34742 Federal Register / Vol. 75, No. 117 / Friday, June 18, 2010 / Notices 

under the Medicare and Medicaid 

programs. An OPO must be certified and 

designated by the Secretary as an OPO 

and must meet performance-related 

standards prescribed by the Secretary. 

The corresponding regulations are 

found at 42 CFR Part 486 (Conditions 

for Coverage of Specialized Services 

Furnished by Suppliers) under subpart 

G (Requirements for Certification and 

Designation and Conditions for 

Coverage: Organ Procurement 

Organizations). 

Since each OPO has a monopoly on 

organ procurement within its donation 

service area, CMS must hold OPOs to 

high standards. Collection of this 

information is necessary for CMS to 

assess the effectiveness of each OPO and 

determine whether it should continue to 

be certified as an OPO and designated 

for a particular donation service area by 

the Secretary or replaced by an OPO 

that can more effectively procure organs 

within the donation service area. Form 

Number: CMS–R–13 (OMB#: 0938– 

0688); Frequency: Occasionally; 

Affected Public: Not-for-profit 

institutions; Number of Respondents: 

79; Total Annual Responses: 79; Total 

Annual Hours: 15,178. (For policy 

questions regarding this collection 

contact Diane Corning at 410–786–8486. 

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

7. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: End Stage Renal 

Disease Medical Evidence Report 

Medicare Entitlement and/or Patient 

Registration; Use: The End Stage Renal 

Disease (ESRD) Medical Evidence 

Report is completed for all ESRD 

patients either by the first treatment 

facility or by a Medicare-approved 

ESRD facility when it is determined by 

a physician that the patient’s condition 

has reached that stage of renal 

impairment that a regular course of 

kidney dialysis or a kidney transplant is 

necessary to maintain life. The data 

reported on the CMS–2728 is used by 

the Federal Government, ESRD 

Networks, treatment facilities, 

researchers and others to monitor and 

assess the quality and type of care 

provided to end stage renal disease 

beneficiaries. The data collection 

captures the specific medical 

information required to determine the 

Medicare medical eligibility of End 

Stage Renal Disease claimants. Form 

Number: CMS–2728 (OMB#: 0938– 

0046); Frequency: Occasionally; 

Affected Public: Individuals or 

households; Number of Respondents: 

100,000; Total Annual Responses: 

100,000; Total Annual Hours: 75,000. 

(For policy questions regarding this 

collection contact Connie Cole at 410– 

786–0257. 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 17, 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: June 15, 2010. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2010–14781 Filed 6–17–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10179, CMS–R– 

234, CMS–2540–10, CMS–10108, CMS– 

10315, CMS–10302, CMS–2744 and CMS– 

2746] 

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: Extension without change of a 

currently approved collection; Title of 

Information Collection: Requests by 

Hospitals for an Alternative Cost-toCharge Ratio. Use: Section 1886(d)(5)(A) 

of the Act provides for additional 

Medicare payments to Inpatient 

Prospective Payment System (IPPS) 

hospitals for cases that incur 

extraordinarily high costs. To qualify for 

outlier payments, a case must have costs 

above a predetermined threshold 

amount (a dollar amount by which the 

estimated cost of a case must exceed the 

Medicare payment). Hospital-specific 

cost-to-charge ratios are applied to the 

covered charges for a case to determine 

the estimated cost of the case. In 

general, additional outlier payments for 

eligible cases are made based on a 

marginal cost factor of 80 percent, i.e. a 

fixed percentage of the costs. Therefore, 

if the estimated cost of the case exceeds 

the Medicare payment for that discharge 

plus the outlier threshold, generally 

Medicare will pay the hospital 80 

percent of the excess amount. The 

outlier threshold is updated annually at 

the beginning of the Federal Fiscal Year. 

