902 Federal Register / Vol. 74, No. 6 / Friday, January 9, 2009 / Notices 

cooperative agreements are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act. If the proposed project 

involves research on human subjects, 

the applicants must comply with 

Department of Health and Human 

Services regulations (45 CFR part 46) 

regarding the protection of human 

subjects. The applicants must ensure 

that the project will be subject to initial 

and continuing review by the 

appropriate institutional review 

committees. Overall, by providing 

additional scientific information for the 

risk assessment process, data generated 

from this research will support other 

researchers who are conducting human 

health assessments involving these two 

substances. 

The mechanisms for implementing 

SSARP are discussed next. The status of 

SSARP in addressing priority data needs 

of the first 60 priority hazardous 

substances through these mechanisms 

was described in a Federal Register 

Notice on December 13, 2005 (70 FR 

73749). 

A. TSCA/FIFRA 

In developing and implementing 

SSARP, ATSDR and EPA established 

procedures to identify priority data 

needs of common interest to multiple 

federal programs. Where practicable, 

these data needs will be addressed 

through a program of toxicologic testing 

under TSCA or FIFRA. This part of the 

research will be conducted according to 

established TSCA/FIFRA procedures 

and guidelines. 

B. Private-Sector Voluntarism 

As part of SSARP, on February 7, 

1992, ATSDR announced a set of 

proposed procedures for conducting 

voluntary research (57 FR 4758). 

Revisions based on public comments 

were published on November 16, 1992 

(57 FR 54160). ATSDR strongly 

encourages private-sector organizations 

to propose research to address priority 

data needs at any time until ATSDR 

announces that research has already 

been initiated for a specific priority data 

need. Private-sector organizations may 

volunteer to conduct research to address 

specific priority data needs identified in 

this notice by submitting a letter of 

intent. 

The letter of intent should be a brief 

statement (1–2 pages) that identifies the 

priority data need(s) to be filled and the 

methods to be used. TASARC will 

review these proposals and recommend 

to ATSDR the voluntary research 

projects that should be pursued—and 

how they should be conducted—with 

the volunteer organizations. ATSDR will 

enter into only those voluntary research 

projects that lead to high-quality, peerreviewed scientific work. Additional 

details regarding the process for 

voluntary research are in the Federal 

Register Notices cited in this section. 

C. CERCLA 

Those priority data needs that are not 

addressed by TSCA/FIFRA or initial 

voluntarism will be considered for 

funding by ATSDR through its CERCLA 

budget. Much of this research program 

is envisioned to be unique to CERCLA— 

for example, research on substances not 

regulated by other programs or research 

needs specific to public health 

assessments. A current example of the 

direct use of CERCLA funds is a 

cooperative agreement with the 

Association of Minority Health 

Professions Schools (AMHPS) that 

supports the AMHPS Environmental 

Health, Health Services, and Toxicology 

Research programs. 

Mechanisms to address these priority 

data needs may include a second call for 

voluntarism. Again, scientific peer 

review of study protocols and results 

would occur for all research conducted 

under this auspice. 

ATSDR encourages private-sector 

organizations and other governmental 

programs to use ATSDR’s priority data 

needs to plan their research activities. 

Dated: January 6, 2009. 

Ken Rose, 

Director, Office of Policy, Planning, and 

Evaluation, National Center for 

Environmental Health/Agency for Toxic 

Substances and Disease Registry. 

[FR Doc. E9–189 Filed 1–8–09; 8:45 am] 

BILLING CODE 4163–70–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–R–262, CMS– 

10142 and CMS–R–137] 

Agency Information Collection 

Activities: Submission for OMB 

Review; 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), Department of Health 

and Human Services, 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 function; 

(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: CY 2010 Plan 

Benefit Package (PBP) and Formulary 

Submission for Medicare Advantage 

(MA) Plans and Prescription Drug Plans 

(PDP) Use: Under the Medicare 

Modernization Act (MMA), Medicare 

Advantage (MA) and Prescription Drug 

Plan (PDP) organizations are required to 

submit plan benefit packages for all 

Medicare beneficiaries residing in their 

service area. The plan benefit package 

submission consists of the formulary 

file, Plan Benefit Package (PBP) 

software, and supporting documentation 

as necessary. MA and PDP organizations 

will generate a formulary to illustrate 

their list of drugs, including information 

on prior authorization, step therapy, 

tiering, and quantity limits. 

Additionally, the PBP software will be 

used to describe their organization’s 

plan benefit packages, including 

information on premiums, cost sharing, 

authorization rules, and supplemental 

benefits. CMS uses the formulary and 

PBP data to review and approve the 

plan benefit packages proposed by each 

MA and PDP organization. 

CMS requires that MA and PDP 

organizations submit a completed 

formulary and PBP as part of the annual 

bidding process. During this process, 

organizations prepare their proposed 

plan benefit packages for the upcoming 

contract year and submit them to CMS 

for review and approval. Based on 

operational changes and policy 

clarifications to the Medicare program 

and continued input and feedback by 

the industry, CMS has made the 

necessary changes to the plan benefit 

package submission. Form Number: 

CMS–R–262 (OMB# 0938–0763); 

Frequency: Yearly; Affected Public: 

Business or other for-profits b. Not-forprofit institutions; Number of 

Respondents: 475; Total Annual 

Responses: 4987.5; Total Annual Hours: 

12112.5. 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

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Federal Register / Vol. 74, No. 6 / Friday, January 9, 2009 / Notices 903 

Information Collection: CY 2010 Bid 

Pricing Tool (BPT) for Medicare 

Advantage (MA) Plans and Prescription 

Drug Plans (PDP). Use: Under the 

Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 (MMA), and implementing 

regulations at 42 CFR, Medicare 

Advantage organizations (MAO) and 

Prescription Drug Plans (PDP) are 

required to submit an actuarial pricing 

‘‘bid’’ for each plan offered to Medicare 

beneficiaries for approval by CMS. 

