[Federal Register Volume 67, Number 101 (Friday, May 24, 2002)]
[Notices]
[Pages 36608-36610]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-13075]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 02136]


Reducing Sexual Risk for HIV Transmission in Substance-Using Men 
Who Have Sex With Men; Notice of Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2002 funds for a cooperative agreement 
program to support research on interventions to reduce sexual risk for 
HIV transmission in substance-using men who have sex with men (MSM). 
This program addresses the ``Healthy People 2010'' focus HIV.
    The purpose of the research is to develop and test behavioral 
interventions that focus on reducing risk for HIV transmission by 
altering the sexual risk behavior of substance using and abusing MSM. 
Under this program, the primary outcome of the project will be the 
development of effective interventions for substance-using MSM which 
may then be adapted and replicated by community-based HIV prevention 
and substance abuse agencies among sub-populations of substance-using 
MSM throughout the U.S. This announcement addresses goals of CDC's HIV 
Prevention Strategic Plan.
    Measurable outcomes of the program will be in alignment with one or 
more of the following performance goals for the National Center for 
HIV, STD & TB Prevention. Through the implementation of HIV prevention 
programs, reduce the number of cases of HIV infection and AIDS: 1. 
acquired heterosexually, 2. related to injecting drug use, 3. 
associated with male-to-male homosexual contact, and 4. acquired 
perinatally.

B. Eligible Applicants

    Applications may be submitted by public and private nonprofit 
organizations and by governments and their agencies; that is, 
universities, colleges, research institutions, hospitals, other public 
and private nonprofit organizations, faith-based organizations, State 
and local governments or their bona fide agents, including the District 
of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the 
Commonwealth of Samoa, Guam, the Federated States of Micronesia, the 
Republic of the Marshall Islands, and the Republic of Palau, and 
federally recognized Indian tribal governments, Indian tribes, or 
Indian tribal organizations.


    Note:
    Title 2 of United States Code Section 1611 states that an 
organization described in section 501(c)(4) of the Internal Revenue 
Code of 1986 that engages in lobbying activities is not eligible to 
receive Federal funds constituting an award, grant or loan.

C. Availability of Funds

    Approximately $1,200,000 is expected to be available in FY 2002 to 
fund up to four awards for the first year of project activities. It is 
expected that the average award will be approximately $300,000 in the 
first year to support development of an intervention in additional 
years and will begin on or before September 30, 2002. The award will be 
made for a 12-month budget period, within a project period of up to 
five years. Funding estimates are expected to increase once recruitment 
and intervention activities begin. Continuation awards within an 
approved project period will be made on the basis of satisfactory 
progress as evidenced by required reports, satisfactory participant 
accrual, and the availability of funds. The Catalog of Federal Domestic 
Assistance number is 93.943.

Funding Preference

    Funding decisions will attempt to achieve regional diversity of the 
four sites (e.g., Northeast, South, Central, West). Funding decisions 
will also take into consideration geographical locations that afford 
sufficient numbers of men from which to sample.

D. Program Requirements

    In conducting activities to achieve the purpose of these programs, 
the recipient will be responsible for the activities listed under 
Recipient Activities, and CDC will be responsible for conducting 
activities listed under CDC Activities:

