[Federal Register Volume 66, Number 127 (Monday, July 2, 2001)]
[Notices]
[Pages 34937-34939]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-16532]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 01158]


Human Immunodeficiency Virus (HIV) Related Applied Research; 
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 for human immunodeficiency virus (HIV) related applied research 
for the control and prevention of HIV. This program addresses the 
``Healthy People 2010'' focus area of HIV. For a copy of ``Healthy 
People 2010'' visit the internet site: http://www.health.gov/healthypeople.
    The purpose of this program is to encourage new and innovative 
methods to further the prevention of HIV infection.
    Projects that will be considered for funding are applied research 
for the control and prevention of HIV that address only the following 
Research Topics:

1. Community Interventions Among Adolescents

    Funds are available to support formative research that will lead to 
community or structural based interventions to prevent HIV among high-
risk adolescents, aged 17 or younger. High-risk adolescents is defined 
as youth 17 or younger who engage in activities that put them at higher 
risk for becoming HIV infected. Structural interventions are defined as 
factors that are barriers to, or facilitators of, an individual's HIV 
prevention behaviors. They directly or indirectly affect an 
individual's ability to avoid exposure to HIV and include physical, 
social, cultural, organizational, community, economic, legal or policy 
aspects of the individual's environment.

2. Demonstration Projects for the Efficient Allocation of HIV 
Prevention Resources

    Funds are available to support research to develop decision making 
tools for the efficient allocation of HIV prevention resources. An 
efficient allocation is defined as expending resources on interventions 
that are cost-effective, producing an optimal outcome at the least 
cost. The research should fully address the data needs and requirements 
for the practical use of cost effectiveness analysis to allocate 
resources. Applicants must demonstrate the ability to either identify 
and evaluate models and tools currently being used by state and local 
health departments and community based organizations or the ability to 
develop, pilot and evaluate models and tools usable by state and local 
health departments and community based organizations. Applicants should 
also demonstrate a willingness to collaborate with CDC and others in 
the documentation and dissemination of the research findings.

3. Biologic Determinants of HIV Transmission

    Funds are available to support research on biologic determinants of 
HIV transmission. These determinants will include the effect of 
antiretroviral use by source partners and other factors such as viral 
load, viral resistance and replication fitness, genetic factors 
including HLA class, and mucosal and humoral immunity. Applicants must 
demonstrate the potential to recruit at least 10 recently infected 
individuals (ie., infected less than six months) per month with their 
source partners and a comparison cohort of uninfected but exposed 
individuals and their partners. The applicants should demonstrate 
adequate laboratory capacity and a willingness to collaborate with the 
CDC laboratory.

4. HIV Testing Survey Among Asians/Pacific Islanders

    Funds are available to implement the HIV testing survey (HITS) 
among Asians/Pacific Islanders in urban settings in geographic areas 
highly impacted by the HIV epidemic. HITS assesses determinants of HIV-
related risk, testing and care-seeking behaviors. Applicants must 
demonstrate the ability to cooperate with health officials and 
community groups to gain access to this target population and to 
interview at least 300 persons during the one-year project period. 
Applicants should also

[[Page 34938]]

demonstrate a willingness to collaborate with CDC in developing and 
disseminating findings from this survey.

5. HIV Testing Survey Among American Indians/Alaska Natives

    Funds are available to implement the HIV testing survey (HITS) 
among American Indians/Alaska Natives in urban settings in geographic 
areas highly impacted by the HIV epidemic. HITS assesses determinants 
of HIV-related risk, testing and care-seeking behaviors. Applicants 
must demonstrate the ability to cooperate with health officials, 
community groups and/or tribal leaders to gain access to this target 
population and to interview at least 300 persons during the one-year 
project period. Applicants should also demonstrate a willingness to 
collaborate with CDC in developing and disseminating findings from this 
survey.

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, public and private non-profit 
organizations, State and local governments or their bona fide agents or 
instrumentalities, federally recognized Indian Tribal governments, 
Indian tribes or organizations.

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

C. Availability of Funds

1. Community Interventions Among Adolescents

    Approximately $200,000 is available in FY 2001 to fund 
approximately one to two new awards. It is expected that the award will 
begin September 30, 2001, and will be made for a 12 month budget period 
within a project period of up to four years. Funding estimates are 
subject to change.

2. Demonstration Projects for the Efficient Allocation of HIV 
Prevention Resources

    Approximately $1,250,000 is available in FY 2001 to fund 
approximately five new awards. It is expected that the average award 
will be $250,000. It is expected that awards will begin September 30, 
2001, and will be made for a 12 month budget period within a project 
period of one year. Funding estimates are subject to change.

3. Biologic Determinants of HIV Transmission

    Approximately $1,000,000 is available in FY 2001 to fund 
approximately up to two new awards. It is expected that the average 
award will be $500,000, ranging from $500,000 to $1,000,000. It is 
expected that awards will begin September 30, 2001, and will be made 
for a 12 month budget period within a project period of up to five 
years. Funding estimates are subject to change.

4. HIV Testing Survey Among Asians/Pacific Islanders

    Approximately $100,000 is available in FY 2001 to fund 
approximately one new award. It is expected that the award will begin 
September 30, 2001, and will be made for a 12 month budget period for a 
one year project period. Funding estimates are subject to change.

