9660 Federal Register / Vol. 77, No. 33 / Friday, February 17, 2012 / Notices 

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] 

BILLING CODE 4151–05–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Committee on Vital and Health 

Statistics: Meeting 

Pursuant to the Federal Advisory 

Committee Act, the Department of 

Health and Human Services (HHS) 

announces the following advisory 

committee meeting. 

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, 

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. 

Dated: February 9, 2012. 

James Scanlon, 

Deputy Assistant Secretary for Planning and 

Evaluation, Office of the Assistant Secretary 

for Planning and Evaluation. 

[FR Doc. 2012–3750 Filed 2–16–12; 8:45 am] 

BILLING CODE 4150–05–P 

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 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 77, No. 33 / Friday, February 17, 2012 / Notices 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 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

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Patients ............................................. Follow-up Patient Survey ................. 150 1 10/60 25 

Providers ........................................... Follow-up Provider Survey ............... 70 1 30/60 35 

Focus Group Moderator Guide ........ 75 1 1 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] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–R–305] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

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, 

mstockstill on DSK4VPTVN1PROD with NOTICES