Published 60 Day FRN

Appendix B1. Federal Register Notice.pdf

Pilot Study of Community-Based Surveillance of Supports for Healthy Eating/Active Living (HE/AL)

Published 60 Day FRN

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62068

Federal Register / Vol. 76, No. 194 / Thursday, October 6, 2011 / Notices

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Delegation of Authorities

Agency for Healthcare Research and
Quality

Notice is hereby given that I have
delegated to the Administrator, Centers
for Medicare & Medicaid Services
(CMS), and the Commissioner, Food and
Drug Administration (FDA), with
authority to re-delegate, the authorities
vested in the Secretary of the
Department of Health and Human
Services under Section 6004 of the
Patient Protection and Affordable Care
Act, Public Law 111–148, which adds
Section 1128H [42 U.S.C. 1320a–7i] to
the Social Security Act.
I hereby delegate to CMS the authority
vested in the Secretary to issue guidance
and take other appropriate actions, to
the extent that Section 1128H [42 U.S.C.
1320a–7i] relates to Titles XVIII
(Medicare), XIX (Medicaid), or XXI
(State Children’s Health Insurance
Program) of the Social Security Act.
I hereby delegate to FDA all other
authority vested in the Secretary under
Section 1128H [42 U.S.C. 1320a–7i].
This shall include, but is not limited to,
issuing guidance and taking other
appropriate action to the extent that
Section 1128H [42 U.S.C. 1320a–7i]
relates to Section 503 of the Federal
Food, Drug, and Cosmetic Act;
identifying the information to be
collected as allowed by Sections
1128H(a)(1)(B) [42 U.S.C. 1320a–
7i(a)(1)(B)] and 1128H(a)(2)(B) [42
U.S.C. 1320a–7i(a)(2)(B)]; and generally,
with respect to the information to be
submitted under Section 1128H(a) [42
U.S.C. 1320a–7i(a)], issuing guidance
and taking other appropriate action to
identify the information to be submitted
and the manner of submission, and
overseeing and making arrangements for
the collection, maintenance, and
availability of such information.
This delegation shall be exercised in
accordance with the Department’s
applicable policies, procedures, and
guidelines.
I hereby affirm and ratify any actions
taken by the Administrator, CMS, the
Commissioner, FDA, or other CMS and
FDA officials, which involve the
exercise of these authorities prior to the
effective date of this delegation.
This delegation of authorities is
effective upon date of signature.
Authority: 44 U.S.C. 3101.
Dated: September 30, 2011.
Kathleen Sebelius,
Secretary of Health and Human Services.
[FR Doc. 2011–25851 Filed 10–5–11; 8:45 am]
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Meeting of the National Advisory
Council for Healthcare Research and
Quality
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Notice of public meeting.
AGENCY:

In accordance with section
10(a) of the Federal Advisory Committee
Act, 5 U.S.C. App. 2, this notice
announces a meeting of the National
Advisory Council for Healthcare
Research and Quality.
DATES: The meeting will be held on
Friday, November 4, 2011, from 8:30
a.m. to 3:30 p.m.
ADDRESSES: The meeting will be held at
the Hubert H. Humphrey Building,
Room 800, 200 Independence Avenue,
SW., Washington, DC 20201.
FOR FURTHER INFORMATION CONTACT:
Karen Brooks, Coordinator of the
Advisory Council, at the Agency for
Healthcare Research and Quality, 540
Gaither Road, Rockville, Maryland
20850, (301) 427–1801. For press-related
information, please contact Karen
Migdail at (301) 427–1855.
If sign language interpretation or other
reasonable accommodation for a
disability is needed, please contact the
Food and Drug Administration (FDA)
Office of Equal Employment
Opportunity and Diversity Management
on (301) 827–4840, no later than
October 21, 2011. The agenda, roster,
and minutes are available from Ms.
Bonnie Campbell, Committee
Management Officer, Agency for
Healthcare Research and Quality, 540
Gaither Road, Rockville, Maryland
20850. Ms. Campbell’s phone number is
(301) 427–1554.
SUPPLEMENTARY INFORMATION:
SUMMARY:

