44854 Federal Register / Vol. 74, No. 167 / Monday, August 31, 2009 / Notices 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent by September 30, 2009 to: 

SAMHSA Desk Officer, Human 

Resources and Housing Branch, Office 

of Management and Budget, New 

Executive Office Building, Room 10235, 

Washington, DC 20503; due to potential 

delays in OMB’s receipt and processing 

of mail sent through the U.S. Postal 

Service, respondents are encouraged to 

submit comments by fax to: 202–395– 

5806. 

Dated: August 19, 2009. 

Elaine Parry, 

Director, Office of Program Services. 

[FR Doc. E9–20900 Filed 8–28–09; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[Docket No. 60Day–09–09CJ] 

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 404–639–5960 or send 

comments to Maryam Daneshvar, CDC 

Reports Clearance Officer, 1600 Clifton 

Road, MS–D74, Atlanta, GA 30333 or 

send an e-mail 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 

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 

Promoting HIV Testing among Low 

Income, Young, Heterosexual Black 

Men—New—National Center for HIV/ 

AIDS, Viral Hepatitis, Sexually 

Transmitted Diseases, and Tuberculosis 

Elimination Programs (NCHHSTP), 

Centers for Disease Control and 

Prevention (CDC). 

Background and Brief Description 

The lifetime risk of acquiring HIV 

infection for black men is 1 in 16. 

Heterosexual transmission is the second 

highest category for HIV infection 

among black men, yet we know little 

about how to successfully access 

heterosexual black men with HIV 

prevention and texting messages. CDC is 

requesting OMB approval for 2 years to 

collect data for this 3-phase study. 

The purpose of the proposed study is 

to elicit attitudes about HIV testing 

among a community-based sample of 

non-Hispanic black, heterosexual men, 

ages 18–25, who are recently arrested 

and/or released from jail/prison. The 

study will develop culturally-tailored 

and gender-specific educational 

materials that promote HIV testing 

among this population. The data 

collection process will take 

approximately 2 years. 

In Phase 1, local investigators will 

conduct qualitative interviews with 20 

non-Hispanic black, heterosexual men, 

ages 18–25, who are recently arrested 

and/or released from jail/prison and 

meet screening criteria. The interviews 

will identify their attitudes towards HIV 

testing, socio-cultural norms, and 

perceived behavioral control factors that 

influence HIV testing. The interviews 

will also elicit their opinions of how to 

promote HIV testing among their peers. 

Each interview will last approximately 

1.5 hours. During Phase 2, the results 

from Phase 1 will be used to identify 

variables for a survey that will examine 

attitudes towards HIV testing, sociocultural norms, and perceived 

behavioral control factors to HIV testing 

intentions and behaviors. The survey 

will include 250 non-Hispanic black 

heterosexual men, ages 18–25, who 

meet screening criteria. Each survey will 

last approximately 30 minutes. 

During Phase 3, using Phase 1 and 2 

results, educational materials promoting 

HIV testing among 24 non-Hispanic 

black heterosexual men will be 

developed and pilot tested in focus 

groups of young black men who meet 

screening criteria to evaluate the 

acceptability of the materials. 

This study will provide important 

epidemiologic information useful for the 

development of HIV prevention 

interventions for young black men. 

There is no cost to respondents except 

for their time. 

ESTIMATED ANNUALIZED BURDEN TABLE

Form name Type of respondents Number of 

respondents 

Number of 

responses per 

respondent 

Average burden per responses 

(hours) 

Hours 

Screener for one-on-one interviews Non-Hispanic, black, heterosexual 

men, ages 18–25, recently arrested and/or released from jail/ 

prison.

