Agency Forms Undergoing Paperwork Reduction Act Review, 8721-8722 [2014-03176]
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8721
Federal Register / Vol. 79, No. 30 / Thursday, February 13, 2014 / Notices
instruments are needed to gather,
process, aggregate, evaluate, and
disseminate information describing the
program’s processes and outcomes. The
information will be used by CDC to
document progress toward meeting
established program goals and
objectives, to evaluate outcomes
generated by the Ready CDC Personal
Preparedness Workshops and to
respond to data inquiries made by other
agencies of the federal government.
Survey instrument questions will
gather perceptions about personal and
survey Web site with the email
invitation) with an option for paper
copy administration. The Follow Up
Survey will be used to document
changes in the categories of questions
dealing with preparedness from the
initial pre-workshop survey.
The estimated total time for data
collection is 35 minutes, resulting in an
annualized estimated burden of 350
hours.
There are no costs to respondents
except their time.
regional preparedness from the
perspective of the participant. Each
participant will be surveyed three times,
once before and twice after their
participation in the Personal
Preparedness Workshop.
It is estimated that there will be a total
of 600 respondents/year with an
estimated time for data collection of 20
minutes each on the pre-workshop
survey, 5 minutes each on the Ready
CDC Workshop Evaluation, and 10
minutes each on the Follow Up Survey.
Instruments will be administered
electronically (by including a link to the
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
(in hours)
Type of respondent
Form name
Federal Employee, Contractor, or other external
governmental and non-governmental organizations.
Federal Employee, Contractor, or other external
governmental and non-governmental organizations.
Federal Employee, Contractor, or other external
governmental and non-governmental organizations.
Pre-Workshop Survey ..
600
1
20/60
200
Ready CDC Workshop
evaluation.
600
1
5/60
50
Follow Up Survey .........
600
1
10/60
100
Total ...............................................................
.......................................
........................
........................
........................
350
LeRoy Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2014–03177 Filed 2–12–14; 8:45 am]
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Centers for Disease Control and
Prevention
[30Day–14–13ZC]
emcdonald on DSK67QTVN1PROD with NOTICES
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call (404) 639–7570 or send an
email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
18:44 Feb 12, 2014
Jkt 232001
Case Studies to Explore Interventions
that Support, Build, and Provide Legacy
Awareness for Young Breast Cancer
Survivors—New—National Center for
Chronic Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VerDate Mar<15>2010
Proposed Project
Young breast cancer survivors (YBCS,
defined as women diagnosed with
breast cancer under 45 years old) may
have a more difficult time coping with
breast cancer treatment and aftercare
when compared to older breast cancer
survivors. As a result of the Young
Women’s Breast Health Education and
Awareness Requires Learning Young
(EARLY) Act, CDC established Funding
Opportunity Announcement, DP11–
1111, Developing Support and
Educational Awareness for Young (< 45
years of age) Breast Cancer Survivors in
the United States. Subsequently, CDC
awarded a three-year cooperative
agreement to seven organizations that
demonstrated a capacity to (1) reach
YBCS, health care providers, and
caregivers/families, (2) implement
interventions that seek to provide
support services, and (3) develop
educational communication and
awareness resources to support YBCS.
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
Other establishments within the U.S.,
such as local and national not-for-profit
organizations and academic institutions,
implement similar YBCS-focused
interventions without funding from
CDC’s DP11–1111 cooperative
agreement. Although these entities are
not funded through CDC, they plan,
develop, and employ similar tools,
strategies, and interventions to reach or
benefit these targeted young cancersurvivor populations.
CDC proposes to conduct exploratory
case studies of organizations that
provide support services and/or
educational resources to YBCS, health
care providers, and/or caregivers/
families. Each selected organization will
serve as a unique case and the unit of
analysis. Information will be collected
from up to 12 organizations: seven case
studies will be conducted with
organizations that receive funding
through CDC’s DP11–1111 cooperative
agreement, and up to five case studies
will be conducted with other
organizations that are implementing
similar YBCS-focused activities and
interventions but do not receive funding
under DP11–1111.
