendee, including
name, title, affiliation, address, email,
and telephone number. Those without
Internet access should contact Susan
Monahan to register. Registrants will
receive confirmation after they have
been accepted. You will be notified if
you are on a waiting list.
Streaming Webcast of the Public
Workshop: This public workshop will
also be Webcast. The webcast link will
be available on the workshop Web page
after February 25, 2016. Please visit
FDA’s Medical Devices News &
Events—Workshops & Conferences
calendar at https://www.fda.gov/
MedicalDevices/NewsEvents/
WorkshopsConferences/default.htm.
(Select this public workshop from the
posted events list.) If you have never
attended a Connect Pro event before,
test your connection at https://
collaboration.fda.gov/common/help/en/
support/meeting_test.htm. To get a
quick overview of the Connect Pro
program, visit https://www.adobe.com/
go/connectpro_overview. (FDA has
verified the Web site addresses in this
document, but FDA is not responsible
for any subsequent changes to the Web
sites after this document publishes in
the Federal Register.)
Requests for Oral Presentations: This
public workshop includes a public
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comment session and topic-focused
sessions. During online registration you
may indicate if you wish to present
during a public comment session or
participate in a specific session, and
which topics you wish to address. FDA
has included general topics in this
document. FDA will do its best to
accommodate requests to make public
comments and participate in the
focused sessions. Individuals and
organizations with common interests are
urged to consolidate or coordinate their
presentations, and request time for a
joint presentation, or submit requests for
designated representatives to participate
in the focused sessions. Following the
close of registration, FDA will
determine the amount of time allotted to
each presenter and the approximate
time each oral presentation is to begin,
and will select and notify participants
by February 25, 2016. All requests to
make oral presentations must be
received by the close of registration on
February 22, 2016, by 4 p.m. (EST). If
selected for presentation, any
presentation materials must be emailed
to Lakshmi Kannan (see FOR FURTHER
INFORMATION CONTACT) no later than
February 25, 2016. No commercial or
promotional material will be permitted
to be presented or distributed at the
public workshop.
FDA is holding this public workshop
to obtain information on development of
TBI biomarkers and data
standardization. In order to permit the
widest possible opportunity to obtain
public comment, FDA is soliciting
either electronic or written comments
on all aspects of the public workshop
topics. The deadline for submitting
comments related to this public
workshop is May 3, 2016.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(see ADDRESSES). A transcript will also
be available in either hardcopy or on
CD–ROM, after submission of a
Freedom of Information request. The
Freedom of Information office address is
available on the Agency’s Web site at
https://www.fda.gov. A link to the
transcripts will also be available
approximately 45 days after the public
workshop on the Internet at https://
www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm. (Select this public
workshop from the posted events list).
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Dated: February 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–02592 Filed 2–9–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (HRSA) announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). Prior to submitting the
ICR to OMB, HRSA seeks comments
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
DATES: Comments on this ICR should be
received no later than April 11, 2016.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N–39, Parklawn
Building, 5600 Fishers Lane, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call the HRSA Information Collection
Clearance Officer at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Rural Opioid Overdose Reversal Grant
Program OMB No. 0906–xxxx–New.
Abstract: This program is authorized
by Section 711(b) of the Social Security
Act (U.S.C. 912(b), as amended and the
Consolidated and Further Continuing
Appropriations Act (Pub. L. 114–113).
The purpose of this grant program is to
reduce the incidences of morbidity and
mortality related to opioid overdoses in
rural communities through the purchase
and placement of emergency devices
SUMMARY:
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Federal Register / Vol. 81, No. 27 / Wednesday, February 10, 2016 / Notices
used to rapidly reverse the effects of
opioid overdose and training of licensed
healthcare professionals and emergency
responders on their use.
Need and Proposed Use of the
Information: For this program,
performance measures have been
drafted to provide data useful to the
program and to enable HRSA to provide
aggregate program data required by
Congress under the Government
Performance and Results Act (GPRA) of
1993 (Pub. L. 103–62). These measures
cover the principal topic areas of
interest to the Federal Office of Rural
Health Policy including: (1) The number
of counties served by the program; (2)
the number and type of devices
purchased and distributed and the
location of the distribution; (3) the
number of training sessions and the
number of individuals trained; and (4)
the number of individuals who were
administered Narcan and the outcome.
These measures will speak to the
Office’s progress toward meeting the set
goals.
Likely Respondents: Rural Opioid
Overdose Reversal Grant Program award
recipients.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this Information
Collection Request are summarized in
the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total
burden hours
Rural Opioid Overdose Reversal Grant Program ................
18
1
18
4
72
Total ..............................................................................
18
1
18
4
72
HRSA specifically requests comments
on: (1) The necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions; (2) the accuracy of the
estimated burden; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2016–02571 Filed 2–9–16; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
asabaliauskas on DSK9F6TC42PROD with NOTICES2
Advisory Council on Blood Stem Cell
Transplantation; Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: Advisory Council on Blood
Stem Cell Transplantation (ACBSCT).
Date and Time: March 3, 2016, from
12:00 p.m. to 4:00 p.m. Eastern Standard
Time.
Place: The meeting will be via audio
conference call and Adobe Connect Pro.
Status: The meeting will be open to
the public.
