Proposed Data Collections Submitted for Public Comment and Recommendations, 9660-9661 [2012-3620]
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9660
Federal Register / Vol. 77, No. 33 / Friday, February 17, 2012 / Notices
National Committee on Vital and Health
Statistics: Meeting
strategic plans and discuss next steps. After
lunch, there will be a briefing on the new
CMS Line of Service for Information
Resources Initiative. The public will be
invited to comment on the information
presented. Further information will be
provided on the NCVHS Web site at https://
www.ncvhs.hhs.gov/.
The times shown above are for the full
Committee meeting. Subcommittee breakout
sessions are scheduled for late in the
afternoon on the first day and 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.
Pursuant to the Federal Advisory
Committee Act, the Department of
Health and Human Services (HHS)
announces the following advisory
committee meeting.
Dated: February 9, 2012.
James Scanlon,
Deputy Assistant Secretary for Planning and
Evaluation, Office of the Assistant Secretary
for Planning and Evaluation.
Name: National Committee on Vital and
Health Statistics (NCVHS), Full Committee
Meeting.
Time and Date: March 1, 2012; 9:00 a.m.–
3:45 p.m. EST. March 2, 2012; 10:00 a.m.–
4:00 p.m. EST.
Place: Double Tree Hilton Hotel Silver
Spring, 8727 Colesville Road, Silver Spring,
Maryland 20910, Tel: 1–301–589–5200.
Status: Open.
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 from the Department (HHS), the
Centers for Medicare and Medicaid Services
(CMS), and the Office of the National
Coordinator (ONC). There will also be
discussion on items for approval: (1)
Recommendation letter on standards for
Claims Attachments; (2) recommendation
letter on ACA requirements to seek input on
improving standardization and uniformity in
new financial and administrative activities
beyond those already being addressed under
HIPAA; and (3) a recommendation letter on
the Standards/Operating Rule Maintenance
Process. After lunch, an update will be given
on the March 8–9, 2012 NCVHS
Socioeconomic Status (SES) Workshop, and
a briefing on the preparation for use of data
after transition to ICD–10 Code Sets.
On the morning of the second day there
will be a review of the final action items
discussed on the first day. Additionally, the
Committee will hear subcommittee reports,
[FR Doc. 2012–3750 Filed 2–16–12; 8:45 am]
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: February 9, 2012.
James Scanlon,
Deputy Assistant Secretary for Planning and
Evaluation, Office of the Assistant Secretary
for Planning and Evaluation.
[FR Doc. 2012–3758 Filed 2–16–12; 8:45 am]
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HUMAN SERVICES
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–12–0814]
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 Kimberly Lane, CDC
Reports Clearance Officer, 1600 Clifton
Road, MS D–74, Atlanta, GA 30333 or
send an email to omb@cdc.gov.
Comments are invited on: (a) Whether
the proposed collection of information
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
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
CDC Cervical Cancer Study
(CX3)(OMB No. 0920–0814, exp. 6/30/
2012)—Revision—National Center for
Chronic Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
The National Breast and Cervical
Cancer Early Detection Program
(NBCCEDP) is the only organized
national screening program in the
United States. The program offers breast
and cervical cancer screening to
underserved women. Given resource
limitations, the screening standards for
cervical cancer in the program include
an annual Pap test until a woman has
had three consecutive normal Pap tests,
at which time the Pap test frequency is
reduced to every three years. HPV DNA
testing has been approved in the U.S. as
a secondary screening tool for ASCUS
(Atypical Squamous Cells of
Undetermined Significance), and as a
primary screening tool for women 30
years of age and older, but it is not
currently a reimbursable expense under
program guidelines. Adopting HPV
testing along with Pap testing in women
over 30 could help the program better
utilize resources by extending the
screening interval of women who are
cytology negative and HPV test negative,
which is estimated to be 80–90% of
women. In 2005, the NBCCEDP
convened an expert panel to determine
policies on reimbursement of the HPV
DNA test with the Pap test (co-test) for
primary screening. The panel
recommended that the program not
reimburse for the HPV DNA test but
instead requested that pilot studies be
performed to measure the feasibility,
acceptability and barriers to use of the
test.
A pilot study, the CDC Cervical
Cancer Study (CX3), is currently being
conducted in 15 clinics in the state of
Illinois. A total of 2,246 women between
the ages of 30 and 60 who visited one
E:\FR\FM\17FEN1.SGM
17FEN1
9661
Federal Register / Vol. 77, No. 33 / Friday, February 17, 2012 / Notices
of the participating clinics for routine
cervical cancer screening were recruited
for the study. Patients who agreed to
participate in the study received an HPV
DNA test in addition to the Pap test. The
clinics were assigned to one of two
study arms. Clinics in the intervention
group administered the HPV DNA tests
to eligible patients, along with a multicomponent educational intervention
involving both providers and patients.
