41436 Federal Register / Vol. 74, No. 157 / Monday, August 17, 2009 / Notices 

modifying existing facilities as 

authorized by a construction permit and 

determines it is necessary to either 

discontinue operation or to operate with 

temporary facilities to continue program 

service for a period not more than 30 

days. Licensees or permittees of 

directional or nondirectional FM, TV or 

Class A TV or nondirectional AM must 

file a notification and comply with 47 

CFR 73.1615(a). Licensees or permittees 

of a directional AM station whose 

modification does not involve a change 

in operating frequency must file a 

notification and comply with 47 CFR 

73.1615(b). Licensees or permittees of a 

directional AM station whose 

modification does involve a change in 

frequency and determines it is necessary 

to discontinue operation for a period not 

more than 30 days must file a 

notification and comply with 47 CFR 

73.1615(d)(2). 

Section 73.1615 informal letter 

requests (47 CFR § 73.1615). Broadcast 

stations (AM, FM, TV or Class A TV 

licensees or permittees) must file an 

informal letter request under 47 CFR 

73.1615(c)(1) when such a station is in 

the process of modifying existing 

facilities pursuant to 47 CFR 73.1615(a) 

or (b) and determines it is necessary to 

either discontinue operation or to 

operate with temporary facilities to 

continue program service for a period of 

more than 30 days. Licensees or 

permittees that filed notifications under 

47 CFR 73.1615(d)(2) but which 

determine that it is necessary to 

discontinue operation for a period more 

than 30 days must file an informal letter 

request and comply with 47 CFR 

73.1615(d)(1) and (2). 

Federal Communications Commission. 

Marlene H. Dortch, 

Secretary. 

[FR Doc. E9–19672 Filed 8–14–09; 8:45 am] 

BILLING CODE: 6712–01–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 applications 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 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 10, 

2009. 

A. Federal Reserve Bank of Atlanta 

(Steve Foley, Vice President) 1000 

Peachtree Street, N.E., Atlanta, Georgia 

30309: 

1. Heart of Georgia Bancshares, Inc., 

Mount Vernon, Georgia; to acquire 100 

percent of the voting shares of The 

Tattnall Bank, Reidsville, Georgia. 

B. Federal Reserve Bank of San 

Francisco (Kenneth Binning, Vice 

President, Applications and 

Enforcement) 101 Market Street, San 

Francisco, California 94105-1579: 

1. Golden Pacific Bancorp, 

Sacramento, California; to acquire 100 

percent of Gold Country Financial 

Services, Inc, and thereby indirectly 

acquire Gold Country Bank, N.A., both 

of Marysville, California. 

Board of Governors of the Federal Reserve 

System, August 12, 2009. 

Robert deV. Frierson, 

Deputy Secretary of the Board. 

[FR Doc. E9–19630 Filed 8–14–09; 8:45 am] 

BILLING CODE 6210–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Notice of Meeting: Secretary’s 

Advisory Committee on Genetics, 

Health, and Society 

Pursuant to Public Law 92–463, 

notice is hereby given of the twentieth 

meeting of the Secretary’s Advisory 

Committee on Genetics, Health, and 

Society (SACGHS), U.S. Public Health 

Service. The meeting will be held from 

8:30 a.m. to approximately 6 p.m. on 

Thursday, October 8, 2009, and from 8 

a.m. to approximately 3:30 p.m. on 

Friday, October 9, 2009, at the Hubert H. 

Humphrey Building, 200 Independence 

Avenue SW., Washington, DC 20201. 

The meeting will be open to the public 

with attendance limited to space 

available. The meeting also will be Web 

cast. 

The main agenda items involve the 

review of three SACGHS draft reports: a 

final draft report and its 

recommendations on gene patents and 

licensing practices along with 

comments received on the public 

consultation draft circulated earlier this 

year; a public consultation draft report 

on genetics education and training; and 

a revised draft paper on direct-toconsumer genetic testing. The first day 

of the meeting will include an extended 

period of time for interested members of 

the public to provide their perspectives 

on gene patents and licensing practices 

and their effect on patient access to 

genetic tests. Members of the public are 

encouraged to contact the SACGHS 

Executive Secretary (see below) by 

September 15, 2009, if they wish to 

participate in this extended public 

comment period. Other agenda items 

include an update on regulations 

implementing the Genetic Information 

Nondiscrimination Act, a report on 

activities of the Clinical Utility and 

Comparative Effectiveness Task Force, 

and a brief discussion to initiate the 

Committee’s work on ethical issues 

related to genomic data sharing. 

As always, the Committee welcomes 

hearing from anyone wishing to provide 

public comment on any issue related to 

genetics, health and society. Individuals 

who would like to provide public 

comment should notify the SACGHS 

Executive Secretary, Ms. Sarah Carr, by 

telephone at 301–496–9838 or e-mail at 

carrs@od.nih.gov. The SACGHS office is 

located at 6705 Rockledge Drive, Suite 

750, Bethesda, MD 20892. Anyone 

planning to attend the meeting who 

needs special assistance, such as sign 

language interpretation or other 

reasonable accommodations, is also 

asked to contact the Executive 

Secretary. 

Under authority of 42 U.S.C. 217a, 

section 222 of the Public Health Service 

Act, as amended, the Department of 

Health and Human Services established 

SACGHS to serve as a public forum for 

deliberations on the broad range of 

human health and societal issues raised 

by the development and use of genetic 

and genomic technologies and, as 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 74, No. 157 / Monday, August 17, 2009 / Notices 41437 

warranted, to provide advice on these 

issues. The draft meeting agenda and 

other information about SACGHS, 

including information about access to 

the Web cast, will be available at the 

following Web site: http:// 

oba.od.nih.gov/SACGHS/ 

sacghs_meetings.html. 

