31790 Federal Register / Vol. 75, No. 107 / Friday, June 4, 2010 / Notices 

Dated: May 28, 2010. 

Martique Jones, 

Director, Regulations Development DivisionB, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2010–13302 Filed 6–3–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10203] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services. 

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: Revision of a currently 

approved collection; Title of 

Information Collection: Medicare Health 

Outcomes Survey (HOS); Use: CMS has 

a responsibility to its Medicare 

beneficiaries to require that care 

provided by managed care organizations 

under contract to CMS is of high 

quality. One way of ensuring high 

quality care in Medicare Managed Care 

Organizations (MCOs), or more 

commonly referred to as Medicare 

Advantage Organizations (MAOs), is 

through the development of 

standardized, uniform performance 

measures to enable CMS to gather the 

data needed to evaluate the care 

provided to Medicare beneficiaries. 

The goal of the Medicare HOS 

program is to gather valid, reliable, 

clinically meaningful health status data 

in Medicare managed care for use in 

quality improvement activities, plan 

accountability, public reporting, and 

improving health. All managed care 

plans with Medicare Advantage (MA) 

contracts must participate. CMS, in 

collaboration with the National 

Committee for Quality Assurance 

(NCQA), launched the Medicare HOS as 

part of the Effectiveness of Care 

component of the former Health Plan 

Employer Data and Information Set, 

now known as the Healthcare 

Effectiveness Data and Information Set 

(HEDIS®). 

The HOS measure was developed 

under the guidance of a Technical 

Expert Panel comprised of individuals 

with specific expertise in the health care 

industry and outcomes measurement. 

The measure includes the most recent 

advances in summarizing physical and 

mental health outcomes results and 

appropriate risk adjustment techinques. 

In addition to health outcomes 

measures, the HOS is used to collect the 

Management of Urinary Incontinence in 

Older Adults, Physical Activity in Older 

Adults, Fall Risk Management, and 

Osteoporosis Testing in Older Women 

HEDIS® measures. The collection of 

Medicare HOS is necessary to hold 

Medicare managed care contractors 

accountable for the quality of care they 

are delivering. This reporting 

requirement allows CMS to obtain the 

information necessary for proper 

oversight of the Medicar Advantage 

program. Form Number: CMS–10203 

(OMB#: 0938–0701; Frequency: Yearly; 

Affected Public: Individuals and 

households; Number of Respondents: 

1,099,560 Total Annual Responses: 

1,099,560; Total Annual Hours: 366,520 

(For policy questions regarding this 

collection contact Chris Haffer at 410– 

786–8764. 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 August 3, 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. 

Date: May 28, 2010. 

Martique Jones, 

Director, Regulations Development DivisionB, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2010–13303 Filed 6–3–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–P–0278] 

Determination That Cysteine 

Hydrochloride Injection, USP, 7.25%, 

Was Not Withdrawn From Sale for 

Reasons of Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing its 

determination that Cysteine 

Hydrochloride Injection, USP, 7.25% 

(Cysteine HCl), was not withdrawn from 

sale for reasons of safety or 

effectiveness. This determination will 

allow FDA to approve abbreviated new 

drug applications (ANDAs) for Cysteine 

HCl if all other legal and regulatory 

requirements are met. 

FOR FURTHER INFORMATION CONTACT: 

David Joy, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, rm. 6358, Silver Spring, 

MD 20993–0002, 301–796–3601. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Public Law 98– 

417) (the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products approved 

under an ANDA procedure. ANDA 

applicants must, with certain 

exceptions, show that the drug for 

which they are seeking approval 

contains the same active ingredient in 

the same strength and dosage form as 

the ‘‘listed drug,’’ which is a version of 

the drug that was previously approved. 


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