Case studies are intended to serve as
an exploration of implementation
activities, as well as to provide the
context for implementation. Information
E:\FR\FM\13FEN1.SGM
13FEN1
8722
Federal Register / Vol. 79, No. 30 / Thursday, February 13, 2014 / Notices
will be collected during a single site
visit to each selected organization to
conduct on-site observations and indepth interviews (IDI) with each
organization’s key informants, such as
Principal Investigators, Program
Managers, Program Staff, and Program
Partners. IDIs will last 1–2 hours each.
Case study findings will help CDC to
identify areas in which CDC can build
upon existing and emerging efforts to
provide support services and
educational resources to YBCS,
highlight barriers and facilitating factors
to implementing interventions targeting
YBCS, determine the added value of
providing the DP11–1111 cooperative
agreement (e.g., funding, technical
assistance) to various entities, identify
lessons learned that can be applied to
future implementation of YBCS
interventions, and better understand the
sustainability of YBCS interventions
following/in the absence of CDC
funding.
Case study selection is based on a
purposeful selection of CDC-funded and
non-CDC funded organizations that
support YBCS populations through
educational or service programs.
Potential organizations for this project
may be funded through state, local, or
Tribal government, or the private sector.
Information will be collected
approximately two years after initiation
of CDC’s cooperative agreement. OMB
approval is requested for one year.
There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
168.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Private Sector Organizations ............................
Number of
responses per
respondent
Average
burden per
response
(in hr)
7
7
7
1
1
1
1
2
2
7
35
21
5
1
1
1
1
1
1
1
1
5
5
1
1
2
2
5
25
15
1
1
1
1
1
1
Worksheet for Identifying Site Visit Interviews .....
Worksheet for Scheduling Site Visit Interviews ...
IDI Guide for Program Directors/Principal Investigators.
IDI Guide for Program Managers .........................
IDI Guide for Program Staff Members .................
IDI Guide for Program Partners ...........................
Worksheet for Identifying Site Visit Interviews. ....
State, Local, and Tribal Government Organizations.
Worksheet for Scheduling Site Visit Interviews ...
IDI Guide for Program Directors/Principal Investigators.
IDI Guide for Program Managers .........................
IDI Guide for Program Staff Members .................
IDI Guide for Program Partners ...........................
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2014–03176 Filed 2–12–14; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Gastroenterology and Urology Devices
Panel of the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
emcdonald on DSK67QTVN1PROD 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.
Name of Committee: Gastroenterology
and Urology Devices Panel of the
Medical Devices Advisory Committee.
VerDate Mar<15>2010
18:44 Feb 12, 2014
Jkt 232001
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 March 20, 2014, from 8 a.m. to
5 p.m.
Location: Holiday Inn, Ballroom, 2
Montgomery Village Ave., Gaithersburg,
MD 20879. The hotel’s telephone
number is 301–948–8900.
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). 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/Advisory
Committees/default.htm and scroll
down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
learn about possible modifications
before coming to the meeting.
Agenda: On March 20, 2014, the
committee will discuss, make
recommendations, and vote on
information regarding the humanitarian
device exemption (HDE) application for
the XVIVO Perfusion System (XPSTM)
sponsored by XVIVO Perfusion, Inc. The
proposed Indication for Use for the
XVIVO Perfusion System, as stated in
the HDE, is as follows:
The XPSTM is intended to be used
with STEEN Solution for flushing and
temporary continuous normothermic
machine perfusion of initially
unacceptable excised donor lungs
during which time the function of the
lungs can be reassessed for
transplantation.
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/
E:\FR\FM\13FEN1.SGM
13FEN1
Agencies
[Federal Register Volume 79, Number 30 (Thursday, February 13, 2014)]
[Notices]
[Pages 8721-8722]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03176]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-14-13ZC]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
(404) 639-7570 or send an email to omb@cdc.gov. Send written comments
to CDC Desk Officer, Office of Management and Budget, Washington, DC or
by fax to (202) 395-5806. Written comments should be received within 30
days of this notice.