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Purpose: Pursuant to Public Law 109–
129, 42 U.S.C. 274k (section 379 of the
Public Health Service Act, as amended),
the ACBSCT advises the Secretary of
Health and Human Services and the
Administrator, Health Resources and
Services Administration (HRSA), on
matters related to the activities of the
C.W. Bill Young Cell Transplantation
Program (Program) and the National
Cord Blood Inventory Program.
Agenda: The Council will hear a
report from the ACBSCT Work Group on
Cord Blood. The Council also will hear
presentations and discussions on topics
including the National Institutes of
Health’s Late Effects Initiative and the
Center for International Blood and
Marrow Transplant Research. Agenda
items are subject to changes as priorities
indicate.
After Council discussions, members
of the public will have an opportunity
to provide comment. Because of the
Council’s full agenda and timeframe in
which to cover the agenda topics, public
comment may be limited. All public
comments will be included in the
record of the ACBSCT meeting. Meeting
summary notes will be posted on the
HRSA’s Program Web site at https://
bloodcell.transplant.hrsa.gov/ABOUT/
Advisory_Council/.
The draft meeting agenda will be
posted on https://www.blsmeetings.net/
ACBSCT/. Those participating at this
meeting should register by visiting
https://www.blsmeetings.net/ACBSCT/.
The deadline to register for this meeting
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is Tuesday, March 1, 2016. For all
logistical questions and concerns, please
contact Anthony Rodell, Seamon
Corporation, at (301) 658–3457 or send
an email to arodell@
SeamonCorporation.com.
The public can join the meeting by:
1. (Audio Portion) Calling the
Conference Phone Number (1–800–988–
9777) and providing the Participant
Code (6253775); and
2. (Visual Portion) Connecting to the
ACBSCT Adobe Connect Pro Meeting
using the following URL and entering as
GUEST: https://
hrsa.connectsolutions.com/acbsct_
webinar/ (copy and paste the link into
your browser if it does not work
directly).
Participants should call and connect
15 minutes prior to the meeting in order
for logistics to be set up. If you have
never attended an Adobe Connect
meeting, please test your connection
using the following URL: https://
hrsa.connectsolutions.com/common/
help/en/support/meeting_test.htm and
get a quick overview by following URL:
https://www.adobe.com/go/connectpro_
overview. Call (301) 443–0437 or send
an email to ptongele@hrsa.gov if you are
having trouble connecting to the
meeting site.
Public Comment: It is preferred that
persons interested in providing an oral
presentation email a written request,
along with a copy of their presentation,
to Patricia Stroup, MBA, MPA,
Executive Secretary, Advisory Council
on Blood Stem Cell Transplantation,
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[Federal Register Volume 81, Number 27 (Wednesday, February 10, 2016)]
[Notices]
[Pages 7130-7131]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02571]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects (Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995), the Health Resources and Services
Administration (HRSA) announces plans to submit an Information
Collection Request (ICR), described below, to the Office of Management
and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks
comments from the public regarding the burden estimate, below, or any
other aspect of the ICR.
DATES: Comments on this ICR should be received no later than April 11,
2016.
ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance Officer, Room 14N-39, Parklawn
Building, 5600 Fishers Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
draft instruments, email paperwork@hrsa.gov or call the HRSA
Information Collection Clearance Officer at (301) 443-1984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference.
Information Collection Request Title: Rural Opioid Overdose
Reversal Grant Program OMB No. 0906-xxxx-New.
Abstract: This program is authorized by Section 711(b) of the
Social Security Act (U.S.C. 912(b), as amended and the Consolidated and
Further Continuing Appropriations Act (Pub. L. 114-113). The purpose of
this grant program is to reduce the incidences of morbidity and
mortality related to opioid overdoses in rural communities through the
purchase and placement of emergency devices
[[Page 7131]]
used to rapidly reverse the effects of opioid overdose and training of
licensed healthcare professionals and emergency responders on their
use.
Need and Proposed Use of the Information: For this program,
performance measures have been drafted to provide data useful to the
program and to enable HRSA to provide aggregate program data required
by Congress under the Government Performance and Results Act (GPRA) of
1993 (Pub. L. 103-62). These measures cover the principal topic areas
of interest to the Federal Office of Rural Health Policy including: (1)
The number of counties served by the program; (2) the number and type
of devices purchased and distributed and the location of the
distribution; (3) the number of training sessions and the number of
individuals trained; and (4) the number of individuals who were
administered Narcan and the outcome. These measures will speak to the
Office's progress toward meeting the set goals.
Likely Respondents: Rural Opioid Overdose Reversal Grant Program
award recipients.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this Information Collection Request are summarized in the table below.
Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Rural Opioid Overdose Reversal 18 1 18 4 72
Grant Program..................
-------------------------------------------------------------------------------
Total....................... 18 1 18 4 72
----------------------------------------------------------------------------------------------------------------
HRSA specifically requests comments on: (1) The necessity and
utility of the proposed information collection for the proper
performance of the agency's functions; (2) the accuracy of the
estimated burden; (3) ways to enhance the quality, utility, and clarity
of the information to be collected; and (4) the use of automated
collection techniques or other forms of information technology to
minimize the information collection burden.
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-02571 Filed 2-9-16; 8:45 am]
BILLING CODE 4165-15-P