1. Recipient Activities

    The program will support four sites to work collaboratively with 
each other and with Federal investigators in conducting an intervention 
study to reduce sexual risk-taking among substance abusing MSM. At each 
site, it is expected that grantees will newly enroll a minimum of 375 
men, including non-injection drug and other substance-using (including 
alcohol) gay identified and non-gay identified MSM.
    The interventions to be tested should be theory-based, group-level 
interventions appropriate for use among a culturally-diverse population 
of MSM who reside within a challenging socio-cultural context. 
Intervention strategies should be sufficiently brief and of a technical 
level that would facilitate rapid dissemination among community-based 
organizations. Approximately one-third of the men should identify as 
African American, one-third as Hispanic/Latino and one-third as 
Caucasian at each study site. Men who are recruited into the study must 
currently use drugs and/or alcohol at a heavy level and have been 
sexually active within the past three months. Men recruited into the 
study can be poly-drug users (including alcohol), but without current 
intravenous drug use. Men can be recruited from a variety of venues, 
including drug using venues, bars, public sex environments known also 
to be sites for drug/alcohol use as well as substance abuse treatment 
organizations. The design of the study should include an attention 
control strategy, so that men randomized to the control condition are 
invited to equivalent time spent in groups that focus on an issue of 
interest to this population.
    Applicants should develop (1) sampling and recruitment strategies 
that ensure that the study includes a demographically diverse group of 
MSM, (2) culturally-sensitive measures of antecedent and outcome 
variables, including both quantitative and qualitative assessments, (3) 
an intervention plan that relates directly to an identified theoretical 
model of sexual risk reduction, (4) a core set of measures that will 
facilitate assessment of substance use and sexual risk behavior, (5) a 
sampling plan that will successfully recruit and retain a large number 
of research participants whose substance use is associated with high 
risk sexual behavior at some level, and (6) stringent safeguards for 
protecting confidentiality of participants.
    Applicants must develop protocols and assessment instruments that 
will increase understanding of a broad array of sociocultural, 
structural, psychological, and behavioral factors as they relate to HIV 
infection risk in substance-using MSM. These factors must be addressed 
in the design of intervention activities, so that the forces that are 
promoting high risk sexual activity within these populations are 
addressed in the intervention. Clear hypotheses should be developed to 
test how these variables--and drug and alcohol use themselves--mediate 
or moderate target risk behaviors. After sites are funded, but before 
research activities begin, grantees and Federal investigators will work 
collaboratively to refine the protocols so that they fit together 
across sites and address

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behavioral intervention research issues in a scientifically rigorous 
manner.
    Collaborate with other Federally sponsored researchers, including 
developing and using common data collection instruments and data 
management procedures, as determined in post-award grantee planning 
conferences.
    Recipients will be required to pool data for analysis and 
publication, but can also conduct independent site-specific analyses, 
as agreed to by the multi-site study group. Recipients are also 
required to work collaboratively as a study group to:
     a. Attend meeting(s) at CDC to develop collaborative research 
protocol.
    b. Develop the research study protocols and standardized data 
collection forms across sites, including standardized measures of drug 
and alcohol use and high risk sexual behaviors.
    c. Prepare an IRB protocol for approval at the local and CDC 
levels.
    d. Identify, recruit, obtain informed consent from, and newly 
enroll an adequate number of study participants as determined by the 
study protocols and the program requirements.
    e. Follow study participants as determined by the study protocols.
    f. Develop the intervention and intervention procedures in 
collaboration with the other funded investigators and implement the 
intervention as defined in study protocols.
    g. Establish procedures to maintain the rights and confidentiality 
of all study participants.
    h. Perform laboratory tests (when appropriate) and data analysis as 
determined in the study protocols.
    i. Collaborate and share data (when appropriate) with other 
collaborators to answer specific research questions.
    j. Conduct data analysis with all collaborators.
    k. Present and publish research findings.
    l. Participate in conference calls with all collaborators.
    m. Attend scheduled meetings with other funded grantees.

2. CDC Activities

    a. Provide technical assistance as needed in intervention 
development and in the design and conduct of research.
    b. Assist in the development of a research protocol for 
Institutional Review Board (IRB) review by all cooperating institutions 
participating in the research project. The CDC IRB will review and 
approve the protocol initially and on at least an annual basis until 
the research project is completed.
    c. Assist as needed in designing a data management system.
    d. Assist as needed in performance of selected laboratory tests.
    e. Work collaboratively with investigators to help facilitate 
research activities across sites involved in the same research project.
    f. Analyze data and present findings at meetings and in 
publications.

E. Application Content

    Use the information in the Program Requirements, Other 
Requirements, and Evaluation Criteria sections to develop your 
application. Your application will be scored based on the criteria 
listed in the Evaluation Criteria, so it is important to follow them in 
laying out your program plan. The narrative should be no more than 20 
double-spaced pages, printed on one side with one inch margins in a 12-
point font or greater. Follow the directions for completing the 
application that are found in the Public Health Service (PHS) 398 kit.

