[Federal Register Volume 68, Number 108 (Thursday, June 5, 2003)]
[Notices]
[Pages 33706-33711]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-14128]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 03097]


Minority Human Immunodeficiency Virus/Acquired Immunodeficiency 
Syndrome (HIV/AIDS) Research Initiative To Build Capacity in Black and 
Hispanic Communities and Among Researchers Who Conduct HIV/AIDS 
Epidemiologic and Prevention Research in These Communities; Notice of 
Availability of Funds

    Application Deadline: August 4, 2003.

A. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under section 301(a) and 317(k)(2) of 
the Public Health Service Act, (42 U.S.C. 241(a) and 274b(k)(2)), as 
amended. The

[[Page 33707]]

Catalog of Federal Domestic Assistance number is 93.943.

B. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2003 funds for a cooperative agreement 
program called the Minority HIV/AIDS Research Initiative (MARI) that is 
funded by the Minority AIDS Initiative (MAI). The MARI program has been 
established to build capacity for HIV epidemiologic and prevention 
research in Black and Hispanic communities and to promote the 
independent research careers of HIV/AIDS investigators working in these 
communities. In addition, MARI aims to engage in capacity building 
among researchers at Historically Black Colleges and Universities, 
Hispanic Serving Institutions and Hispanic Serving Health Professions 
Schools as stipulated in Federally promulgated Executive Orders 13256 
and 13230, respectively. You may reference these Executive Orders at 
the following Web Sites: http://www.whitehouse.gov/news/releases/2001/10/20011012-10.html and http://www.whitehouse.gov/news/releases/2002/02/20020212-3.html
    This initiative addresses the ``Healthy People 2010'' focus area of 
HIV as well as the CDC's HIV prevention strategic plan through 2005. 
The overarching national goal stated in the CDC's HIV prevention 
strategic plan is to reduce the number of new HIV infections in the 
U.S. by 50 percent by 2005 by focusing on eliminating racial and ethnic 
disparities in new HIV infections. The CDC 2001 year-end HIV/AIDS 
surveillance report, which outlines the racial disparities in HIV/AIDS, 
reveals that Blacks and Hispanics together represented 57 percent of 
reported AIDS cases and 62 percent of reported HIV cases in 2001. 
Furthermore, of the new HIV cases in 2001, 58 percent of Black and 
Hispanic men and approximately 40 percent of Black and Hispanic women 
had unknown or unreported risk upon presentation for HIV testing. These 
statistics highlight the urgent need for HIV epidemiologic and 
prevention research in Black and Hispanic populations that are at-risk 
for HIV infection.
    The goals of the MARI program are to:
    (1) To build HIV prevention research capacity in Black and Hispanic 
communities in which insufficient research has been conducted by 
partnering with and developing new investigators from these communities 
to address pertinent research questions.
    (2) To engage in career development and provide research 
opportunities for new investigators from Black and Hispanic communities 
through collaboration with the Division of HIV/AIDS Prevention at CDC. 
This will be achieved by encouraging these scientists to develop 
independent research skills needed to gain experience in HIV 
epidemiologic and prevention research, to present the results of their 
research at national conferences and to publish their results in peer-
reviewed journals.
    (3) Develop and conduct HIV epidemiologic prevention research, in 
the form of limited case-control, cross-sectional or qualitative 
projects that have public health relevance to Black and Hispanic 
communities.
    Measurable outcomes of the program will be in alignment with the 
following performance goals for the National Center for HIV, STD and TB 
Prevention (NCHSTP):
    (1) Decrease the number of persons at high risk for acquiring or 
transmitting HIV infection;
    (2) Increase the proportion of HIV-infected people who know they 
are infected;
    (3) Increase the proportion of HIV-infected people who are linked 
to appropriate prevention, care, and treatment services; and
    (4) Strengthen the capacity to develop and implement effective HIV 
prevention interventions.
    Given the goals of MARI and the CDC's HIV strategic plan, this 
program announcement calls for epidemiologic and prevention research 
that will advance scientific knowledge about HIV transmission, testing 
and treatment patterns, as well as social and environmental factors 
that influence risk behaviors in Black and Hispanic communities. This 
announcement specifically invites applications addressing a variety of 
scientific research topics outlined below in sections ``I'' and ``II''.