30 1 10/60 5 

One-on-one interviews ...................... ........................................................... 20 1 1.5 30 

Screener for surveys ......................... ........................................................... 300 1 10/60 50 

Surveys ............................................. ........................................................... 250 1 30/60 125 

Screener for focus groups ................ ........................................................... 40 1 10/60 7 

Focus groups .................................... ........................................................... 24 1 2 48 

Total Burden Hours ................... ........................................................... ........................ ........................ ........................ 265 


cprice-sewell on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 74, No. 167 / Monday, August 31, 2009 / Notices 44855 

Dated: August 3, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–20967 Filed 8–28–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0565] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Guidance for Industry on Formal 

Dispute Resolution; Appeals Above 

the Division Level 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Guidance for Industry on Formal 

Dispute Resolution; Appeals Above the 

Division Level’’ has been approved by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management (HFA–710), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

Elizabeth.Berbakos@fda.hhs.gov, 301– 

796–3792. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of April 28, 2009 (74 

FR 19225), the agency announced that 

the proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0396. The 

approval expires on August 31, 2012. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.reginfo.gov/ 

public/do/PRAMain. 

Dated: August 21, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–20895 Filed 8–28–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; Evaluation of the NIAID HIV 

Vaccine Research Education Initiative 

SUMMARY: 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 

National Institute of Allergy and 

Infectious Diseases (NIAID), the 

National Institutes of Health (NIH) will 

publish periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

Proposed Collection: Title: Evaluation 

of the NIAID HIV Vaccine Research 

Education Initiative, Highly Impacted 

Population Survey. Type of Information 

Collection Request: NEW. Need and Use 

of Information Collection: Developing 

measures that protect against HIV 

infection is one of NIAID’s highest 

priorities. Methods in development for 

the prevention of HIV infection include: 

HIV vaccines, microbicides, and preexposure prophylaxis (PrEP). Given the 

daunting complexity of the HIV virus, 

developing these methods will 

ultimately require tens of thousands of 

volunteers to participate in HIV 

prevention clinical trials. In the U.S., 

minority participation in clinical trials 

of HIV prevention technologies is 

essential; nearly two-thirds of people 

diagnosed with HIV in the United States 

are African American or Hispanic/ 

Latino. Historically, recruitment of 

racial/ethnic populations has been a 

critical challenge for medical 

researchers, and initiatives to increase 

recruitment of these groups into cancer 

and chronic disease trials have only 

been partially successful. 

To address the need for volunteers in 

HIV vaccine clinical trials, and enable 

NIAID to fulfill its Congressional 

mandate to prevent infectious diseases 

like HIV/AIDS, NIAID created the 

NIAID HIV Vaccine Research Education 

Initiative (NHVREI). The goal of 

NHVREI is to increase knowledge about 

and support for HIV vaccine research 

among U.S. populations most heavily 

affected by HIV/AIDS—in particular, 

African Americans, Hispanics/Latinos, 

men who have sex with men (MSM), 

women and youth, recognizing the 

intersection of these groups. 

A critical component of NHVREI is 

outreach to members of these specific 

highly impacted populations. With the 

assistance of funded community-based 

and national organizations, NHVREI is 

designing, developing, and 

disseminating HIV vaccine researchrelated messages to NHVREI target 

audiences. These messages are delivered 

through print (e.g., brochures, posters, 

fact sheets, information kits), radio, TV, 

and Internet resources. Print materials 

are distributed through various NHVREI 

program activities (e.g., trainings, 

conferences, symposia) and other 

NIAID-funded partners, governmental 

and non-governmental organizations. 

NIAID is conducting an evaluation of 

the NHVREI program in order to assess 

its impact and generate key findings 

applicable toward the design of future 

educational initiatives. Part of the 

evaluation includes a population survey 

to guide future NHVREI activities. 

With this document, NIAID requests 

clearance for the third part of the 

evaluation, a survey of the general 

population and members of the U.S. 

populations most heavily impacted by 

HIV/AIDS. The survey will be 

conducted once in 2010. The total 

number of respondent burden hours 

will not exceed 1167 annually. 

Frequency of Response: Once. Affected 

Public: Individuals. Type of 

Respondents: General U.S. population 

with oversampling of subpopulations 

highly impacted by HIV. The annual 

reporting burden is shown in the table 

below. There are no Capital Costs to 

report. There are no Operating or 

Maintenance Costs to report. 

Total No. of 

respondents 

Hours per response Total hours 

Highly Impacted Population Surveys ........................................................................................... 3,500 0.33333 1,167 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of the function of the 

agency, including whether the 

information will have practical utility; 


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