Federal Register / Vol. 69, No. 240 / Wednesday, December 15, 2004 / Notices 75073

Reason: Surrendered license 

voluntarily.

License Number: 015646N. 

Name: Universe Freight Brokers, Inc. 

dba Seacarriers. 

Address: 3625 NW. 82nd Avenue, 

Suite 401, Miami, FL 33126. 

Date Revoked: October 30, 2004. 

Reason: Failed to maintain a valid 

bond.

Sandra L. Kusumoto, 

Director, Bureau of Certification and 

Licensing.

[FR Doc. 04–27441 Filed 12–14–04; 8:45 am] 

BILLING CODE 6730–01–P

FEDERAL RESERVE SYSTEM

Change in Bank Control Notices; 

Acquisition of Shares of Bank or Bank 

Holding Companies

The notificants listed below have 

applied under the Change in Bank 

Control Act (12 U.S.C. 1817(j)) and 

§ 225.41 of the Board’s Regulation Y (12 

CFR 225.41) to acquire a bank or bank 

holding company. The factors that are 

considered in acting on the notices are 

set forth in paragraph 7 of the Act (12 

U.S.C. 1817(j)(7)).

The notices are available for 

immediate inspection at the Federal 

Reserve Bank indicated. The notices 

also will be available for inspection at 

the office of the Board of Governors. 

Interested persons may express their 

views in writing to the Reserve Bank 

indicated for that notice or to the offices 

of the Board of Governors. Comments 

must be received not later than 

December 29, 2004.

A. Federal Reserve Bank of Atlanta

(Sue Costello, Vice President) 1000 

Peachtree Street, N.E., Atlanta, Georgia 

30303:

1. Evan R. Marbin, North Miami 

Beach, Florida, individually and as 

trustee of The SEE Trust, Miami, 

Florida, The SEE Trust, Miami, Florida, 

and Sherrie Marbin, North Miami 

Beach, Florida, to retain voting shares of 

Transatlantic Bank, Miami, Florida.

B. Federal Reserve Bank of Kansas 

City (Donna J. Ward, Assistant Vice 

President) 925 Grand Avenue, Kansas 

City, Missouri 64198–0001:

1. Charles W. Masner and Ella C. 

Masner, both of Anthony, Kansas; to 

acquire control of Olathe 

Bancorporation, Inc., and thereby 

indirectly acquire control of Olathe 

State Bank, both in Olathe, Colorado.

Board of Governors of the Federal Reserve 

System, December 9, 2004.

Robert deV. Frierson,

Deputy Secretary of the Board.

[FR Doc. 04–27475 Filed 12–14–04; 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 application 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 January 10, 

2005.

A. Federal Reserve Bank of Chicago

(Patrick Wilder, Assistant Vice 

President) 230 South LaSalle Street, 

Chicago, Illinois 60690–1414:

1. American Central Bancorporation, 

Inc., Springfield, Illinois; to merge with 

American Central Financial Group, Inc., 

Springfield, Illinois, and thereby 

indirectly acquire Farmers State Bank of 

Fulton County, Lewistown, Illinois, and 

The Bank, Charleston, Illinois.

Board of Governors of the Federal Reserve 

System, December 9, 2004.

Robert deV. Frierson,

Deputy Secretary of the Board.

[FR Doc. 04–27476 Filed 12–14–04; 8:45 am]

BILLING CODE 6210–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 2003M–0172, 2004M–0309, 

2004M–0433, 2004M–0341, 2004M–0356, 

2004M–0403, 2004M–0310, 2004M–0312, 

2004M–0313, 2004M–0342, 2004M–0323, 

2004M–0345, 2004M–0350, 2004M–0387, 

2004M–0415, 2004M–0388, and 2004M–0430]

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 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:

Thinh Nguyen, Center for Devices and 

Radiological Health (HFZ–402), Food 

and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

301–594–2186.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of January 30, 

1998 (63 FR 4571), FDA published a 

final rule that revised 21 CFR 814.44(d) 

and 814.45(d) to discontinue individual 

publication of PMA approvals and 

denials in the Federal Register. Instead, 

the agency now posts this information 

on the Internet on FDA’s home page at 

http://www.fda.gov. FDA believes that 

this procedure expedites public 

75074 Federal Register / Vol. 69, No. 240 / Wednesday, December 15, 2004 / Notices 

notification of these actions because 

announcements can be placed on the 

Internet more quickly than they can be 

published in the Federal Register, and 

FDA believes that the Internet is 

accessible to more people than the 

Federal Register.

In accordance with section 515(d)(4) 

and (e)(2) of the Federal Food, Drug, and 

Cosmetic Act (the act) (21 U.S.C. 

360e(d)(4) and (e)(2)), notification of an 

order approving, denying, or 

withdrawing approval of a PMA will 

continue to include a notice of 

opportunity to request review of the 

order under section 515(g) of the act. 

