Published 60 Day FRN

Attachment 2a. 60 day FRN.pdf

Million Hearts Hypertension Control Challenge

Published 60 Day FRN

OMB: 0920-0976

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75168

Federal Register / Vol. 77, No. 244 / Wednesday, December 19, 2012 / Notices

response burden is estimated at 2000
hours for 4000 web-based surveys.

There are no costs to respondents
other than their time.

ANNUALIZED BURDEN HOURS
Respondents

Form name

Number of
respondents

Number of
responses per
respondent

Average
burden per
response
(hrs.)

Young adults ...................................................

Web-based survey .........................................

4000

1

30/60

Dated: December 13, 2012.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI),
Office of the Associate Director for Science
(OADS), Office of the Director, Centers for
Disease Control and Prevention.

Proposed Project
Million HeartsTM Hypertension
Control Challenge—New—National
Center for Chronic Disease Prevention
and Health Promotion (NCCDPHP),
Centers for Disease Control and
Prevention (CDC).

[FR Doc. 2012–30563 Filed 12–18–12; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60-Day–13–13EP]

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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 404–639–7570 or send
comments to Ron Otten, 1600 Clifton
Road, MS–D74, Atlanta, GA 30333 or
send an email 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
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.

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Background and Brief Description
Cardiovascular disease is a leading
cause of death for men and women in
the United States, among the most
costly health problems facing our nation
today, and among the most preventable.
Heart disease and stroke also contribute
significantly to disability. High blood
pressure, also known as hypertension, is
one of the leading causes of heart
disease and stroke. Currently, about 67
million American adults have high
blood pressure but fewer than half
(46%) have adequately controlled blood
pressure. The costs of hypertension and
its associated diseases are estimated at
$156 billion annually, including the
cost of medical care and the cost of lost
productivity.
In September 2011, CDC launched the
Million HeartsTM initiative with the goal
of preventing one million heart attacks
and strokes by 2017. In order to achieve
this goal, at least 10 million more
Americans must have their blood
pressure under control. Toward this
end, Million HeartsTM is promoting
clinical practices that are effective in
increasing blood pressure control among
patient populations. There is scientific
evidence that provides general guidance
on the types of system-based changes to
clinical practice that can improve
patient blood pressure control, but more
information is needed to fully
understand implementation practices so
that they can be shared and promoted.
In May 2013, CDC proposes to launch
the Million HeartsTM Hypertension
Control Challenge to identify clinical
practices and health systems that have
been successful in achieving high rates
of hypertension control and to develop
models for dissemination. The most
successful clinical practices or health
plans will be recognized as Million
HeartsTM Hypertension Control
Champions and will receive a cash

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award of $5,000–$15,000. Recognition
will be provided to two groups of
practices: Those that represent fewer
than 50,000 covered lives, and those
that represent 50,000 or more covered
lives. Providers eligible to apply for
recognition include single practice
providers, group practice providers, and
healthcare systems. The Challenge is
authorized by Public Law 111–358, the
America Creating Opportunities to
Meaningfully Promote Excellence in
Technology, Education and Science
Reauthorization Act of 2010
(COMPETES Act).
CDC requests OMB approval to collect
the information needed to identify,
qualify, and rank applicants for
recognition through the Million
HeartsTM Hypertension Control
Challenge. Interested providers or
clinical programs may voluntarily selfnominate their practice or healthcare
system by completing a web-based
nomination form located on the
Challenge.gov web portal. The
nomination process will include
submission of the minimum amount of
data needed to provide evidence of
clinical success in achieving
hypertension control, including: (a) Two
point-in-time measures of the clinical
hypertension control rate for the patient
population, (b) the size of the clinic
population served, and (c) a description
of the sustainable systems adopted to
achieve hypertension control rates. The
estimated burden for completing the
nomination form is 30 minutes.
CDC scientists or contractors will
assign a preliminary score to each
submitted nomination form. Those with
the highest preliminary scores will be
further reviewed by a CDC-sponsored
panel of three to five experts in
hypertension control. The panel will
provide CDC with a ranked list of
nominees recommended for recognition
through the Million HeartsTM
Hypertension Control Challenge.
Finalists will be asked to participate
in a data verification process so that
CDC can verify the information
submitted on the nomination form. The
estimated burden to the respondent is
one hour, which includes time to review

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Federal Register / Vol. 77, No. 244 / Wednesday, December 19, 2012 / Notices
the nomination form with a reviewer or
abstractor in person or by phone, and to
describe to the reviewer how
information was obtained from
electronic records, chart reviews, or
other sources. Finalists may be
eliminated based on the results of data
verification.
Each remaining finalist, or Champion,
will be asked to participate in a semistructured interview. The interview will
provide detailed information about the
strategies employed by the practice or
health system to achieve exemplary
rates of hypertension control, including
barriers and facilitators for those
strategies. The interview will focus on
systems and processes and should take
no preparation time by the finalist. The
estimated burden to the respondent is
two hours, which includes time to
review the interview protocol with the
interviewer, respond to the interview
questions, and review qualitative data.