I. Purpose
The National Advisory Council for
Healthcare Research and Quality is
authorized by Section 941 of the Public
Health Service Act, 42 U.S.C. 299c. In
accordance with its statutory mandate,
the Council is to advise the Secretary of
the Department of Health and Human
Services and the Director, Agency for
Healthcare Research and Quality
(AHRQ), on matters related to AHRQ’s
conduct of its mission including
providing guidance on (A) Priorities for
health care research, (B) the field of
health care research including training
needs and information dissemination on
health care quality and (C) the role of

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the Agency in light of private sector
activity and opportunities for public
private partnerships.
The Council is composed of members
of the public, appointed by the
Secretary, and Federal ex-officio
members specified in the authorizing
legislation.
II. Agenda
On Friday, November 4, there will be
a subcommittee meeting for the National
Healthcare Quality and Disparities
Report scheduled to begin at 7:30 a.m.
The Council meeting will convene at
8:30 a.m., with the call to order by the
Council Chair and approval of previous
Council summary notes. The AHRQ
Director will present her update on
current research, programs, and
initiatives. The final agenda will be
available on the AHRQ Web site at
http://www.ahrq.gov no later than
October 31, 2011.
Dated: September 26, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011–25692 Filed 10–5–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–11–11KS]

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 e-mail to [email protected].
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

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Federal Register / Vol. 76, No. 194 / Thursday, October 6, 2011 / Notices
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
Community-Based Surveillance of
Supports for Healthy Eating and Active
Living—New—National Center for
Chronic Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
There is growing consensus among
experts that the environment plays a
critical role in promoting or
discouraging healthy choices and
behaviors. For example, consumption of
a healthful diet may be constrained by
lack of access to fresh foods, and
physical activity, particularly as it
relates to active forms of transportation,
such as walking and bicycling, may be
limited by poor street design or
concerns about safety. Policies
implemented by municipalities can
change local environments to support
residents’ decisions to consume
healthful diets and be physically active.
CDC has identified 24 strategies that
local communities can implement to
encourage healthy eating and active
living, as well as indicators for
monitoring community-level progress in
implementing these strategies. However,
at this time, there is no systematic
national information collection about
community-level policies related to
healthy eating and active living, or how
these policies are changing over time.
Although some public health
surveillance systems measure health
and behavioral factors at the individual
level, these systems are insufficient to
address broader contextual factors, such
as community-level supports and

policies related to nutrition and
physical activity.
To address this gap in information,
CDC proposes to conduct a pilot study
to examine the feasibility of establishing
a national community-level surveillance
system on policy supports for healthful
eating and active living. The pilot study
will be conducted in two states with a
sample of 400 communities, 200 in each
state. Respondents will be local
governments from a representative
sample of municipalities in each state.
The sample frame will be generated
from the U.S. Census of Governments.
The proposed pilot study is designed
to address three key methodological
objectives. The first objective is to test
the feasibility of the proposed sampling
frame and to answer sample design
issues related to determining sampling
criteria for inclusion, as well as the
development of weights and estimates.
The second objective is to identify
and critically evaluate whether
respondents in diverse municipalities of
various sizes and organizational
structures are able to answer a selfadministered survey questionnaire. The
survey questionnaire includes 42 items
on the following topics: Communitywide planning efforts for healthy eating
and active living, the built environment
and policies that support physical
activity, and policies and practices that
support access to healthy food and
healthy eating. The estimated burden
per response is one hour. Issues to be
addressed include critical assessment of
the strengths and weaknesses of
methods for identifying the best
respondents for completing the survey
questionnaire; conducting a limited
process evaluation that identifies the
barriers and challenges respondents
may incur in providing reasonable and
current data for the questionnaire; and
arriving at a data collection instrument
with the lowest possible threshold for
respondent burden.