The 30-day period for requesting 

reconsideration of an FDA action under 

§ 10.33(b) (21 CFR 10.33(b)) for notices 

announcing approval of a PMA begins 

on the day the notice is placed on the 

Internet. Section 10.33(b) provides that 

FDA may, for good cause, extend this 

30-day period. Reconsideration of a 

denial or withdrawal of approval of a 

PMA may be sought only by the 

applicant; in these cases, the 30-day 

period will begin when the applicant is 

notified by FDA in writing of its 

decision.

The regulations provide that FDA 

publish a quarterly list of available 

safety and effectiveness summaries of 

PMA approvals and denials that were 

announced during that quarter. The 

following is a list of approved PMAs for 

which summaries of safety and 

effectiveness were placed on the 

Internet from July 1, 2004, through 

September 30, 2004. There were no 

denial actions during this period. The 

list provides the manufacturer’s name, 

the product’s generic name or the trade 

name, and the approval date.

TABLE 1.—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JULY 1, 

2004, THROUGH SEPTEMBER 30, 2004

PMA No./Docket No. Applicant Trade Name Approval Date 

P020026/2003M–0172 Cordis Corp. CYPHER SIROLIMUS-ELUTING CORONARY 

STENT ON THE RAPTOR OVER-THE-WIRE 

DELIVERY SYSTEM OR RAPTORRAIL 

RAPID EXCHANGE DELIVERY SYSTEM

April 24, 2003

P020023/2004M–0309 Q-Med Scandinavia, Inc. RESTYLANE INJECTABLE GEL December 12, 

2003

P030044/2004M–0433 DakoCytomation California, Inc. DAKOCYTOMATION EGFR PHARMDX February 12, 

2004

P030024/2004M–0341 Ortho-Clinical Diagnostics, Inc. VITROS IMMUNODIAGNOSTIC PRODUCTS 

ANTI-HBC REAGENT PACK AND CALIBRATOR

March 4, 2004

P030026/2004M–0356 Ortho-Clinical Diagnostics, Inc. VITROS IMMUNODIAGOSTIC PRODUCTS 

ANTI-HBC IGM REAGENT PACK AND CALIBRATOR

March 4, 2004

P030025/2004M–0403 Boston Scientific Corp. TAXUS EXPRESS2 PACLITAXEL-ELUTING 

CORONARY STENT SYSTEM (MONORAIL 

AND OVER-THE-WIRE)

March 4, 2004

P020030/2004M–0310 Ela Medical, Inc. STELID II/STELIX/STELIX II ENDOCARDIAL 

PACING LEAD

June 17, 2004

P970043 (S015)/2004M–0312 Alcon Laboratories, Inc. LADARVISION 4000 EXCIMER LASER SYSTEM June 29, 2004

P030054/2004M–0313 St. Jude Medical, Inc. ST. JUDE MEDICAL EPIC HF SYSTEM June 30, 2004

P040008/2004M–0342 bioMerieux, Inc. VIDAS TPSA ASSAY July 8, 2004

P030012/2004M–0323 R2 Technology, Inc. IMAGECHECKER CT CAD SOFTWARE SYSTEM (MODEL LN–1000)July 8, 2004

P010061/2004M–0345 Photo Cure, ASA CURELIGHT BROADBAND (MODEL 

CURELIGHT 01)

July 28, 2004

P030050/2004M–0350 Dermik Laboratories SCULPTRA August 3, 2004

P030010/2004M–0387 Siemens Medical Solutions USA, 

Inc.

SIEMENS MAMMOMAT NOVATIONDR FULL 

FIELD DIGITAL MAMMOGRAPHY SYSTEM

August 20, 

2004

H030009/2004M–0415 Synthes (USA) VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR)August 24, 

2004

P040012/2004M–0388 Guidant Corp. ACULINK CAROTID STENT SYSTEM & RX 

ACCULINK CAROTID STENT SYSTEM

August 30, 

2004

P010012 (S026)/2004M–0430 Guidant Corp. CONTAK CD (MODEL 1823), CONTAK CD 2 

(MODELS H115 & H119), RENEWAL (MODEL 

H135), RENEWAL 3 (MODELS H170, H175, 

H177, & H179)

September 14, 

2004

Federal Register / Vol. 69, No. 240 / Wednesday, December 15, 2004 / Notices 75075

II. Electronic Access

Persons with access to the Internet 

may obtain the documents at http://

www.fda.gov/cdrh/pmapage.html.

Dated: December 3, 2004.

Linda S. Kahan,

Deputy Director, Center for Devices and 

Radiological Health.

[FR Doc. 04–27387 Filed 12–14–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Committee on Heritable 

Disorders and Genetic Diseases in 

Newborns and Children; Notice of 

Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Public Law 92–463), notice is hereby 

given of the following meeting:

Name: Advisory Committee on Heritable 

Disorders and Genetic Diseases in Newborns 

and Children (ACHDGDNC). 

