[Federal Register Volume 66, Number 138 (Wednesday, July 18, 2001)]
[Notices]
[Pages 37475-37478]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-17912]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 01138]


Epidemiologic HIV/AIDS Research in African-American and Hispanic 
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) 2001 funds for a cooperative agreement 
program to support research on the sociocultural, structural, 
psychological, and behavioral factors that promote HIV infection in 
African-American and Hispanic men who have sex with men (MSM).
    The purpose of the research is to increase understanding of the 
manner in which these factors relate to the prevalence of HIV infection 
and incidence of recent infection in these populations. Additionally, 
under this program, it is expected that the investigators will use the 
data collected to begin to develop culturally-tailored intervention 
strategies, although the actual conduct of those interventions will not 
be part of this cooperative agreement. This announcement addresses 
goals of CDC's HIV prevention strategic plan through 2005.
Research Study
    The program will support four sites to work collaboratively with 
each other and with CDC investigators in conducting a cross-sectional 
study that includes HIV testing and counseling. Two sites will be 
devoted to the recruitment and assessment of African-American MSM, and 
two sites will be devoted to the recruitment and assessment of Hispanic 
MSM. Applicants should indicate clearly whether their application 
pertains to Hispanics or African-Americans. At each site, it is 
expected that grantees will enroll a minimum of 500 MSM, including gay 
identified MSM, non-gay-identified MSM, and MSM who inject drugs.
    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) 
a core set of measures that will facilitate ethnic and cultural 
comparisons, and (4) stringent safeguards for protecting 
confidentiality of participants.
    In conducting the research, it is also expected that grantees will 
establish a partnership with at least one community-based organization 
(CBO) to consult on all aspects of conducting the study and to help 
link participants to prevention and medical services.
    We invite applicants to 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 African-American and Hispanic MSM. 
These factors may include, but are not limited to:

Cultural attitudes and values
Social and economic discrimination
Social and sexual networks
Acculturation and immigration
Family relations
Community involvement
Experience with and influence of correctional systems
Homophobia
Self-esteem
Resiliency
Religious Beliefs
Beliefs about HIV disease and its treatment
HIV testing history and perceived and actual barriers to testing
Bisexual practices

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Drug use
Fluidity of risk behavior

    Assessment of the prevalence of HIV infection and incidence of 
early infection is also a central component of the research. 
Understanding the risk factors associated with recent HIV 
seroconversion will inform the design of behavioral interventions. 
Grantees should be prepared to perform HIV testing of participants 
using both standard serologic assays and the detuned assay and provide 
culturally-tailored pre- and post-test counseling and referral to 
medical care, prevention services, and to other services (social, 
mental health, drug treatment) as needed. After sites are funded, but 
before research activities begin, grantees and CDC investigators will 
work collaboratively to refine the protocols so that they fit together 
as a whole and address the research issues in a scientifically rigorous 
manner.

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, 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 Mircronesia, the Republic of the 
Marshall Islands, and the Republic of Palau, and federally recognized 
Indian tribal governments, Indian tribes, or Indian tribal 
organizations.

    Note: Public Law 104-65 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, cooperative agreement, contract, loan, 
or any other form.

C. Availability of Funds

    Approximately $800,000 is expected to be available in FY 2001 to 
fund up to four awards. It is expected that the average award will be 
approximately $200,000 in the first year and will begin on September 
30, 2001. The award will be made for a 12-month budget period, within a 
project period of up to four years. Funding estimates may change. 
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. 
Increased funding may be available in years two and three after 
protocols are established and research has started.
Funding Preference
    Funding decisions will attempt to achieve regional diversity of the 
two African-American MSM sites and the two Hispanic MSM sites (e.g., 
Northeast, South, Central, West). Funding decisions will also take into 
consideration geographical locations that afford ample numbers of MSM 
from which to sample and locations that provide the investigators with 
the opportunity to consult with CBOs in conducting the study.

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
    Collaborate with other CDC-sponsored researchers, including 
developing and using common data collection instruments, specimen 
collection protocols, and data management procedures, as determined in 
post-award grantee planning conferences. Recipients will be required to 
pool data for analysis and publication. 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.
    c. Identify, recruit, obtain informed consent from, and enroll an 
adequate number of study participants as determined by the study 
protocols and the program requirements.
    d. Follow study participants as determined by the study protocols.
    e. Establish procedures to maintain the rights and confidentiality 
of all study participants.
    f. Perform laboratory tests (when appropriate) and data analysis as 
determined in the study protocols.
    g. Collaborate and share data and specimens (when appropriate) with 
other collaborators to answer specific research questions.
    h. Conduct data analysis with all collaborators.
    i. Present and publish research findings.
    j. Participate in biweekly conference calls with all collaborators.
    k. Attend biannual meetings with other funded grantees.
2. CDC Activities
    a. Provide technical assistance as needed in the design and conduct 
of the research.
    b. Facilitate and 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. Assist in the analysis of research information and the 
presentation and publication of research findings.