Dated: August 10, 2009. 

Jennifer Spaeth, 

Director, NIH Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–19584 Filed 8–14–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Sterilization of Persons in Federally 

Assisted Family Planning Projects 

(July 17, 2009); Correction 

AGENCY: Department of Health and 

Human Services. 

ACTION: Notice: correction. 

SUMMARY: The Department of Health and 

Human Services (HHS) published a 

document in the Federal Register of 

July 17, 2009, requesting OMB 

reauthorization of the form 

‘‘Sterilization of Persons in Federally 

Assisted Family Planning Projects.’’ The 

document contained an incorrect 

citation to the HHS sterilization 

regulations; incorrectly identified the 

Office of Population Affairs (OPA), 

rather than the Public Health Service 

(PHS), as the agency within HHS that 

administers programs of health services 

which are supported by Federal 

financial assistance and which are 

required to obtain informed consent 

from persons undergoing sterilizations; 

incorrectly described the form that is 

required to be used to obtain informed 

consent; and incorrectly referred to the 

regulations to which the consent form is 

appended as OPA regulations rather 

than PHS regulations. 

FOR FURTHER INFORMATION CONTACT: 

Sherette Funn-Coleman, 202–690–5683. 

Corrections: 

In the Federal Register of July 17, 

2009, in FR Doc. OS–0937–0166, on 

page 34757, in the second column, 

correct the citation to the sterilization 

regulations to read: 

Proposed Project: HHS 42 CFR part 

50, subpart B; Sterilization of Persons in 

Federally Assisted Family Planning 

Projects— 

In the third column, correct the 

‘‘Abstract’’ related to the consent form 

to read as follows: 

The consent form solicits information 

to assure voluntary and informed 

consent to persons undergoing 

sterilization in programs of health 

services which are supported by Federal 

financial assistance administered by the 

Public Health Service (PHS). The form 

provides additional procedural 

protections to individuals undergoing 

sterilization. In order to obtain informed 

consent, the regulation requires that 

programs use either the form that is 

appended to the PHS regulation or 

another consent form approved by the 

Secretary. 

Dated: August 7, 2009. 

Seleda Perryman, 

Office of the Secretary, Paperwork Reduction 

Act Reports Clearance Officer. 

[FR Doc. E9–19566 Filed 8–14–09; 8:45 am] 

BILLING CODE 4150–34–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–P–0443] 

Determination That DEMADEX 

(Torsemide) Injection, 20 Milligrams/2 

Milliliter (10 Milligrams/Milliliter) and 50 

Milligrams/5 Milliliter (10 Milligrams/ 

Milliliter), Was Not Withdrawn From 

Sale for Reasons of Safety or 

Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing its 

determination that DEMADEX 

(torsemide) injection, 20 milligrams 

(mg)/2 milliliter (mL) (10 mg/mL) and 

50 mg/5 mL (10 mg/mL), was not 

withdrawn from sale for reasons of 

safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for torsemide 

injection, 20 mg/2mL (10 mg/mL) and 

50 mg/5 mL (10 mg/mL), if all other 

legal and regulatory requirements are 

met. 

FOR FURTHER INFORMATION CONTACT: 

Nikki Mueller, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6312, 

Silver Spring, MD 20993–0002, 301– 

796–3601. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Public Law 98– 

417 (the 1984 amendments)), which 

authorized the approval of duplicate 

versions of drug products approved 

under an ANDA procedure. ANDA 

applicants must, with certain 

exceptions, show that the drug for 

which they are seeking approval 

contains the same active ingredient in 

the same strength and dosage form as 

the ‘‘listed drug,’’ which is a version of 

the drug that was previously approved. 

ANDA applicants do not have to repeat 

the extensive clinical testing otherwise 

necessary to gain approval of a new 

drug application (NDA). The only 

clinical data required in an ANDA are 

data to show that the drug that is the 

subject of the ANDA is bioequivalent to 

the listed drug. 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’ 

which is known generally as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are removed from the list if the 

agency withdraws or suspends approval 

of the drug’s NDA or ANDA for reasons 

of safety or effectiveness, or if FDA 

determines that the listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness (21 CFR 314.162). 

Under § 314.161(a)(1) (21 CFR 

314.161(a)(1)), the agency must 

determine whether a listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness before an ANDA 

that refers to that listed drug may be 

approved. FDA may not approve an 

ANDA that does not refer to a listed 

drug. 

PharmaForce, Inc., submitted a citizen 

petition dated August 5, 2008 (Docket 

No. FDA–2008–P–0443), under 21 CFR 

10.30 requesting that the agency 

determine whether DEMADEX 

(torsemide) injection, 20 mg/2 mL (10 

mg/mL) and 50 mg/5 mL (10 mg/mL), 

was withdrawn from sale for reasons of 

safety or effectiveness. DEMADEX 

(torsemide) injection is the subject of 

NDA 20–137, held by Roche 

Pharmaceuticals (Roche) and was 

initially approved on August 23, 1993. 

DEMADEX is indicated for the 

treatment of edema associated with 

congestive heart failure, renal disease, 

or hepatic disease. Roche notified FDA 

on June 16, 2008, that it was no longer 

marketing DEMADEX (torsemide) 

injection, 20 mg/2 mL (10 mg/mL) and 

50 mg/5 mL (10 mg/mL), and the drug 

product was moved to the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. 

FDA has reviewed its records and, 

under § 314.161, has determined that 

DEMADEX (torsemide) injection, 20 mg/ 

2 mL (10 mg/mL) and 50 mg/5 mL (10 

mstockstill on DSKH9S0YB1PROD with NOTICES