Clinics in the comparison group
administered the HPV tests but patients
and providers did not receive the
educational intervention.
The purpose of the CX3 study is to
examine whether or not there is an
increase in the cervical cancer screening
interval to three years for women in the
target age range with a normal Pap test
and a negative HPV DNA test. Primary
goals of the study are to: (1) Assess
whether provider and patient education
will lead to extended screening intervals
for women who have negative screening
results; (2) identify facilitators and
barriers to acceptance and appropriate
use of the HPV test and longer screening
intervals; (3) track costs associated with
HPV testing and educational
interventions; and (4) identify the HPV
genotypes among this sample of low
income women. Secondary goals of the
study are to: (1) Assess follow-up of
women with positive test results and (2)
determine provider knowledge and
acceptability of the HPV vaccine.
During the first three years (Phase I)
of the study, data were collected from a
number of sources. Completed data
collection activities include: before
beginning patient recruitment a
provider baseline survey was
administered to providers at the
participating clinics who routinely
perform Pap testing; a patient baseline
survey was administered to a sample of
patients during their initial clinic visit
prior to the patient’s HPV test; a
monthly clinic survey was administered
to all participating clinics during the
first year of patient recruitment to
obtain information regarding resources
associated with participating in the
study; and a provider follow-up survey
was administered to clinic providers 12
months following study initiation. In
addition, information collection for an
18-month follow-up survey was
initiated among patients who completed
a baseline survey.
Approval is currently being requested
to continue data collection during Phase
II of the study. These data collection
activities include: continuing
administration of the patient follow-up
survey 18 months following the
patient’s initial clinic visit;
administration of a provider follow-up
survey 36 months following study
initiation; and conducting qualitative
interviews with providers to identify
facilitators and barriers to acceptance
and appropriate use of the HPV test and
longer screening intervals. The followup surveys for patients and providers
will assess changes in knowledge,
attitudes, beliefs and behavior regarding
cervical cancer screening. An additional
source of data for the analysis includes
patient medical and billing records,
which will be reviewed to provide
information necessary to determine
whether or not HPV co-testing leads to
extended screening intervals for women
with negative results (and to determine
what type of follow-up care was
provided to women with positive HPV
test results).
The results of this study will provide
information regarding the extent to
which providers are willing to extend
the cervical cancer screening interval to
three years for women in the target age
range with a normal Pap test and a
negative HPV DNA test. It will also
provide information regarding whether
provider and patient education will lead
to extended screening intervals for
women who have negative screening
results. In addition, the study results
will provide information regarding the
level of knowledge regarding cervical
cancer screening among low-income,
underserved women—who represent the
demographic most needy of highly
sensitive screening methodologies that
can increase the likelihood of detecting
cervical dysplasia at less frequent
screening intervals. The findings from
this study will help inform standards
regarding the HPV DNA test on a
national level for cervical cancer
screening in the NBCCEDP.
Participation in the CX3 study is
voluntary and there are no costs to
respondents other than their time. OMB
approval is requested for one year.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
(in hours)
Type of respondent
Form name
Patients .............................................
Providers ...........................................
Follow-up Patient Survey .................
Follow-up Provider Survey ...............
Focus Group Moderator Guide ........
150
70
75
1
1
1
10/60
30/60
1
25
35
75
Total ...........................................
...........................................................
........................
........................
........................
135
Dated: February 10, 2012.
Ronald Otten,
Deputy Chief, Centers for Disease Control and
Prevention.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
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[FR Doc. 2012–3620 Filed 2–16–12; 8:45 am]
[Document Identifier: CMS–R–305]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
AGENCY:
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Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS) is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
E:\FR\FM\17FEN1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 33 (Friday, February 17, 2012)]
[Notices]
[Pages 9660-9661]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3620]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-12-0814]
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 Kimberly Lane, CDC Reports Clearance Officer, 1600
Clifton Road, MS D-74, Atlanta, GA 30333 or send an email 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
CDC Cervical Cancer Study (CX3)(OMB No. 0920-0814, exp. 6/30/
2012)--Revision--National Center for Chronic Disease Prevention and
Health Promotion (NCCDPHP), Centers for Disease Control and Prevention
(CDC).