5. HIV Testing Survey Among American Indians/Alaska Natives

    Approximately $100,000 is available in FY 2001 to fund 
approximately one new award. It is expected that the award will begin 
September 30, 2001, and will be made for a 12 month budget period for a 
one year project period. Funding estimates are subject to change.
    Continued 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.

D. Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for the activities under 1. 
(Recipient Activities), and CDC will be responsible for the activities 
under 2. (CDC Activities). Recipient activities to achieve the purposes 
of this program will vary by project.

1. Recipient Activities

    a. Develop research protocol.
    b. Carry out the activities according to the approved protocol.
    c. Ensure that appropriate approvals are secured for the protection 
of human subjects, Office of Management and Budget and Paperwork 
Reduction Act, privacy, confidentiality, and data security.
    d. Compile and disseminate findings.

2. CDC Activities

    a. Through publications and other methods, CDC will collaborate as 
necessary in the development of a research common 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.
    b. Monitor and evaluate scientific and operational accomplishments 
of the project through periodic site visits, frequent telephone calls, 
and review of technical reports and interim data analysis.
    c. Assist in facilitating the planning and implementation of the 
necessary linkages with local or State health departments and assist 
with the developmental strategies for applied clinical or prevention 
oriented research programs, for recipients whose projects involve 
collaboration with a State or local health department.
    d. Assist with the facilitation of the technological and 
methodological dissemination of successful prevention and intervention 
models among appropriate target groups, such as, State and local health 
departments, community based organizations, and other health 
professionals.
    e. Provide technical assistance in planning and evaluating 
strategies and protocols, as requested.

E. Application Content

    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, excluding the budget, should be no more than 11 
doubled-spaced pages, printed on one side, with one inch margins, and 
unreduced font.
    The application narrative should consist of:
    1. Abstract (Not to exceed 1 page): An executive summary of your 
program covered under this announcement. Identify the Research Topic 
that the application addresses.
    2. Program Plan (Not to exceed 10 pages): In developing the 
application under this announcement, please review the recipient 
activities and, in particular, evaluation criteria and respond 
concisely and completely.
    3. Budget: Submit an itemized budget and supporting justification 
that is consistent with your proposed program plan.

F. Submission and Deadlines

    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 available in the application kit and at the 
following Internet address: www.cdc.gov/od/pgo/forminfo.htm.

[[Page 34939]]

    On or before August 17, 2001, submit your 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 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. CDC 
will act as reviewer for these applications.
    1. The inclusion of a brief review of the scientific literature 
pertinent to the study being proposed and specific research questions 
or hypotheses that will guide the research. The originality and need 
for the proposed research, the extent to which it does not replicate 
past or present research efforts, and how findings will be used to 
guide prevention and control efforts. (25 points)
    2. The quality of the plans to develop and implement the study. 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.
    (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. (25 
points)
    3. Extent to which proposed activities, if well executed, support 
attaining project objectives. (25 points)
    4. Extent to which personnel involved in this project are 
qualified, including evidence of past achievements appropriate to the 
project, and realistic and sufficient time commitments. Evidence of 
adequacy of facilities and other resources supported to carry out the 
project. (25 points)
    5. Other (not scored)
    (a) Budget: Will be reviewed to determine the extent to which it is 
reasonable, clearly justified, consistent with the intended use of the 
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. An annual progress report;
    2. Financial status report, no more than 90 days after the end of 
the budget period; and
    3. final financial status report and performance report, 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.
    The following additional requirements are applicable to this 
program. For a complete description of each, see Attachment 1 of the 
announcement in the application kit.

AR-1--Human Subjects Requirements
AR-2--Inclusion of Women and Racial and Ethnic Minorities in Research 
Requirements
AR-4--HIV/AIDS Confidentiality Provisions
AR-5--HIV Program Review Panel Requirements
AR-6--Patient Care Prohibitions
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 the Public Health Service Act, 
Section 317(k)(2) [42 U.S.C. 247b(k)(2)], as amended. The Catalog of 
Federal Domestic Assistance number 93.943, Epidemiologic Research 
Studies of Acquired Immunodeficiency Syndrome (AIDS) and Human 
Immunodeficiency Virus (HIV) Infection in Selected Population Groups.

J. Where To Obtain Additional Information

    This and other CDC announcements can be found on the CDC home page 
e-mail address www.cdc.gov. Click on ``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 
documents, business management technical assistance may be obtained 
from: Brenda Hayes, Grants Management Specialist, Grants Management 
Branch, Procurement and Grants Office, Centers for Disease Control and 
Prevention (CDC), 2920 Brandywine Road, Room 3000, Atlanta, GA 30341-
4146, telephone (770) 488-2741, or facsimile at (770) 488-2847, or 
Email address: [email protected].
    You may obtain programmatic technical assistance from: Sharon 
Robertson, National Center for HIV, STD and TB Prevention, Centers for 
Disease Control and Prevention (CDC), 1600 Clifton Road, NE, Atlanta, 
GA 30333, Telephone (404) 639-4592, Email address: [email protected].

    Dated: June 26, 2001.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 01-16532 Filed 6-29-01; 8:45 am]
BILLING CODE 4163-18-P