Federal Register / Vol. 73, No. 25 / Wednesday, February 6, 2008 / Notices 6971 

Americas Bank, N.A., both of Atlanta, 

Georgia. 

C. Federal Reserve Bank of Kansas 

City (Todd Offenbacker, Assistant Vice 

President) 925 Grand Avenue, Kansas 

City, Missouri 64198–0001: 

1. Kelly J. Schoen; to acquire voting 

shares of Freedom Bancshares, Inc., and 

thereby indirectly acquire voting shares 

of Freedom Bank, all of Overland Park, 

Kansas. 

Board of Governors of the Federal Reserve 

System, February 1, 2008. 

Jennifer J. Johnson, 

Secretary of the Board. 

[FR Doc. E8–2126 Filed 2–5–08; 8:45 am] 

BILLING CODE 6210–01–S 

FEDERAL RESERVE SYSTEM 

Formations of, Acquisitions by, and 

Mergers of Bank Holding Companies 

The companies listed in this notice 

have applied to the Board for approval, 

pursuant to the Bank Holding Company 

Act of 1956 (12 U.S.C. 1841 et seq.) 

(BHC Act), Regulation Y (12 CFR Part 

225), and all other applicable statutes 

and regulations to become a bank 

holding company and/or to acquire the 

assets or the ownership of, control of, or 

the power to vote shares of a bank or 

bank holding company and all of the 

banks and nonbanking companies 

owned by the bank holding company, 

including the companies listed below. 

The applications listed below, as well 

as other related filings required by the 

Board, are available for immediate 

inspection at the Federal Reserve Bank 

indicated. The applications also will be 

available for inspection at the offices of 

the Board of Governors. Interested 

persons may express their views in 

writing on the standards enumerated in 

the BHC Act (12 U.S.C. 1842(c)). If the 

proposal also involves the acquisition of 

a nonbanking company, the review also 

includes whether the acquisition of the 

nonbanking company complies with the 

standards in section 4 of the BHC Act 

(12 U.S.C. 1843). Unless otherwise 

noted, nonbanking activities will be 

conducted throughout the United States. 

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 each of these applications 

must be received at the Reserve Bank 

indicated or the offices of the Board of 

Governors not later than March 3, 2008. 

A. Federal Reserve Bank of Chicago 

(Burl Thornton, Assistant Vice 

President) 230 South LaSalle Street, 

Chicago, Illinois 60690–1414: 

1. West Suburban Bancorp, Inc., 

Lombard, Illinois; to acquire 100 

percent of the voting shares of G.R. 

Bancorp, Ltd., and thereby indirectly 

acquire voting shares of The First 

National Bank of Grand Ridge, both of 

Grand Ridge, Illinois. 

B. Federal Reserve Bank of Kansas 

City (Todd Offenbacker, Assistant Vice 

President) 925 Grand Avenue, Kansas 

City, Missouri 64198–0001: 

1. ENB Acquisition Corporation, 

Oklahoma City, Oklahoma; to become a 

bank holding company by acquiring 100 

percent of the voting shares of Exchange 

Bancshares of Moore, Inc., and thereby 

indirectly acquire Exchange National 

Bank of Moore, both of Moore, 

Oklahoma. 

Board of Governors of the Federal Reserve 

System, February 1, 2008. 

Jennifer J. Johnson, 

Secretary of the Board. 

[FR Doc. E8–2125 Filed 2–5–08; 8:45 am] 

BILLING CODE 6210–01–S 

FEDERAL RESERVE SYSTEM 

Formations of, Acquisitions by, and 

Mergers of Bank Holding Companies; 

Correction 

This notice corrects a notice (FR Doc. 

E8–1202 published on page 4573 of the 

issue for Friday, January 25, 2008. 

Under the Federal Reserve Bank of 

Kansas City heading, the entry for 

HOTC, Inc., Wray, Coloardo, is revised 

to read as follows: 

A. Federal Reserve Bank of Kansas 

City (Todd Offenbacker, Assistant Vice 

President) 925 Grand Avenue, Kansas 

City, Missouri 64198–0001: 

1. HOTC, Investment Company, to 

become a bank holding company by 

acquiring 100 percent of the voting 

shares of Wray State Bank, both of 

Wray, Colorado. 

Comments on this application must 

be received by February 19, 2008. 

Board of Governors of the Federal Reserve 

System, February 1, 2008. 

Jennifer J. Johnson, 

Secretary of the Board. 

[FR Doc. E8–2127 Filed 2–5–08 8:45 am] 

BILLING CODE 6210–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the National Coordinator for 

Health Information Technology; 

American Health Information 

Community Meeting 

ACTION: Meeting announcement. 

