Proposed Data Collections Submitted for Public Comment and Recommendations, 32339-32340 [05-10950]
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Federal Register / Vol. 70, No. 105 / Thursday, June 2, 2005 / Notices
Purpose: At this meeting the Committee
will hear presentations and hold discussions
on several health data policy topics. On the
morning of the first day the Committee will
hear updates and status reports from the
Department on topics including Clinical Data
Standards, the Consolidated Health
Informatics Initiative, and HIPAA Privacy
Rule compliance. They will also discuss
drafts of two Committee reports. In the
afternoon the Committee will hear an update
from the Office of the National Coordinator
for Health Information Technology and
briefings on the Federal Health Architecture
initiative and the Commission on Systemic
Interoperability.
On the morning of the second day the
Committee will hear an update from the
Certification Commission for Healthcare
Information Technology (CCHIT) and a
presentation by an American National
Standards Institute’s Healthcare Informatics
Standards Board (ANSI HISB) panel. There
will also be an update on the National Health
Information Infrastructure and public health.
In the afternoon, there will be reports from
the subcommittees and a discussion of
agendas for future Committee meetings.
The times shown above are for the full
Committee meetings. Subcommittee breakout
sessions are scheduled for late in the
afternoon of the first day in the morning prior
to the full Committee meeting on the second
day. Agendas for these breakout sessions will
be posted on the NCVHS Web site (URL
below) when available.
Contact Person for More Information:
Substantive program information as well as
summaries of meetings and a roster of
committee members may be obtained from
Marjorie S. Greenberg, Executive Secretary,
NCVHS, National Center for Health statistics,
Centers for Disease Control and Prevention,
3311 Toledo Road, Room 2402, Hyattsville,
Maryland 20782, telephone (301) 458–4245.
Information also is available on the NCVHS
home page of the HHS Web site: https://
www.ncvhs.hhs.gov/, where further
information including an agenda will be
posted when available.
Should you require reasonable
accommodation, please contact the CDC
Office of Equal Employment Opportunity on
(301) 458–4EEO (4336) as soon as possible.
Dated: May 23, 2005.
James Scanlon,
Acting Deputy Assistant Secretary for Science
and Data Policy, Office of the Assistant
Secretary for Planning and Evaluation.
[FR Doc. 05–10965 Filed 6–1–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–05–05CJ)
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 404–371–5983 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
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
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 is requesting approval to
collect individual patient-level
screening, diagnostic, and treatment
data in association with a new
colorectal cancer screening
demonstration program. CDC is
planning to fund 3–5 cooperative
agreements in fiscal year (FY) 2005 to
implement new colorectal cancer (CRC)
demonstration programs. These 3-year
demonstration programs are designed to
increase population-based CRC
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32339
screening among persons 50 years and
older in a geographically defined area,
focusing screening efforts on persons
age 50 years and older with low
incomes and inadequate or no health
insurance coverage for CRC screening
(priority population).
Colorectal Cancer is the second
leading cause of cancer-related deaths in
the United States, following lung
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, which 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 and clinical services and
outcomes, and submit these data to CDC
on a quarterly basis. Some of the
cooperative agreement recipients may
receive funding for program
components other than the provision of
screening and diagnostic services.
Programs that do not receive CDC
funding to provide screening and
diagnostic follow up services will still
collect individual patient-level data but
will only submit the data in aggregate to
CDC, on a quarterly basis. Grantees may
be asked by CDC to submit
individualized data if aggregate data do
not meet quality indicator standards.
While CDC funds will not be used for
treatment, programs will need to
monitor treatment and document that
patients are receiving appropriate
treatment services. Submitted data must
contain no patient identifiers.
All programs will additionally submit
annual program-level data to CDC to be
used to evaluate program effectiveness
and monitor cost, funding sources, and
an increase in population-based
screening over the 3-year program
period.
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32340
Federal Register / Vol. 70, No. 105 / Thursday, June 2, 2005 / Notices
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 program-level
data will continue over the 3 years of
the demonstration programs. There is no
cost to respondents other than their
time.
ESTIMATED ANNUALIZED BURDEN TABLE
Number of responses per respondent
Number of
respondents*
Form
Average burden
per response
(in hours)
Number of
times per year
Total burden
(in hours)
Patient-level clinical data .........................................
Annual program-level data .......................................
3
3
70
1
4
1
25/60
25/60
350
1.25
Total ..................................................................
..........................
..........................
..........................
..........................
351.25
* Respondents are cooperative agreement recipients
Dated: May 26, 2005.