MAOs and PDPs use the Bid Pricing 

Tool (BPT) software to develop their 

actuarial pricing bid. The information 

provided in the BPT is the basis for the 

plan’s enrollee premiums and CMS 

payments for each contract year. The 

tool collects data such as medical 

expense development (from claims data 

and/or manual rating), administrative 

expenses, profit levels, and projected 

plan enrollment information. By statute, 

completed BPTs are due to CMS by the 

first Monday of June each year. CMS 

reviews and analyzes the information 

provided on the Bid Pricing Tool. 

Ultimately, CMS decides whether to 

approve the plan pricing (i.e., payment 

and premium) proposed by each 

organization. Form Number: CMS– 

10142 (OMB# 0938–0944); Frequency: 

Yearly; Affected Public: Business or 

other for-profits b. Not-for-profit 

institutions; Number of Respondents: 

550; Total Annual Responses: 6050; 

Total Annual Hours: 42,350. 

3. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Internal 

Revenue Service (IRS)/Social Security 

Administration (SSA)/Centers for 

Medicare and Medicaid Services (CMS) 

Data Match and Supporting Regulations 

in 42 CFR 411.20–491.206 Use: 

Medicare Secondary Payer (MSP) is 

essentially the same concept known in 

the private insurance industry as 

coordination of benefits; it refers to 

those situations where Medicare 

assumes a secondary payer role to 

certain types of private insurance for 

covered services provided to a Medicare 

beneficiary. 

Congress sought to reduce the losses 

to the Medicare program by requiring in 

42 U.S.C. 1395y(b)(5) that the Internal 

Revenue Service (IRS), the Social 

Security Administration (SSA), and 

CMS perform an annual data match (the 

IRS/SSA/CMS Data Match, or ‘‘Data 

Match’’ for short). CMS uses the 

information obtained through Data 

Match to contact employers concerning 

possible application of the MSP 

provisions by requesting information 

about specifically identified employees 

(either a Medicare beneficiary or the 

working spouse of a Medicare 

beneficiary). This statutory data match 

and employer information collection 

activity enhances CMS’s ability to 

identify both past and present MSP 

situations. Form Number: CMS–R–137 

(OMB# 0938–0763); Frequency: 

Annually; Affected Public: Business or 

other for-profit, not-for-profit 

institutions, farms, State, Local or Tribal 

Governments; Number of Respondents: 

326,597; Total Annual Responses: 

326,597; Total Annual Hours: 1,900,795. 

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 February 9, 2009: OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer, New 

Executive Office Building, Room 10235, 

Washington, DC 20503, Fax Number: 

(202) 395–6974. 

Dated: December 28, 2008. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E9–52 Filed 1–8–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10062, CMS– 

10275, and CMS–10137] 

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: Extension of a currently 

approved collection; Title of 

Information Collection: Collection of 

Diagnostic Data from Medicare 

Advantage Organizations for Risk 

Adjusted Payments: Use: CMS requires 

hospital inpatient, hospital outpatient 

and physician diagnostic data from 

Medicare Advantage (MA) organizations 

to continue making payment under the 

risk adjustment methodology as 

required by the Social Security Act, as 

amended by the Balanced Budget Act; 

the Medicare, Medicaid and SCHIP 

Benefits Improvement and Protection 

Act; and the Medicare Prescription Drug 

Benefit, Improvement and 

Modernization Act. CMS will use the 

data to make risk adjusted payment 

under Parts C. MA and MA–PD plans 

will use the data to develop their Parts 

C bids. As required by law, CMS also 

annually publishes the risk adjustment 

factors for plans and other interested 

entities in the Advance Notice of 

Methodological Changes for MA 

Payment Rates (every February) and the 

Announcement of Medicare Advantage 

Payment Rates (every April). Lastly, 

CMS issues monthly reports to each 

individual plan that contains the CMSHierarchical Condition Category (HCC) 

and RxHCC models’ output and the risk 

scores and reimbursements for each 

beneficiary that is enrolled in their plan. 

Form Number: CMS–10062 (OMB# 

0938–0878); Frequency: Quarterly; 

Affected Public: Business or other forprofit and not-for-profit institutions; 

Number of Respondents: 852; Total 

Annual Responses: 22,097,070; Total 

Annual Hours: 10,826.1. 

2. Type of Information Collection 

Request: New collection; Title of 

Information Collection: CAHPS Home 

Health Care Survey: Use: As part of the 

Department of Health and Human 

Services (DHHS) Transparency Initiative 

on Quality Reporting, CMS plans to 

implement a process to measure and 

publicly report home health care patient 

experiences through the CAHPS 

(Consumer Assessment of Healthcare 

mstockstill on PROD1PC66 with NOTICES