OMB approval is requested for three
years. On an annual basis, CDC
estimates that information will be
collected from 1,750 nominees using the
nomination form, at most 30 data
verification forms, and at most 30 semistructured interviews that include
review of qualitative data. The number
of Champions recognized in the first
year of the challenge may be less than
30. As the Challenge becomes known,
the number of recognized Champions
may increase to a maximum of 30.
The overall goal of the Million
HeartsTM initiative is to improve the
quality of care delivered to hypertensive
patients. CDC will use the information
collected through the Million HeartsTM
Hypertension Control Challenge to
increase widespread attention to
hypertension at the clinical practice
level, improve understanding of
successful implementation strategies at
the health system level, bring prestige to

organizations that invest in
hypertension control, and motivate
individual practices to strengthen their
hypertension control efforts. Although
some providers and healthcare systems
routinely provide data on hypertension
control rates to entities such as quality
improvement committees, these entities
do not collect or disseminate
information about the clinic processes
used to achieve hypertension control.
Information collected through the
Million HeartsTM Hypertension Control
Challenge will link success in clinical
outcomes of hypertension control with
information about procedures that can
be used to achieve similar favorable
outcomes. The Challenge will allow
interested providers and health care
systems to replicate successful the
strategies.
Participation is voluntary and there
are no costs to respondents other than
their time.

ESTIMATED ANNUALIZED BURDEN HOURS
Avg. burden
per response
(in hr)

Total burden
(in hr)

Form name

Physicians (Single or Group Practices).
Finalists .............................................
Selected Champion ...........................

Million HeartsTM Hypertension Control Champion Nomination form.
Data Verification Form .....................
Semi-structured Interview ................

1,750

1

.5

875

30
30

1
1

1
2

30
60

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

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

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

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

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

965

Dated: December 13, 2012.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI),
Office of the Associate Director for Science
(OADS), Office of the Director, Centers for
Disease Control and Prevention.
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket Number CDC–2012–0014; NIOSH–
260]

Silver Nanoparticles (AgNPs);
Information and Comment Request
National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC),
Department of Health and Human
Services (HHS).

AGENCY:

Request for information and
comment.

ACTION:

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The National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC), as part of
its mission to investigate new and
emerging hazards, has initiated an
evaluation of the scientific data on
silver nanoparticles (AgNPs) to ascertain
the potential health risks to workers and
to identify gaps in knowledge so that
appropriate laboratory and field
research studies can be conducted.
NIOSH has identified a number of
relevant publications on AgNPs. This
listing (Evaluation of the scientific data
on silver nanoparticles (AgNPs) can be
found in Docket CDC–2012–0014 at
http://www.regulations.gov.
NIOSH is requesting additional
information on the following: (1)
Published and unpublished reports and
findings from in vitro and in vivo
toxicity studies with AgNPs, (2)
information on possible health effects
observed in workers exposed to AgNPs,
(3) information on workplaces and
products in which AgNPs can be found,
(4) description of work tasks and
scenarios with a potential for exposure,
(5) information on measurement

SUMMARY:

[FR Doc. 2012–30564 Filed 12–18–12; 8:45 am]

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Number of
responses per
respondent

Number of
respondents

Type of respondent

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methods and, workplace exposure data,
and (6) information on control measures
(e.g., engineering controls, work
practices, PPE) that are being used in
workplaces where potential exposures
to AgNPs occur.
Electronic or written comments
must be received on or before February
19, 2013.

DATES:

You may submit comments,
identified by CDC–2012–0014 and
docket number NIOSH–260, by any of
the following methods:
• Federal eRulemaking Portal: http://
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: NIOSH Docket Office, Robert
A. Taft Laboratories, MS–C34, 4676
Columbia Parkway, Cincinnati, OH
45226.
All information received in response
to this notice must include the agency
name and docket number (CDC–2012–
0014; NIOSH–260). All relevant
comments received will be posted
without change to www.regulations.gov,
including any personal information
provided. For access to the docket to
read background documents or

ADDRESSES:

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