Proposed Project
Case Studies to Explore Interventions that Support, Build, and
Provide Legacy Awareness for Young Breast Cancer Survivors--New--
National Center for Chronic Disease Prevention and Health Promotion
(NCCDPHP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Young breast cancer survivors (YBCS, defined as women diagnosed
with breast cancer under 45 years old) may have a more difficult time
coping with breast cancer treatment and aftercare when compared to
older breast cancer survivors. As a result of the Young Women's Breast
Health Education and Awareness Requires Learning Young (EARLY) Act, CDC
established Funding Opportunity Announcement, DP11-1111, Developing
Support and Educational Awareness for Young (< 45 years of age) Breast
Cancer Survivors in the United States. Subsequently, CDC awarded a
three-year cooperative agreement to seven organizations that
demonstrated a capacity to (1) reach YBCS, health care providers, and
caregivers/families, (2) implement interventions that seek to provide
support services, and (3) develop educational communication and
awareness resources to support YBCS.
Other establishments within the U.S., such as local and national
not-for-profit organizations and academic institutions, implement
similar YBCS-focused interventions without funding from CDC's DP11-1111
cooperative agreement. Although these entities are not funded through
CDC, they plan, develop, and employ similar tools, strategies, and
interventions to reach or benefit these targeted young cancer-survivor
populations.
CDC proposes to conduct exploratory case studies of organizations
that provide support services and/or educational resources to YBCS,
health care providers, and/or caregivers/families. Each selected
organization will serve as a unique case and the unit of analysis.
Information will be collected from up to 12 organizations: seven case
studies will be conducted with organizations that receive funding
through CDC's DP11-1111 cooperative agreement, and up to five case
studies will be conducted with other organizations that are
implementing similar YBCS-focused activities and interventions but do
not receive funding under DP11-1111.
Case studies are intended to serve as an exploration of
implementation activities, as well as to provide the context for
implementation. Information
[[Page 8722]]
will be collected during a single site visit to each selected
organization to conduct on-site observations and in-depth interviews
(IDI) with each organization's key informants, such as Principal
Investigators, Program Managers, Program Staff, and Program Partners.
IDIs will last 1-2 hours each. Case study findings will help CDC to
identify areas in which CDC can build upon existing and emerging
efforts to provide support services and educational resources to YBCS,
highlight barriers and facilitating factors to implementing
interventions targeting YBCS, determine the added value of providing
the DP11-1111 cooperative agreement (e.g., funding, technical
assistance) to various entities, identify lessons learned that can be
applied to future implementation of YBCS interventions, and better
understand the sustainability of YBCS interventions following/in the
absence of CDC funding.
Case study selection is based on a purposeful selection of CDC-
funded and non-CDC funded organizations that support YBCS populations
through educational or service programs. Potential organizations for
this project may be funded through state, local, or Tribal government,
or the private sector. Information will be collected approximately two
years after initiation of CDC's cooperative agreement. OMB approval is
requested for one year.
There are no costs to respondents other than their time. The total
estimated annualized burden hours are 168.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Type of respondents Form name respondents responses per response
respondent (in hr)
----------------------------------------------------------------------------------------------------------------
Private Sector Organizations.......... Worksheet for Identifying Site 7 1 1
Visit Interviews.
Worksheet for Scheduling Site 7 1 2
Visit Interviews.
IDI Guide for Program 7 1 2
Directors/Principal
Investigators.
IDI Guide for Program Managers 7 1 1
IDI Guide for Program Staff 35 1 1
Members.
IDI Guide for Program Partners 21 1 1
State, Local, and Tribal Government Worksheet for Identifying Site 5 1 1
Organizations. Visit Interviews..
Worksheet for Scheduling Site 5 1 2
Visit Interviews.
IDI Guide for Program 5 1 2
Directors/Principal
Investigators.
IDI Guide for Program Managers 5 1 1
IDI Guide for Program Staff 25 1 1
Members.
IDI Guide for Program Partners 15 1 1
----------------------------------------------------------------------------------------------------------------
Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for Science, Office of the
Director, Centers for Disease Control and Prevention.
[FR Doc. 2014-03176 Filed 2-12-14; 8:45 am]
BILLING CODE 4163-18-P