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36344 Federal Register / Vol. 71, No.

122 / Monday, June 26, 2006 / Notices

coordinated approach for effectively safety and efficacy of emerging genetic will be targeted to advocacy and
translating genomic applications into tests. disease-specific support groups and
clinical practice and health policy is We are proposing an evaluation OGDP Web site visitors.
still needed. In response to this need, research activity to assess outcomes of Surveys will be administered during
CDC’s Office of Genomics and Disease the EGAPP Project. The study will be four survey periods staggered at
Prevention (OGDP) initiated the EGAPP conducted in collaboration with outside intervals of six months. Feedback from
Project in fall 2004. The ultimate goal of consultants who will work with CDC to healthcare providers and payers
the project is to develop and evaluate a design the study, collect data for the suggests that they are the most
coordinated, systematic process for study, conduct data analyses, and interested and ready to receive and use
assessing genetic tests and other develop written reports of results. EGAPP products (e.g., evidence reports
genomic applications in transition from The purpose of this evaluation and Working Group recommendations).
research to clinical and public health research activity is to collect Therefore, they will be the subjects of
information on the value and impact of Survey 1 (about 6 months after release
practice. To support this goal, an
the EGAPP process and the products of products) and Survey 3 (one year
independent, non-federal,
developed and disseminated (e.g., later). Consumers, policy makers, and
multidisciplinary EGAPP Working evidence reviews, published evidence healthcare purchasers are expected to
Group was established in April, 2005. summaries, published Working Group receive and be impacted by information
The roles of the Working Group are to recommendations, informational developed by EGAPP later. Therefore,
prioritize and select genomic messages) by surveying members of four these groups will be the subjects of
applications for evaluation, establish key stakeholder groups identified for the Survey 2 (6 months after Survey 1) and
methods and processes, monitor EGAPP pilot project. The four key Survey 4 (one year later).
progress of commissioned evidence stakeholder groups selected are: The second mechanism for
reports, and develop conclusions and Healthcare providers (e.g., physicians, identifying participants will be through
recommendations based on the mid-level practitioners, nurses), policy the EGAPP Web site. During specified
evidence. The knowledge and makers, healthcare payers (e.g., health periods of time, individuals accessing
experience gained through the project plans, insurers) and purchasers (e.g., the Web site will be asked to participate.
will be used to inform the development organizations purchasing healthcare), There is no cost to the respondents
of a sustainable process for assessing the and consumers. Surveying of consumers other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of Average
Number of responses burden per Total burden
Respondent Form respondents per respond- response hours
ent (in hours)

Healthcare Providers:
Primary Care Providers ............. Healthcare Provider Survey ............. 385 1 10/60 64
Specialists .................................. ........................................................... 385 1 10/60 64
Genetic Counselors ................... ........................................................... 200 1 10/60 33
Mid-level Practitioners ............... ........................................................... 385 1 10/60 64
Nurses ........................................ ........................................................... 385 1 10/60 64
Targeted Consumers ................. General Survey ................................ 770 1 10/60 128
Healthcare Payers ..................... Policy/Payer Survey ......................... 100 1 10/60 17
Policy Makers ............................ Policy Survey ................................... 50 1 10/60 8
Healthcare Purchasers .............. Purchase Survey .............................. 31 1 10/60 5

Total Burden ....................... ........................................................... ........................ ........................ ........................ 447

Dated: June 20, 2006. DEPARTMENT OF HEALTH AND proposed projects or to obtain a copy of
Joan F. Karr, HUMAN SERVICES the data collection plans and
Acting Reports Clearance Officer, Centers for instruments, call 404–639–5960 and
Disease Control and Prevention. Centers for Disease Control and send comments to Seleda Perryman,
[FR Doc. E6–10003 Filed 6–23–06; 8:45 am]
Prevention CDC Assistant Reports Clearance
Officer, 1600 Clifton Road, MS–D74,
BILLING CODE 4163–18–P
[60Day–06–05CJ] Atlanta, GA 30333 or send an e-mail to
omb@cdc.gov.
Proposed Data Collections Submitted
for Public Comment and Comments are invited on: (a) Whether
Recommendations the proposed collection of information
is necessary for the proper performance
In compliance with the requirement of the functions of the agency, including
of Section 3506(c)(2)(A) of the whether the information shall have
Paperwork Reduction Act of 1995 for practical utility; (b) the accuracy of the
opportunity for public comment on agency’s estimate of the burden of the
rwilkins on PROD1PC63 with NOTICES

proposed data collection projects, the proposed collection of information; (c)


Centers for Disease Control and ways to enhance the quality, utility, and
Prevention (CDC) will publish periodic clarity of the information to be
summaries of proposed projects. To collected; and (d) ways to minimize the
request more information on the burden of the collection of information