E. Application Content

    Use the information in the Program Requirements, Other 
Requirements, and Evaluation Criteria sections to develop your 
application. Your application will be evaluated on the criteria listed, 
so it is important to follow them in laying out your program plan. 
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 five 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 August 30, 2001, submit the application to the Grants 
Management Specialist identified in the ``Where to Obtain Additional 
Information'' section of this announcement. Deadline: Applications 
shall be considered as meeting the deadline if they are either:
    1. Received on or before the deadline date; or
    2. Sent on or before the deadline date and received in time for 
submission to the independent review group. (Applicants must request a 
legibly dated U.S. Postal Service postmark or obtain a legibly dated 
receipt from a commercial carrier or U.S. Postal Service. Private 
metered postmarks shall not be acceptable as proof of timely mailing.)
    Late Applications: Applications which do not meet the criteria in 
1. or 2. Above will be returned to the applicant.

[[Page 37477]]

G. Evaluation Criteria

    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 Study Population (25 points)
    a. Extent of the applicant's knowledge of issues faced by study 
population and experience in working with the population.
    b. Existence of linkages to facilitate recruitment from and 
referral to programs providing services for the study population and 
letters of support.
    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. Evidence that plans for recruitment and outreach for study 
participants will include establishing partnerships with communities.
2. Description and Justification of a 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 and specific 
study design.
    d. Feasibility of plan to sample, recruit, and enroll study 
participants in a culturally and linguistically appropriate manner. 
This includes plans for achieving a demographically diverse sample 
within the African-American or Hispanic MSM populations (including gay 
identified MSM, non-gay-identified MSM, and MSM who inject drugs), 
conducting multi-venue sampling, and demonstration of statistical power 
to address research questions.
    e. Feasibility of plan for collecting both quantitative and 
qualitative research data.
    f. Comprehensiveness of the plan to protect the rights and 
confidentiality of all participants.
    g. Feasibility of plan for conducting HIV counseling and testing in 
a culturally-sensitive manner.
    h. Feasibility of plan for collecting, testing, storing, and 
shipping blood specimens.
    i. Thoroughness of statistical analysis plans, including data 
cleaning, management, and substantive analyses.
    j. Extent to which study proposal demonstrates assurance of 
compliance with multisite research requirements (e.g., common protocol, 
data collection, and computer and data management systems).
    k. The degree to which the applicant has met the CDC 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; (4) 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.
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 CBO to consult on all aspects of conducting the study and to link 
participants with prevention and medical services as needed.
    c. Demonstration of epidemiologic, behavioral, clinical, 
laboratory, 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 data analysis.
4. Staffing, Facilities, and Time-Line (15 points)
    a. Availability of qualified personnel with realistic and 
sufficient percentage-time commitments; clarity of the described duties 
and responsibilities of project personnel including clear lines of 
authority and supervisory capacity over the behavioral, epidemiologic, 
administrative, clinical, laboratory, 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: Does the application adequately address the 
requirements of Title 45 CFR part 46 for the protection of human 
subjects? __Yes __No Comments:

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.
    4. Projects that involve the collection of information from 10 or 
more individuals and funded by cooperative agreement will be subject to 
review and approval by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act.
    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

[[Page 37478]]

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. 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.''
    To receive additional written information and to request an 
application kit, call 1-888-GRANTS4 (1-888-472-6874). You will be asked 
to leave your name and address and will be instructed to identify the 
Announcement number of interest.
    If you have questions after reviewing the contents of all the 
documents, business management technical assistance may be obtained 
from: Ann Cole, Grants Management Specialist, Grants Management Branch, 
Procurement and Grants Office, Announcement #01138, Centers for Disease 
Control and Prevention (CDC), 2920 Brandywine Rd., Room 3000, Mailstop 
E-15, Atlanta, GA 30341, Telephone: (770) 488-2731, Email address: 
[email protected].
    For program technical assistance, contact: Jeff Efird, MPA, Deputy 
Chief, Epidemiology Branch, Division of HIV/AIDS Prevention 
Surveillance & Epidemiology, National Center for HIV, STD, TB 
Prevention, Centers for Disease Control and Prevention (CDC), 1600 
Clifton Road, NE., Mailstop E-45, Atlanta, Georgia 30333, Telephone: 
(404) 639-6130, Email address: [email protected].

    Dated: July 12, 2001.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 01-17912 Filed 7-17-01; 8:45 am]
BILLING CODE 4163-18-P