Dates and Times: January 13, 2005, 9 a.m. 

to 5 p.m. January 14, 2005, 9 a.m. to 5 p.m. 

Place: Ronald Reagan Building and 

International Trade Center, 1300 

Pennsylvania Avenue, NW., Washington, DC 

20004. 

Status: The meeting will be open to the 

public with attendance limited to space 

availability. 

Purpose: The Advisory Committee 

provides advice and recommendations 

concerning the grants and projects authorized 

under the Heritable Disorders Program and 

technical information to develop policies and 

priorities for this program that will enhance 

the ability of State and local health agencies 

to provide for newborn and child screening, 

counseling and health care services for 

newborns and children having or at risk for 

heritable disorders. Specifically, the 

Committee shall advise and guide the 

Secretary regarding the most appropriate 

application of universal newborn screening 

tests, technologies, policies, guidelines and 

programs for effectively reducing morbidity 

and mortality in newborns and children 

having or at risk for heritable disorders. 

Agenda: The first day will be devoted to 

presentations on and a discussion of the 

status of the report from the American 

College of Medical Genetics; an update of the 

current status of state specific issues; 

presentations on the Rare Disease Centers of 

Excellence funded by the National Institutes 

of Health and the Regional Genetics; and 

Newborn Screening Collaboratives funded by 

the Health Resources and Services 

Administration. The presentations will be 

followed on the first and second day with 

more detailed discussions aimed at 

formulating the ACHDGDNC issues agenda. 

Proposed agenda items are subject to 

change. 

Time will be provided each day for public 

comment. Individuals who wish to provide 

public comment or who plan to attend the 

meeting and need special assistance, such as 

sign language interpretation or other 

reasonable accommodations, should notify 

the ACHDGDNC Executive Secretary, 

Michele A. Lloyd-Puryear, M.D., Ph.D. 

(contact information provided below). 

Contact Person: Anyone interested in 

obtaining a roster of members or other 

relevant information should write or contact 

Michele A. Lloyd-Puryear, M.D., Ph.D., 

Maternal and Child Health Bureau, Health 

Resources and Services Administration, 

Room 18A–19, Parklawn Building, 5600 

Fishers Lane, Rockville, Maryland 20857, 

Telephone (301) 443–1080. Information on 

the Advisory Committee is available at

http://mchb.hrsa.gov/programs/genetics/

committee.

Dated: December 8, 2004. 

Tina M. Cheatham, 

Director, Division of Policy Review and 

Coordination.

[FR Doc. 04–27388 Filed 12–14–04; 8:45 am] 

BILLING CODE 4165–15–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the meeting of the 

President’s Cancer Panel. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in section 

552b(c)(9)(B), Title 5 U.S.C., as 

amended, because the premature 

disclosure of information and the 

discussions would likely to significantly 

frustrate implementation of 

recommendations.

Name of Committee: President’s Cancer 

Panel. 

Date: January 24–25, 2005. 

Open: January 24, 2005, 8 a.m. to 4 p.m. 

Agenda: Translating Research to Reduce 

Burden of Cancer. 

Place: Memorial Sloan-Kettering Cancer 

Center, 1275 York Avenue, New York, NY 

10021. 

Closed: January 25, 2005, 9 a.m. to 12 p.m. 

Agenda: The Panel will supplement its 

public hearings with discussion of 

prepublication manuscripts on Translating 

Research into Clinical Practice. These 

manuscripts have been provided by their 

authors with the understanding that the 

Panel will not break prepublication embargo 

conditions. 

Place: Memorial Sloan-Kettering Cancer 

Center, 1275 York Avenue, New York, NY 

10021. 

Contact Person: Maureen O. Wilson, PhD, 

Executive Secretary, National Cancer 

Institute, National Institutes of Health, 31 

Center Drive, Building 31, Room 3A18, 

Bethesda, MD 20892, 301/496–1148. 

Any interested person may file written 

comments with the committee by forwarding 

the comments to the Contact Person listed on 

this notice. The comments should include 

the name, address, telephone number and, 

when applicable, the business or professional 

affiliation of the interested person. 

Information is also available on the 

Institute’s/Center’s home page: 

deainfo.nci.nih.gov/advisory/pcp/pcp.htm,

where an agenda and any additional 

information for the meeting will be posed 

when available.

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; Cancer Centers Support; 93.398, 

Cancer Research Manpower; 93.399, Cancer 

Control, National Institutes of Health, HHS)

Dated: December 6, 2004. 

LaVerne Y. Stringfield, 

Director, Office of Federal Advisory 

Committee Policy.

[FR Doc. 04–27407 Filed 12–14–04; 8:45 am] 

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy.

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel