51194 Federal Register / Vol. 71, No. 167 / Tuesday, August 29, 2006 / Notices 

SUMMARY: This notice sets forth the 

schedule and summary agenda for a 

meeting of the President’s Council of 

Advisors on Science and Technology 

(PCAST), and describes the functions of 

the Council. Notice of this meeting is 

required under the Federal Advisory 

Committee Act (FACA). 

Dates and Place: September 12, 2006, 

Washington, DC. The meeting will be 

held in the Continental Ballroom of the 

George Washington University Marvin 

Center Building, 800 21st St. NW., 

Washington DC 20052. 

Type of Meeting: Open. Further 

details on the meeting agenda will be 

posted on the PCAST Web site at: 

http://www.ostp.gov/PCAST/pcast.html. 

Proposed Schedule and Agenda: The 

President’s Council of Advisors on 

Science and Technology is scheduled to 

meet in open session on Tuesday 

September 12, 2006, at approximately 9 

a.m. The PCAST is tentatively 

scheduled to discuss its report and 

recommendations related to energy 

technology. The co-chairs of the PCAST 

subcommittee on networking and 

information technology are tentatively 

scheduled to provide an update on 

subcommittee activities and lead a 

discussion on the PCAST review of the 

Federal Networking and Information 

Technology Research and Development 

(NITRD) Program. A presentation on 

ethical and societal issues related to 

emerging technology capabilities is also 

tentatively scheduled to occur. This 

session will end at approximately 5 p.m. 

Additional information and the final 

agenda will be posted at the PCAST 

Web site at: http://www.ostp.gov/ 

PCAST/pcast.html. 

Public Comments: There will be time 

allocated for the public to speak on the 

above agenda items. This public 

comment time is designed for 

substantive commentary on PCAST’s 

work topics, not for business marketing 

purposes. Please submit a request for 

the opportunity to make a public 

comment five (5) days in advance of the 

meeting. The time for public comments 

will be limited to no more than 5 

minutes per person. Written comments 

are also welcome at any time following 

the meeting. Please notify Celia 

Merzbacher, PCAST Executive Director, 

at (202) 456–7116, or fax your request/ 

comments to (202) 456–6021. 

FOR FURTHER INFORMATION CONTACT: For 

information regarding time, place and 

agenda, please call Celia Merzbacher at 

(202) 456–7116, prior to 3 p.m. on 

Friday, September 8, 2006. Information 

will also be available at the PCAST Web 

site at: http://www.ostp.gov/PCAST/ 

pcast.html. Please note that public 

seating for this meeting is limited and 

is available on a first-come, first-served 

basis. 

SUPPLEMENTARY INFORMATION: The 

President’s Council of Advisors on 

Science and Technology was 

established by Executive Order 13226, 

on September 30, 2001. The purpose of 

PCAST is to advise the President on 

matters of science and technology 

policy, and to assist the President’s 

National Science and Technology 

Council in securing private sector 

participation in its activities. The 

Council members are distinguished 

individuals appointed by the President 

from non-Federal sectors. The PCAST is 

co-chaired by Dr. John H. Marburger, III, 

the Director of the Office of Science and 

Technology Policy, and by E. Floyd 

Kvamme, a Partner at Kleiner Perkins 

Caufield & Byers. 

Celia Merzbacher, 

PCAST Executive Director, Office of Science 

and Technology Policy. 

[FR Doc. E6–14451 Filed 8–28–06; 8:45 am] 

BILLING CODE 3170–W4–P 

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 

Web site at http://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 September 25, 

2006. 

A. Federal Reserve Bank of Atlanta 

(Andre Anderson, Vice President) 1000 

Peachtree Street, N.E., Atlanta, Georgia 

30309: 

1. Southcrest Financial Group, Inc., 

Fayetteville, Georgia; to merge with 

Maplesville Bancorp, and thereby 

indirectly acquire Peachtree Bank, both 

of Maplesville, Alabama. 

B. Federal Reserve Bank of 

Minneapolis (Jacqueline G. King, 

Community Affairs Officer) 90 

Hennepin Avenue, Minneapolis, 

Minnesota 55480-0291: 

2. Baldwin Bancshares, Inc., Baldwin, 

Wisconsin; to acquire 100 percent of the 

voting shares of Gavic Services, Inc., 

Spring Valley, Wisconsin, and thereby 

indirectly acquire voting shares of The 

Bank of Spring Valley, Spring Valley, 

Wisconsin. 

Board of Governors of the Federal Reserve 

System, August 24, 2006. 

Robert deV. Frierson, 

Deputy Secretary of the Board. 

