67146 Federal Register / Vol. 69, No. 220 / Tuesday, November 16, 2004 / Notices 

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 December 9, 

2004.

A. Federal Reserve Bank of Atlanta

(Sue Costello, Vice President) 1000 

Peachtree Street, N.E., Atlanta, Georgia 

30303:

1. Great Financial Corporation, Miami 

Lakes, Florida; to become a bank 

holding company by acquiring 100 

percent of the voting shares of Great 

Florida Bank, Miami, Florida.

B. Federal Reserve Bank of 

Minneapolis (Jacqueline G. Nicholas, 

Community Affairs Officer) 90 

Hennepin Avenue, Minneapolis, 

Minnesota 55480–0291:

1. Western Transaction Corporation, 

Duluth, Minnesota; to become a bank 

holding company by acquiring 100 

percent of the voting shares of Western 

National Bank, Duluth, Minnesota, and 

Cass Lake Company, Cass Lake, 

Minnesota, and thereby indirectly 

acquire voting shares of First National 

Bank of Cass Lake, Cass Lake, 

Minnesota.

In connection with this application, 

Applicant also has applied to acquire 

Premier Credit Corporation, Duluth, 

Minnesota, and thereby engage in 

operating an industrial loan company 

and to engage directly in general 

insurance agency activities in a town 

with a population not exceeding 5,000, 

pursuant to sections 225.28(b)(4)(i) and 

(b)(11)(iii) of Regulation Y.

Board of Governors of the Federal Reserve 

System, November 9, 2004.

Robert deV. Frierson,

Deputy Secretary of the Board.

[FR Doc. 04–25387 Filed 11–15–04; 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 November 29, 2004.

A. Federal Reserve Bank of Atlanta

(Sue Costello, Vice President) 1000 

Peachtree Street, N.E., Atlanta, Georgia 

30303:

1. Civitas BankGroup, Inc., Franklin, 

Tennessee; to engage de novo through 

its subsidiary, Civitas Management 

Company, Inc., Franklin, Tennessee, in 

making, acquiring, brokering, or 

servicing loans or other extensions of 

credit, and to engage in activities related 

to extending credit, pursuant to sections 

225.28(b)(1) and (b)(2)(i) of Regulation 

Y.

Board of Governors of the Federal Reserve 

System, November 9, 2004.

Robert deV. Frierson,

Deputy Secretary of the Board.

[FR Doc.04–25386 Filed 11–15–04; 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., Monday, 

November 22, 2004.

PLACE: Marriner S. Eccles Federal 

Reserve Board Building, 20th and C 

Streets, N.W., Washington, D.C. 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 A. Smith, Director, Office of 

Board Members; 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 

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, November 12, 2004.

Robert deV. Frierson,

Deputy Secretary of the Board.

[FR Doc. 04–25528 Filed 11–12–04; 3:11 pm]

BILLING CODE 6210–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Notice of Interest Rate on Overdue 

Debts 

Section 30.13 of the Department of 

Health and Human Services’ claims 

collection regulations (45 CFR part 30) 

provides that the Secretary shall charge 

an annual rate of interest as fixed by the 

Secretary of the Treasury after taking 

into consideration private consumer

Federal Register / Vol. 69, No. 220 / Tuesday, November 16, 2004 / Notices 67147

rates of interest prevailing on the date 

that HHS becomes entitled to recovery. 

The rate generally cannot be lower than 

the Department of Treasury’s current 

value of funds rate or the applicable rate 

determined from the ‘‘Schedule of 

Certified Interest Rates with Range of 

Maturities.’’ This rate may be revised 

quarterly by the Secretary of the 

Treasury and shall be published 

quarterly by the Department of Health 

and Human Services in the Federal 

Register. 

The Secretary of the Treasury has 

certified a rate of 12% for the quarter 

ended September 30, 2004. This interest 

rate will remain in effect until such time 

as the Secretary of the Treasury notifies 

HHS of the change.

Dated: November 8, 2004. 

George Strader, 

Deputy Assistant Secretary, Finance.

[FR Doc. 04–25357 Filed 11–15–04; 8:45 am] 

BILLING CODE 4150–02–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Low Income Home Energy 

Assistance Program (LIHEAP) Grantee 

Survey. 

OMB No.: 0970–0076. 

Description: The LIHEAP Grantee 

Survey is an annual data collection 

activity, which is sent to the 50 States 

and the District of Columbia grantees 

administering the Low Income Home 

Energy Assistance Program (LIHEAP). 

The survey is mandatory in order that 

national estimates of the sources and 

uses of LIHEAP funds can be calculated 

in a timely manner; a range can be 

calculated of state average LIHEAP 

benefits; and maximum income cutoffs 

for 4-person households can be obtained 

for estimating the number of lowincome households that are income 

eligible for LIHEAP under State income 

standards. 

Respondents: 50 States and the 

District of Columbia. 

Annual Burden Estimates:

Instrument Number of

respondents 

Number of

responses per 

respondent 

Average

burden hours

per response 

Total burden 

hours 

Survey .............................................................................................................. 51 1 3.4 173.4

Estimated Total Annual Burden 

Hours: 173.4. 

Additional Information: The need for 

the survey is to provide the 

Administration and Congress with fiscal 

estimates in time for hearings about 

LIHEAP appropriations and program 

performance. The information also is 

included in the Department’s annual 

LIHEAP Report to Congress. Survey 

information also will be posted on 

Office of Community Services LIHEAP 

web site for access by grantees and other 

interested parties. 

Copies of the proposed collection may 

be obtained by writing to the 

Administration for Children and 

Families, Office of Administration, 

Office of Information services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. All request should be identified 

by the title of the information collection. 

E-mail address: grjohnson@acf.hhs.gov.

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Attn: Desk Officer for 

ACF, e-mail address: 

Katherine_T._Astrich@omb.eop.gov.

Dated: November 9, 2004. 

Robert Sargis, 

Reports Clearance Officer.

[FR Doc. 04–25341 Filed 11–15–04; 8:45 am] 

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004P–0051]

Determination That DYCLONE 

(Dyclonine Hydrochloride) 0.5% and 

1.0% Topical Solutions Were 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) has determined 

that DYCLONE (dyclonine 

hydrochloride (HCl)) 0.5% and 1.0% 

Topical Solutions were not withdrawn 

from sale for reasons of safety or 

effectiveness. This determination will 

allow FDA to approve abbreviated new 

drug applications (ANDAs) for 

DYCLONE HCl 0.5 and 1.0% Topical 

Solutions.

FOR FURTHER INFORMATION CONTACT:

Mary Catchings, Center for Drug 

Evaluation and Research (HFD–7), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–594–

2041.

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 

sponsors 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. Sponsors of 

ANDAs 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 generally known 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).