52964 Federal Register / Vol. 74, No. 198 / Thursday, October 15, 2009 / Notices 

Transportation Intermediary 

Applicants: 

Interport Company, Inc. dba Interport 

Lines, 2300 E. Higgins Road, Ste. 

312, Elk Grove Village, IL 60007. 

Officer: Antonio J. Alvaro, President 

(Qualifying Individual). 

Consolidators International, Inc., dba 

Corrigan’s Express Freight dba 

Backstage Cargo USA, 8900 

Bellanca Avenue, Los Angeles, CA 

90045. Officer: Ronen Donde, Vice 

President (Qualifying Individual). 

Dated: October 9, 2009. 

Tanga S. FitzGibbon, 

Assistant Secretary. 

[FR Doc. E9–24835 Filed 10–14–09; 8:45 am] 

BILLING CODE 6730–01–P 

FEDERAL RESERVE SYSTEM 

Notice of Proposals to Engage in 

Permissible Nonbanking Activities or 

to Acquire Companies that are 

Engaged in Permissible Nonbanking 

Activities 

The companies listed in this notice 

have given notice under section 4 of the 

Bank Holding Company Act (12 U.S.C. 

1843) (BHC Act) and Regulation Y (12 

CFR Part 225) to engage de novo, or to 

acquire or control voting securities or 

assets of a company, including the 

companies listed below, that engages 

either directly or through a subsidiary or 

other company, in a nonbanking activity 

that is listed in § 225.28 of Regulation Y 

(12 CFR 225.28) or that the Board has 

determined by Order to be closely 

related to banking and permissible for 

bank holding companies. Unless 

otherwise noted, these activities will be 

conducted throughout the United States. 

Each notice is available for inspection 

at the Federal Reserve Bank indicated. 

The notice also will be available for 

inspection at the offices of the Board of 

Governors. Interested persons may 

express their views in writing on the 

question whether the proposal complies 

with the standards of section 4 of the 

BHC Act. Additional information on all 

bank holding companies may be 

obtained from the National Information 

Center website at www.ffiec.gov/nic/. 

Unless otherwise noted, comments 

regarding the applications must be 

received at the Reserve Bank indicated 

or the offices of the Board of Governors 

not later than October 29, 2009. 

A. Federal Reserve Bank of Chicago 

(Colette A. Fried, Assistant Vice 

President) 230 South LaSalle Street, 

Chicago, Illinois 60690–1414: 

1. Iowa Credit Union League, and 

Affiliates Management Company, both 

of Clive, Iowa; to acquire 100 percent of 

the voting shares of The Members 

Group, Inc., Clive, Iowa, and thereby 

engage in data procesing, real estate 

leasing, and asset management, 

servicing, and collection activities, 

pursuant to sections 225.28(2)(vi), (b)(3), 

and (b)(14)(i) of Regulation Y. 

2. Iowa Credit Union League, and 

Affiliates Management Company, both 

of Clive, Iowa; to acquire 53 percent of 

the voting shares of Community 

Business Lenders, L.L.C., Clive, Iowa, 

and thereby engage in extending credit 

and servicing loans, pursuant to section 

225.28(b)(1) of Regulation Y. 

3. Iowa Credit Union League, and 

Affiliates Management Company, both 

of Clive, Iowa; to acquire 89 percent of 

the voting shares of TMG Financial 

Services,Inc., Clive, Iowa, and thereby 

engage in extending credit and servicing 

loans, pursuant to section 225.28(b)(1) 

of Regulation Y. 

4. Iowa Credit Union League, and 

Affiliates Management Company, both 

of Clive, Iowa; to acquire 90 percent of 

the voting shares of Coopera Consulting, 

L.L.C., Clive, Iowa, and thereby engage 

in community development advisory 

activities, pursuant to section 

225.28(b)(12)(ii) of Regulation Y. 

Board of Governors of the Federal Reserve 

System, October 9, 2009. 

Jennifer J. Johnson, 

Secretary of the Board. 

[FR Doc. E9–24766 Filed 10–14–09; 8:45 am] 

BILLING CODE 6210–01–S?≤ 

FEDERAL TRADE COMMISSION 

Senior Executive Service Performance 

Review Board 

AGENCY: Federal Trade Commission. 

