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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 http://
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: http://
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.

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: http://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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DEPARTMENT OF HEALTH AND
HUMAN SERVICES

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,

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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 [email protected].
Comments are invited on: (a) Whether
the proposed collection of information

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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

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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
responses per
respondent

Average
burden per
response
(in hours)

Total burden
(in hours)

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.
[FR Doc. 2012–3620 Filed 2–16–12; 8:45 am]

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–R–305]

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Number of
respondents

Type of respondent

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,

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