Proposed Data Collections Submitted for Public Comment and Recommendations, 76165-76166 [2011-31243]
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76165
Federal Register / Vol. 76, No. 234 / Tuesday, December 6, 2011 / Notices
Keith A. Tucker,
Office of the Secretary, Paperwork Reduction
Act Clearance Officer.
[FR Doc. 2011–31199 Filed 12–5–11; 8:45 am]
BILLING CODE 4150–30–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier OS–0990–New]
Agency Information Collection
Request. 60-Day Public Comment
Request
Office of the Secretary, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Office of the Secretary (OS), Department
of Health and Human Services, is
publishing the following summary of a
proposed information collection request
for public comment. Interested persons
are invited to send comments regarding
this burden estimate or any other aspect
of this collection of information,
including any of the following subjects:
(1) The necessity and utility of the
proposed information collection for the
proper performance of the agency’s
AGENCY:
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.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, email your request,
including your address, phone number,
OMB number, and OS document
identifier, to
Sherette.funncoleman@hhs.gov, or call
the Reports Clearance Office on (202)
690–6162. Written comments and
recommendations for the proposed
information collections must be directed
to the OS Paperwork Clearance Officer
at the above email address within 60days.
Proposed Project: Evaluation of the
Consumer Education Campaign ‘‘Make
the Call—Don’t Miss a Beat’’ for the
Office on Women’s Health (OWH), U.S.
Department of Health and Human
Services (HHS) (New)—OMB No. 0990–
NEW.
Abstract: The ‘‘Make the Call. Don’t
Miss a Beat’’ campaign is a national
Public Service Announcement (PSA)
campaign that aims to educate, engage
and empower women and their families
to learn the seven most common
symptoms of a heart attack and to call
911 as soon as those symptoms arise.
The campaign launched in February,
2011 and includes TV, radio, print and
social media PSA. This study will
collect information on awareness of the
Make the Call—Don’t Miss a Beat
campaign, knowledge about heart
disease, risk status, and likelihood of
calling 911 as the first response to the
symptoms of a heart attack. Information
will also be collected on demographic
variables including age, sex, race,
education, income, primary language,
and marital status. Information will be
collected through the use of a
probability sample, Random Digit Dial
telephone survey. The respondent base
will be surveyed only once, as this is a
single-wave survey. The sampling plan
is to include a minimum of 1200 women
from the United States general
population, with at least 600 of these
women 50 years or older.
ESTIMATED ANNUALIZED BURDEN TABLE
Form
Screener ........................................
Main instrument ............................
Total .......................................
General
Population,
Women, 25+.
General
Population,
Women, 25+.
Total burden
hours
1
5/60
358
Adult
1200
1
15/60
300
.......................................................
..........................
..........................
..........................
658
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60-Day-12–12BO]
jlentini on DSK4TPTVN1PROD with NOTICES
Average burden
hours per
response
4300
[FR Doc. 2011–31201 Filed 12–5–11; 8:45 am]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
17:04 Dec 05, 2011
Number of
responses per
respondent
Adult
Keith A. Tucker,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
VerDate Mar<15>2010
Number of
respondents
Type of respondent
Jkt 226001
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call (404) 639–5960 or
send comments to Daniel Holcomb, CDC
Reports Clearance Officer, 1600 Clifton
Road, MS D–74, Atlanta, GA 30333 or
send an email to omb@cdc.gov.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (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
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
Proposed Project
Monitoring and Reporting System for
Community Transformation Grant
Awardees—New—National Center for
Chronic Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Chronic diseases, including heart
disease, cancer, stroke, diabetes,
arthritis, are the leading causes of death
and disability in the United States,
accounting for seven of every ten deaths
and affecting the quality of life of 90
million Americans. Reducing death and
disability through the prevention and
control of these conditions, and related
risk factors such as tobacco use,
E:\FR\FM\06DEN1.SGM
06DEN1
76166
Federal Register / Vol. 76, No. 234 / Tuesday, December 6, 2011 / Notices
physical inactivity, poor diet, and
obesity, has critical importance for
public health.
The Prevention and Public Health
Fund (PPHF) of the Patient Protection
and Affordable Care Act of 2010 (ACA)
provides an important opportunity for
states, counties, territories and tribes to
advance public health across the
lifespan and to reduce health
disparities. The PPHF authorizes
Community Transformation Grants
(CTG) for the implementation,
evaluation, and dissemination of
evidence-based community preventive
health activities. The CTG program will
create healthier communities by
building capacity to implement broad
evidence and practice-based policy,
environmental, programmatic and
infrastructure changes, and supporting
implementation of such interventions.