Form Number: CMS–10179 (OMB#: 

0938–1020); Frequency: Occasionally; 

Affected Public: Private Sector and 

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

Respondents: 18; Total Annual 

Responses: 18; Total Annual Hours: 

144. (For policy questions regarding this 

collection contact Michael Treitel at 

410–786–4552. 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: Subpart D— 

Private Contracts and Supporting 

Regulations contained in 42 CFR 

405.410, 405.430, 405.435, 405.440, 

405.445, and 405.455. Use: Section 4507 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 117 / Friday, June 18, 2010 / Notices 34743 

of Balancing Budget Act (BBA) 1997 

amended section 1802 of the Social 

Security Act to permit certain 

physicians and practitioners to opt-out 

of Medicare and to provide through 

private contracts services that would 

otherwise be covered by Medicare. 

Under such contracts the mandatory 

claims submission and limiting charge 

rules of section 1848(g) of the Act would 

not apply. Subpart D and the 

Supporting Regulations contained in 42 

CFR 405.410, 405.430, 405.435, 405.440, 

405.445, and 405.455, counters the 

effect of certain provisions of Medicare 

law that, absent section 4507 of BBA 

1997, preclude physicians and 

practitioners from contracting privately 

with Medicare beneficiaries to pay 

without regard to Medicare limits. Form 

Number: CMS–R–234 (OMB#: 0938– 

0730); Frequency: Biennially; Affected 

Public: Private Sector and Business or 

other for-profits; Number of 

Respondents: 26,820; Total Annual 

Responses: 26,820; Total Annual Hours: 

7,197. (For policy questions regarding 

this collection contact Fred Grabau at 

410–786–0206. For all other issues call 

410–786–1326.) 

3. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Skilled Nursing 

Facility Health Care Complex Cost 

Report. Use: Providers of services 

participating in the Medicare program 

are required under sections 1815(a), and 

1861(v)(1)(A) of the Social Security Act 

to submit annual information to achieve 

settlement of costs for health care 

services rendered to Medicare 

beneficiaries. The CMS–2540–10 cost 

report is needed to determine the 

amount of reimbursement that is due to 

these providers furnishing medical 

services to Medicare beneficiaries. 

CMS is requesting review and 

approval of revisions made to the 

Skilled Nursing Facility (SNF) Cost 

Report FORM CMS–2540–10, (for cost 

reporting periods beginning on or after 

December 1, 2010) which replaces the 

existing FORM CMS 2540–96. Revisions 

made to update the forms currently in 

use are incorporated within this request 

for approval. Refer to the supporting 

documents for a list of revision to the 

cost reporting forms. Form Number: 

CMS–2540–10 (OMB#: 0938–0463); 

Frequency: Yearly; Affected Public: 

Private Sector and Business or other forprofits; Number of Respondents: 15,037; 

Total Annual Responses: 15,037; Total 

Annual Hours: 2,706,660. (For policy 

questions regarding this collection 

contact Edwin Gill at 410–786–4525. 

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

4. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Medicaid 

Managed Care Regulations for 42 CFR 

438.6, 438.8, 438.10, 438.12, 438.50, 

438.56, 438.102, 438.114, 438.202, 

438.204, 438.206, 438.207, 438.240, 

438.242, 438.402, 438.404, 438.406, 

438.408, 438.410, 438.414, 438.416, 

438.604, 437.710, 438.722, 438.724, and 

438.810; Use: These information 

collection requirements implement 

regulations that allow States greater 

flexibility to implement mandatory 

managed care program, implement new 

beneficiary protections, and eliminate 

certain requirements viewed by State 

agencies as impediments to the growth 

of managed care programs. Information 

collected includes information about 

managed care programs, grievances and 

appeals, enrollment broker contracts, 

and managed care organizational 

capacity to provide health care services. 

Form Number: CMS–10108 (OMB#: 

0938–0920); Frequency: Reporting: 

Occasionally; Affected Public: State, 

Local, or Tribal Government; Number of 

Respondents: 39,114,558; Total Annual 

Responses: 4,640,344; Total Annual 

Hours: 3,930,093.5. (For policy 

questions regarding this collection 

contact Angela Garner at 410–786–7062. 

