Attachment 7. 60-day FRN

36344

Federal Register / Vol. 71, No. 122 / Monday, June 26, 2006 / Notices

coordinated approach for effectively
translating genomic applications into
clinical practice and health policy is
still needed. In response to this need,
CDC’s Office of Genomics and Disease
Prevention (OGDP) initiated the EGAPP
Project in fall 2004. The ultimate goal of
the project is to develop and evaluate a
coordinated, systematic process for
assessing genetic tests and other
genomic applications in transition from
research to clinical and public health
practice. To support this goal, an
independent, non-federal,
multidisciplinary EGAPP Working
Group was established in April, 2005.
The roles of the Working Group are to
prioritize and select genomic
applications for evaluation, establish
methods and processes, monitor
progress of commissioned evidence
reports, and develop conclusions and
recommendations based on the
evidence. The knowledge and
experience gained through the project
will be used to inform the development
of a sustainable process for assessing the

will be targeted to advocacy and
disease-specific support groups and
OGDP Web site visitors.
Surveys will be administered during
four survey periods staggered at
intervals of six months. Feedback from
healthcare providers and payers
suggests that they are the most
interested and ready to receive and use
EGAPP products (e.g., evidence reports
and Working Group recommendations).
Therefore, they will be the subjects of
Survey 1 (about 6 months after release
of products) and Survey 3 (one year
later). Consumers, policy makers, and
healthcare purchasers are expected to
receive and be impacted by information
developed by EGAPP later. Therefore,
these groups will be the subjects of
Survey 2 (6 months after Survey 1) and
Survey 4 (one year later).
The second mechanism for
identifying participants will be through
the EGAPP Web site. During specified
periods of time, individuals accessing
the Web site will be asked to participate.
There is no cost to the respondents
other than their time.

safety and efficacy of emerging genetic
tests.
We are proposing an evaluation
research activity to assess outcomes of
the EGAPP Project. The study will be
conducted in collaboration with outside
consultants who will work with CDC to
design the study, collect data for the
study, conduct data analyses, and
develop written reports of results.
The purpose of this evaluation
research activity is to collect
information on the value and impact of
the EGAPP process and the products
developed and disseminated (e.g.,
evidence reviews, published evidence
summaries, published Working Group
recommendations, informational
messages) by surveying members of four
key stakeholder groups identified for the
EGAPP pilot project. The four key
stakeholder groups selected are:
Healthcare providers (e.g., physicians,
mid-level practitioners, nurses), policy
makers, healthcare payers (e.g., health
plans, insurers) and purchasers (e.g.,
organizations purchasing healthcare),
and consumers. Surveying of consumers

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Average
burden per
response
(in hours)

Total burden
hours

Form

Healthcare Providers:
Primary Care Providers .............
Specialists ..................................
Genetic Counselors ...................
Mid-level Practitioners ...............
Nurses ........................................
Targeted Consumers .................
Healthcare Payers .....................
Policy Makers ............................
Healthcare Purchasers ..............

Healthcare Provider Survey .............
...........................................................
...........................................................
...........................................................
...........................................................
General Survey ................................
Policy/Payer Survey .........................
Policy Survey ...................................
Purchase Survey ..............................

385
385
200
385
385
770
100
50
31

1
1
1
1
1
1
1
1
1

10/60
10/60
10/60
10/60
10/60
10/60
10/60
10/60
10/60

64
64
33
64
64
128
17
8
5

Total Burden .......................

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

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

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

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

447

Dated: June 20, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E6–10003 Filed 6–23–06; 8:45 am]

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

BILLING CODE 4163–18–P

[60Day–06–05CJ]

Centers for Disease Control and
Prevention

Proposed Data Collections Submitted
for Public Comment and
Recommendations

rwilkins on PROD1PC63 with NOTICES

Number of
responses
per respondent

Respondent

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

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proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–5960 and
send comments to Seleda Perryman,
CDC Assistant Reports Clearance
Officer, 1600 Clifton Road, MS–D74,
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

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36345

Federal Register / Vol. 71, No. 122 / Monday, June 26, 2006 / Notices
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
Colorectal Cancer Screening
Demonstration Program—New—
Division of Cancer Prevention and
Control (DCPC), National Center for
Chronic Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
The CDC, DCPC is requesting
approval to collect individual patientlevel screening, diagnostic, and
treatment data in association with a new
colorectal cancer screening
demonstration program. DCPC is
funding 5 cooperative agreements from
fiscal year (FY) 2005–2008 for
implementation of new colorectal
cancer (CRC) demonstration programs.
These 3-year demonstration programs
are designed to increase populationbased CRC screening among persons 50
years and older with low income and
inadequate or no health insurance
coverage in a geographically defined
area.
Colorectal Cancer (CRC) is the second
leading cause of cancer-related deaths in
the United States, following lung

Submitted data must contain no patient
identifiers.
All programs will additionally submit
annual cost data to CDC to be used to
monitor cost and cost-effectiveness over
the 3-year program period.
The additional burden to these
respondents will be small, since CDC
will only select programs that are
already performing some CRC screening,
and will therefore already be collecting
these types of data. Data collection for
both patient-level and cost data will
continue over the 3 years of the
demonstration programs.
In the burden table below, two data
collection forms will be used: Patientlevel clinical data collection forms and
cost data collection forms. The data will
be collected from the 5 cooperative
agreement recipients, i.e., the
respondents. The estimated number of
responses represents the number of
patients receiving clinical services per
recipient program, one report per
patient per quarterly reporting period
(estimated at 70 patients per program
per quarter). This would result in an
estimated annualized burden for the
quarterly reports of 583 hours.
Additionally, respondents will report
annual cost data. For reporting the
annual cost data, the respondents will
submit only one report each for the
entire year.
There is no cost to respondents other
than their time.

cancer. Based on scientific evidence
which indicates that regular screening is
effective in reducing CRC incidence and
mortality, regular CRC screening is now
recommended for average-risk persons
with one or a combination of the
following tests: Fecal occult blood
testing (FOBT), flexible sigmoidoscopy,
colonoscopy, and/or double-contrast
barium enema (DCBE). Fecal
immunochemical testing (FIT) is
considered an acceptable alternative to
FOBT. In the absence of evidence
indicating a single most effective test,
selected programs will be able to choose
which screening test(s) they will use
from the above list of recommended
tests.
All funded programs will be required
to submit patient-level data on CRC
screening and diagnostic services
provided as part of this demonstration
project. This information will be used to
assess the quality and appropriateness
of the services delivered.
Programs that receive CDC funding to
provide screening and diagnostic
services will collect individual patientlevel data to capture demographic
information, clinical services and
outcomes, and submit these data to CDC
on a quarterly basis. While CDC funds
will not be used for treatment, programs
will need to monitor treatment and
document that patients are receiving
appropriate treatment services.

ESTIMATED ANNUALIZED BURDEN HOURS
Form type

Number of
respondents

Number of responses per
respondent

Average
burden per
response
(in hours)

Total burden
hours

Quarterly patient-level clinical data ..................................................................
Annual cost data ..............................................................................................

5
5

280
1

25/60
25/60

583
2

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

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

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

585

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

Dated: June 20, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E6–10024 Filed 6–23–06; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–06–06BJ]

rwilkins on PROD1PC63 with NOTICES

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

VerDate Aug<31>2005

17:00 Jun 23, 2006

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PO 00000

Frm 00032

Fmt 4703

Sfmt 4703

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 and
send comments to Seleda Perryman,
CDC Assistant Reports Clearance
Officer, 1600 Clifton Road, MS–D74,
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)

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