4412 Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Notices 

Background and Brief Description 

Each year in the United States, more 

than 30,000 children are born with 

congenital CMV infection. 

Approximately 80% develop normally, 

while the remaining 20% are born with 

or subsequently develop disabilities 

such as hearing loss or mental 

retardation. A similar number of 

children are affected by serious CMVrelated disabilities than by several 

better-known childhood conditions, 

including Down Syndrome and Spina 

Bifida. 

The birth prevalence of congenital 

CMV infection is several times higher 

than the combined birth prevalence of 

all metabolic or endocrine disorders in 

the core U.S. newborn screening panel. 

Because newborn CMV screening is 

rarely performed, and because a 

definitive diagnosis of congenital CMV 

requires access to urine, saliva, or blood 

collected soon after birth, most infected 

children are never diagnosed. Newborn 

CMV screening offers some clear 

potential benefits, but few studies have 

assessed the potential for harm (e.g., 

increased parental anxiety, ‘‘fragile 

child syndrome’’). 

CDC is requesting OMB approval for 

one year to collect information about 

newborn CMV screening. The purpose 

of this information collection is to 

understand the psychosocial impact of 

newborn screening on parents whose 

infants underwent CMV screening as 

part of a routine infant CMV screening 

program in Houston, Texas. The 

potential study population includes 

approximately 70 CMV-infected 

children who were symptomatic at 

birth, 100 CMV-infected children who 

were asymptomatic at birth (20 of whom 

developed sequelae), and 50 controls 

that were CMV-uninfected. The goals of 

this information collection are to: (1) 

Document the positive and negative 

psychosocial impacts of newborn CMV 

screening on parents and their children; 

(2) identify modifiable factors that might 

increase positive psychosocial impacts 

and decrease negative psychosocial 

impacts of newborn CMV screening; (3) 

use what is learned about psychosocial 

impacts to identify key messages that 

parents need relative to newborn CMV 

screening and follow-up; and (4) to 

learn what challenges are associated 

with obtaining a congenital CMV 

diagnosis in the absence of CMV 

newborn screening. 

Much of the potential study 

population is unique in that their 

children experienced newborn CMV 

screening as part of a previous research 

study. Universal CMV screening has not 

been recommended by medical 

associations or state or federal 

governments and as a result newborn 

CMV screening is not typically 

performed. The parents’ experience 

with CMV screening and follow-up will 

help inform decisions about whether 

newborn CMV screening would be good 

public health policy. This study 

represents the first assessment of the 

experiences of parents whose children 

were screened for CMV at birth. 

Respondents fall into four categories 

depending on the past experiences of 

their child who was screened for CMV: 

• Parent Group 1 (PG1)—Child 

screened positive for congenital CMV at 

birth, asymptomatic at birth, but did not 

develop sequelae 

• Parent Group 2 (PG2)—Child 

screened positive for congenital CMV at 

birth, asymptomatic at birth, but did 

subsequently develop sequelae (e.g., 

hearing loss) 

• Parent Group 3 (PG3)—Child was 

diagnosed with congenital CMV and 

had symptoms at birth 

• Parent Group 4 (PG4)—Child 

screened negative for congenital CMV at 

birth 

Information will be collected from 

PG1 via focus groups, from PG2 and 

PG3 via interviews, and from all four 

parent groups via a mail survey. The 

focus group, interview and survey 

respondents will be asked to participate 

only once. It is estimated that 71 parents 

will participate in either individual 

interviews or focus groups and that 230 

will participate in the mail survey. The 

interviews are planned to take 60 

minutes while the focus groups will be 

held for 90 minutes. The survey is 

estimated to take 10 minutes per 

respondent to complete and mail based 

on previous administrations reported in 

the literature. Reading and responding 

to the focus group and interview 

recruitment letters is estimated to take 

5 minutes each. There is no cost to 

respondents other than their time. The 

annualized estimated burden hours are 

135. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Responses 

per 

respondent 

Average 

burden per 

response 

(in hours) 

Parent Group 1 ............................................... Focus Group Guide ........................................ 36 1 1.5 

Focus group recruitment letter ....................... 50 1 5/60 

Parent Groups 2 and 3 ................................... Interviewer guide ............................................ 35 1 1 

Interview recruitment letter ............................. 50 1 5/60 

Parent Groups 1,2,3, and 4 ............................ Survey ............................................................ 230 1 10/60 

Dated: January 14, 2013. 

Ron A. Otten, 

Director, Office of Scientific Integrity (OSI), 

Office of the Associate Director for Science 

(OADS), Office of the Director, Centers for 

Disease Control and Prevention. 

