40370 Federal Register / Vol. 76, No. 131 / Friday, July 8, 2011 / Notices 

and concurrence/non-concurrence 

signatures and dates from 3 CMS 

System Manager or Business Owners. 

While the data elements collected are 

not subject to change, the 

individualized clauses that are 

incorporated into any specific DUA are 

subject to change based on a specific 

case or situation such as disclosures to 

states, oversight agencies or DUAs for 

disproportionate share hospital (DSH) 

data requests as well as updates to 

DUAs with additional data descriptions, 

changes to the requestor or adding 

custodians to current DUAs. Form 

Number: CMS–R–235 (OCN: 0938–0734) 

Frequency: Once; Affected Public: 

Private Sector—Business or other Forprofits and Not-for-profit Institutions; 

Number of Respondents: 2,200; Number 

of Responses: 2,200; Total Annual 

Hours: 916. (For policy questions 

regarding this collection, contact Sharon 

Kavanagh at 410–786–5441. For all 

other issues call (410) 786–1326.) 

4. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Medicaid Drug 

Rebate Program—Labelers 

Reconciliation of State Invoice (CMS– 

304) and Prior Quarter Adjustment 

Statement (CMS–304a); Use: Section 

1927(b)(2) of the Social Security Act 

establishes manufacturer requirements 

for paying quarterly rebates to States as 

part of the Medicaid Drug Rebate 

Program. Specifically, in order to 

receive a rebate on drugs dispensed to 

Medicaid recipients, States are required 

to submit quarterly utilization data to 

drug manufacturers that have national 

rebate agreements with the Federal 

Government. Form CMS–304 is used by 

manufacturers for both unit adjustments 

and disputes in response to the State’s 

invoice for current quarter utilization. 

The form CMS–304a is required only in 

those instances where a manufacturer 

discovers unit adjustments and/or 

disputes from a previous quarter’s State 

invoice. Both forms are used to 

reconcile drug rebate payments made by 

manufacturer with the State invoices of 

rebates due; Form Numbers: CMS–304 

and CMS–304a (OMB#: 0938–0676); 

Frequency: Quarterly; Affected Public: 

Private Sector: Business or other forprofits; Number of Respondents: 1,011; 

Total Annual Responses: 4,044; Total 

Annual Hours: 183,120. (For policy 

questions regarding this collection 

contact Andrea Wellington at 410–786– 

3490. For all other issues call 410–786– 

1326.) 

5. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: State Medicaid 

Drug Rebate Forms: CMS–368 

(Administrative Data) and CMS–R–144 

(Quarterly Report Data); Use: Section 

1927(b)(2) of the Social Security Act 

establishes State requirements for 

reporting drug utilization data to CMS 

and to drug manufacturers participating 

in the Medicaid Drug Rebate Program. 

Specifically, in order to receive a rebate 

on drugs dispensed to Medicaid 

recipients, States are required to submit 

quarterly utilization data reports to drug 

manufacturers that have national rebate 

agreements with the Federal 

Government. In addition, a copy of 

these reports must also be submitted to 

CMS. Form CMS–R–144 is used by the 

States to submit this utilization 

information to both manufacturers and 

CMS. Form CMS–368 is a report of 

contact for the State to name the 

individuals involved in the drug rebate 

program and is required only in those 

instances where a change to the original 

data submittal is necessary. The ability 

to require the reporting of any changes 

to these data is necessary to the efficient 

operation of the rebate program; Form 

Numbers: CMS–R–144 and CMS–368 

(OMB#: 0938–0852); Frequency: 

Quarterly; Affected Public: State, Local 

or Tribal Governments; Number of 

Respondents: 56; Total Annual 

Responses: 224; Total Annual Hours: 

12,101. (For policy questions regarding 

this collection contact Andrea 

Wellington at 410–786–3490. For all 

other issues call 410–786–1326.) 

6. Type of Information Collection 

Request: Extension of a currently 

approved collection; 

7. Title of Information Collection: 

Notice of Provider Non-Coverage (CMS– 

10123) and Detailed Explanation of 

Non-Coverage (CMS–10124); Use: The 

Notice of Medicare Provider NonCoverage (CMS–10123) is used to 

inform fee-for-service Medicare 

beneficiaries of the determination that 

their provider services will end, and of 

their right to an expedited review of that 

determination. The Detailed 

Explanation of Non-Coverage (CMS– 

10124) is used to provide beneficiaries 

who request an expedited determination 

with detailed information of why the 

services should end. The revised Notice 

of Provider Non-Coverage and Detailed 

Explanation of Provider Non-Coverage 

will no longer require use of the 

beneficiary’s Medicare number as a 

patient identifier. Instead, when 

applicable, providers may use a number 

that helps to link the notice with a 

related claim. Form Number: CMS– 

10123 and 10124 (OMB#: 0938–0953); 

Frequency: Occasionally; Affected 

Public: Business or other for-profit, Notfor-profit institutions, and Individuals 

or households; Number of Respondents: 

5,314,164; Total Annual Responses: 

5,314,194; Total Annual Hours: 885,699. 