Betsey Dunaway,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 05–10950 Filed 6–1–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60 Day-05–05CH)
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 404–371–5983 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
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
Epidemiologic HIV/AIDS Research
among African American and Hispanic
Women at Risk for HIV Infection in the
Southern United States and Puerto
Rico—New—National Center for HIV/
AIDS, STD and TB Prevention
(NCHSTP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
CDC is requesting OMB approval to
administer a questionnaire and test for
HIV and other sexually transmitted
infections (STI) in heterosexual African
American and Hispanic women at four
sites in the southern United States and
Puerto Rico. This proposed data
collection will occur over 3 years.
This study is designed to assess risk
factors for HIV infection in these women
and addresses goals of CDC’s ‘‘HIV
Prevention Strategic Plan Through
2005’’. CDC plans to meet specific goals
by (1) decreasing the number of persons
at high risk of acquiring or transmitting
HIV infection; (2) increasing the
proportion of HIV-infected persons who
know they are infected; (3) increasing
the number of HIV-infected persons
who are linked to appropriate
prevention, care, and treatment services;
and (4) strengthening the capacity
nationwide to monitor the HIV
epidemic. In addition, project data will
provide important epidemiologic
information useful for the development
and targeting of future HIV prevention
activities.
A sample of 2000 female study
participants (500 per site) will be
recruited directly from specific venues
(e.g health clinics, etc.), by word of
mouth, and through other site
designated strategies. They will receive
HIV and STI counseling and testing and
respond to a one-time computerized
questionnaire capturing information on
demographics, risk behaviors, attitudes
and knowledge related to HIV/STD
transmission and prevention. The
testing and interview will take
approximately 1 hour to complete for
those who agree to participate in the
study and 10 minutes to complete for
those who decline to enroll. There is no
cost to respondents except for their
time.
ESTIMATE OF ANNUALIZED BURDEN TABLE
Number of
respondents
Respondents
Number of
respondents per
respondent
Burden per
response
Total burden
hours
Women—screening interview ..................................................................
Women—completed interview .................................................................
3460
2000
1
1
10/60
1
577
2000
Total ..................................................................................................
..........................
..........................
..........................
2577
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]]>Agencies
[Federal Register Volume 70, Number 105 (Thursday, June 2, 2005)]
[Notices]
[Pages 32339-32340]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-10950]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-05-05CJ)
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 404-371-5983
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 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
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 is requesting approval to collect individual patient-level
screening, diagnostic, and treatment data in association with a new
colorectal cancer screening demonstration program. CDC is planning to
fund 3-5 cooperative agreements in fiscal year (FY) 2005 to implement
new colorectal cancer (CRC) demonstration programs. These 3-year
demonstration programs are designed to increase population-based CRC
screening among persons 50 years and older in a geographically defined
area, focusing screening efforts on persons age 50 years and older with
low incomes and inadequate or no health insurance coverage for CRC
screening (priority population).
Colorectal Cancer is the second leading cause of cancer-related
deaths in the United States, following lung 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, which 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 patient-level data to
capture demographic information and clinical services and outcomes, and
submit these data to CDC on a quarterly basis. Some of the cooperative
agreement recipients may receive funding for program components other
than the provision of screening and diagnostic services. Programs that
do not receive CDC funding to provide screening and diagnostic follow
up services will still collect individual patient-level data but will
only submit the data in aggregate to CDC, on a quarterly basis.
Grantees may be asked by CDC to submit individualized data if aggregate
data do not meet quality indicator standards. While CDC funds will not
be used for treatment, programs will need to monitor treatment and
document that patients are receiving appropriate treatment services.
Submitted data must contain no patient identifiers.
All programs will additionally submit annual program-level data to
CDC to be used to evaluate program effectiveness and monitor cost,
funding sources, and an increase in population-based screening over the
3-year program period.
[[Page 32340]]
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 program-level data
will continue over the 3 years of the demonstration programs. There is
no cost to respondents other than their time.
Estimated Annualized Burden Table
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Form Number of responses per Number of times per response Total burden
respondents* respondent per year (in hours) (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Patient-level clinical data....................................... 3 70 4 25/60 350
Annual program-level data......................................... 3 1 1 25/60 1.25
------------------
Total......................................................... ............... ............... ............... ............... 351.25
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Respondents are cooperative agreement recipients
Dated: May 26, 2005.
Betsey Dunaway,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. 05-10950 Filed 6-1-05; 8:45 am]
BILLING CODE 4163-18-P
