Federal Register / Vol. 77, No. 193 / Thursday, October 4, 2012 / Notices 60703 

must be received at the Reserve Bank 

indicated or the offices of the Board of 

Governors not later than October 29, 

2012. 

A. Federal Reserve Bank of Chicago 

(Colette A. Fried, Assistant Vice 

President) 230 South LaSalle Street, 

Chicago, Illinois 60690–1414: 

1. Wintrust Financial Corporation, 

Rosemont, Illinois; to acquire 100 

percent of the voting shares of HPK 

Financial Corporation, and thereby 

indirectly acquire voting shares of Hyde 

Park Bank & Trust Company, both in 

Chicago, Illinois. 

B. Federal Reserve Bank of 

Minneapolis (Jacqueline G. King, 

Community Affairs Officer) 90 

Hennepin Avenue, Minneapolis, 

Minnesota 55480–0291: 

1. Forstrom Bancorporation, Inc., 

Clara City, Minnesota; to acquire 100 

percent of the voting shares of Murdock 

Bancor, Inc., Mendota Heights, 

Minnesota, and thereby indirectly 

acquire voting shares of First State Bank 

of Murdock, Murdock, Minnesota. 

C. Federal Reserve Bank of Kansas 

City (Dennis Denney, Assistant Vice 

President) 1 Memorial Drive, Kansas 

City, Missouri 64198–0001: 

1. Pony Express Bancorp, Inc., 

Elwood, Kansas; to merge with Don-Co 

Investment Company, and thereby 

indirectly acquire 1st Bank of Troy, both 

in Troy, Kansas. 

Board of Governors of the Federal Reserve 

System, October 1, 2012. 

Michael J. Lewandowski, 

Assistant Secretary of the Board. 

[FR Doc. 2012–24516 Filed 10–3–12; 8:45 am] 

BILLING CODE 6210–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Breast and Cervical Cancer Early 

Detection and Control Advisory 

Committee: Notice of Charter Renewal 

This gives notice under the Federal 

Advisory Committee Act (Pub. L. 92– 

463) of October 6, 1972, that the Breast 

and Cervical Cancer Early Detection and 

Control Advisory Committee, 

Department of Health and Human 

Services, HHS, has been renewed for a 

2-year period through September 12, 

2014. 

For information, contact Ms. Jameka 

Blackmon, Designated Federal Officer, 

BCCEDCAC, CDC, 1600 Clifton Road 

NE., M/S K57, Atlanta, Georgia, 30333, 

telephone (770)488–4740; fax (770)488– 

3230. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Dated: September 24, 2012. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2012–24503 Filed 10–3–12; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1453–NC] 

Medicare and Medicaid Programs; 

Announcement of Application From 

Hospital Requesting Waiver for Organ 

Procurement Service Area 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice with comment period. 

SUMMARY: This notice with comment 

period announces a hospital’s request 

for a waiver from the requirement to 

have an agreement with its designated 

Organ Procurement Organization (OPO). 

The request was made in accordance 

with section 1138(a)(2) of the Social 

Security Act (the Act). In addition, this 

notice requests comments from OPOs 

and the general public for our 

consideration in determining whether 

we should grant the requested waiver. 

DATES: Comment Date: To be assured 

consideration, comments must be 

received at one of the addresses 

provided below, no later than 5 p.m. on 

December 3, 2012. 

ADDRESSES: In commenting, please refer 

to file code CMS–1453–NC. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the instructions under the ‘‘More Search 

Options’’ tab. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Attention: CMS– 

1453–NC, P.O. Box 8010, Baltimore, 

MD 21244–1850. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: 

Department of Health and Human 

Services, Attention: CMS–1453–NC, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244– 

1850. 

4. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments before the close 

of the comment period to either of the 

following addresses: 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue SW., 

Washington, DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey Building is not 

readily available to persons without 

Federal government identification, 

commenters are encouraged to leave 

their comments in the CMS drop slots 

located in the main lobby of the 

building. A stamp-in clock is available 

for persons wishing to retain a proof of 

filing by stamping in and retaining an 

extra copy of the comments being filed.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244– 

1850. 

If you intend to deliver your 

comments to the Baltimore address, 

please call telephone number (410) 786– 

9994 in advance to schedule your 

arrival with one of our staff members. 

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Patricia Taft, (410) 786–4561. 

SUPPLEMENTARY INFORMATION: Inspection 

of Public Comments: All comments 

received before the close of the 

comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 


emcdonald on DSK67QTVN1PROD with NOTICES
60704 Federal Register / Vol. 77, No. 193 / Thursday, October 4, 2012 / Notices 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http:// 

www.regulations.gov. Follow the search 

instructions on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 8:30 

a.m. to 4 p.m. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

I. Background 

Organ Procurement Organizations 

(OPOs) are not-for-profit organizations 

that are responsible for the 

procurement, preservation, and 

transport of transplantable organs to 

transplant centers throughout the 

country. Qualified OPOs are designated 

by the Centers for Medicare & Medicaid 

Services (CMS) to recover or procure 

organs in CMS-defined exclusive 

geographic service areas, pursuant to 

section 371(b)(1) of the Public Health 

Service Act (42 U.S.C. 273(b)(1) and our 

regulations at 42 CFR § 486.306. Once 

an OPO has been designated for an area, 

hospitals in that area that participate in 

Medicare and Medicaid are required to 

work with that OPO in providing organs 

for transplant, pursuant to section 

1138(a)(1)(C) of the Social Security Act 

(the Act) and our regulations at 42 CFR 

482.45. 