[FR Doc. E6–14310 Filed 8–28–06; 8:45 am] 

BILLING CODE 6210–01–S 

FEDERAL RESERVE SYSTEM 

Sunshine Act Meeting 

AGENCY HOLDING THE MEETING: Board of 

Governors of the Federal Reserve 

System. 

TIME AND DATE: 11:30 a.m., Tuesday, 

September 5, 2006. 

PLACE: Marriner S. Eccles Federal 

Reserve Board Building, 20th and C 

Streets, NW., Washington, DC 20551. 

STATUS: Closed. 

MATTERS TO BE CONSIDERED: 

1. Personnel actions (appointments, 

promotions, assignments, 

reassignments, and salary actions) 

involving individual Federal Reserve 

System employees. 

2. Any items carried forward from a 

previously announced meeting. 

FOR FURTHER INFORMATION CONTACT: 

Michelle Smith, Director, or Dave 

Skidmore, Assistant to the Board, Office 

of Board Members at 202–452–2955. 

SUPPLEMENTARY INFORMATION: You may 

call 202–452–3206 beginning at 

approximately 5 p.m. two business days 

before the meeting for a recorded 

announcement of bank and bank 

holding company applications 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 71, No. 167 / Tuesday, August 29, 2006 / Notices 51195 

scheduled for the meeting; or you may 

contact the Board’s Web site at http:// 

www.federalreserve.gov for an electronic 

announcement that not only lists 

applications, but also indicates 

procedural and other information about 

the meeting. 

Board of Governors of the Federal Reserve 

System, August 25, 2006. 

Robert deV. Frierson, 

Deputy Secretary of the Board. 

[FR Doc. 06–7253 Filed 8–25–06; 1:17 pm] 

BILLING CODE 6210–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006N–0203] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; User Fee Cover 

Sheet; Form FDA 3397 

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 September 

28, 2006. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–4659. 

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. 

User Fee Cover Sheet; Form FDA 

3397—(OMB Control Number 0910– 

0297)—Extension 

Under sections 735 and 736 of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 379g and 379h), the 

Prescription Drug User Fee Act of 1992 

(PDUFA) (Public Law 102–571), as 

amended by the Food and Drug 

Administration Modernization Act of 

1997 (Public Law 105–115), and the 

Public Health Security and Bioterrorism 

Preparedness and Response Act of 2002, 

which includes the Prescription Drug 

User Fee Amendments of 2002 (Public 

Law 107–188), FDA has the authority to 

assess and collect user fees for certain 

drug and biologics license applications 

and supplements. Under this authority, 

pharmaceutical companies pay a fee for 

certain new human drug applications, 

biologics license applications, or 

supplements submitted to FDA for 

review. Because the submission of user 

fees concurrently with applications and 

supplements is required, review of an 

application by FDA cannot begin until 

the fee is submitted. Form FDA 3397, 

the user fee cover sheet, is designed to 

provide the minimum necessary 

information to determine whether a fee 

is required for review of an application, 

to determine the amount of the fee 

required, and to account for and track 

user fees. The form provides a crossreference of the fee submitted for an 

application with the actual application 

by using a unique number tracking 

system. The information collected is 

used by FDA’s Center for Drug 

Evaluation and Research (CDER) and 

Center for Biologics Evaluation and 

Research (CBER) to initiate the 

administrative screening of new drug 

applications, biologics license 

applications, and supplemental 

applications. 

Respondents to this collection of 

information are new drug and biologics 

manufacturers. Based on FDA’s database 

system for fiscal year (FY) 2005, there 

are an estimated 243 manufacturers of 

products subject to PDUFA. However, 

not all manufacturers will have any 

submissions, and some may have 

multiple submissions in a given year. 

The total number of annual responses is 

based on the number of submissions 

received by FDA in FY 2005. CDER 

estimates 3,085 annual responses that 

include the following submissions: 101 

new drug applications; 3 biologics 

license applications; 1,915 

manufacturing supplements; 921 

labeling supplements; and 145 efficacy 

supplements. CBER estimates 676 

annual responses that include the 

following submissions: 6 biologics 

license applications, 614 manufacturing 

supplements, 46 labeling supplements, 

and 10 efficacy supplements. Based on 

previous estimates, the rate of 

submissions is not expected to change 

significantly in the next few years. The 

estimated hours per response are based 

on past FDA experience with the 

various submissions, and range from 5 

to 30 minutes. The hours per response 

are based on the average of these 

estimates. 

In the Federal Register of May 25, 

2006 (71 FR 30144), 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

Form No. of Respondents Annual Frequency per 

Response 

Total Annual 

Responses Hours per Respondent Total Hours 

FDA 3397 243 15.48 3,761 0.30 1,128 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 


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