The CTG program emphasizes five
strategic areas: Tobacco-free living,
active living and healthy eating, high
impact evidence-based clinical and
other preventive services, social and
emotional wellness, and a healthy and
safe physical environment. The CTG
program is administered by the Centers
for Disease Control and Prevention
(CDC), National Center for Chronic
Disease Prevention and Health
Promotion (NCCDPHP).
enumeration of CTG-funded efforts. In
addition, this feature will facilitate
communications with CDC and prompt,
data-driven technical assistance. Third,
information stored in the MIS can be
used to satisfy routine, semi-annual
reporting requirements while
minimizing data re-entry for
information that has not changed.
Finally, the electronic MIS will allow
CDC to formulate ad hoc analyses and
reports that would be impracticable
using paper-based information sources.
Information collected through the MIS
will be used to monitor awardee
progress, identify and support CDC
technical assistance to awardees, and
respond to inquiries from the
Department of Health and Human
Services (HHS), the White House,
Congress and other sources. NCCDPHP
has successfully implemented similar
MIS-based information collections with
other chronic disease prevention and
control programs.
OMB approval is requested for three
years. Awardees will report information
to CDC twice per year. The average
burden per response is estimated to be
three hours. CDC’s collection of this
information is authorized by section and
sections 311 and 317(k)(2) of the Public
Health Service Act, 42 U.S. Code 243
and 247b(k)2. There are no costs to
respondents other than their time.
CDC awarded 68 CTG cooperative
agreements to state and local
governmental agencies, tribes and
territories, state or local non-profit
organizations, and national networks of
community-based organizations. Fiftyfour awardees were from state, local and
tribal government, and 14 awardees
were from the private, non-profit sector.
Each awardee is charged with
implementing a community-or awardeespecific work plan that will lead to
specific, measurable health outcomes in
its jurisdiction (or service area) among
an entire population or a specific
population subgroup. Each CTG
awardee is required to provide semiannual reports to CDC describing its
work plan, objectives, activities,
partnerships, resources, and progress.
CDC plans to collect the required
progress report information using an
electronic management information
system (MIS), which has a number of
advantages when compared to the
collection of narrative reports. First, the
MIS will help awardees formulate
objectives that are specific, measurable,
achievable, relevant and time-framed
(SMART), as required by CDC’s
evaluation strategy. Second, awardees
will have the capacity to enter updates
on an ongoing basis. This capacity is
expected to improve respondent
satisfaction and result in more complete
ESTIMATED ANNUALIZED BURDEN HOURS
Average burden per response
(in hours)
Number of respondents
Number of responses per
respondent
Community Transformation Grant Awardees (state, local and tribal government sector) .................................................................................................
CTG Awardees (private sector) .......................................................................
54
14
2
2
3
3
324
84
Total ..........................................................................................................
........................
........................
........................
408
Type of respondents
Dated: November 29, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2011–31243 Filed 12–5–11; 8:45 am]
[Docket No. FDA–2011–D–0464]
jlentini on DSK4TPTVN1PROD with NOTICES
BILLING CODE 4163–18–P
Food and Drug Administration
Draft Guidance for Industry and Food
and Drug Administration Staff; the
Content of Investigational Device
Exemption and Premarket Approval
Applications for Artificial Pancreas
Device Systems; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
SUMMARY:
VerDate Mar<15>2010
17:04 Dec 05, 2011
Jkt 226001
PO 00000
Frm 00047
Fmt 4703
document entitled ‘‘Draft Guidance for
Industry and FDA Staff: The Content of
Investigational Device Exemption (IDE)
and Premarket Approval (PMA)
Applications for Artificial Pancreas
Device Systems.’’ This draft guidance
document provides industry and the
Agency staff with guidelines for
developing premarket submissions for
artificial pancreas device systems, in
particular, the Control-to-Range (CTR)
and Control-to-Target (CTT) device
systems. This draft guidance is not final
nor is it in effect at this time.
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
DATES:
Notice.
