53250 Federal Register / Vol. 73, No. 179 / Monday, September 15, 2008 / Notices 

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 

September 29, 2008. 

A. Federal Reserve Bank of Atlanta 

(Steve Foley, Vice President) 1000 

Peachtree Street, N.E., Atlanta, Georgia 

30309: 

1. Leslie D. Ligon, Jr., Clinton, 

Louisiana; to acquire additional shares 

of Clinton Bancshares, Inc., and thereby 

acquire shares of Landmark Bank, both 

of Clinton, Louisiana. 

Board of Governors of the Federal Reserve 

System, September 10, 2008. 

Robert deV. Frierson, 

Deputy Secretary of the Board. 

[FR Doc. E8–21451 Filed 9–12–08; 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 October 10, 2008. 

A. Federal Reserve Bank of Chicago 

(Burl Thornton, Assistant Vice 

President) 230 South LaSalle Street, 

Chicago, Illinois 60690-1414: 

1. PrivateBancorp, Inc., Chicago, 

Illinois; to acquire 100 percent of the 

voting shares of The PrivateWealth 

Trust Company, a federal savings bank 

(in organization), Chicago, Illinois, and 

thereby engage in operating a savings 

bank pursuant to section 225.28(b)(4)(ii) 

of Regulation Y. 

Board of Governors of the Federal Reserve 

System, September 10, 2008. 

Robert deV. Frierson, 

Deputy Secretary of the Board. 

[FR Doc. E8–21452 Filed 9–12–08; 8:45 am] 

BILLING CODE 6210–01–S 

GENERAL SERVICES 

ADMINISTRATION 

Office of Small Business Utilization; 

Small Business Advisory Committee; 

Notice of Request for Nominations for 

Subcommittee on Service Disabled 

Veteran Owned Small Business 

(SDVOSB), GSA Small Business 

Advisory Committee 

AGENCY: Office of Small Business 

Utilization, GSA. 

ACTION: Notice. 

SUMMARY: The General Services 

Administration (GSA) is requesting the 

public to submit nominations of 

individuals for the Service Disabled 

Veteran Owned Small Business 

Subcommittee of the GSA Small 

Business Advisory Committee as a part 

of GSA’s initiative to meet and exceed 

its three percent contracting goal for 

Service-Disabled Veteran-Owned Small 

Businesses. 

DATES: Interested parties should submit 

the nomination form on or before 

September 30, 2008. 

ADDRESSES: The nomination form is 

available at http://www.gsa.gov/servicedisabled and should be submitted to 

sbac@gsa.gov. When submitting a 

nomination via email, please put 

‘‘SDVOSB Subcommittee nomination’’ 

in the subject line. Nominations may 

also be sent by mail to: General Services 

Administration, Small Business 

Advisory Committee, 1800 F Street NW, 

Room 6029, Washington, DC 20405. 

Those wishing to send the 

nominations by fax may do so using 

(202) 501–2590. 

FOR FURTHER INFORMATION CONTACT

Aaron Collmann, Room 6029, GSA 

Building, 1800 F Street, NW., 

Washington, DC 20405 (202) 501–1021 

or email at sbac@gsa.gov. 

SUPPLEMENTARY INFORMATION: This 

notice is published in accordance with 

the provisions of the Federal Advisory 

Committee Act (FACA) (Pub. L. 92– 

463). The purpose of this subcommittee 

is to advise GSA in issues pertaining to 

Service Disabled Veteran Owned Small 

Businesses (SDVOSB’s) as outlined in 

Gun number 2 (Advocacy) of GSA’s 21 

Gun Salute initiative for SDVOSB’s. 

Information on the 21 Gun Salute can be 

found at http://www.gsa.gov/servicedisabled. Please note that nominees who 

are selected and agree to serve may be 

asked to complete a financial disclosure 

form. 

Dated: September 9, 2008. 

Michael Rigas, 

Deputy Associate Administrator, Office of 

Small Business Utilization, General Services 

Administration. 

[FR Doc. E8–21455 Filed 9–12–08; 8:45 am] 

BILLING CODE 6820–34–S 

OFFICE OF GOVERNMENT ETHICS 

Updated OGE Senior Executive Service 

Performance Review Board 

AGENCY: Office of Government Ethics 

(OGE). 

ACTION: Notice. 

SUMMARY: Notice is hereby given of the 

appointment of the members of the 

updated OGE Senior Executive Service 

(SES) Performance Review Board. 

DATES: Effective Date: September 15, 

2008. 

FOR FURTHER INFORMATION CONTACT: 

Joseph E. Gangloff, Deputy Director for 

Agency Programs, Office of Government 

Ethics, Suite 500, 1201 New York 

Avenue, NW., Washington, DC 20005– 

3917; Telephone: 202–482–9300; TDD: 

202–482–9293; FAX: 202–482–9238. 

SUPPLEMENTARY INFORMATION: 5 U.S.C. 

4314(c) requires each agency to 

establish, in accordance with 

regulations prescribed by the Office of 

Personnel Management at 5 CFR part 

430, subpart C and § 430.310 thereof in 

particular, one or more Senior Executive 

Service performance review boards. As 

a small executive branch agency, OGE 

has just one board. In order to ensure an 

adequate level of staffing and to avoid 

a constant series of recusals, the 

designated members of OGE’s SES 

Performance Review Board are being 

drawn, as in the past, in large measure 

from the ranks of other agencies. The 

board shall review and evaluate the 

initial appraisal of each OGE senior 

executive’s performance by his or her 

supervisor, along with any 

recommendations in each instance to 

the appointing authority relative to the 

performance of the senior executive. 

