[Federal Register Volume 64, Number 97 (Thursday, May 20, 1999)]
[Notices]
[Pages 27560-27564]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12695]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Program Announcement 99101]


Intervention Epidemiologic Research Studies of HIV/AIDS

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1999 funds for a cooperative agreement 
program to support intervention epidemiologic research studies of AIDS 
and HIV infection. These awards will help support researchers in two 
areas: the development and evaluation of innovative interventions for 
preventing and reducing the transmission of HIV infection in young and 
recently initiated injection drug users (IDUs); the development and 
evaluation of an intervention study to improve access to antiretroviral 
therapy in HIV-infected disadvantaged populations. This program 
addresses the ``Healthy People 2000'' priority area of HIV infection.
    I. Intervention Studies for Young and Recently Initiated Drug 
Users: The CDC has successfully funded multi-center, HIV 
epidemiological studies in IDUs for the last six years as part of the 
Collaborative Injection Drug Users Studies (CIDUS 1 and 2). Through 
these studies, well over 5,000 participants have been recruited in non-
clinic settings or on the street to describe HIV, Hepatitis B and 
Hepatitis C prevalence, incidence and behaviors related to transmission 
and acquisition of these infections. The purpose of this program is to 
support research targeting reduction of sexual and blood-borne 
infection among IDUs and to continue efforts to describe the HIV, 
Hepatitis B and Hepatitis C epidemics in these high risk populations.
    Specifically, the interest is in HIV studies involving innovative 
strategies that are culturally appropriate and geographically relevant. 
It is expected

[[Page 27561]]

the studies funded through this announcement should be part of creative 
HIV risk reduction programs targeting young or recently initiated 
injection drug users who are street-recruited and not routinely seen in 
clinics, hospitals, or similar institutional settings.
    Intervention study applications are solicited through this 
announcement that will decrease HIV risk by changing unsafe sexual, 
needle borne, and injection paraphernalia practices in HIV negative 
IDUs. Recipients will design and participate in a multi-center, 
randomized trial addressing questions on the efficacy of HIV risk 
reduction strategies for young or recently initiated street-recruited 
IDUs. Proposed interventions should specifically address the following 
goals:
    1. To reduce the risk of blood-borne pathogen infection.
    2. To have a sustained effect in reducing unsafe injection 
behavior.
    3. To have a sustained effect in reducing unsafe sex practices.
    4. To reduce IDUs' drug injection frequency and assist them in 
stopping to inject.
    Projects should involve community outreach to enroll recently 
initiated sero-negative drug users for interview, examination, 
intervention, and follow-up; research should focus on inner-city or 
suburban areas where drug use among young adults is prevalent and 
should include strategies to reduce risky behaviors in particularly 
resistant-to-change individuals. Linkages with community-based 
organizations and local or state providers of health and social 
services are highly desirable. Establishing referral services offered 
through the research project that are sustainable is also highly 
desirable.
    II. Assess and Develop Intervention Studies to Improve Access to 
Antiretroviral Therapy in HIV-Infected Disadvantaged Populations: The 
purpose of this program is to solicit applications that identify, 
enroll, and follow disadvantaged and minority populations with a well-
balanced representation of men and women for the purpose of conducting 
an intervention study of access to antiretroviral therapy (ART). The 
interest is specifically for three separate research components: a 
baseline assessment, an intervention component, and a provider survey. 
The baseline assessment component is intended to determine what factors 
improve and hamper access to ART in persons recently diagnosed (within 
6 to 24 months) with HIV. The intervention component is intended to 
evaluate methods that increase utilization of HIV care and use of ART. 
The intervention may involve more individualized patient needs 
assessment, linkages to new HIV care providers, linkages to integrated, 
innovative or outreach-oriented health care services. If possible, a 
separate data collection from local HIV care providers should attempt 
to identify barriers to providing ART and particularly to providing 
highly active antiretroviral therapy (HAART). Providers should be asked 
about conditions under which they would and would not prescribe ART to 
HIV-infected patients, using a standard questionnaire. Each applicant 
should propose to do at least two of the components.
    Preference will be given to sites (1) where at least 100 HIV-
infected subjects can be identified, enrolled, and followed in a well-
described intervention to improve access to ART, (2) where subjects 
that are not already in HIV follow-up care can be identified and 
recruited, and (3) which have the ability to locate persons diagnosed 
with HIV in the previous two years at testing centers such as sexually 
transmitted disease clinics, emergency rooms and other clinics. Follow-
up would need to include at least two visits to an HIV care provider 
and would involve: (1) collecting information on HIV-related clinical 
conditions, HIV-related medication use, health care provider visits, 
hospitalizations, and vital status; and (2) collecting blood specimens 
for viral load testing, lymphocyte immunophenotyping, and storage for 
other HIV-related testing. Applicants must demonstrate that they can 
provide adequate rates of follow-up, including collection of laboratory 
specimens. Applicants should be willing to participate in collaborative 
studies with other CDC-sponsored HIV projects, including the 
development of and use of common data collection instruments, specimen 
collection protocols, and data management procedures. Applicants must 
demonstrate cost-efficient local data management and statistical 
capability.

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, 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

    I. Approximately $2.4 million is available in FY 1999 to fund 
approximately 4-6 awards for HIV intervention epidemiologic research 
studies that foster prevention and reduce transmission of HIV infection 
in young IDUs. It is expected that the average award will be $400,000 
ranging from $250,000 to $600,000.
    II. Approximately $600,000 is available in FY 1999 to fund 
approximately 3 awards for HIV intervention studies to improve access 
to antiretroviral therapy in disadvantaged populations. It is expected 
that awards will range from $100,000 to $250,000.
    It is expected that all awards will begin on or about September 30, 
1999, and will be made for a 12-month budget period, within a project 
period of up to 4 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 Preference

    Preference will be given to achieve geographical diversity (e.g., 
Northeast, South, Central, and West).

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

    Applicants addressing the same research issue should be willing to 
participate in collaborative studies 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. Develop the research study protocols and standardized data 
collection forms across sites.
    b. Identify, recruit, obtain informed consent from, and enroll an 
adequate

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number of study participants as determined by the study protocols and 
the program requirements.
    c. Continue to 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. Collaborate and share data and specimens (when appropriate) with 
other collaborators to answer specific research questions.
    g. Contribute blood specimens (every 6-12 months, depending on the 
protocol requirements) for shipment and storage at a centralized 
repository system at CDC.
    h. Conduct data analysis with all collaborators as well as present 
and publish research findings.

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. 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. If you are applying for both 
activities, you must submit a separate application for each.

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. On or before July 16,1999, 
submit the application to: Kevin Moore, Grants Management Specialist, 
Grants Management Branch, Procurement and Grants Office, Announcement 
99101, Centers for Disease Control and Prevention (CDC), Grants 
Management Branch, Mailstop E-15, 2920 Brandywine Rd., Room 3000, 
Atlanta, Georgia 30341.
    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 or timely 
mailing.

    Late Applications: Applications that do not meet these criteria are 
considered late applications, will not be considered, and will be 
returned to the applicant.

G. Evaluation Criteria

    Each application will be evaluated individually against the 
following criteria by an independent review group appointed by CDC. 
Applicants will be ranked on a scale of 100 maximum points according to 
the research area identified. All applicants must state which research 
category they are addressing. Applications must demonstrate the 
applicant's ability to address the research in a collaborative manner 
with other recipients. Applications will be reviewed and evaluated 
based on the evidence submitted, as they specifically describe the 
applicant's abilities to meet the following criteria:

I. Intervention Studies for Young and Recently Initiated Drug Users

1. Recruitment, Retention and Adherence to Study Protocol (30 Points)
    a. Extent of applicant's experience in IDU-HIV infection 
epidemiologic research.
    b. Evidence of ability to successfully recruit and follow IDUs in 
longitudinal research studies.
    c. Ability to organize and provide counseling and voluntary rapid 
HIV testing program as well as hepatitis B and hepatitis C testing 
among IDUs with unknown sero status.
    d. Evidence of ability to collect complete data and to obtain a 
sufficiently large blood sample from IDUs.
    e. Evidence of ability to collect complete data and to obtain 
regular blood samples from IDUs for testing that may include: HIV, 
hepatitis B, hepatitis C testing as well as serum storage.
    f. Ability to recruit and retain sufficient HIV uninfected IDUs 
fulfilling the objectives of the study.
    g. Ability to oversee specimen collection for the timely 
processing, storage, and retrieval of laboratory specimens as needed 
for the study. This includes transfer of certain specimens to a central 
repository at CDC and transfer of other specimens to designated 
laboratories for specific laboratory studies.
2. Description and Justification of Research Plans (30 Points)
    a. Extent of familiarity and quality of experience pertinent to 
proposed research activities.
    b. Understanding of the research objectives as evidenced by the 
high quality and scientific rigor of the proposed plan for research and 
a study design that is appropriate to answer research questions.
    c. Extent to which the applicant demonstrates willingness to work 
with other recipients to develop a common core research protocol across 
funded sites.
    d. Feasibility of plans to follow study participants. This includes 
demonstration of the experience of the investigator in following IDUs, 
and the comprehensiveness of the plan to protect the rights and 
confidentiality of all participants.
    e. Thoroughness of plans for data management, data analysis, and 
laboratory analysis; reasonableness of data collected; and statistical 
rigor.
    f. Extent to which proposal demonstrates feasible plans for 
coordinating research activities of multiple study sites, where 
appropriate. Letters of support from cooperating organizations that 
demonstrate the nature and extent of such cooperation should be 
included.
    g. 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.

[[Page 27563]]

3. Research and Intervention Capability (20 Points)
    a. Applicant's ability to carry out the proposed research as 
demonstrated by the training and experience of the proposed research 
team and organizational setting, including demonstration of ability to 
collect, manage, and analyze accurate data in a timely manner.
    b. Demonstration of working relationships with proposed 
investigators and extent to which services to be provided by external 
experts or consultants are documented by memoranda of agreement.
    c. Demonstration of epidemiologic, behavioral, clinical, 
administrative, laboratory, data management and statistical analysis 
expertise needed to conduct proposed research.
4. Staffing, Facilities and Time-line (20 Points)
    a. Availability of qualified and experienced personnel with 
sufficient time dedicated to the proposed project.
    b. Clarity of the described duties and responsibilities of project 
personnel.
    c. Adequacy of plans for project oversight to assure quality of 
data.
    d. Adequacy of facilities, equipment, data management resources, 
and systems for ensuring data security and patient confidentiality.
    e. Adequacy of time line for completion of project activities.
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?

II. Assess and Develop Intervention Studies to Improve Access to 
Antiretroviral Therapy in HIV-Infected Disadvantaged Populations

1. Recruitment, Retention, and Adherence to Study Protocol (20 Points)
    a. Extent of applicant's experience in HIV infection epidemiologic 
research.
    b. Evidence of ability to successfully follow HIV-infected persons 
in longitudinal research studies.
    c. Evidence of ability to collect complete data from HIV-infected 
study participants.
2. Description and Justification of Research Plans (30 Points)
    a. Extent of familiarity and quality of experience pertinent to 
proposed research activities.
    b. Understanding of the research objectives as evidenced by high 
quality of the proposed plan for research and a study design that is 
appropriate to answer research questions.
    c. Originality of research, extent to which it does not replicate 
past or present research efforts, and direct relevance of research to 
guiding current efforts to improve access and use of antiretroviral 
therapy in HIV-infected populations.
    d. Feasibility of plans to follow study participants. This includes 
demonstration of the experience of the investigator in enrolling and 
following such persons, and the comprehensiveness of the plan to 
protect the rights and confidentiality of all participants.
    e. Thoroughness of plans for data management, data analysis, and 
laboratory analysis; reasonableness of data collected; and statistical 
rigor.
    f. The degree to which the applicant has met the CDC Policy 
requirements regarding the inclusion of women, ethnic, and racial 
groups in the proposed research. This includes: (a) the proposed plan 
for the inclusion of both sexes and racial and ethnic minority 
populations for appropriate representation; (b) the proposed 
justification when representation is limited or absent; (c) a statement 
as to whether the design of the study is adequate to measure 
differences when warranted; and (d) 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. Research Capability (30 Points)
    a. Capacity to conduct study as evidenced by quality of experience 
with similar or related research conducted previously, including 
demonstration of ability to collect, manage, and analyze accurate data 
in a timely manner.
    b. Demonstration of working relationships with proposed 
investigators and extent to which services to be provided by external 
experts or consultants are documented by memoranda of agreement.
    c. Demonstration of epidemiologic, behavioral, administrative, 
clinical, laboratory, data management, and statistical expertise needed 
to conduct proposed research.
4. Staffing, Facilities, and Time-Line (20 Points)
    a. Availability of qualified personnel with realistic and 
sufficient percentage-time commitments, and the clarity of the 
descriptions of the duties and responsibilities of project personnel.
    b. Adequacy of plans for project oversight to assure quality of 
data.
    c. Adequacy of facilities, equipment, data processing and analysis 
capacity, and systems for management of data security and participant 
confidentiality.
    d. Adequacy of time line for completion of project activities.
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?

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 paragraph J. Where to Obtain 
Additional Information.
    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-8  Public Health System Reporting Requirements
AR-9  Paperwork Reduction Act Requirements
AR-10  Smoke-Free Workplace Requirements
AR-11  Healthy People 2000
AR-12  Lobbying Restrictions

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.

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J. Where To Obtain Additional Information

    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 (use 99101).
    If you have questions after reviewing the contents of all the 
documents, business management technical assistance may be obtained 
from: Kevin Moore, Grants Management Specialist Grants Management 
Branch, Procurement and Grants Office Announcement 99101, Centers for 
Disease Control and Prevention (CDC), Grants Management Office Room 
3000, ATTN: Colgate Building, 2920 Brandywine Rd., Mailstop E-15, 
Atlanta, GA 30341, telephone (770) 488-2737, Email address 
[email protected].
    For program technical assistance, contact: Jeff Efird, MPA, Deputy 
Chief, Epidemiology Branch, Division of HIV/AIDS Prevention 
Surveillance and 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, E-mail [email protected].
    For a detailed description of the additional requirements in 
Attachment 1, to download forms required by this announcement, and to 
review other CDC program announcements, see the CDC home page on the 
Internet: HTTP://www.cdc.gov. Eligible applicants are encouraged to 
call before developing and submitting their applications.

    Dated: May 14, 1999.
Henry S. Cassell III,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention (CDC).
[FR Doc. 99-12695 Filed 5-19-99; 8:45 am]
BILLING CODE 4163-18-P