Background and Brief Description
The National Breast and Cervical Cancer Early Detection Program
(NBCCEDP) is the only organized national screening program in the
United States. The program offers breast and cervical cancer screening
to underserved women. Given resource limitations, the screening
standards for cervical cancer in the program include an annual Pap test
until a woman has had three consecutive normal Pap tests, at which time
the Pap test frequency is reduced to every three years. HPV DNA testing
has been approved in the U.S. as a secondary screening tool for ASCUS
(Atypical Squamous Cells of Undetermined Significance), and as a
primary screening tool for women 30 years of age and older, but it is
not currently a reimbursable expense under program guidelines. Adopting
HPV testing along with Pap testing in women over 30 could help the
program better utilize resources by extending the screening interval of
women who are cytology negative and HPV test negative, which is
estimated to be 80-90% of women. In 2005, the NBCCEDP convened an
expert panel to determine policies on reimbursement of the HPV DNA test
with the Pap test (co-test) for primary screening. The panel
recommended that the program not reimburse for the HPV DNA test but
instead requested that pilot studies be performed to measure the
feasibility, acceptability and barriers to use of the test.
A pilot study, the CDC Cervical Cancer Study (CX3), is currently
being conducted in 15 clinics in the state of Illinois. A total of
2,246 women between the ages of 30 and 60 who visited one
[[Page 9661]]
of the participating clinics for routine cervical cancer screening were
recruited for the study. Patients who agreed to participate in the
study received an HPV DNA test in addition to the Pap test. The clinics
were assigned to one of two study arms. Clinics in the intervention
group administered the HPV DNA tests to eligible patients, along with a
multi-component educational intervention involving both providers and
patients. Clinics in the comparison group administered the HPV tests
but patients and providers did not receive the educational
intervention.
The purpose of the CX3 study is to examine whether or not there is
an increase in the cervical cancer screening interval to three years
for women in the target age range with a normal Pap test and a negative
HPV DNA test. Primary goals of the study are to: (1) Assess whether
provider and patient education will lead to extended screening
intervals for women who have negative screening results; (2) identify
facilitators and barriers to acceptance and appropriate use of the HPV
test and longer screening intervals; (3) track costs associated with
HPV testing and educational interventions; and (4) identify the HPV
genotypes among this sample of low income women. Secondary goals of the
study are to: (1) Assess follow-up of women with positive test results
and (2) determine provider knowledge and acceptability of the HPV
vaccine.
During the first three years (Phase I) of the study, data were
collected from a number of sources. Completed data collection
activities include: before beginning patient recruitment a provider
baseline survey was administered to providers at the participating
clinics who routinely perform Pap testing; a patient baseline survey
was administered to a sample of patients during their initial clinic
visit prior to the patient's HPV test; a monthly clinic survey was
administered to all participating clinics during the first year of
patient recruitment to obtain information regarding resources
associated with participating in the study; and a provider follow-up
survey was administered to clinic providers 12 months following study
initiation. In addition, information collection for an 18-month follow-
up survey was initiated among patients who completed a baseline survey.
Approval is currently being requested to continue data collection
during Phase II of the study. These data collection activities include:
continuing administration of the patient follow-up survey 18 months
following the patient's initial clinic visit; administration of a
provider follow-up survey 36 months following study initiation; and
conducting qualitative interviews with providers to identify
facilitators and barriers to acceptance and appropriate use of the HPV
test and longer screening intervals. The follow-up surveys for patients
and providers will assess changes in knowledge, attitudes, beliefs and
behavior regarding cervical cancer screening. An additional source of
data for the analysis includes patient medical and billing records,
which will be reviewed to provide information necessary to determine
whether or not HPV co-testing leads to extended screening intervals for
women with negative results (and to determine what type of follow-up
care was provided to women with positive HPV test results).
The results of this study will provide information regarding the
extent to which providers are willing to extend the cervical cancer
screening interval to three years for women in the target age range
with a normal Pap test and a negative HPV DNA test. It will also
provide information regarding whether provider and patient education
will lead to extended screening intervals for women who have negative
screening results. In addition, the study results will provide
information regarding the level of knowledge regarding cervical cancer
screening among low-income, underserved women--who represent the
demographic most needy of highly sensitive screening methodologies that
can increase the likelihood of detecting cervical dysplasia at less
frequent screening intervals. The findings from this study will help
inform standards regarding the HPV DNA test on a national level for
cervical cancer screening in the NBCCEDP. Participation in the CX3
study is voluntary and there are no costs to respondents other than
their time. OMB approval is requested for one year.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Type of respondent Form name respondents responses per response (in (in hours)
respondent hours)
----------------------------------------------------------------------------------------------------------------
Patients...................... Follow-up 150 1 10/60 25
Patient Survey.
Providers..................... Follow-up 70 1 30/60 35
Provider Survey.
Focus Group 75 1 1 75
Moderator Guide.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 135
----------------------------------------------------------------------------------------------------------------
Dated: February 10, 2012.
Ronald Otten,
Deputy Chief, Centers for Disease Control and Prevention.
[FR Doc. 2012-3620 Filed 2-16-12; 8:45 am]
BILLING CODE 4163-18-P