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Federal Register / Vol. 71, No. 122 / Monday, June 26, 2006 / Notices 36345

on respondents, including through the cancer. Based on scientific evidence Submitted data must contain no patient
use of automated collection techniques which indicates that regular screening is identifiers.
or other forms of information effective in reducing CRC incidence and All programs will additionally submit
technology. Written comments should mortality, regular CRC screening is now annual cost data to CDC to be used to
be received within 60 days of this recommended for average-risk persons monitor cost and cost-effectiveness over
notice. with one or a combination of the the 3-year program period.
following tests: Fecal occult blood The additional burden to these
Proposed Project
testing (FOBT), flexible sigmoidoscopy, respondents will be small, since CDC
Colorectal Cancer Screening colonoscopy, and/or double-contrast will only select programs that are
Demonstration Program—New— barium enema (DCBE). Fecal already performing some CRC screening,
Division of Cancer Prevention and immunochemical testing (FIT) is and will therefore already be collecting
Control (DCPC), National Center for considered an acceptable alternative to these types of data. Data collection for
Chronic Disease Prevention and Health FOBT. In the absence of evidence both patient-level and cost data will
Promotion (NCCDPHP), Centers for indicating a single most effective test, continue over the 3 years of the
Disease Control and Prevention (CDC). selected programs will be able to choose demonstration programs.
which screening test(s) they will use In the burden table below, two data
Background and Brief Description
from the above list of recommended collection forms will be used: Patient-
The CDC, DCPC is requesting tests. level clinical data collection forms and
approval to collect individual patient- cost data collection forms. The data will
level screening, diagnostic, and All funded programs will be required
be collected from the 5 cooperative
treatment data in association with a new to submit patient-level data on CRC
agreement recipients, i.e., the
colorectal cancer screening screening and diagnostic services
respondents. The estimated number of
demonstration program. DCPC is provided as part of this demonstration responses represents the number of
funding 5 cooperative agreements from project. This information will be used to patients receiving clinical services per
fiscal year (FY) 2005–2008 for assess the quality and appropriateness recipient program, one report per
implementation of new colorectal of the services delivered. patient per quarterly reporting period
cancer (CRC) demonstration programs. Programs that receive CDC funding to (estimated at 70 patients per program
These 3-year demonstration programs provide screening and diagnostic per quarter). This would result in an
are designed to increase population- services will collect individual patient- estimated annualized burden for the
based CRC screening among persons 50 level data to capture demographic quarterly reports of 583 hours.
years and older with low income and information, clinical services and Additionally, respondents will report
inadequate or no health insurance outcomes, and submit these data to CDC annual cost data. For reporting the
coverage in a geographically defined on a quarterly basis. While CDC funds annual cost data, the respondents will
area. will not be used for treatment, programs submit only one report each for the
Colorectal Cancer (CRC) is the second will need to monitor treatment and entire year.
leading cause of cancer-related deaths in document that patients are receiving There is no cost to respondents other
the United States, following lung appropriate treatment services. than their time.

ESTIMATED ANNUALIZED BURDEN HOURS


Average
Number of re-
Number of burden per Total burden
Form type sponses per
respondents response hours
respondent (in hours)

Quarterly patient-level clinical data .................................................................. 5 280 25/60 583


Annual cost data .............................................................................................. 5 1 25/60 2

Total .......................................................................................................... ........................ ........................ ........................ 585

Dated: June 20, 2006. DEPARTMENT OF HEALTH AND summaries of proposed projects. To
Joan F. Karr, HUMAN SERVICES request more information on the
Acting Reports Clearance Officer, Centers for proposed projects or to obtain a copy of
Disease Control and Prevention. Centers for Disease Control and the data collection plans and
[FR Doc. E6–10024 Filed 6–23–06; 8:45 am]
Prevention instruments, call 404–639–5960 and
BILLING CODE 4163–18–P
send comments to Seleda Perryman,
[60Day–06–06BJ] CDC Assistant Reports Clearance
Officer, 1600 Clifton Road, MS–D74,
Proposed Data Collections Submitted Atlanta, GA 30333 or send an e-mail to
for Public Comment and omb@cdc.gov.
Recommendations
Comments are invited on: (a) Whether
In compliance with the requirement the proposed collection of information
of Section 3506(c)(2)(A) of the is necessary for the proper performance
rwilkins on PROD1PC63 with NOTICES

Paperwork Reduction Act of 1995 for of the functions of the agency, including
opportunity for public comment on whether the information shall have
proposed data collection projects, the practical utility; (b) the accuracy of the
Centers for Disease Control and agency’s estimate of the burden of the
Prevention (CDC) will publish periodic proposed collection of information; (c)

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