ACTION: Notice. 

SUMMARY: Notice is hereby given of the 

appointment of members to the Federal 

Trade Commission’s Performance 

Review Board. 

FOR FURTHER INFORMATION CONTACT: 

Karen Leydon, Director of Human 

Resources, 600 Pennsylvania Avenue 

NW, Washington, DC 20580, (202) 326- 

3633. 

SUPPLEMENTARY INFORMATION: 

Publication of the Performance Review 

Board (PRB) membership is required by 

5 U.S.C. 4314 (c)(4). The PRB reviews 

and evaluates the initial appraisal of a 

senior executive’s performance by the 

supervisor, and makes 

recommendations regarding 

performance ratings, performance 

awards, and pay-for-performance pay 

adjustments to the Chairman. 

The following individuals have been 

designated to serve on the Commission’s 

Performance Review Board: 

∑ Charles H. Schneider, Executive 

Director, Chairman 

∑ Willard K. Tom, General Counsel 

∑ Pauline M. Ippolito, Deputy 

Director, Bureau of Economics 

By direction of the Commission. 

Donald S. Clark 

Secretary 

[FR Doc. E9–24731 Filed 10–14–09: 9:55 am] 

BILLING CODE 6750–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of Inspector General; Notice for 

Potential Monitors for Quality-of-Care 

Corporate Integrity Agreements 

AGENCY: Office of Inspector General 

(OIG), Department of Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Office of Inspector 

General (OIG) is seeking to identify 

potential organizations to monitor 

health care entities under quality-of-care 

Corporate Integrity Agreements (CIA) 

with OIG. OIG is interested in receiving 

information from organizations that 

believe they have the capability to be 

monitors for quality-of-care CIAs. This 

is not a request for proposals and does 

not commit OIG to select or consider a 

particular organization to be a monitor. 

Any information provided to OIG in 

response to this notice is strictly 

voluntary. The Government will not pay 

for information submitted in response to 

this notice. 

DATES: Responses may be submitted on 

an ongoing basis. 

ADDRESSES: Please mail or deliver any 

response to the following address: 

Office of Counsel to the Inspector 

General, Department of Health and 

Human Services, Room 5527, Cohen 

Building, 330 Independence Avenue, 

SW., Washington, DC 20201. 

Prominently identify the title of notice 

on the first page of any submitted 

response. Electronic responses may be 

sent to imnotice@oig.hhs.gov. 

FOR FURTHER INFORMATION CONTACT: 

Katie A. Arnholt, Senior Counsel, Office 

of Counsel to the Inspector General, 

(202) 205–3203, or 

katie.arnholt@oig.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

OIG often negotiates compliance 

obligations with health care providers 

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Federal Register / Vol. 74, No. 198 / Thursday, October 15, 2009 / Notices 52965 

and other entities as part of the 

settlement of Federal health care 

program fraud investigations arising 

under civil and administrative false 

claims statutes. These obligations are set 

forth in a CIA. A provider or an entity 

consents to a CIA in conjunction with 

a civil or administrative settlement and 

in exchange for OIG’s agreement not to 

seek to exclude that health care provider 

or entity from participation in Medicare, 

Medicaid, and other Federal health care 

programs under 42 U.S.C. 1320a–7. 

False claims submitted in violation of 

the False Claims Act or Civil Monetary 

Penalties Law give rise to OIG’s 

permissive exclusion authority under 42 

U.S.C. 1320a–7(b)(7). 

The typical term of a CIA is 5 years. 

CIAs seek to ensure the integrity of 

Federal health care program claims 

submitted by the provider. CIAs 

generally include requirements to, 

among other things: (1) Hire a 

compliance officer; (2) appoint a 

compliance committee; (3) develop 

written standards and policies; (4) 

implement a comprehensive employee 

training program; (5) establish a 

confidential disclosure program; (6) 

restrict employment of ineligible 

persons; (7) report overpayments, 

reportable events, and ongoing 

investigations/legal proceedings; and (8) 

provide an implementation report and 

annual reports to OIG on the status of 

the entity’s compliance activities. 