SUMMARY: This notice announces the 

meeting date for the 20th meeting of the 

American Health Information 

Community in accordance with the 

Federal Advisory Committee Act (Pub. 

L. No. 92–463, 5 U.S.C., App.). The 

American Health Information 

Community will advise the Secretary 

and recommend specific actions to 

achieve a common interoperability 

framework for health information 

technology (IT). 

DATES: Meeting Date: February 26, 2008, 

from 10:30 a.m. to 3 p.m. (Eastern time). 

ADDRESSES: Rosen Centre Hotel, Salon 9 

and 10, 9840 International Drive, 

Orlando, FL 32819. This meeting will be 

held in conjunction with the Healthcare 

Information and Management Systems 

Society (HIMSS) annual conference. 

SUPPLEMENTARY INFORMATION: The 

meeting will include presentations by 

the Confidentiality, Privacy and 

Security Workgroup and the 

Personalized Healthcare Workgroup on 

Recommendations to the Community; 

an update on the Nationwide Health 

Information Network (NHIN); and an 

update on the AHIC Successor. 

FOR FURTHER INFORMATION: Visit http:// 

www.hhs.gov/healthit/ahic.html. A Web 

cast of the Community meeting will be 

available on the NIH Web site at: 

http://www.videocast.nih.gov/. 

If you have special needs for the 

meeting, please contact (202) 690–7151. 

Dated: January 29, 2008. 

Judith Sparrow, 

Director, American Health Information 

Community, Office of Programs and 

Coordination, Office of the National 

Coordinator for Health Information 

Technology. 

[FR Doc. 08–516 Filed 2–5–08; 8:45 am] 

BILLING CODE 4150–45–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–5014–N] 

Medicare Program; Rural Community 

Hospital Demonstration Program; 

Solicitation of Additional Participants 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces a 

solicitation for up to six additional 

hospitals to participate in the Rural 

Community Hospital Demonstration 

Program for the remainder of the 5-year 

time period allowed by section 410A of 


pwalker on PROD1PC71 with NOTICES
6972 Federal Register / Vol. 73, No. 25 / Wednesday, February 6, 2008 / Notices 

the MMA that is currently scheduled to 

end in 2010. 

DATES: Application Submission 

Deadline: Applications must be received 

by 5 p.m., e.s.t. on or before March 24, 

2008. Only applications that are 

considered ‘‘timely’’ will be reviewed 

and considered by the technical panel. 

ADDRESSES: The applications should be 

MAILED or sent by an overnight 

delivery service to the following 

address: Centers for Medicare & 

Medicaid Services, ATTN: Sid 

Mazumdar, Rural Community Hospital 

Demonstration, Medicare 

Demonstrations Program Group, Mail 

Stop C4–17–27, 7500 Security 

Boulevard, Baltimore, MD 21244. 

Please allow sufficient time for mailed 

information to be received in a timely 

manner in the event of delivery delays. 

Because of staffing and resources 

limitations, and because we require an 

application containing an original 

signature, we cannot accept applications 

by facsimile (Fax) transmission. 

FOR FURTHER INFORMATION CONTACT: Sid 

Mazumdar at (410) 786–6673 or by email at: 

Siddhartha.mazumdar@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 410A(a) of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (Pub. L. 108–

173) (MMA) requires the Secretary to 

establish a demonstration to test the 

feasibility and advisability of 

establishing ‘‘rural community 

hospitals’’ for Medicare payment 

purposes for covered hospital inpatient 

services furnished to Medicare 

beneficiaries. A rural community 

hospital, as defined in section 

410A(f)(1) of the MMA, is a hospital 

that—

• Is located in a rural area (as defined 

in section 1886(d)(2)(D) of the Social 

Security Act (the Act) (42 U.S.C. 

1395ww(d)(2)(D))) or treated as being so 

located pursuant to section 

1886(d)(8)(E) of the Act (42 U.S.C. 

1395ww(d)(8)(E)); 

• Has fewer than 51 acute care 

inpatient beds, as reported in its most 

recent cost report; 

• Makes available 24-hour emergency 

care services; and 

• Is not eligible for critical access 

hospital (CAH) designation, or has not 

been designated a CAH under section 

1820 of the Act. 

Section 410A(a)(4) of the MMA 

specifies that the Secretary is to select 

for participation no more than 15 rural 

community hospitals in rural areas of 

States that the Secretary identifies as 

having low population densities. Using 

2002 data from the U.S. Census Bureau, 

we identified the 10 States with the 

lowest population densities in which 

rural community hospitals must be 

located to participate in the 

demonstration: Alaska, Idaho, Montana, 

Nebraska, Nevada, New Mexico, North 

Dakota, South Dakota, Utah, and 

Wyoming. (Source: U.S. Census Bureau, 

Statistical Abstract of the United States: 

2003). 

