72122 Federal Register / Vol. 70, No. 230 / Thursday, December 1, 2005 / Notices 

Community Bank, Bluffton, South 

Carolina (in organization). 

B. Federal Reserve Bank of Chicago 

(Patrick M. Wilder, Assistant Vice 

President) 230 South LaSalle Street, 

Chicago, Illinois 60690-1414: 

1. Capitol Bancorp LTD, and Capital 

Development Bancorp Limited, III, both 

of Lansing, Michigan; to acquire 51 

percent of the voting shares of 

Community Bank of Rowan, Salisbury, 

North Carolina (in organization). 

Board of Governors of the Federal Reserve 

System, November 28, 2005. 

Robert deV. Frierson, 

Deputy Secretary of the Board. 

[FR Doc. E5–6740 Filed 11–30–05; 8:45 am] 

BILLING CODE 6210–01–S 

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 December 27, 2005. 

A. Federal Reserve Bank of St. Louis 

(Glenda Wilson, Community Affairs 

Officer) 411 Locust Street, St. Louis, 

Missouri 63166-2034: 

1. Reliance Bancshares, Inc., Des 

Peres, Missouri; to engage de novo 

through its subsidiary Reliance Bank, 

FSB, Fort Myers, Florida, in operating a 

savings association, pursuant to section 

225.28(b)(4)(ii) of Regulation Y. 

Board of Governors of the Federal Reserve 

System, November 28, 2005. 

Robert deV. Frierson, 

Deputy Secretary of the Board. 

[FR Doc. E5–6741 Filed 11–30–05; 8:45 am] 

BILLING CODE 6210–01–S 

GENERAL SERVICES 

ADMINISTRATION 

Peace Arch Port of Entry, Blaine, 

Washington, Draft Environmental 

Impact Statement 

AGENCY: Public Buildings Service, 

General Services Administration (GSA). 

ACTION: Notice of availability. 

SUMMARY: The US General Services 

Administration (GSA) hereby gives 

notice that it has prepared and is 

distributing a Draft Environmental 

Impact Statement (DEIS) pursuant to the 

requirements of the National 

Environmental Policy Act (NEPA) of 

1969, and the President’s Council on 

Environmental Quality Regulations, for 

the construction of a new Peace Arch 

Port of Entry facility in the City of 

Blaine, Whatcom County, Washington. 

This project is at the planning and 

design stage, and site acquisition 

funding has been approved by Congress. 

The US Dept of Homeland Security is 

currently located in the existing Peace 

Arch Port of Entry facility. The existing 

facility does not currently meet the 

tenant agencies space or mission 

requirements. The existing facility 

cannot be adapted to accommodate the 

required future space needs of the 

agency tenants. GSA, assisted by 

Herrera Environmental Consultants, will 

prepare the Environmental Impact 

Statement (EIS). GSA is the lead agency 

in conducting the NEPA study with US 

Department of Transportation - Federal 

Highways Administration and 

Washington State Department of 

Transportation serving as cooperating 

agencies. GSA invites interested 

individuals, organizations, and federal, 

state, and local agencies to participate in 

defining and identifying any significant 

impacts and issues to be studied in the 

EIS. 

DATES: Interested parties should submit 

comments in writing on or before 

January 17, 2006 to be considered in the 

formulation of the final rule. 

ADDRESSES: Submit comments to U.S. 

General Services Administration, 

Regional Environmental Program 

Analyst (10PTTB), 400 – 15th Street 

SW, Auburn, WA 98001, ATTN: 

Michael Levine. 

FOR FURTHER INFORMATION CONTACT: Art 

Campbell at Herrera Environmental 

Consultants at (206) 441-9080, 2200 

Sixth Ave, Suite 1100, Seattle, WA 

98121, or Michael Levine, Regional 

Environmental Program Analyst, GSA, 

at (253)931-7263. 

Mailing List: If you wish to be placed 

on the project mailing list to receive 

further information as the EIS process 

develops, contact Art Campbell at the 

address and telephone number noted 

above. 

Purpose: 

On November 30, 2004, a third public 

NEPA scoping meeting was held to 

gather comments from the public. On 

December 8, 2005 at 6:00pm, an 

informal open house will be held to 

inform the public about the status of the 

project and to answer any questions. On 

December 13, 2005 at 6:00pm, an 

official NEPA DEIS public comment 

meeting will be held to ensure that the 

public has an opportunity to give 

comments about the DEIS that will 

become part of the official record. A 

court stenographer will transcribe all 

comments. Both meetings will be held 

at the Blaine Community Senior Center, 

763 G Street in Blaine, WA. With the 

printing of this Notice of Availability in 

the Federal Register, the 45 day NEPA 

DEIS comment period begins. The 

notice of the dates of the informal open 

house meeting and formal comment 

meeting will be accomplished through 

direct mailing correspondence to 

interested persons, agencies, tribes and 

organizations, and notices in local 

newspapers. 

The DEIS will evaluate the proposed 

project, including all reasonable 

alternatives identified through the 

scoping process and a no-action 

alternative. GSA will respond to all 

relevant comments to the draft EIS 

received during the 45-day public 

comment period and they will become 

part of the Final Environmental Impact 

Statement (FEIS). With the release to the 

public of the FEIS, GSA will identify its 

preferred alternative. 