When resolving cases that involve 

quality-of-care allegations, OIG often 

requires health care providers to enter 

into quality-of-care CIAs. OIG may enter 

into quality-of-care CIAs with many 

different types of health care providers, 

including, but not limited to, skilled 

nursing facilities, assisted-living 

facilities, psychiatric facilities, 

intermediate care facilities for the 

mentally retarded, hospitals, physician 

practices, dental practices, and 

management companies. Under these 

quality-of-care CIAs, health care 

providers agree to compliance 

obligations that include quality 

assurance and improvement. One such 

obligation is to retain an appropriately 

qualified monitor, which is appointed 

by OIG after consultation with the 

health care provider. The monitor 

selected contracts directly with the 

provider. The monitor does not enter 

into any contractual relationship with 

OIG or act as an agent for OIG. 

The monitor typically is responsible 

for assessing the effectiveness, 

reliability, and thoroughness of the 

provider’s: (1) Internal quality control 

systems; (2) response to quality-of-care 

issues; (3) development and 

implementation of corrective action 

plans and the timeliness of such actions; 

(4) proactive steps to ensure that each 

patient receives care in accordance with 

basic care, treatment, and protectionfrom-harm standards; the governing 

regulations; and the policies and 

procedures required to be adopted 

under the CIA; and (5) in residential 

settings, compliance with staffing 

requirements. In making these 

assessments, the monitor conducts site 

visits, analyzes available data, observes 

facility and corporate-level committee 

meetings, and reviews relevant 

documents. The monitor submits 

regular written reports to the provider 

and OIG. 

Responses to This Notice 

OIG is interested in hearing from 

organizations that believe they have the 

capability to be a monitor for quality-ofcare CIAs. Please include in any 

response to this notice the following: 

1. The name of the organization; 

2. The size and location(s) of the 

organization; 

3. The qualifications of the 

organization to serve as a monitor for 

quality-of-care CIAs; 

4. The organization’s capacity to 

monitor large providers with locations 

in multiple States; 

5. The organization’s clinical 

experience and expertise; 

6. The organization’s experience with 

quality assessment, assurance, and 

improvement; 

7. The organization’s prior monitoring 

experience, including, but not limited 

to, systems reviews and auditing; and 

8. An indication of whether the 

organization has any current or prior 

(within the last 5 years) Federal 

Government contracts or is on any 

General Services Administration or HHS 

list of approved contractors. 

OIG will review each response 

submitted to this notice to assess 

whether the organization may be 

appropriate to serve as a monitor for 

quality-of-care CIAs. The assessment 

will not be for the purpose of making 

any definitive determination regarding 

whether a particular organization is 

qualified to be a monitor or creating a 

list of pre-approved monitors. Factors 

that OIG considers when assessing 

whether an organization may be an 

appropriate monitor for a particular CIA 

include, among other things, the 

organization’s clinical expertise, 

capacity to handle a particular 

monitoring relationship, quality 

monitoring experience, geographic 

location, and independence and 

objectivity. Each provider and qualityof-care CIA is unique. Accordingly, the 

selection of an appropriate monitor for 

any given quality-of-care CIA requires 

consideration of unique and 

individualized factors. In order to select 

an appropriate monitor for any 

individual quality-of-care CIA, OIG may 

contact an organization that submitted 

information in response to this notice to 

request additional information. In 

selecting a monitor, OIG will not be 

limited to organizations that submitted 

information in response to this notice. 

Any organization submitting 

information in response to this notice 

should identify any information that it 

believes is trade secret, or commercial 

or financial information, and privileged 

or confidential under exemption four of 

the Freedom of Information Act (FOIA). 

Consistent with the HHS FOIA 

regulations, set forth in 45 CFR Part 5, 

when OIG receives a request for such 

records and OIG determines that OIG 

may be required to disclose them, OIG 

will make reasonable efforts to notify 

the organization about these facts. 

Daniel R. Levinson, 

Inspector General. 

[FR Doc. E9–24715 Filed 10–14–09; 8:45 am] 

BILLING CODE 4152–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0483] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Medical Device 

User Fee Cover Sheet; Form FDA 3601 

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 

Form FDA 3601 entitled ‘‘Medical 

Device User Fee Cover Sheet,’’ which 

must be submitted along with certain 

medical device product applications, 

supplements, and fee payment of those 

applications. 

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