F. Submission and Deadline

    Submit the original and two copies of PHS-398 (OMB Number 0925-
0001) (adhere to the instructions on the Errata Instruction Sheet for 
PHS 398). Forms are in the application kit and at the following 
Internet address: www.cdc.gov/od/pgo/forminfo.htm.
    On or before July 31, 2002 submit the application to:
    Technical Information Management Section, PA <#>02136, 
Procurement and Grants Office, Centers for Disease Control and 
Prevention (CDC), 2920 Brandywine Road, Room 3000, Atlanta, GA 30341-
4146.
    Deadline: Applications shall be considered as meeting the deadline 
if they are:
    Received on or before the deadline date.
    Late Applications: Applications which do not meet the criteria 
above will be returned to the applicant.

G. Evaluation Criteria

Application

    Applicants are required to provide Measures of Effectiveness that 
will demonstrate the accomplishment of the various identified 
objectives of the grant or cooperative agreement. Measures of 
Effectiveness must relate to the performance goal (or goals) as stated 
in section ``A. Purpose'' of this announcement. Measures must be 
objective and quantitative and must measure the intended outcome. These 
Measures of Effectiveness shall be submitted with the application and 
shall be an element of evaluation.
    Each application will be evaluated individually against the 
following criteria by an independent review group appointed by CDC. 
Applications will be ranked on a scale of 100 maximum points. 
Applications will be reviewed and evaluated based on the evidence 
submitted and the applicant's abilities to meet the following criteria:
1. Familiarity With and Access to the Study Population (25 points)
    a. Extent of the applicant's knowledge of issues faced by study 
population, including substance use and sexual risk behaviors, access 
to the study population and experience in working with the population.
    b. Existence of linkages to facilitate recruitment from and 
referral to community-based programs providing services for the study 
population, including letters of support given in an appendix.
    c. Feasibility of plans to involve the study population, their 
advocates, or service providers in the development of research 
activities and to inform them of research results.
    d. Feasibility of plans for recruitment and outreach to new study 
participants (e.g. not men currently enrolled in an ongoing study).
2. Description and Justification of an Intervention and Research Plan 
(40 points)
    a. Quality of the review of the scientific literature pertinent to 
the proposed study, including the theoretical basis for the 
investigation and relevance of research questions.
    b. The originality of the research, including the extent to which 
it addresses important gaps in knowledge and has strong relevance for 
guiding behavioral interventions.
    c. Applicant's understanding of the research objectives as 
evidenced by the quality of the proposed research plan, specific study 
design and the choice of the theory to guide the intervention 
activities as well as the quality of the plan to operationalize 
intervention activities.
    d. Feasibility of plan to sample, recruit, obtain informed consent 
and newly enroll 375 study participants in a culturally and 
linguistically appropriate manner. This includes plans for achieving a 
demographically diverse sample within the African-American and Hispanic 
populations, conducting multi-venue sampling.
    e. Feasibility of plan for collecting both quantitative and 
qualitative formative research data and to follow research participants 
over time.