The third objective is to identify and
critically evaluate different methods of
study recruitment and non-response
follow-up. A split-sample approach will
be used to assign each target respondent
to one of two groups: A low-intensity
recruitment group or a moderateintensity recruitment group. All target
respondents in the study sample will
receive e-mail reminders to encourage
participation in the survey. Target
respondents in the moderate-intensity
recruitment group will also receive up
to three telephone contacts to address
questions. These follow-up contacts will
serve as additional reminders. The
estimated burden per telephone contact
is five minutes.
Results of the methodological
component of the feasibility study will
be used to assess the feasibility of
establishing a national surveillance
system and the best methods for
encouraging a high response rate in a
representative sample of communities.
The overall goal is to establish a
surveillance system that will be useful
to local, state, and federal public health
programs that promote healthful eating
and physical activity. Information to be
collected through surveillance will help
these groups identify areas for
community-level interventions, track
the progress of communities in changing
policy and environmental supports, and
evaluate interventions that address the
obesity epidemic through changing diet
and physical activity.
Target respondents will be city/town
planners and managers, or individuals
with similar responsibilities. The
majority of survey responses will be
collected using a secure, web-based
survey data collection system. A paper
version of the survey will also be
available. OMB approval is requested
for one year. Participation is voluntary
and there are no costs to respondents
other than their time.

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ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent

Number of
respondents

Average burden
per response
(in hr)

Total burden
(in hr)

Type of respondent

Form name

City/Town Manager-Planner

Survey Questionnaire ...................
Telephone Follow-up for Non-Responders.

400
200

1
3

1
5/60

400
50

.......................................................

............................

............................

............................

450

Total ..............................

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Federal Register / Vol. 76, No. 194 / Thursday, October 6, 2011 / Notices

Dated: September 29, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2011–25753 Filed 10–5–11; 8:45 am]
BILLING CODE 4163–18–P

use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
Proposed Project
Racial and Ethnic Approaches to
Community Health (REACH) US
Evaluation—Revision—National Center
for Chronic Disease Prevention and
Health Promotion (NCCDPHP), Centers
for Disease Control and Prevention
(CDC).

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–11–0805]

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 e-mail to [email protected].
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

Background and Brief Description
In 2007, the Centers for Disease
Control and Prevention (CDC) launched
Racial and Ethnic Approaches to
Community Health across the U.S.
(REACH US), a national multilevel
program to reduce and eliminate health
disparities in racial and ethnic
minorities. Priority populations for the
program are African American,
American Indian, Alaska Native,
Hispanic American, Asian American,
and Pacific Islander citizens. Each state
or community funded through the
REACH US program developed a
community action plan building on the
application, synthesis, and
dissemination of promising community
public health practices in one or more
priority areas: Breast and cervical
cancer; cardiovascular disease; diabetes
mellitus; adult/older adult
immunization, hepatitis B, and/or
tuberculosis; asthma; and infant
mortality. The program priority areas
were selected based on statistical
analysis of ‘‘excess deaths,’’ which
examined differences in minority health
in relation to non-minority health and
identified the specific health areas that
accounted for the majority of the higher

annual proportion of minority deaths in
the U.S.
As part of the REACH US evaluation
plan, CDC sponsored household-based
risk factor surveys in 2009, 2010, and
2011 (OMB No. 0920–0805, exp. 2/28/
2012). Respondents were selected based
on a unique address-based sampling
approach that targets specific
geographic areas across the country
where REACH U.S. interventions have
been implemented. The risk factor
survey data allow CDC to track trends in
community health in the areas where
REACH U.S. interventions have been
launched.
CDC is requesting OMB approval to
conduct two additional cycles of data
collection in 2012 and 2013. Risk factor
surveys will be conducted in 28 REACH
U.S. communities (900 individuals per
community). After households have
been selected through address-based
sampling, health information will be
collected through a self-administered,
mailed questionnaire, or through
interviews conducted by telephone or
in-person with members of the selected
households. The surveys will help to
assess the prevalence of various risk
factors associated with chronic diseases,
deficits in breast and cervical cancer
screening and management, and deficits
in adult immunizations. Survey results
will also be used to assess progress
towards the national goal of eliminating
health disparities within minority
populations.
OMB approval is requested for two
years. Minor changes to the survey
questions will be implemented, and
adjustments will be made to the
estimated number of respondents.
Respondents will be adults ages 18
years and older. Participation is
voluntary and there are no costs to
respondents except their time.

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents
Members of REACH U.S.
communities.

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Total ..............................

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Number of
responses per
respondent

Number of
respondents

Form name

Average burden
per response
(in hours)

Total burden
(in hours)

Screening Interview ......................

14,700

1

3/60

735

Household Member Interview .......
REACH Study Booklet self-administered questionnaire.

10,600
24,300

1
1

15/60
15/60

2,650
6,075

.......................................................

............................

............................

............................

9,460

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