Sfmt 4703
Total burden
(in hours)
E:\FR\FM\06DEN1.SGM
06DEN1
Agencies
[Federal Register Volume 76, Number 234 (Tuesday, December 6, 2011)]
[Notices]
[Pages 76165-76166]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-31243]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60-Day-12-12BO]
Proposed Data Collections Submitted for Public Comment and
Recommendations
In compliance with the requirement of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for opportunity for public comment on
proposed data collection projects, the Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call (404) 639-5960
or send comments to Daniel Holcomb, CDC Reports Clearance Officer, 1600
Clifton Road, MS D-74, Atlanta, GA 30333 or send an email to
omb@cdc.gov.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (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. Written comments should be received
within 60 days of this notice.
Proposed Project
Monitoring and Reporting System for Community Transformation Grant
Awardees--New--National Center for Chronic Disease Prevention and
Health Promotion (NCCDPHP), Centers for Disease Control and Prevention
(CDC).
Background and Brief Description
Chronic diseases, including heart disease, cancer, stroke,
diabetes, arthritis, are the leading causes of death and disability in
the United States, accounting for seven of every ten deaths and
affecting the quality of life of 90 million Americans. Reducing death
and disability through the prevention and control of these conditions,
and related risk factors such as tobacco use,
[[Page 76166]]
physical inactivity, poor diet, and obesity, has critical importance
for public health.
The Prevention and Public Health Fund (PPHF) of the Patient
Protection and Affordable Care Act of 2010 (ACA) provides an important
opportunity for states, counties, territories and tribes to advance
public health across the lifespan and to reduce health disparities. The
PPHF authorizes Community Transformation Grants (CTG) for the
implementation, evaluation, and dissemination of evidence-based
community preventive health activities. The CTG program will create
healthier communities by building capacity to implement broad evidence
and practice-based policy, environmental, programmatic and
infrastructure changes, and supporting implementation of such
interventions. The CTG program emphasizes five strategic areas:
Tobacco-free living, active living and healthy eating, high impact
evidence-based clinical and other preventive services, social and
emotional wellness, and a healthy and safe physical environment. The
CTG program is administered by the Centers for Disease Control and
Prevention (CDC), National Center for Chronic Disease Prevention and
Health Promotion (NCCDPHP).
CDC awarded 68 CTG cooperative agreements to state and local
governmental agencies, tribes and territories, state or local non-
profit organizations, and national networks of community-based
organizations. Fifty-four awardees were from state, local and tribal
government, and 14 awardees were from the private, non-profit sector.
Each awardee is charged with implementing a community-or awardee-
specific work plan that will lead to specific, measurable health
outcomes in its jurisdiction (or service area) among an entire
population or a specific population subgroup. Each CTG awardee is
required to provide semi-annual reports to CDC describing its work
plan, objectives, activities, partnerships, resources, and progress.
CDC plans to collect the required progress report information using
an electronic management information system (MIS), which has a number
of advantages when compared to the collection of narrative reports.
First, the MIS will help awardees formulate objectives that are
specific, measurable, achievable, relevant and time-framed (SMART), as
required by CDC's evaluation strategy. Second, awardees will have the
capacity to enter updates on an ongoing basis. This capacity is
expected to improve respondent satisfaction and result in more complete
enumeration of CTG-funded efforts. In addition, this feature will
facilitate communications with CDC and prompt, data-driven technical
assistance. Third, information stored in the MIS can be used to satisfy
routine, semi-annual reporting requirements while minimizing data re-
entry for information that has not changed. Finally, the electronic MIS
will allow CDC to formulate ad hoc analyses and reports that would be
impracticable using paper-based information sources. Information
collected through the MIS will be used to monitor awardee progress,
identify and support CDC technical assistance to awardees, and respond
to inquiries from the Department of Health and Human Services (HHS),
the White House, Congress and other sources. NCCDPHP has successfully
implemented similar MIS-based information collections with other
chronic disease prevention and control programs.
OMB approval is requested for three years. Awardees will report
information to CDC twice per year. The average burden per response is
estimated to be three hours. CDC's collection of this information is
authorized by section and sections 311 and 317(k)(2) of the Public
Health Service Act, 42 U.S. Code 243 and 247b(k)2. There are no costs
to respondents other than their time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
----------------------------------------------------------------------------------------------------------------
Community Transformation Grant Awardees (state, 54 2 3 324
local and tribal government sector)............
CTG Awardees (private sector)................... 14 2 3 84
---------------------------------------------------------------
Total....................................... .............. .............. .............. 408
----------------------------------------------------------------------------------------------------------------
Dated: November 29, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2011-31243 Filed 12-5-11; 8:45 am]
BILLING CODE 4163-18-P