(For policy questions regarding this 

collection contact Janet Miller at 404– 

562–1799. 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. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on August 8, 2011. 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS Desk 

Officer, Fax Number: (202) 395–6974, Email: OIRA_submission@omb.eop.gov. 

Dated: July 1, 2011. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2011–17052 Filed 7–7–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10209] 

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, 

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Federal Register / Vol. 76, No. 131 / Friday, July 8, 2011 / Notices 40371 

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 

Advantage Chronic Care Improvement 

Program and Quality Improvement 

Project Reporting Tools; Use: Section 

1852e(1), (2), (3)(a)(i) of the Social 

Security Act and 42 CFR 422.152 of the 

regulations describe CMS’ regulatory 

authority to require each Medicare 

Advantage Organization (MAO) 

coordinated care plan that offers one or 

more MA plans to have an ongoing 

quality assessment and performance 

improvement program. This program 

must include assessing performance 

using standard measures required by the 

Center for Medicare and Medicaid 

Services (CMS), and reporting its 

performance to CMS. 

MAOs will submit their Chronic Care 

Improvement Programs (CCIPs) and 

Quality Improvement Project (QIPs) 

using the revised CCIP and QIP 

Reporting Tools that are included in this 

collection. The tools have been 

redesigned: (1) To decrease the response 

burden through limiting the amount of 

narrative required and using an 

automated system; (2) to be more 

aligned with the standard QI reporting 

format; and (3) to improve the 

information provided by MAOs by using 

more structured reporting tools. CMS 

believes the new reporting tools will 

provide a simpler, easier way for MAOs 

to report the required data. The new tool 

will also generate consistency in 

reporting among plans so that collected 

data can be used more efficiently by 

CMS and the plans. Form Number: 

CMS–10209 (OMB#: 0938–1023); 

Frequency: Yearly; Affected Public: 

Private Sector—Business or other forprofits and Not-for-profit institutions; 

Number of Respondents: 1,904; Total 

Annual Responses: 1,904; Total Annual 

Hours: 9,520. (For policy questions 

regarding this collection contact Letticia 

Ramsey at 410–786–5262. 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 

at http://www.cms.gov/ 

PaperworkReductionActof1995/PRAL/ 

list.asp#TopOfPage 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 at 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 September 6, 2011: 

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: July 1, 2011. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2011–17087 Filed 7–7–11; 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: Personal Responsibility 

Education Program (PREP) MultiComponent Evaluation. 

OMB No.: New Collection. 

Description: The Family and Youth 

Services Bureau (HHS/ACF/ACYF/ 

FYSB) and the Office of Planning, 

Research, and Evaluation (HHS/ACF/ 

OPRE) in the Administration for 

Children and Families (ACF) are 

proposing a data collection activity to be 

undertaken for the Personal 

Responsibility Education Program 

(PREP) Multi-Component Evaluation. 

The impact study included in the 

PREP Multi-Component Evaluation is a 

random assignment evaluation which 

will expand available evidence on 

whether the replication of evidencebased effective programs, or the 

substantial incorporation of elements of 

these programs, funded as part of the 

Personal Responsibility Education 

Program, are effective at delaying sexual 

activity, increasing condom or 

contraceptive use for sexually active 

youth, or reducing pregnancy among 

youth. The evaluation will document 

and test a range of pregnancy prevention 

approaches in up to five program sites. 

The findings from the evaluation will be 

of interest to the general public, to 

policy-makers, and to organizations 

interested in teen pregnancy prevention. 

This Federal Register Notice is to 

notify the public regarding field data 

collection for the ‘‘Impact and In-Depth 

Implementation Study’’ component of 

the Personal Responsibility ’Education 

Program (PREP) Multi-Component 

Evaluation. 

The proposed field data collection 

activity involves the collection of 

information from interviews, focus 

groups, and short surveys with a range 

of experts and persons involved with 

programs about various aspects of 

existing prevention programs and topics 

the experts view as important to address 

through evaluation. Interviews and 

short surveys will focus on information 

leading to site selection. These data will 

be also used to help enhance decisions 

about the types of programs to be 

evaluated in the study. 

Respondents 

Researchers; Policy Experts; State 

Level Coordinators; Program Directors; 

Program Staff; Program Participants; 

School Administrators. 

ANNUAL BURDEN ESTIMATES

Field data collection instrument clearance 

Instrument 

Annual 

number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Discussion Guide for Use with Researchers, Policy Experts, and MacroLevel Coordinators ................................................................................... 10 1 1 10 

Discussion Guide for Use with Program Directors ...................................... 20 2 2 80 

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