[Federal Register Volume 66, Number 146 (Monday, July 30, 2001)]
[Notices]
[Pages 39316-39317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-18861]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Announcement Number 01188]


Human Immunodeficiency Virus (HIV) Prevention Intervention 
Research Studies: Social and Environmental Interventions to Prevent 
HIV; Notice of Availability of Funds Amendment

    A notice announcing the availability of Fiscal Year 2001 funds for 
HIV Research Studies--Social and Environmental Interventions to Prevent 
HIV was published in the Federal Register on July 20, 2001, (Vol. 66, 
No. 140, pages 37969-37971). The notice is amended as follows:
    On page 37970, First Column, under section G. Evaluation Criteria, 
change to read:

Section G. Evaluation Criteria

    The quality of each application will be evaluated individually 
against the following criteria by an independent review group 
appointed by CDC.
    1. Background and Objectives (10 points): Demonstrate the 
proposed study will provide data for publication that's not 
otherwise available concerning social and environmental 
interventions to reduce HIV incidence.
    The application should include a detailed review of the 
scientific literature pertinent to the study being proposed, with 
evidence for the relationship of social and environmental

[[Page 39317]]

factors to the incidence of HIV. This literature review and a review 
of conditions in the study community should suggest specific 
research questions that will guide the research. The goals and 
objectives for the research should be clearly stated along with how 
the intervention would impact one of the underlying factors 
determining HIV incidence in the community.
    2. Site Selection (15 points): Demonstrate high prevalence of 
HIV or AIDS in the study area. Demonstrate ability to work in the 
community or communities.
    The application should include a description of the size and 
characteristics of the communities proposed for study. Describe the 
prevalence and estimated incidence of HIV infection in the study 
community. Include the age, gender, race/ethnicity, and HIV-risks of 
persons with HIV in the community where the intervention will be 
implemented. Describe the likely acceptability of the intervention 
by persons in the community. Letters of support from cooperating 
organizations should be included which detail the nature and extent 
of such cooperation.
    3. Methods (45 points): Appropriateness of methods for 
implementing and evaluating the social and environmental 
interventions to reduce HIV incidence and assessing the potential 
impact of the intervention within a community or geographic area.
    The application should describe the social-environmental issue 
that the recipient wants to address, how the potential intervention 
will influence the issue, and how the intervention might impact on 
HIV incidence in the study area. It should specify potential 
barriers to implementing the intervention and how barriers will be 
overcome. The potential impact on HIV reduction should be clear. The 
intervention should be new and sustainable in the future without 
ongoing CDC funding. (40 points)
    In addition, (5 points)
    Applications will be evaluated on 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.
    4. Research Capacity (20 points): Experience in similar social 
interventions, human rights evaluations, and HIV prevention 
research; and availability of qualified and experienced personnel.
    The application should describe the capacity and experience of 
the research team and should include curriculum vitaes and position 
descriptions for key staff and project participants. The percentage-
time commitments, duties, and responsibilities of project personnel 
should be sufficient to operationalize the proposed methodology. 
Letters of support from key collaborators and community groups 
should be included.
    5. Evaluation Plan (10 points): Appropriateness and 
comprehensiveness of:
    a. the schedule for accomplishing the activities of the 
research;
    b. an evaluation plan that identifies methods and instruments 
for evaluating progress in implementing the research objectives; and
    c. a proposal to complete and submit for publication, a report 
of research findings.
    The application should include time-phased and measurable 
objectives. The proposed report of research findings should document 
the process of identifying and implementing the intervention and the 
acceptability and estimated impact within the community.
    6. Budget (not scored): The extent to which the budget is 
reasonable, clearly justified, and consistent with the intent of the 
announcement.
    The 12 month budget should anticipate the organizational and 
operational needs of the study. The budget should include staff, 
supplies, and travel (including two trips per year for up to four 
members of the study team to meet with CDC staff and other 
investigators).
    7. Human Subjects (not scored): Does the application adequately 
address the requirements of Title 45 CFR Part 46 for the protection 
of human subjects?''


    Dated: July 24, 2001.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 01-18861 Filed 7-27-01; 8:45 am]
BILLING CODE 4163-18-P