79000 Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 

entitlement to Part A and 

Supplementary Medical Insurance (Part 

B). Form Number: CMS–18F5 (OMB#: 

0938–0251); Frequency: Once; Affected 

Public: Individuals or households; 

Number of Respondents: 50,000; Total 

Annual Responses: 50,000; Total 

Annual Hours: 12,495. (For policy 

questions regarding this collection 

contact Naomi Rappaport at 410–786– 

2175. For all other issues call 410–786– 

1326.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Clinical 

Laboratory Improvement Amendment 

(CLIA) of 1988 and Supporting 

Regulations in 42 CFR 493.1–.2001; Use: 

The information collection requirements 

in 42 CFR part 493 outline the 

requirements necessary to determine an 

entity’s compliance with CLIA. CLIA 

requires laboratories that perform 

testing on human beings to meet 

performance requirements (quality 

standards) in order to be certified by the 

Department of Health and Human 

Services (DHHS). DHHS conducts 

inspections to determine a laboratory’s 

compliance with CLIA requirements. 

CLIA implements the certificate, 

laboratory standards and inspection 

requirements; Form Number: 

CMS–R–26 (OMB#: 0938–0612); 

Frequency: Occasionally; Affected 

Public: Federal Government; State, 

Local, or Tribal Governments; Private 

Sector: Business or other for-profits and 

not-for-profit institutions; Number of 

Respondents: 168,688; Total Annual 

Responses: 756,240; Total Annual 

Hours: 11,363,280. (For policy questions 

regarding this collection contact Raelene 

Perfetto at 410–786–6876. 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 January 18, 2011. 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS Desk 

Officer, Fax Number: (202) 395–6974. 

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

Dated: December 10, 2010. 

Martique Jones, 

Director, Regulations Development DivisionB, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2010–31599 Filed 12–16–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–102 and CMS– 

105, CMS–10241, CMS–10261, CMS–10185, 

and CMS–10340] 

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: Extension without change of a 

currently approved collection; Title of 

Information Collection: Clinical 

Laboratory Improvement Amendments 

of 1988 (CLIA) Budget Workload 

Reports and Supporting Regulations in 

42 CFR 493.1-.2001; Use: The collected 

information will be used by CMS to 

determine the amount of Federal 

reimbursement for surveys conducted. 

Use of the information includes program 

evaluation, audit, budget formulation 

and budget approval. Form CMS–102 is 

a multi-purpose form designed to 

capture and record all budget and 

expenditure data. Form CMS–105 

captures the annual projected CLIA 

workload that the State survey agency 

will accomplish. It is also used by the 

CMS regional office to approve the 

annual projected CLIA workload. The 

information is required as part of the 

section 1864 agreement with the State; 

Form Numbers: CMS–102 and CMS–105 

(OMB#: 0938–0599); Frequency: 

Quarterly; Affected Public: State, Local, 

or Tribal Governments; Number of 

Respondents: 50; Total Annual 

Responses: 50; Total Annual Hours: 

4,500. (For policy questions regarding 

this collection contact Carla Ausby at 

410–786–2153. For all other issues call 

410–786–1326.) 

2. Type of Information Collection 

Request: Extension without change of a 

currently approved collection; Title of 

Information Collection: Annual State 

Report and Annual State Performance 

Rankings; Use: Section 6001(f) of the 

Deficit Reduction Act (DRA) requires 

CMS to contract with a vendor to 

conduct a monthly national survey of 

retail prescription drug prices and to 

report the prices to the States. These 

national average prices may be used as 

a benchmark by the States for the 

management of their prescription drug 

programs. The DRA also requires that 

the States submit pricing information 

for the 50 most widely prescribed drugs 

so that the States’ prices can be 

compared to the national average prices 

obtained from the survey. The States 

pricing information will be compared 

and the States will be ranked. The Act 

also requires that States report their 

drug utilization rates for noninnovator 

multiple source (generic) drugs, their 

payment rates under their State plan, 

and their dispensing fees. The template 

has been developed to facilitate data 

collection; Form Number: CMS–10241 

(OMB#: 0938–1041); Frequency: Yearly; 

Affected Public: State, Local, or Tribal 

Governments; Number of Respondents: 

51; Total Annual Responses: 51; Total 

Annual Hours: 765. (For policy 

questions regarding this collection 

contact Joseph Fine at 410–786–2128. 

