Federal Register / Vol. 77, No. 39 / Tuesday, February 28, 2012 / Notices 12057 

institutions that are located in the 

Caribbean or the United Kingdom. 

Estimated annual reporting hours: 

574 hours. 

Estimated average hours per response: 

3.5 hours. 

Number of respondents: 41. 

General description of report: This 

information collection is required (12 

U.S.C. 248(a)(2), 461, 602, and 625) and 

is given confidential treatment (5 U.S.C. 

552(b)(4)). 

Abstract: The FR 2502q collects data 

quarterly on the geographic distribution 

of the assets and liabilities of major U.K. 

or Caribbean branches and subsidiaries 

of U.S. commercial banks, bank holding 

companies, including financial holding 

companies, and of banking Edge and 

agreement corporations. Data from this 

reporting form comprise a piece of the 

flow of funds data that are compiled by 

the Federal Reserve. FR 2502q data also 

helps the Federal Reserve understand 

the nature of activities of foreign offices 

of U.S. banks, particularly the scope of 

cross-border activity that is conducted 

by different foreign offices in the United 

Kingdom and the Caribbean. 

Current Actions: On December 8, 2011 

the Federal Reserve published a notice 

in the Federal Register (76 FR 76730) 

requesting public comment for 60 days 

on the extension, with revision, of the 

Quarterly Report of Assets and 

Liabilities of Large Foreign Offices of 

U.S. Banks. The comment period for 

this notice expired on February 6, 2012. 

The Federal Reserve did not receive any 

comments. The revisions will be 

implemented as proposed. 

Board of Governors of the Federal Reserve 

System, February 22, 2012. 

Jennifer J. Johnson, 

Secretary of the Board. 

[FR Doc. 2012–4527 Filed 2–27–12; 8:45 am] 

BILLING CODE 6210–01–P 

FEDERAL RESERVE SYSTEM 

Change in Bank Control Notices; 

Acquisitions of Shares of a Bank or 

Bank Holding Company 

The notificants listed below have 

applied under the Change in Bank 

Control Act (12 U.S.C. 1817(j)) and 

§ 225.41 of the Board’s Regulation Y (12 

CFR 225.41) to acquire shares of a bank 

or bank holding company. The factors 

that are considered in acting on the 

notices are set forth in paragraph 7 of 

the Act (12 U.S.C. 1817(j)(7)). 

The notices are available for 

immediate inspection at the Federal 

Reserve Bank indicated. The notices 

also will be available for inspection at 

the offices of the Board of Governors. 

Interested persons may express their 

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 March 

14, 2012. 

A. Federal Reserve Bank of Chicago 

(Colette A. Fried, Assistant Vice 

President) 230 South LaSalle Street, 

Chicago, Illinois 60690–1414: 

1. Perry Hodgson, Alexander 

Hodgson, and Raymond Hodgson, all of 

Charlevoix, Michigan; to join the 

existing Hodgson control group and to 

retain and acquire voting shares of 

Charlevoix First Corporation, and 

indirectly retain and acquire voting 

shares of Charlevoix State Bank, 

Charlevoix, Michigan. 

Board of Governors of the Federal Reserve 

System, February 23, 2012. 

Robert deV. Frierson, 

Deputy Secretary of the Board. 

[FR Doc. 2012–4616 Filed 2–27–12; 8:45 am] 

BILLING CODE 6210–01–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 applications will also 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. 

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 March 23, 

2012. 

A. Federal Reserve Bank of Richmond 

(Adam M. Drimer, Assistant Vice 

President) 701 East Byrd Street, 

Richmond, Virginia 23261–4528: 

1. SCBT Financial Corporation, 

Columbia, South Carolina; to acquire 

100 percent of the voting shares of 

Peoples Bancorporation, Inc., and 

thereby indirectly acquire voting shares 

of The Peoples National Bank, both in 

Easley, South Carolina, Bank of 

Anderson, NA, Anderson, South 

Carolina, and Seneca National Bank, 

Seneca, South Carolina. 

B. Federal Reserve Bank of Atlanta 

(Chapelle Davis, Assistant Vice 

President) 1000 Peachtree Street NE., 

Atlanta, Georgia 30309: 

1. United Group of Central Florida II, 

LLC, Longwood, Florida, to become a 

bank holding company by acquiring 100 

percent of the voting shares of Citizens 

Bancorp of Oviedo, Inc., and thereby 

indirectly acquire voting shares of 

Citizens Bank of Florida, both in 

Oviedo, Florida. 

Board of Governors of the Federal Reserve 

System, February 23, 2012. 

Robert deV. Frierson, 

Deputy Secretary of the Board. 

[FR Doc. 2012–4617 Filed 2–27–12; 8:45 am] 

BILLING CODE 6210–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–12–12EL] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

In compliance with the requirement 

of Section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995 for 

opportunity for public comment on 

proposed data collection projects, the 

Centers for Disease Control and 

Prevention (CDC) will publish periodic 

summaries of proposed projects. To 

request more information on the 

proposed projects or to obtain a copy of 

the data collection plans and 

instruments, call 404–639–7570 and 

send comments to Kimberly S. Lane, 

CDC Reports Clearance Officer, 1600 

Clifton Road, MS–D74, Atlanta, GA 

30333 or send an email to omb@cdc.gov. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 


tkelley on DSK3SPTVN1PROD with NOTICES
12058 Federal Register / Vol. 77, No. 39 / Tuesday, February 28, 2012 / Notices 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

Critical Thinking and Cultural 

Affirmation (CTCA): Evaluation of a 

Locally Developed HIV Prevention 

Intervention—New—National Center for 

HIV/AIDS, Viral Hepatitis, STD, TB 

Prevention (NCHHSTP), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

In 2005, the Centers for Disease 

Control and Prevention (CDC) reported 

that 80,187 African Americans were 

diagnosed with HIV/AIDS, which 

represents 51% of persons diagnosed. 

African-American men with HIV/AIDS 

represented 44% of all cases among 

males (Centers for Disease Control and 

Prevention [CDC], 2005). These statistics 

have been consistently disproportional 

since the late 1990s, with African 

Americans bearing the greatest burden 

of new HIV cases in most regions of the 

United States. The Centers for Disease 

Control and Prevention estimates that at 

the end of 2006, Blacks were 

disproportionately affected by HIV. The 

2006 HIV infection rate in Blacks was 

nearly twice the rate of Whites (92 out 

of every 100,000 Blacks compared to 48 

per 100,000 Whites and 31 per 100,000 

Hispanics). Among males, Black males 

accounted for the largest number of 

diagnosed HIV infections and have the 

highest HIV infection rate of any race/ 

ethnicity group (144 per 100,000, 

compared to 94 per 100,000 for White 

males and 50 per 100,000 for Hispanic 

males. 

While many HIV prevention and 

intervention studies include samples of 

African-American men and AfricanAmerican Men who have Sex with Men 

(AAMSM), beyond demonstrating 

disparities in seroprevalence between 

and among racial groups, few have been 

specifically designed and evaluated for 

efficacy among African-American men. 

Because few HIV prevention 

interventions targeting AAMSM have 

been developed and rigorously 

evaluated, while their HIV infection 

rates remain disproportionately high 

and continue to rise, identifying 

effective interventions for AAMSM is a 

public health imperative. 

The purpose of this project is to test 

the efficacy of an HIV transmission 

prevention intervention for reducing 

sexual risk among African American 

men who have sex with men in Chicago, 

Illinois. The intervention is a 3-day 

weekend retreat, group-level CTCA 

intervention that combines cultural 

affirmation with critical thinking and 

empowerment, to increase reasoning 

skill, problem solving capacity, selfprotective behavior change, and wellbeing which facilitates the reduction of 

risky sexual behaviors. A convenience 

sample of 438 AAMSM will be recruited 

to participate in the study. We 

anticipate recruiting potential 

participants for the CTCA RCT through 

a variety of community venues, using 

both active (i.e., venue outreach) and 

passive (i.e., referral, flyers/handcards, 

Internet) recruitment techniques. The 

intervention will be evaluated using 

baseline, 3-month and 6-month follow 

up assessments. This project will also 

conduct exit surveys to identify men 

who were more favorable—men who 

agreed with positive comments about 

the intervention and those who were 

less favorable—men who disagreed with 

positive comments about the 

intervention. Exit interviews will be 

conducted with 15 favorable and 15 less 

favorable men identified by the Exit 

Survey to help understand participants’ 

experiences with the CTCA intervention 

and their thoughts about the content of 

the intervention and ways in which it 

could be improved. Using the 

participant responses to the exit survey, 

we will categorize participants into two 

categories: favorable (those men 

reporting a favorable reaction to the 

intervention) and unfavorable (those 

men reporting an unfavorable reaction 

to the intervention). Once we have 50 

participants in each category, we will 

randomly select 15 participants from 

each group and invite them to 

participate in the exit interview. We 

anticipate that we will need to repeat 

these procedures and extend an 

invitation to at least 65 participants in 

order to reach and successfully 

interview 15 participants in each group. 

CDC is requesting approval for a 3- 

year clearance for data collection. Data 

collection will begin November 2012 

and end January 2015. The data 

collection system involves a pre and full 

screening, brief locator information, 

record locator information, baseline 

assessment, 3-month follow-up 

assessment, 6-month follow-up 

assessment, participant evaluation 

forms, exit survey, and exit interviews. 

An estimated 700 men will be prescreened and 500 will be full-screened 

for eligibility in order to enroll 438 men. 

The baseline and follow-up 

questionnaires will be administered 

electronically using audio computer 

assisted self-interview (ACASI). The 

ACASI interview includes questions 

about participants’ socio-demographic 

information, health and healthcare, 

sexual activity, substance use, and other 

psychosocial issues. The duration of 

each baseline, 3-month, and 6-month 

assessment is estimated to be 60 

minutes; the exit survey 10 minutes; the 

exit interview 30 minutes; pre-screening 

form 5 minutes; full-screening form 10 

minutes; brief locator information form 

5 minutes; record locator information 

form 10 minutes; each participant 

evaluation survey 5 minutes. 

There is no cost to participants other 

than their time. 

Type of respondent Form name Number of 

respondents 

Number 

responses per 

respondent 

Average 

burden per 

respondent 

(in hours) 

Total annual 

burden in 

hours 

Prospective Study Participant ........... Pre-Screening Form ......................... 700 1 5/60 58 

Prospective Study Participant ........... Full-Screening Form ......................... 515 1 10/60 86 

Prospective Study Participant ........... Brief Locator Form ........................... 515 1 5/60 43 

Enrolled Study Participant ................ Record Locator Form ....................... 438 1 10/60 73 

Enrolled Study Participant ................ Baseline Assessment ....................... 438 1 1 438 

Enrolled Study Participant ................ 3-month Follow-up Assessment ....... 395 1 1 395 

Enrolled Study Participant ................ 6-month Follow-up Assessment ....... 350 1 1 350 

Enrolled Study Participant ................ Participant Evaluation Forms ........... 438 6 5/60 219 

Enrolled Study Participant ................ Exit Survey ....................................... 350 1 10/60 58 

Enrolled Study Participant ................ Exit Interview .................................... 30 1 30/60 15 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 39 / Tuesday, February 28, 2012 / Notices 12059 

Type of respondent Form name Number of 

respondents 

Number 

responses per 

respondent 

Average 

burden per 

respondent 

(in hours) 

Total annual 

burden in 

hours 

Total ........................................... ........................................................... ........................ ........................ ........................ 1735 

Kimberly S. Lane, 

Reports Clearance Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2012–4566 Filed 2–27–12; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0171] 

Using Innovative Technologies and 

Other Conditions of Safe Use To 

Expand Which Drug Products Can Be 

Considered Nonprescription; Public 

Hearing 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public hearing; request 

for comments. 

SUMMARY: The U.S. Food and Drug 

Administration (FDA or the Agency) is 

announcing a public hearing to obtain 

input on a new paradigm we are 

considering. Under this paradigm, the 

Agency would approve certain drugs 

that would otherwise require a 

prescription for nonprescription use 

(also known as over-the-counter or OTC) 

under conditions of safe use. These 

conditions of safe use would be specific 

to the drug product and might require 

sale in certain pre-defined health care 

settings, such as a pharmacy. This 

public hearing is being held to obtain 

information and comments from the 

public on the feasibility of this 

paradigm and its potential benefits and 

costs. 

DATES: Public Hearing: The public 

hearing will be held on March 22 and 

23, 2012, from 9 a.m. to 4 p.m. The 

meeting may be extended or may end 

early depending on the level of public 

participation. 

Presentations and Comments: Submit 

either electronic or written requests for 

oral presentations and comments by 

March 9, 2012. (See section IV of this 

document for details.) Either electronic 

or written comments will be accepted 

after the hearing until May 7, 2012 (See 

section VI of this document for details.) 

ADDRESSES: The public hearing will be 

held at FDA’s White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31, 

Rm. 1503, Silver Spring, MD, 20993– 

0002. 

Comments and Transcripts: Submit 

either electronic or written comments to 

the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http://www.

regulations.gov. All comments should 

be identified with the docket number 

found in brackets in the heading of this 

document. Transcripts of the hearing 

will be available for review at the 

Division of Dockets Management and on 

the Internet at http://www.

regulations.gov approximately 45 days 

after the hearing. 

FOR FURTHER INFORMATION CONTACT: Lee 

Lemley, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20903–0002, 

301–796–3441, Fax: 301–847–8753, 

email: OTCTechnologiesPublic

Meeting@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing a public hearing to obtain 

input on a potential new paradigm 

under which the Agency would approve 

certain drugs that would otherwise 

require a prescription for 

nonprescription use under conditions of 

safe use specific to the drug product. 

Some drugs approved in this manner 

might require sale in certain pre-defined 

health care settings, such as a pharmacy. 

I. Background 

A. Prescription and Nonprescription 

Drugs 

Under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act), FDA 

approves new drugs under section 505 

(21 U.S.C. 355) either as prescription or 

nonprescription. Under section 

503(b)(1)(A) of the FD&C Act (21 U.S.C. 

353(b)(1)(A)), a drug must be dispensed 

by prescription if, ‘‘because of its 

toxicity or other potentiality for harmful 

effect, or the method of its use, or the 

collateral measures necessary to its use, 

[it] is not safe for use except under the 

supervision of a practitioner licensed by 

law to administer such drug.’’ Under 

sections 505(d)(1) and (d)(4), FDA has 

considerable latitude in determining 

whether the information submitted as 

part of a new drug application (NDA) is 

sufficient to ensure that a drug is safe 

for use under its proposed labeling. FDA 

also makes a determination under 

503(b) as to whether the product meets 

the criteria for prescription-only 

dispensing. 

Prescription drugs are dispensed 

upon receipt of a prescription from a 

practitioner licensed by law to 

administer the drug (which may include 

health care professionals such as 

physicians, nurse practitioners, 

physician’s assistants, and others whom 

we will refer to here as practitioners or 

prescribers). (See 21 U.S.C. 353(b).) In 

many instances, under the current 

regulatory system, a patient has to 

obtain at least the initial prescription, 

and in some cases, prescription refills, 

from a practitioner through an in person 

interaction. Obtaining a refill for other 

prescription drugs involves at least a 

telephone call or other communication 

with the practitioner. In contrast, 

nonprescription drugs (sometimes 

referred to as over-the-counter or OTC 

products) can be purchased by 

consumers in pharmacies, 

supermarkets, and other retail 

establishments without the need for a 

prescription. Currently, consumers can 

purchase nonprescription drugs from a 

retailer for diseases or conditions that 

do not meet the statutory criteria for 

prescription products and that are safe 

and effective for use in self-medication 

as directed in the labeling. (See 21 

U.S.C. 353(b).) Generally, OTC products: 

(1) Are available to treat diseases or 

conditions that can be self-diagnosed 

without a prior interaction with a 

practitioner, (2) are not associated with 

toxicities that require an evaluation of 

the benefits and risks by a practitioner; 

and (3) do not require a practitioner’s 

input for use. 

B. Undertreatment of Diseases and 

Other Effects on the Health Care System 

Undertreatment of many common 

diseases or conditions in the United 

States is a well recognized public health 

problem. Increasing the number of 

people who are able to obtain for the 

first time and those who continue on 

necessary drug therapy could provide 

improved health outcomes. The 

requirement to obtain a prescription for 

appropriate medication (and to make 

one or more visits to a practitioner) may 

contribute to undertreatment of certain 

common medical conditions including 


tkelley on DSK3SPTVN1PROD with NOTICES