Section I

Participation of Minorities in Government-Sponsored Research

    The participation of communities of color in HIV vaccine research 
is critical to ensuring that HIV vaccine candidates are effective 
across diverse racial and ethnic groups and that all groups have equal 
access to eventual vaccines. Community-based studies are needed to 
understand facilitators and barriers related to participation in 
government-sponsored research, which may include examination of the 
following: (1) Perceptions of AIDS in relationship to other community 
health issues, (2) community and individual attitudes of research 
related to HIV/AIDS, particularly vaccine trials, (3) the relationship 
between socioeconomic status, stigma, and disenfranchisement to 
research involvement, (4) strategies for enhancing community 
partnerships in the support and conduct of research, and (5) the 
historical context of government-sponsored research in minority 
communities such as the Tuskegee Syphilis Study.

Voluntary HIV Testing and Counseling of Young Men Who Have Sex with Men 
(MSM)

    Recent data indicate that up to 90 percent of young MSM of color 
who are infected with HIV are unaware of their seropositive status. 
Other studies indicate that HIV+ men who become aware of their status 
substantially reduce their sexual risk behaviors. Studies are needed to 
increase HIV testing among young MSM of color who are at risk for 
transmitting or contracting HIV and to determine motivating factors in 
the desire to seek HIV testing. Of particular interest are studies that 
test different types of persuasive communications to promote HIV 
testing in this population.

Prevalence of Intravenous Drug Use (IDU) Related HIV in the Southeast

    The epidemiology of the HIV among intravenous drug users has been 
well defined in the United States, with the exception of the Southeast 
region. Epidemiologic and surveillance studies are needed to assess the 
prevalence, incidence and risk factors for HIV infection among 
Southeastern U.S. intravenous drug users. In addition, data are needed 
to quantify the seroprevalence of Hepatitis B and C and attendant risks 
for acquisition of these diseases in southern populations.

Missed Opportunities for Prevention of Perinatal Transmission

    Perinatal transmission in the U.S. has been drastically reduced 
since 1993. However, greater than 75 percent of babies with HIV 
continue to be born to Black and Hispanic mothers. Elimination of 
perinatal transmission can only be achieved by reducing missed 
opportunities that occur among these women and by addressing issues 
associated with failures of prevention efforts. Reasons for these 
missed opportunities and prevention failures vary and warrant 
investigation. Studies are needed to understand why prevention failures 
occur among Black and Hispanic women and infants who access the 
required services and to address the reasons that these mothers and 
infants may not access prevention

[[Page 33708]]

services required to reduce perinatal transmission.

Section II

Behavioral, Psychosocial, and Cultural Determinants of HIV Risk 
Behavior

    The majority of HIV prevention research in the U.S. has been 
conducted in gay, white male populations. Consequently, many of the 
current prevention interventions have been informed and developed based 
on data from this population. Qualitative and quantitative studies of 
Black and Hispanic populations are needed to understand the unique 
psychological, social, and cultural factors that influence HIV-related 
knowledge, attitudes, perceptions and behaviors in these minority 
populations. Studies are needed to understand a wide-range of issues 
including but not limited to perceptions of risk, injection drug use, 
sexual risk-taking, response to HIV prevention messages, decisions to 
seek HIV testing and counseling, and decisions to seek HIV care and 
related treatment. Specific areas of interest include:
    (1) Effect of social, community (including religious influences), 
and family dynamics on attitudes, knowledge, risk perceptions, and 
willingness to seek HIV testing.
    (2) The role of gender and sexual identity and their relationship 
to HIV attitudes and risk behaviors.
    (3) How social, economic, and cultural environments influence 
attitudes about HIV, response to prevention messages, and behavior 
change.
    (4) The role of social and sexual networks in HIV transmission.
    (5) Pilot studies to assess explanations for disparities in HIV 
rates in minority populations.
    (6) Identification of factors associated with sexual- and drug-risk 
behavior in persons of color who have tested positive for HIV.

Treatment Adherence

    Studies are needed to understand many aspects of treatment 
adherence in Black and Hispanic HIV-infected patients such as (but not 
limited to), its relationship to mental illness, patient/provider 
concordance and/or relationships, pill burden and structural barriers 
impacting adherence.

Biological Disparities

    Ethnicity may play a role in the biological and immunological 
responses to HIV, as well as the responses to treatment and therapy for 
opportunistic infections. Studies are needed to determine the role of 
immunology, virology and the host response(s) in any of these areas.