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

3. Type of Information Collection 

Request: Revision of currently approved 

collection; Title of Information 

Collection: Part C Medicare Advantage 

(MA) Reporting Requirements and 

Supporting Regulations; Use: CMS has 

authority to establish reporting 

requirements for Medicare Advantage 

Organizations (MAO’s) as described in 

42 CFR § 422.516 (a). Each MAO must 

have an effective procedure to develop, 

compile, evaluate, and report to CMS, to 

its enrollees, and to the general public, 

at the times and in the manner that CMS 

requires, and while safeguarding the 

confidentiality of the doctor-patient 

relationship, statistics and other 

information with respect to the cost of 

its operations, patterns of service 

utilization, availability, accessibility, 


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Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 79001 

and acceptability of its services, 

developments in the health status of its 

enrollees, and other matters that CMS 

may require. Data collected via 

Medicare Part C Reporting 

Requirements will be an integral 

resource for oversight, monitoring, 

compliance and auditing activities 

necessary to ensure quality provision of 

the benefits provided by MA plans to 

enrollees. Form Number: CMS–10261 

(OMB# 0938–1054); Frequency: Yearly, 

Quarterly; Affected Public: Business or 

other for-profits; Number of 

Respondents: 588; Total Annual 

Responses: 1158; Total Annual Hours: 

245,528. (For policy questions regarding 

this collection contact Terry Leid at 

410–786–8973. For all other issues call 

410–786–1326.) 

4. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Medicare Part D 

Reporting Requirements and Supporting 

Regulations; Use: 42 CFR part 423, 

§ 423.514, requires each Part D Sponsor 

to have an effective procedure to 

provide statistics indicating: the cost of 

its operations, the patterns of utilization 

of its services, the availability, 

accessibility, and acceptability of its 

services, information demonstrating it 

has a fiscally sound operation and other 

matters as required by CMS. In addition, 

subsection 423.505 of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act (MMA), establishes 

as a contract provision that Part D 

Sponsors must comply with the 

reporting requirements for submitting 

drug claims and related information to 

CMS. Data collected via Medicare Part 

D Reporting Requirements will be an 

integral resource for oversight, 

monitoring, compliance and auditing 

activities necessary to ensure quality 

provision of the Medicare Prescription 

Drug Benefit to beneficiaries. Data will 

be validated, analyzed, and utilized for 

trend reporting by the Division of 

Clinical and Operational Performance 

(DCOP) within the Medicare Drug 

Benefit Group. Form Number: CMS– 

10185 (OMB#: 0938–0992); Frequency: 

Yearly, Quarterly, Semi-Annually; 

Affected Public: Private sector, business 

or other for-profit; Number of 

Respondents: 2993; Total Annual 

Responses: 48,490; Total Annual Hours: 

128,754. (For policy questions regarding 

this collection contact LaToyia Grant at 

410–786–5434. For all other issues call 

410–786–1326.) 

5. Type of Information Collection 

Request: New collection; Title of 

Information Collection: Collection of 

Encounter Data from Medicare 

Advantage Organizations; Use: The 

Centers for Medicare and Medicaid 

Services (CMS) intends to collect 

encounter data, or data on each item or 

service delivered to an enrollee, from 

Medicare Advantage Organizations. 

Medicare Advantage organizations will 

obtain this data from providers. CMS 

would collect the data electronically 

from Medicare Advantage Organizations 

via the Health Insurance Portability and 

Accountability Act (HIPAA) compliant 

standard Health Care Claims 

transactions for professional data and 

institutional data. The information is 

used to submit health care claims or 

equivalent health encounter 

information, carry out health plan 

enrollments and disenrollments, 

determine health plan eligibility, send 

and receive health care payment and 

remittance advices, transmit health plan 

premium payments, determine health 

care claim status, provide referral 

certifications and authorizations, and 

coordinate the benefits for individuals 

who have more than one health plan. 

Form Number: CMS–10340 (OMB#: 

0938–New); Frequency: Weekly; 

Affected Public: Private sector; 

businesses or other for-profits; Number 

of Respondents: 678; Total Annual 

Responses: 384,041,063; Total Annual 

Hours: 768. (For policy questions 

regarding this collection contact Sean 

Creighton at 410–786–9302 or Deondra 

Moseley at 410–786–4577. 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 February 15, 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: December 10, 2010. 

Martique Jones, 

Director, Regulations Development DivisionB, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2010–31541 Filed 12–16–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0627] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Application for 

Food and Drug Administration 

Approval to Market a New Drug 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

requirements governing applications for 

FDA approval to market a new drug. 

DATES: Submit either electronic or 

written comments on the collection of 

information by February 15, 2011. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to: http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

P150–400B, Rockville, MD 20850, 301– 

796–3792, 

Elizabeth.Berbakos@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 


emcdonald on DSK2BSOYB1PROD with NOTICES