An additional public informal 

comment meeting will be held after the 

release of the Final Environmental 

Impact Statement. After a minimum 30- 

day period following publication of the 

Final Environmental Impact Statement, 

GSA will issue a Record of Decision 

(ROD) that will identify all alternatives 

considered by GSA in reaching its 

decision, specifying the alternative 

which is environmental preferable. GSA 

may discuss preferences among 

alternatives based on relevant factors 

Federal Register / Vol. 70, No. 230 / Thursday, December 1, 2005 / Notices 72123 

including economic and technical 

considerations and agency statutory 

missions. GSA shall identify and 

discuss all such factors including any 

essential considerations of national 

policy which is balanced by GSA in 

making its decision and state how those 

considerations entered into its decision. 

Supplemental Information: 

GSA invites interested individuals, 

organizations, and federal, state, and 

local agencies to participate in defining 

and identifying any significant impacts 

and issues to be studied in the EIS. The 

EIS will examine the short and longterm impacts on the natural and 

physical environment. The assessment 

will include but not be limited to 

impacts such as social environment, 

changes in land use, aesthetics, changes 

in adjacent park land, changes in traffic 

patterns and access to the ‘‘D’’ street 

intersection, economic impacts, and 

consideration of City planning and 

zoning requirements. The EIS will 

examine measures to mitigate 

significant adverse impacts resulting 

from the proposed action. Concurrent 

with NEPA implementation, GSA will 

also implement its consultation 

responsibilities under Section 106 of the 

National Historic Preservation Act to 

identify potential impacts to existing 

historic or cultural resources. GSA will 

consult with Native American tribes 

through-out the NEPA process. 

The EIS will consider a no-action 

alternative and action alternatives. The 

no-action alternative would continue 

the occupancy in the existing Peace 

Arch Port of Entry facility in Blaine. The 

action alternatives will consist of three 

different configurations for construction 

of a new port of Entry facility. 

Dated: 11/18/2005. 

William L. DuBray, 

Executive Director, Region 10. 

[FR Doc. 05–23522 Filed 11–30–05; 8:45 am] 

BILLING CODE 6820–EP–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0335] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Medical Device 

Recall Authority 

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 January 3, 

2006. 

ADDRESSES: OMB is still experiencing 

significant delays in the regular mail, 

including first class and express mail, 

and messenger deliveries are not being 

accepted. To ensure that comments on 

the information collection are received, 

OMB recommends that comments be 

faxed to the Office of Information and 

Regulatory Affairs, OMB, Attn: Fumie 

Yokota, Desk Officer for FDA, FAX: 

202–395–6974. 

FOR FURTHER INFORMATION CONTACT: 

Peggy Robbins, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1223. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Medical Device Recall Authority—21 

CFR Part 810 (OMB Control Number 

0910–0432)—Extension 

This collection implements medical 

device recall authority provisions under 

section 518(e) of the Federal Food, Drug, 

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

360h) and part 810 (21 CFR part 810). 

Section 518(e) of the act gives FDA the 

authority to issue an order requiring the 

appropriate person, including 

manufacturers, importers, distributors, 

and retailers of a device, to immediately 

cease distribution of such device, to 

immediately notify health professionals 

and device-user facilities of the order, 

and to instruct such professionals and 

facilities to cease use of such device, if 

FDA finds that there is reasonable 

probability that the device intended for 

human use would cause serious adverse 

health consequences or death. 

Section 518(e) of the act sets out a 

three-step procedure for issuance of a 

mandatory device recall order. First, if 

there is a reasonable probability that a 

device intended for human use would 

cause serious, adverse health 

consequences or death, FDA may issue 

a cease distribution and notification 

order requiring the appropriate person 

to immediately do the following: (1) 

Cease distribution of the device, (2) 

notify health professionals and device 

user facilities of the order, and (3) 

instruct those professionals and 

facilities to cease use of the device. 

Second, FDA will provide the person 

named in the cease distribution and 

notification order with the opportunity 

for an informal hearing on whether the 

order should be modified, vacated, or 

amended to require a mandatory recall 

of the device. Third, after providing the 

opportunity for an informal hearing, 

FDA may issue a mandatory recall order 

if the agency determines that such an 

order is necessary. 

The information collected under the 

recall authority will be used by FDA to 

ensure that all devices entering the 

market are safe and effective, to 

accurately and immediately detect 

serious problems with medical devices, 

and to remove dangerous and defective 

devices from the market. 

The respondents to this proposed 

collection of information are 

manufacturers, importers, distributors, 

and retailers of medical devices. 

In the Federal Register of September 

2, 2005 (70 FR 52397), FDA published 

a 60-day notice requesting public 

comment on the information collection 

provisions. No comments were received 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of Respondents Annual Frequency per 

Response 

Total Annual Responses Hours per Response Total Hours 

810.10(d) 2 1 2 8 16 

810.11(a) 1 1 1 8 8 

810.12(a) through (b) 1 1 1 8 8