C. Eligible Applicants

    [sbull] Applications may be submitted by:
    [sbull] Public nonprofit organizations
    [sbull] Private nonprofit organizations
    [sbull] For profit organizations
    [sbull] Small, minority, women-owned businesses
    [sbull] Universities
    [sbull] Colleges
    [sbull] Technical schools
    [sbull] Research institutions
    [sbull] Hospitals
    [sbull] Community-based organizations
    [sbull] Faith-based organizations
    [sbull] Federally recognized Indian tribal governments
    [sbull] Indian tribes
    [sbull] Indian tribal organizations
    [sbull] State and local governments or their bona fide agents (this 
includes the District of Columbia, the Commonwealth of Puerto Rico, the 
Virgin Islands, the Commonwealth of the Northern Marianna Islands, 
American Samoa, Guam, the Federated States of Micronesia, the Republic 
of the Marshall Islands, and the Republic of Palau)
    [sbull] Political subdivisions of States (in consultation with 
States)
    The primary investigator from the applying entity must also meet 
and be able to demonstrate the following additional requirements:
    (1) Possession of a research or a health-professional masters or 
doctorate-level degree from an accredited school/program;
    (2) Have never been a primary investigator on a National Institute 
of Health (NIH) R-01 award for $250,000 or greater;
    (3) Be knowledgeable about HIV/AIDS epidemiology and prevention, as 
well as have basic but minimal research experience in or related to the 
field of HIV/AIDS;
    (4) Have a documented history of working in Black and Hispanic 
communities;
    (5) Have documented linkages to Black and Hispanic communities that 
are impacted by HIV;
    (6) Have the ability to establish effective and well-defined 
working relationships with community advisory boards, community-based 
organizations or similar entities which will ensure appropriateness of 
proposed research and implementation of the proposed activities. The 
investigator must demonstrate efforts to develop this relationship by 
submitting letters of support or equivalent statement(s); and
    (7) Demonstrate willingness to partner with HIV epidemiologic and 
prevention researchers at CDC to ensure timely development of protocols 
and study instruments, submission of protocols to required human 
subjects review boards, conduct of investigations and to analyze, 
present and publish study results.
    Documentation of the above requirements must be included in the 
application. This includes, but is not limited to letters indicating 
involvement in HIV/AIDS research or HIV/AIDS-related publications, 
curriculum vitas and/or letters of support.
    Applications are encouraged from organizations that serve 
predominantly racial and ethnic minority populations that are 
disproportionately impacted by HIV/AIDS or those who are representative 
of the minority communities targeted in this program announcement.

D. Funding

Availability of Funds

    Approximately $1.4 million is available in FY 2003, to fund 
approximately six to ten awards. Up to five awards may be granted for 
each section ``I'' and ``II''. It is expected that the average award 
will be $200,000, ranging from $75,000 to $300,000. The awards will 
begin on or about September 15, 2003 and will be made for a 12-month 
budget period within a project period of one to three 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 
and the availability of funds.

Funding Priority

    Priority will be given to:
    (1) Projects that demonstrate strong community partnerships and 
access to predominantly Black and Hispanic communities that are 
disproportionately affected by the HIV/AIDS epidemic.
    (2) Projects that are cross-sectional or pilot in nature and that 
will require one to three years of funding to ensure the availability 
of funding for a greater number of applicants.

Funding Preferences

    Preference will be given to applicants that:
    (1) Have the ability to implement culturally and linguistically 
competent methodology within the study design;
    (2) Have a history of service to Black and Hispanic communities;
    (3) Are indigenous to the targeted population; and
    (4) Have linkages to the targeted population.

[[Page 33709]]

    Funding decisions will attempt to achieve regional diversity. 
Preference will be given to proposals addressing HIV prevention needs 
in Black and Hispanic communities with the highest rates of HIV. In 
addition, preference will be given to proposals targeting areas with 
increasing rates of HIV such as the Southeast.

Recipient Financial Participation

    Matching funds are not required for this program.

E. Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for the activities in 1. Recipient 
Activities and CDC will be responsible for the activities listed in 2. 
CDC Activities:
1. Recipient Activities
    a. Collaborate with CDC researchers and community-based 
organizations or similar community liaisons for duration of project 
period on several activities such as development of data collection 
instruments, specimen collection protocols, and data management 
procedures.
    b. Identify, recruit, obtain informed consent form, and enroll an 
adequate number of study participants as determined by the study 
protocols and the program requirements.
    c. Follow study participants as determined by the study protocols.
    d. Establish procedures to maintain the rights and confidentiality 
of all study participants.
    e. Perform laboratory tests (when appropriate) and data analysis as 
determined in the study protocols
    f. Present and publish research findings
    g. Participate in conference calls with CDC project officer(s) and 
research team
    h. Attend initial and annual meetings with other MARI-funded 
grantees to promote research dissemination and networking among 
investigators.
2. CDC Activities
    a. Provide technical assistance 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 in designing a data management system.
    d. Assist in performance of selected laboratory tests.
    e. Assist in the analysis of research data information and the 
presentation and publication of research findings.
    f. Conduct site visits to ensure that venues are properly selected, 
collaborations outlined in proposals are true and that the community is 
involved in the research activities, and that investigators are 
complying with the research protocol.
    g. Conduct initial and annual meetings of MARI-funded investigators 
to facilitate the exchange of research progress among recipients and to 
offer additional technical expertise for the conduct of research.

F. Content

Letter of Intent (LOI)

    A LOI is required for this program. The Program Announcement title 
and number must appear in the LOI. The narrative should be no more than 
one page, single-spaced or two pages double-spaced. Your letter of 
intent will be used to assess the number of applications to anticipate, 
plan the review process more effectively and efficiently, and determine 
the level of interest in the MARI goals and objectives.
    Your letter of intent should include the following information: 
Name, address and affiliation of the primary investigator, a brief 
description of the scope and intent of the proposed research, any 
plans/provisions to collaborate with community agencies.

Applications

    The Program Announcement title and number must appear in the 
application. Use the information in the Program Requirements, Other 
Requirements, and Evaluation Criteria sections to develop the 
application content. Your application will be evaluated on the criteria 
listed, so it is important to follow them in laying out your program 
plan.
    The narrative should be no more than 25 pages, double-spaced, 
printed on one side, with one-inch margins, and 12-point font.
    The narrative at a minimum should include a plan, objectives, 
methods, evaluation, budget and timeline.
    The program plan should address activities to be conducted over the 
entire one to three-year project period. The budget must cover the 
first one-year budget period.

G. Submission and Deadline

Letter of Intent (LOI) Submission

    On or before June 15, 2003, submit the LOI to the Grants Management 
Specialist identified in the ``Where to Obtain Additional Information'' 
section of this announcement.

Application Forms

    Submit the signed original and two copies of PHS 398 (OMB Number 
0925-0001). Adhere to the instructions on the Errata Instruction Sheet 
(posted on the CDC Web site) for PHS 398. Forms are available at the 
following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm.
    If you do not have access to the Internet, or if you have 
difficulty accessing the forms on-line, you may contact the CDC 
Procurement and Grants Office Technical Information Management Section 
at: 770-488-2700. Application forms can be mailed to you.

Submission Date, Time and Address

    The application must be received by 4 p.m. Eastern Time August 4, 
2003. Submit the application to: Technical Information Management--
PA 03097, CDC Procurement and Grants Office, 2920 Brandywine 
Rd, Room 3000, Atlanta, GA 30341-4146.
    Applications may not be submitted electronically.

CDC Acknowledgement of Application Receipt

    A postcard will be mailed by PGO-TIM, notifying you that CDC has 
received your application.

Deadline

    Letters of intent and applications shall be considered as meeting 
the deadline if they are received before 4 p.m. Eastern Time on the 
deadline date. Any applicant who sends their application by the United 
States Postal Service or commercial delivery services must ensure that 
the carrier will be able to guarantee delivery of the application by 
the closing date and time. If an application is received after closing 
due to (1) carrier error, when the carrier accepted the package with a 
guarantee for delivery by the closing date and time, or (2) significant 
weather delays or natural disasters, CDC will upon receipt of proper 
documentation, consider the application as having been received by the 
deadline.
    Any application that does not meet the above criteria will not be 
eligible for competition and will be discarded. Applicants will be 
notified of their failure to meet the submission requirements.