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

5. Type of Information Collection 

Request: New collection; Title of 

Information Collection: Patient Safety 

Survey Under the 9th Scope of Work: 

Nursing Home in Need (NHIN). Use: 

The Centers for Medicare & Medicaid 

Services (CMS) is requesting OMB 

clearance for the Nursing Homes in 

Need (NHIN) Survey. The NHIN is a 

component of the Patient Safety Theme 

of the Quality Improvement 

Organization (QIO) Program’s 9th Scope 

of Work (SOW). The statutory authority 

for this scope of work is found in Part 

B of Title XI of the Social Security Act 

(the Act) as amended by the Peer 

Review Improvement Act of 1982. The 

Act established the Utilization and 

Quality Control Peer Review 

Organization Program, now known as 

the Quality Improvement Organization 

(QIO) Program. 

The QIO in each State will provide 

special technical assistance to a small 

number of nursing homes in need of 

assistance with quality improvement 

efforts. This special technical assistance 

will be for the QIO to conduct a root 

cause analysis (RCA) with one nursing 

home in its state per year (three over 

three years). Under this component, it is 

expected that within the first quarter of 

the contract period, CMS will assign one 

nursing home to each QIO. The 

determination of which nursing homes 

are eligible under this component will 

be made by CMS. Some of these 

facilities may meet criteria for Special 

Focus Facilities (SFF). The intent of this 

component is that each State QIO will 

work with three nursing homes over the 

three-year contract period; these 

assignments are expected to be spaced 

out so that each State QIO will get one 

nursing home assigned approximately 

every 12 months. 

The NHIN Survey is a new 

information collection to be used by 

CMS to obtain information on nursing 

home satisfaction with technical 

assistance strategies delivered as a 

component of the NHIN. The NHIN 

Survey will be a census of 53 nursing 

homes working with their respective 

QIOs. The survey will be conducted one 

time for each of the nursing homes 

assisted in the first two years under the 

9th SOW and it will be conducted twice 

with nursing homes assisted in the third 

year. The information collected through 

this survey will allow CMS to help 

focus the NHIN task to maximize the 

benefit to participating nursing homes. 

The NHIN Survey will be administered 

via telephone by trained and 

experienced interviewers. Responses 

will be entered into a pre-programmed 

Computer-Assisted Telephone 

Interviewing (CATI) interface. 

The NHIN Survey will include 

questions to determine if the QIO has 

conducted a root cause analysis and 

developed an action plan. These will be 

followed by questions about their 

satisfaction with the QIO and their 

perceived value of the QIO’s assistance. 

The NHIN Survey will address the 

following: 

• Background information; 

• Current work—information and 

assessment; 

• Satisfaction with QIOs; 

• Value of QIO assistance; 

• Sources of information; and 

• Respondent comments. 

All survey protocol and 

correspondence will be translated into 

Spanish and bi-lingual telephone 

interviewers will be used as needed. 

Form Number: CMS–10315 (OMB#: 

0938–New); Frequency: Occasionally; 

Affected Public: Businesses and other 

for-profit and not-for-profit institutions; 

Number of Respondents: 53; Total 

Annual Responses: 106; Total Annual 

Hours: 17.5 hours (years 1 and 2), 35 

hours (year 3). (For policy questions 

regarding this collection contact Bob 

Kambic 410–786–1515. For all other 

issues call 410–786–1326.) 

6. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 


srobinson on DSKHWCL6B1PROD with NOTICES
34744 Federal Register / Vol. 75, No. 117 / Friday, June 18, 2010 / Notices 

Information Collection: Collection 

Requirements for Compendia for 

Determination of Medically-accepted 

Indications for Off-label Uses of Drugs 

and Biologicals in an Anti-cancer 

Chemotherapeutic Regimen Use: 

Congress enacted the Medicare 

Improvement of Patients and Providers 

Act (MIPPA). Section 182(b) of MIPPA 

amended Section 1861(t)(2)(B) of the 

Social Security Act (42 U.S.C. 

1395x(t)(2)(B)) by adding at the end the 

following new sentence: ‘On and after 

January 1, 2010, no compendia may be 

included on the list of compendia under 

this subparagraph unless the compendia 

has a publicly transparent process for 

evaluating therapies and for identifying 

potential conflicts of interest.’ We 

believe that the implementation of this 

statutory provision that compendia have 

a ‘‘publicly transparent process for 

evaluating therapies and for identifying 

potential conflicts of interests’’ is best 

accomplished by amending 42 CFR 

414.930 to include the MIPPA 

requirements and by defining the key 

components of publicly transparent 

processes for evaluating therapies and 

for identifying potential conflicts of 

interests. 

All currently listed compendia will be 

required to comply with these 

provisions, as of January 1, 2010, to 

remain on the list of recognized 

compendia. In addition, any 

compendium that is the subject of a 

future request for inclusion on the list 

of recognized compendia will be 

required to comply with these 

provisions. No compendium can be on 

the list if it does not fully meet the 

standard described in section 

1861(t)(2)(B) of the Act, as revised by 

section 182(b) of the MIPPA. Form 

Number: CMS–10302 (OMB#: 0938– 

1078); Frequency: Reporting, 

Recordkeeping and Third-party 

disclosure; Affected Public: Business 

and other for-profits and Not-for-profit 

institutions; Number of Respondents: 

845; Total Annual Responses: 900; Total 

Annual Hours: 5,135. (For policy 

questions regarding this collection 

contact Brijet Burton at 410–786–7364. 

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

7. Type of Information Collection 

Request: Reinstatement without change 

of a previously approved collection; 

Title of Information Collection: End 

Stage Renal Disease (ESRD) Medical 

Information Facility Survey; Form 

Number: CMS–2744 (OMB#: 0938– 

0447); Use: The End Stage Renal Disease 

(ESRD) Medical Information Facility 

Survey form (CMS–2744) is completed 

annually by Medicare-approved 

providers of dialysis and transplant 

services. The CMS–2744 is designed to 

collect information concerning 

treatment trends, utilization of services 

and patterns of practice in treating 

ESRD patients. The information is used 

to assess and evaluate the local, regional 

and national levels of medical and 

social impact of ESRD care and is used 

extensively by researchers and suppliers 

of services for trend analysis. The 

information is available on the CMS 

Dialysis Facility Compare website and 

will enable patients to make informed 

decisions about their care by comparing 

dialysis facilities in their area. 

Frequency: Yearly; Affected Public: 

Business or other for-profit, Not-forprofit institutions; Number of 

Respondents: 5,465; Total Annual 

Responses: 5,465; Total Annual Hours: 

43,720. (For policy questions regarding 

this collection contact Connie Cole at 

410–786–0257. For all other issues call 

410–786–1326.) 

8. Type of Information Collection 

Request: Reinstatement without change 

of a previously approved collection; 

Title of Information Collection: End 

Stage Renal Disease Death Notification 

P.L. 95–292; 42 CFR 405.2133, 45 CFR 

5–5b; 20 CFR Parts 401 and 422E Use: 

The ESRD Death Notification (CMS– 

2746) is completed by all Medicareapproved ESRD facilities upon the death 

of an ESRD patient. Its primary purpose 

is to collect fact of death and cause of 

death of ESRD patients. Certain other 

identifying information (e.g., name, 

Medicare claim number, and date of 

birth) is required for matching purposes. 

Federal regulations require that the 

ESRD Networks examine the mortality 

rates of every Medicare-approved 

facility within its area of responsibility. 

The Death Form provides the necessary 

data to assist the ESRD Networks in 

making decisions that result in 

improved patient care and in costeffective distribution of ESRD resources. 

The data is used by the ESRD Networks 

to verify facility deaths and to monitor 

facility performance. Form Number: 

CMS–2746 (OMB#: 0938–0448); 

Frequency: On occasion; Affected 

Public: Business or other for-profit, Notfor-profit institutions; Number of 

Respondents: 5,173; Total Annual 

Responses: 82,768; Total Annual Hours: 

41,384. (For policy questions regarding 

this collection contact Connie Cole at 

410–786–0257. 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 July 19, 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: June 15, 2010. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2010–14780 Filed 6–17–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0083] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Substances 

Prohibited From Use in Animal Food or 

Feed; Animal Proteins Prohibited in 

Ruminant Feed 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by July 19, 

2010. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0339. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., 


srobinson on DSKHWCL6B1PROD with NOTICES