Section 1138(a)(1)(A)(iii) of the Act 

provides that a hospital must notify the 

designated OPO (for the service area in 

which it is located) of potential organ 

donors. Under section 1138(a)(1)(C) of 

the Act, every participating hospital 

must have an agreement to identify 

potential donors only with its 

designated OPO. 

However, section 1138(a)(2)(A) of the 

Act provides that a hospital may obtain 

a waiver of the above requirements from 

the Secretary under certain specified 

conditions. A waiver allows the hospital 

to have an agreement with an OPO other 

than the one initially designated by 

CMS, if the hospital meets certain 

conditions specified in section 

1138(a)(2)(A) of the Act. In addition, the 

Secretary may review additional criteria 

described in section 1138(a)(2)(B) of the 

Act to evaluate the hospital’s request for 

a waiver. 

Section 1138(a)(2)(A) of the Act states 

that in granting a waiver, the Secretary 

must determine that the waiver—(1) is 

expected to increase organ donations; 

and (2) will ensure equitable treatment 

of patients referred for transplants 

within the service area served by the 

designated OPO and within the service 

area served by the OPO with which the 

hospital seeks to enter into an 

agreement under the waiver. In making 

a waiver determination, section 

1138(a)(2)(B) of the Act provides that 

the Secretary may consider, among 

other factors: (1) Cost-effectiveness; (2) 

improvements in quality; (3) whether 

there has been any change in a 

hospital’s designated OPO due to the 

changes made in definitions for 

metropolitan statistical areas; and (4) 

the length and continuity of a hospital’s 

relationship with an OPO other than the 

hospital’s designated OPO. Under 

section 1138(a)(2)(D) of the Act, the 

Secretary is required to publish a notice 

of any waiver application received from 

a hospital within 30 days of receiving 

the application, and to offer interested 

parties an opportunity to comment in 

writing during the 60-day period 

beginning on the publication date in the 

Federal Register. 

The criteria that the Secretary uses to 

evaluate the waiver in these cases are 

the same as those described above under 

sections 1138(a)(2)(A) and (B) of the Act 

and have been incorporated into the 

regulations at § 486.308(e) and (f). 

II. Waiver Request Procedures 

In October 1995, we issued a Program 

Memorandum (Transmittal No. A–95– 

11) detailing the waiver process and 

discussing the information hospitals 

must provide in requesting a waiver. We 

indicated that upon receipt of a waiver 

request, we would publish a Federal 

Register notice to solicit public 

comments, as required by section 

1138(a)(2)(D) of the Act. 

According to these requirements, we 

will review the request and comments 

received. During the review process, we 

may consult on an as-needed basis with 

the Health Resources and Services 

Administration’s Division of 

Transplantation, the United Network for 

Organ Sharing, and our regional offices. 

If necessary, we may request additional 

clarifying information from the applying 

hospital or others. We will then make a 

final determination on the waiver 

request and notify the hospital and the 

designated and requested OPOs. 

III. Hospital Waiver Request 

As permitted by § 486.308(e), the 

following hospital has requested a 

waiver in order to enter into an 

agreement with a designated OPO other 

than the OPO designated for the service 

area in which the hospital is located: 

Quitman County Hospital, LLC. of 

Marks, Mississippi, is requesting a 

waiver to work with: 

Mississippi Organ Recovery Agency, 

4400 Lakeland Drive, Flowood, MS 

39232. 

The Hospital’s Designated OPO is: 

Mid-South Transplant Foundation, Inc., 

8001 Centerview Parkway, Suite 302, 

Memphis, TN 38018. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; Program No. 93.774, Medicare— 

Supplementary Medical Insurance, and 

Program No. 93.778, Medical Assistance 

Program) 

Dated: September 28, 2012. 

Marilyn Tavenner, 

Acting Administrator and Chief Operating 

Officer, Centers for Medicare & Medicaid 

Services. 

[FR Doc. 2012–24496 Filed 10–3–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2012–M–0371, FDA– 

2012–M–0372, FDA–2012–M–0373, FDA– 

2012–M–0390, FDA–2012–M–0407, FDA– 

2012–M–0562, and FDA–2012–M–0638] 

Medical Devices; Availability of Safety 

and Effectiveness Summaries for 

Premarket Approval Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

list of premarket approval applications 

(PMAs) that have been approved. This 

list is intended to inform the public of 

the availability of safety and 

effectiveness summaries of approved 

PMAs through the Internet and the 

Agency’s Division of Dockets 

Management. 

ADDRESSES: Submit written requests for 

copies of summaries of safety and 

effectiveness data to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Please cite the appropriate docket 

number as listed in table 1 of this 

document when submitting a written 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the summaries of safety and 

effectiveness. 

FOR FURTHER INFORMATION CONTACT: 

Nicole Wolanski, Center for Devices and 

Radiological Health, Food and Drug 


emcdonald on DSK67QTVN1PROD with NOTICES