[FR Doc. 2013–01163 Filed 1–18–13; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10191] 

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 


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Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Notices 4413 

information collection for the proper 

performance of the agency’s functions; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

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: Medicare Parts 

C and D Universal Audit Guide. Use: 

Under the Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 and implementing regulations 

under 42 CFR parts 422 and 423, 

Medicare Part D plan sponsors and 

Medicare Advantage organizations are 

required to comply with all Medicare 

Parts C and D program requirements. In 

2010 the explosive growth of these 

sponsoring organizations forced CMS to 

develop an audit strategy to ensure we 

continue to obtain meaningful audit 

results. As a result, CMS’ audit strategy 

reflected a move to a more targeted, 

data-driven and risk-based audit 

approach that focused on high-risk areas 

having the greatest potential for 

beneficiary harm. 

To accomplish this we have combined 

all Part C and Part D audit elements into 

one universal guide which will also 

promote consistency, effectiveness and 

reduce financial and time burdens for 

both CMS and Medicare-contracting 

entities. The combined Medicare Part C 

& D Universal Audit Guide received 

OMB approval in 2010. The Health Plan 

Management System (HPMS) is the 

current conduit by which organizations 

submit many sources of audit materials 

such as bids and other ongoing updates 

to CMS. Please note the guide is very 

comprehensive in that it describes all 

areas that could be audited. Due to 

limited resources, CMS is unable to 

audit all areas for any particular 

sponsor. Some areas could be monitored 

by the account manager, etc. Other areas 

could be audited in the program audits. 

To maximize resources, CMS will 

focus on assisting the industry to 

improve their operations to ensure 

beneficiaries receive access to care. One 

way to accomplish this is CMS will 

develop an annual audit strategy which 

describes how sponsors will be selected 

for audit and the areas that will be 

audited. The audit strategy will be 

shared with the industry via the CMS 

Web site, HPMS memo, the Part C & D 

user call, and other conferences. Once 

the audit areas are defined, CMS will 

design audit protocols describing in 

detail the focus of the audit, the data 

required for the audit, etc. The 

Engagement Letter and Protocols will be 

sent to all sponsors selected for audit 4 

weeks prior to starting the audit. In 

addition, the protocols will be released 

to the industry at the beginning of each 

calendar year via the same manner as 

the audit strategy. To assist in 

improving the audit process, CMS sends 

the plan sponsors a survey at the end of 

each audit to complete in order to 

obtain the sponsor’s feedback. The 

sponsor is not required to complete the 

survey. 

Form Number: CMS–10191 (OCN 

0938–1000). Frequency: Yearly. Affected 

Public: Private Sector (business or other 

for-profit and not-for-profit institutions). 

Number of Respondents: 195. Total 

Annual Responses: 195. Total Annual 

Hours: 24,180. (For policy questions 

regarding this collection contact Tracey 

Roberts at 410–786–8643. 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 March 25, 2013: 

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 __, Room C4–26–05, 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: January 16, 2013. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2013–01167 Filed 1–18–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier CMS–10453] 

Public Information Collection 

Requirements Submitted to the Office 

of Management and Budget (OMB); 

Extension of Comment Period 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Agency information collection 

activities: Proposed collection; comment 

request; extension of comment period. 

SUMMARY: This notice extends the 

comment period for a 60-day notice 

request for proposed information 

collection request associated with the 

notice [Document Identifier: CMS– 

10453] entitled ‘‘The Medicare 

Advantage and Prescription Drug 

Program: Part C Explanation of Benefits 

CFR 422.111(b)(12)’’ that was published 

in the November 26, 2012 (77 FR 70445) 

Federal Register. The comment period 

for the information collection request, 

which would have ended on January 25, 

2013, is extended to February 1, 2013. 

DATES: The comment period for the 

information collection request 

published in the January 25, 2013, 

Federal Register (77 FR 70445) is 

extended to February 1, 2013. 

FOR FURTHER INFORMATION CONTACT: 

William Parham, (410) 786–4669. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the FR Doc. 2012–28570 of 

November 26, 2012 (77 FR 70445), we 

published a Paperwork Reduction Act 

notice requesting a 60-day public 

comment period for the document 

entitled ‘‘The Medicare Advantage and 

Prescription Drug Program: Part C 

Explanation of Benefits CFR 

422.111(b)(12).’’ 

There were technical delays with 

making the information collection 

request publicly available; therefore, in 

this notice we are extending the 

comment period from the date originally 

listed in the November 26, 2012, notice. 

II. Extension of Comment Period 

We are extending the comment period 

for the notice [Document Identifier: 

CMS–10453] in FR Doc. 2012–28570 

published on November 26, 2012 (77 FR 

70445). 

The date listed on page 70445, third 

column, second full paragraph, on the 

fifth line in the paragraph beginning 

with ‘‘To be assured consideration, 


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