H. Evaluation Criteria

Application

    Applicants are required to provide measures of effectiveness that 
will demonstrate the accomplishment of the

[[Page 33710]]

various identified objectives of MARI or cooperative agreement. 
Measures of effectiveness must relate to the performance goals as 
stated in section ``B. 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.
    An independent review group appointed by CDC will evaluate each 
application against the following criteria:
    (1) Description and Justification of Research Plan, Objectives and 
Methodology (35 points)
    a. Applicability and relevance of study objectives to Black and 
Hispanic communities.
    b. Integration of culturally competent and relevant study 
methodology for Black and Hispanic communities.
    c. Study questions address gaps in the HIV/AIDS research literature 
or build on the findings of previously conducted research in Black and 
Hispanic populations.
    d. Applicant's understanding of research objectives as evidenced by 
the quality of the proposed research plan and specific study design and 
methods.
    e. Feasibility of plan to sample, recruit and enroll study 
participants in a culturally appropriate manner and design study 
instruments that are culturally appropriate to Black and Hispanic 
populations.
    f. Plan to ensure confidentiality of participants.
    (2) Familiarity with and access to Black and Hispanic communities 
most adversely and disproportionately affected by the HIV/AIDS epidemic 
(30 points)
    a. Experience conducting research and working in Black and Hispanic 
communities.
    b. Ability of the investigator to identify with Black and/or 
Hispanic populations at-risk for HIV.
    c. Extent of applicant's knowledge of issues faced by Black and/or 
Hispanic communities affected by HIV.
    d. Demonstrable ability to recruit study population and obtain 
valid data through the use of culturally appropriate methods and 
instruments.
    (3) Demonstration of community collaboration during study design, 
recruitment and project implementation. (20 points)
    a. Evidence of plan for establishing a partnership with at least 
one community organization to consult on all aspects of conducting the 
study and to link participants with prevention and medical services as 
needed.
    b. Evidence that plans for recruitment and outreach for study 
participants will include establishing partnerships with communities.
    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.
    (4) Demonstration of Capability to Conduct Research (15 points)
    a. Applicant's ability to carry out the proposed research as 
demonstrated by the experience of the principal investigator and the 
proposed research team and organizational setting.
    b. Demonstration of epidemiologic, behavioral, clinical, 
laboratory, administrative, and management expertise needed to conduct 
the proposed research.
    c. Demonstration that principal investigator and staff have 
experience working with the targeted population of study participants.
Budget (reviewed, but not scored)
    Extent to which budget is reasonable, itemized, clearly justified 
and within funding limits of this program announcement.
Human subjects: (not scored)
    Does the application adequately address the requirements of Title 
45 CFR Part 46 for the protection of human subjects?
    Does the application adequately address the CDC Policy requirements 
regarding the inclusion of women, ethnic, and racial groups in the 
proposed research. This includes:
    1. The proposed plan for the inclusion of both sexes and 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 Community(ies) and recognition of mutual benefits.

I. Other Requirements

Technical Reporting Requirements

    Provide CDC with original plus two copies of:
    1. Interim progress report, no less than 90 days before the end of 
the budget period. The progress report will serve as your non-competing 
continuation application, and must contain the following elements:
    a. Current Budget Period Activities Objectives.
    b. Current Budget Period Financial Progress.
    c. New Budget Period Program Proposed Activity Objectives.
    d. Detailed Line-Item Budget and Justification.
    e. Additional Requested Information.
    2. Financial status report, no more than 90 days after the end of 
the budget period.
    3. Final financial 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 
the ``Where to Obtain Additional Information'' section of this 
announcement.

Additional Requirements

    The following additional requirements are applicable to this 
program. For a complete description of each, see Attachment I of the 
program announcement as posted on the CDC Web site.

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

J. Where To Obtain Additional Information

    This and other CDC announcements, the necessary applications, and 
associated forms can be found on the CDC Web site, Internet address: 
http://www.cdc.gov.
    Click on ``Funding'' then ``Grants and Cooperative Agreements''.
    For general questions about this announcement, contact: Technical 
Information Management, CDC Procurement and Grants Office, 2920 
Brandywine Road, Atlanta, GA 30341-4146, Telephone: 770-488-2700.
    For business management and budget assistance, contact: Carlos 
Smiley, Grants Management Officer, Procurement and Grants Office, 
Centers for Disease Control and Prevention, 2920 Brandywine Road, 
Atlanta, GA 30341-4146, Telephone: 770-488-2722, e-mail address: 
[email protected].

[[Page 33711]]

    For program technical assistance, contact: Lisa K. Fitzpatrick, MD, 
MPH, Division of HIV/AIDS Prevention, Centers for Disease Control and 
Prevention, 1600 Clifton Rd. E-45, Atlanta, GA 30333, 404-639-
5166.

    Dated: May 30, 2003.
Edward Schultz,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 03-14128 Filed 6-4-03; 8:45 am]
BILLING CODE 4163-18-P