The demonstration is designed to test 

the feasibility and advisability of 

reasonable cost reimbursement for 

inpatient services to small rural 

hospitals. The demonstration is aimed 

at increasing the capability of the 

selected rural hospitals to meet the 

needs of their service areas. 

Section 410A(a)(5) of the MMA states 

the Secretary shall conduct the 

demonstration program for a 5-year 

period. We originally solicited 

applicants for the demonstration in May 

2004; 13 hospitals began participation 

with cost report years beginning on or 

after October 1, 2004. Four of these 13 

hospitals have withdrawn from the 

program and have become CAHs. For 

the remaining 9 participating hospitals, 

the demonstration will end in 2010 

when each hospital has completed its 

fifth cost report year. 

II. Provisions of the Notice 

This notice announces the solicitation 

for up to six additional hospitals to 

participate in the Rural Community 

Hospital Demonstration Program. 

Hospitals that enter the demonstration 

under this solicitation will be able to 

participate for no more than 2 years. We 

will adhere to the requirement under 

section 410A of the MMA to limit the 

demonstration to 5 years, that is, the 

program will end in 2010. 

A. Demonstration Payment Methodology 

Section 410A of the MMA requires 

that ‘‘in conducting the demonstration 

program under this section, the 

Secretary shall ensure that the aggregate 

payments made by the Secretary do not 

exceed the amount which the Secretary 

would have paid if the demonstration 

program under this section was not 

implemented.’’ In order to achieve 

budget neutrality for this demonstration 

program for FYs 2005, 2006, 2007, and 

2008, we adjusted the national hospital 

inpatient prospective payment system 

(IPPS) rates by an amount sufficient to 

offset the added costs of this 

demonstration program. We will present 

an estimate of the amount needed to 

offset the additional costs incurred 

under the demonstration in FY 2009, 

including the cost of newly selected 

rural community hospitals, in the FY 

2009 IPPS proposed rule. 

Hospitals selected for participation in 

the demonstration will receive payment 

for covered inpatient services, with the 

exclusion of services furnished in a 

psychiatric or rehabilitation unit that is 

a distinct part of the hospital, using the 

following rules. For discharges 

occurring—

• In the first cost reporting period on 

or after the implementation of the 

program, their reasonable costs for 

covered inpatient services; or 

• During the second or subsequent 

cost reporting period, the lesser of their 

reasonable costs or a target amount. The 

target amount in the second cost 

reporting period is defined as the 

reasonable costs of providing covered 

inpatient hospital services in the first 

cost reporting period, increased by the 

IPPS update factor (as defined in section 

1886(b)(3)(B) of the Act) for that 

particular cost reporting period. The 

target amount in subsequent cost 

reporting periods is defined as the 

preceding cost reporting period’s target 

amount increased by the IPPS update 

factor for that particular cost reporting 

period. 

Covered inpatient hospital services 

means inpatient hospital services 

(defined in section 1861(b) of the Act) 

and including extended care services 

furnished under an agreement under 

section 1883 of the Act. 

B. Participation in the Demonstration 

To participate in this demonstration, 

a hospital must be located in one of the 

identified States and meet the criteria 

for a rural community hospital. Eligible 

hospitals that desire to participate in the 

demonstration must submit an 

application to CMS. Information about 

the demonstration and details on how to 

apply can be found on the CMS Web 

site at http://www.cms.hhs.gov/Demo

ProjectsEvalRpts/downloads/ 

2004_Rural_Community_Hospital_Demonstration_Program.pdf. 

III. Collection of Information 

Requirements 

The information collection 

requirements contained in this notice 

are subject to the Paperwork Reduction 

Act of 1995 (PRA). As discussed in 

section II.B. of this notice, a hospital 

must submit the required information 

on the cover sheet of the CMS Medicare 

Waiver Demonstration Application to 

receive consideration by the technical 

review panel. The burden associated 

with voluntary requirement is the time 

and effort necessary to complete the 

Medicare Waiver Demonstration 

Application and submit the information 


pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 73, No. 25 / Wednesday, February 6, 2008 / Notices 6973 

to CMS. The burden associated with this 

requirement is currently approved 

under OMB control number 0938–0880 

with an expiration date of November 20, 

2010. 

Authority: Section 410A of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003, Pub. L. No. 108–

173. (Catalog of Federal Domestic Assistance 

Program No. 93.773 Medicare—Hospital 

Insurance Program; and No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program). 

