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

9662 Federal Register / Vol. 77, No. 33 / Friday, February 17, 2012 / Notices 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection. Title of 

Information Collection: External Quality 

Review Protocols. Use: The results of 

Medicare reviews, Medicare 

accreditation services, and Medicaid 

external quality reviews will be used by 

States in assessing the quality of care 

provided to Medicaid beneficiaries by 

managed care organizations and to 

provide information on the quality of 

care provided to the general public 

upon request. The revised protocols are 

in draft and must not be used until they 

are approved by OMB through the PRA 

process. Form Number: CMS–R–305 

(OCN 0938–0786). 

Frequency of Reporting: Yearly. 

Affected Public: State, Local or Tribal 

Governments. Number of Respondents: 

42. Total Annual Responses: 70. Total 

Annual Hours: 415,643. (For policy 

questions regarding this collection 

contact Gary B. Jackson at 410–786– 

1218. For all other issues call 410–786– 

1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’ Web Site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or 

Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

In commenting on the proposed 

information collections please reference 

the document identifier or OMB control 

number. To be assured consideration, 

comments and recommendations must 

be submitted in one of the following 

ways by April 17, 2012: 

1. Electronically. You may submit 

your comments electronically to http:// 

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) accepting comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number CMS–R–305 (OCN 

0938–0786), Room C4–26–05, 7500 

Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: February 13, 2012. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2012–3790 Filed 2–16–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Low Income Home Energy 

Assistance Program LIHEAP Leveraging 

Report. 

OMB No.: 0970–0121. 

Description: The LIHEAP leveraging 

incentive program rewards LIHEAP 

grantees that have leveraged non-federal 

home energy resources for low-income 

households. The LIHEAP leveraging 

report is the application for leveraging 

incentive funds that these LIHEAP 

grantees submit to the Department of 

Health and Human Services for each 

fiscal year in which they leverage 

countable resources. Participation in the 

leveraging incentive program is 

voluntary and is described at 45 CFR 

96.87. The LIHEAP leveraging report 

obtains information on the resources 

leveraged by LIHEAP grantees each 

fiscal year (as cash, discounts, waivers, 

and in-kind); the benefits provided to 

low-income households by these 

resources (for example, as fuel and 

payments for fuel, as home heating and 

cooling equipment, and as 

weatherization materials and 

installation); and the fair market value 

of these resources/benefits. 

HHS needs this information in order 

to carry out statutory requirements for 

administering the LIHEAP leveraging 

incentive program, to determine 

countability and valuation of grantees 

leveraged non-federal home energy 

resources, and to determine grantees 

shares of leveraging incentive funds. 

HHS proposes to request a three-year 

extension of OMB approval for the 

currently approved LIHEAP leveraging 

report information collection. 

Respondents: State, local or tribal 

governments. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

LIHEAP Leveraging Report ............................................................................. 70 1 38 2,660 

Estimated Total Annual Burden 

Hours: 2,660. 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Planning, Research and Evaluation, 370 

L’Enfant Promenade SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. All requests should be 

identified by the title of the information 

collection. Email address: 

infocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: 

Office of Management and Budget, 

Paperwork Reduction Project, Fax: 202– 

395–7285, Email: 

OIRA_SUBMISSION@OMB.EOP.GOV, 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2012–3680 Filed 2–16–12; 8:45 am] 

BILLING CODE 4184–01–P 

mstockstill on DSK4VPTVN1PROD with NOTICES