This notice updates the membership of 

mstockstill on PROD1PC66 with NOTICES

Federal Register / Vol. 73, No. 179 / Monday, September 15, 2008 / Notices 53251 

OGE’s SES Performance Review Board 

as it was most recently published at 72 

FR 54666–54667 (September 26, 2007). 

Approved: September 9, 2008. 

Robert I. Cusick, 

Director, Office of Government Ethics. 

The following officials have been 

appointed as regular members of the 

SES Performance Review Board of the 

Office of Government Ethics: 

Joseph E. Gangloff [Chair], Deputy 

Director for Agency Programs, Office 

of Government Ethics; 

Don W. Fox [Alternate Chair], General 

Counsel, Office of Government Ethics; 

Daniel L. Koffsky, Special Counsel, 

Office of Legal Counsel, Department 

of Justice; 

David Maggi, Chief, Ethics Law and 

Programs Division, Office of the 

Assistant General Counsel for 

Administration, Department of 

Commerce; and 

Robert A. Shapiro, Associate Solicitor 

for Legal Counsel, Department of 

Labor. 

[FR Doc. E8–21447 Filed 9–12–08; 8:45 am] 

BILLING CODE 6345–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0434] (formerly 

Docket No. 2007D–0386) 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance for 

Industry on Postmarketing Adverse 

Event Reporting for Nonprescription 

Human Drug Products Marketed 

Without an Approved Application 

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 October 15, 

2008. 

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, or e-mailed to 

baguilar@omb.eop.gov. All comments 

should be identified with the OMB 

control number 0910–NEW and title 

‘‘Guidance for Industry on 

Postmarketing Adverse Event Reporting 

for Nonprescription Human Drug 

Products Marketed Without an 

Approved Application.’’ Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management (HFA–710), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–796–3792. 

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. 

Guidance for Industry on 

Postmarketing Adverse Event Reporting 

for Nonprescription Human Drug 

Products Marketed Without an 

Approved Application 

Public Law 109–462, the Dietary 

Supplement and Nonprescription Drug 

Consumer Protection Act, amended the 

Federal Food, Drug, and Cosmetic Act 

(the act) to add safety reporting 

requirements for nonprescription drug 

products that are marketed without an 

approved application. In accordance 

with section 760(b) of the act (21 U.S.C. 

379aa), the manufacturer, packer, or 

distributor whose name appears on the 

label of a nonprescription drug 

marketed in the United States without 

an approved application (referred to as 

the responsible person) must submit to 

FDA any report of a serious adverse 

event associated with such drug when 

used in the United States, accompanied 

by a copy of the label on or within the 

retail package of such drug. In addition, 

the responsible person must submit 

followup reports of new medical 

information related to a submitted 

serious adverse event report that is 

received within 1 year of the initial 

report (section 760(c)(2) of the act). 

Section 760(e) of the act also requires 

that responsible persons maintain 

records of nonprescription drug adverse 

event reports, whether or not the event 

is serious, for a period of 6 years. The 

guidance document provides 

information on: (1) The minimum data 

elements that should be included in a 

serious adverse event report, (2) the 

label that should be included with the 

report, (3) reporting formats for paper 

and electronic submissions, and (4) how 

and where to submit the reports. 

Title: Guidance for Industry on 

Postmarketing Adverse Event Reporting 

for Nonprescription Human Drug 

Products Marketed Without an 

Approved Application. 

Description of Respondents: 

Respondents to this collection of 

information are manufacturers, packers, 

or distributors whose name appears on 

the label of a nonprescription drug 

marketed in the United States without 

an approved application. 

Burden Estimate: FDA is requesting 

public comment on estimates of the 

number of annual submissions from 

these respondents and recordkeeping, as 

required by Public Law 109–462 and 

described in the guidance 

‘‘Postmarketing Adverse Event 

Reporting for Nonprescription Human 

Drug Products Marketed Without an 

Approved Application.’’ The estimates 

for annual reporting and recordkeeping 

are based on FDA’s knowledge of 

adverse drug experience reports 

historically submitted annually for 

prescription drug products and for 

nonprescription drug products marketed 

under an approved application, 

including knowledge about the time 

needed to prepare the reports and to 

maintain records. 

FDA receives approximately 2,500 

serious adverse event reports for 

nonprescription drug products marketed 

under approved applications, which 

comprise approximately 20 percent of 

the overall nonprescription drug market. 

Based on this data, we estimate between 

10,000 and 15,000 (i.e., 12,500) total 

annual responses from approximately 

50 respondents for nonprescription 

drugs marketed without an approved 

application, and that each submission 

will take approximately 2 hours to 

prepare and submit to FDA. 

In the Federal Register of October 15, 

2007 (72 FR 58316), FDA published a 

60-day notice requesting public 

comment on the information collection 

provisions. No comments were received 

on the information collection. 

FDA estimates the burden of this 

collection of information as follows: 

mstockstill on PROD1PC66 with NOTICES