Dated: January 11, 2008. 

Kerry Weems, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 08–511 Filed 2–1–08; 10:00 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0079] 

Guidance for Industry: Fish and 

Fisheries Products Hazards and 

Controls Guidance Third Edition June 

2001: Letter to Seafood Processors 

that Purchase Grouper, Amberjack, 

and Related Predatory Reef Species 

Captured in the Northern Gulf of 

Mexico 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance document 

entitled ‘‘Fish and Fisheries Products 

Hazards and Controls Guidance, Third 

Edition June 2001: Letter to Seafood 

Processors that Purchase Grouper, 

Amberjack and Related Predatory Reef 

Species Captured in the Northern Gulf 

of Mexico.’’ The guidance sets forth the 

agency’s recommendations for ensuring 

the safety of grouper, amberjack, and 

related predatory reef species captured 

in the northern Gulf of Mexico with 

respect to ciguatera fish poisoning 

(CFP). The guidance is in response to 

recent cases of CFP that have occurred 

in the United States. 

DATES: This guidance is final February 

6, 2008. Submit written or electronic 

comments on the guidance document at 

any time. 

ADDRESSES: Submit written comments 

on the guidance to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments to http:// 

www.regulations.gov. Submit written 

requests for single copies of the 

guidance to the Office of Food Safety 

(HFS–317), Center for Food Safety and 

Applied Nutrition, 5100 Paint Branch 

Pkwy., College Park, MD 20740. Send 

one self-addressed adhesive label to 

assist the office in processing your 

request, or fax your request to 301–436–

2651. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Byron Truglio, Center for Food Safety 

and Applied Nutrition (HFS–325), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

301–436–1420. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance document entitled ‘‘Fish and 

Fisheries Products Hazards and Controls 

Guidance, Third Edition June 2001: 

Letter to Seafood Processors that 

Purchase Grouper, Amberjack and 

Related Predatory Reef Species 

Captured in the Northern Gulf of 

Mexico.’’ The purpose of the document 

is to revise guidance provided to 

industry for processing potentially 

ciguatoxic fish species captured in the 

northern Gulf of Mexico which are 

subject to the provisions of the Hazard 

Analysis and Critical Control Point 

regulation for seafood (21 CFR part 123) 

(the seafood HACCP regulation). This 

guidance is in response to recent CFP 

outbreaks that have been traced to fish 

captured in an area in the United States 

where ciguatera was previously 

extremely rare. CFP is caused by 

consumption of fish that have eaten 

toxic marine algae directly or that have 

eaten other toxin-contaminated fish. 

CFP can result in gastrointestinal, 

cardiovascular, and neurological 

symptoms. In severe cases, recurring 

neurological symptoms can persist for 

months to years. 

FDA is issuing this guidance as level 

1 guidance consistent with FDA’s good 

guidance practices regulation (§ 10.115 

(21 CFR 10.115)). Consistent with FDA’s 

good guidance practices regulation, the 

agency will accept comment, but is 

implementing the guidance document 

immediately in accordance with 

§ 10.115(g) (2) because the agency has 

determined that prior public 

participation is not feasible or 

appropriate in light of the need to 

respond expeditiously to the recent 

cases of CFP. The guidance represents 

the agency’s current thinking on CFP 

from fish in the Northern Gulf of 

Mexico. It does not create or confer any 

rights for or on any person and does not 

operate to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations. This guidance modifies 

our previous guidance on this subject 

(See ‘‘Fish and Fisheries Products 

Hazards and Controls Guidance, Third 

Edition June 2001’’ http:// 

www.cfsan.fda.gov/guidance.html). The 

recommendations in this guidance only 

pertain to grouper, amberjack, and 

related predatory reef species associated 

with CFP that have been captured in the 

Northern Gulf of Mexico. This guidance 

does not pertain to other species of fish 

that have not been associated with CFP. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this guidance. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. The guidance 

and received comments may be seen in 

the Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

Please note that on January 15, 2008, 

the FDA Web site transitioned to the 

Federal Dockets Management System 

(FDMS). FDMS is a Government-wide, 

electronic docket management system. 

Electronic submissions will be accepted 

by FDA through FDMS only. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the guidance document at 

http://www.cfsan.fda.gov/ 

guidance.html. 

Dated: January 31, 2008. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 08–537 Filed 2–1–08; 4:38 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[FDA No. 225–07–8007] 

Memorandum of Understanding 

Between the Food and Drug 

Administration and the National 

Institutes of Health 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 


pwalker on PROD1PC71 with NOTICES