63484 Federal Register / Vol. 75, No. 199 / Friday, October 15, 2010 / Notices 

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 November 15, 2010. 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS Desk 

Officer, Fax Number: (202) 395–6974, 

e-mail: OIRA_submission@omb.eop.gov. 

Dated: October 8, 2010. 

Martique Jones, 

Director, Regulations Development Division— 

B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2010–25943 Filed 10–14–10; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–R–153 and 

CMS–10152] 

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, 

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: Reinstatement with change of a 

previously approved collection; Title of 

Information Collection: Medicaid Drug 

Utilization Review (DUR) Annual 

Report; Use: The DUR program is 

required to assure that prescriptions are 

appropriate, medically necessary and 

are not likely to result in adverse 

medical results. Each State DUR 

program must consist of prospective 

drug use review, retrospective drug use 

review, data assessment of drug use 

against predetermined standards, and 

ongoing educational outreach activities. 

In addition, States are required to 

submit an annual DUR program report 

that includes a description of the nature 

and scope of State DUR activities as 

outlined in the statute and regulations. 

Over the years, technology has changed 

as has the practice of the pharmacy. 

Therefore, CMS has revised the old 

survey vehicle to more fully address the 

current practices and areas of concern 

with the Medicaid Pharmacy Programs. 

Form Number: CMS–R–153 (OMB#: 

0938–0659); Frequency: Annually; 

Affected Public: State, Local, or Tribal 

Governments; Number of Respondents: 

51; Total Annual Responses: 51; Total 

Annual Hours: 20,298. (For policy 

questions regarding this collection 

contact Madlyn Kruh at 410–786–3239. 

For all other issues call 410–786–1326.) 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Data Collection 

for Medicare Beneficiaries Using 

NaF–18 Positron Emission Tomography 

(PET) to Identify Bone Metastasis in 

Cancer; Use: In Decision Memorandum 

# CAG–00065R, issued on February 26, 

2010, the Centers for Medicare and 

Medicaid Services (CMS) determined 

that the evidence is sufficient to 

conclude that for Medicare beneficiaries 

receiving NaF–18 PET scan to identify 

bone metastasis in cancer is reasonable 

and necessary only when the provider is 

participating in and patients are 

enrolled in a clinical study designed to 

information at the time of the scan to 

assist in initial antitumor treatment 

planning or to guide subsequent 

treatment strategy by the identification, 

location and quantification of bone 

metastases in beneficiaries in whom 

bone metastases are strongly suspected 

based on clinical symptoms or the 

results of other diagnostic studies. 

Qualifying clinical studies must ensure 

that specific hypotheses are addressed; 

appropriate data elements are collected; 

hospitals and providers are qualified to 

provide the PET scan and interpret the 

results; participating hospitals and 

providers accurately report data on all 

Medicare enrolled patients; and all 

patient confidentiality, privacy, and 

other Federal laws must be followed. 

Consistent with section 1142 of the 

Social Security Act, the Agency for 

Healthcare Research and Quality 

(AHRQ) supports clinical research 

studies that the CMS determines meet 

specified standards and address the 

specified research questions. 

To qualify for payment, providers 

must prescribe certain NaF–18 PET 

scans for beneficiaries with a set of 

clinical criteria specific to each solid 

tumor. The statuary authority for this 

policy is section 1862(a)(1)(E) of the 

Social Security Act. The need to 

prospectively collect information at the 

time of the scan is to assist the provider 

in decision making for patient 

management. To qualify for payment, 

providers must prescribe certain 

NaF–18 PET scans for beneficiaries with 

a set of clinical criteria specific to each 

solid tumor. Data elements will be 

transmitted to CMS for evaluation of the 

short and long-term benefits of NaF–18 

PET to beneficiaries and for use in 

future clinical decision making. Form 

Number: CMS–10152 (OMB#: 0938– 

0968); Frequency: Annually; Affected 

Public: Individuals or Households; 

Number of Respondents: 25,000; Total 

Annual Responses: 25,000; Total 

Annual Hours: 2,084. (For policy 

questions regarding this collection 

contact Stuart Caplan at 410–786–9564. 

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.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 December 14, 2010: 

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: October 8, 2010. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2010–25934 Filed 10–14–10; 8:45 am] 

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