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    f. Comprehensiveness of the plan to protect the rights and 
confidentiality of all participants.
    g. Thoroughness of statistical analysis plans, including data 
cleaning, management, and substantive analyses, and plans for timely 
provision of data for pooled analyses.
    h. Extent to which study proposal demonstrates agreement to comply 
with multi-site research requirements (e.g., common protocol, data 
collection, and computer and data management systems).
    i. The degree to which the applicant has met the HHS Policy 
requirements regarding the inclusion of ethnic and racial groups in the 
proposed research. This includes: (1) the proposed plan for the 
inclusion of racial and ethnic minority populations for appropriate 
representation; (2) the proposed justification when representation is 
limited or absent; (3) a statement as to whether the design of the 
study is adequate to measure differences when warranted;
    j. Provide a statement as to whether the plans for recruitment and 
outreach for study participants include the process of establishing 
partnerships with communities and recognition of mutual benefits.
    k. Provide general time line for conducting the research and a 
detailed time line for the first year of the study, including 
measurable process objectives for the first year of the study.
3. Demonstration of Staff's Capability to Conduct Research (20 points)
    a. Applicant's ability to carry out the proposed research as 
demonstrated by the training, experience, and expertise of the 
principal investigator and the proposed research team and 
organizational setting, including demonstration of ability to collect, 
manage, and analyze accurate data in a timely manner.
    b. Evidence of plan for establishing a partnership with at least 
one community based organization to link participants with prevention 
and medical services as needed, and to consult on study procedures as 
needed.
    c. Demonstration of epidemiologic, behavioral intervention, 
clinical, administrative, and management expertise needed to conduct 
the proposed research.
    d. Demonstration that principal investigator and staff have 
experience working with the targeted population of study participants.
    e. Demonstration that investigative team includes a staff member 
with expertise in qualitative formative data analysis.
4. Staffing, Facilities, and Time-Line (15 points)
    a. Availability of qualified personnel with realistic and 
sufficient percentage-time commitments (including an estimated staffing 
plan for years in which intervention activities will occur); clarity of 
the described duties and responsibilities of project personnel 
including clear lines of authority and supervisory capacity over the 
behavioral, epidemiologic, clinical, administrative, data management, 
and statistical aspects of the research.
    b. Adequacy of the facilities, equipment, data processing and 
analysis capacity, and systems for management of data security and 
participant confidentiality.
    c. Adequacy of base staff to keep pace with anticipated workload.
    d. Adequacy of time-line for conducting the research.
5. Other (not scored)
    a. Budget: The extent to which it is reasonable, clearly justified, 
consistent with the intended use of funds, and allowable. All budget 
categories should be itemized.
    b. Human Subjects: The application adequately address the 
requirements of Title 45 CFR Part 46 for the protection of human 
subjects.

H. Other Requirements

Technical Reporting Requirements

    Provide CDC with original plus two copies of
    1. annual progress reports;
    2. financial status report, no more than 90 days after the end of 
the budget period; and
    3. final financial status and performance reports, no more than 90 
days after the end of the project period.
    Send all reports to the Grants Management Specialist identified in 
section J (``Where to Obtain Additional Information'') of this 
document.
    The following additional requirements are applicable to this 
program. For a complete description of each, see Attachment 1 in the 
application kit.
AR-1 Human Subjects Requirements
AR-2 Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
AR-4 HIV/AIDS Confidentiality Provisions
AR-5 HIV Program Review Panel Requirements
AR-6 Patient Care
AR-7 Executive Order 12372 Review
AR-9 Paperwork Reduction Act Requirements
AR-10 Smoke-Free Workplace Requirements
AR-11 Healthy People 2010
AR-12 Lobbying Restrictions
AR-22 Research Integrity

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under sections 301(a) and 317 (k)(2)of 
the Public Health Service Act, [42 U.S.C. section 241(a) and 
247b(k)(2)], as amended. The Catalog of Federal Domestic Assistance 
number is 93.943.

J. Where to Obtain Additional Information

    This and other CDC announcements can be found on the CDC home page 
Internet address--http://www.cdc.gov Click ``Funding'' then ``Grants 
and Cooperative Agreements.''
    If you have questions after reviewing the contents of all the 
documents, business management technical assistance may be obtained 
from:
    Lynn Mercer, Grants Management Officer, Grants Management Branch, 
Procurement and Grants Office, Announcement <#>02136, Centers for 
Disease Control and Prevention (CDC), 2920 Brandywine Rd. Room 3000, 
Mailstop E-15, Atlanta, GA 30341, Telephone: (770) 488-2810, E-mail 
address: [email protected].
    For program technical assistance, contact: Craig Studer, Deputy 
Chief, Behavioral Intervention Research Branch, Division of HIV/AIDS 
Prevention--IRS, National Center for HIV, STD, TB Prevention ,Centers 
for Disease Control and Prevention (CDC), 1600 Clifton Road, NE., 
Mailstop E-37, Atlanta, Georgia 30333, Telephone: (404) 639-1900, E-
mail address: [email protected].

    Dated: May 20, 2002.
Edward J. Schultz,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention (CDC).
[FR Doc. 02-13075 Filed 5-23-02; 8:45 am]
BILLING CODE 4163-18-P