[Federal Register Volume 66, Number 146 (Monday, July 30, 2001)]
[Notices]
[Pages 39319-39320]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-18866]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Announcement Number 01190]


Human Immunodeficiency Virus (HIV) Prevention Intervention 
Research Studies--Prevention for HIV-Positive Persons; Notice of 
Availability of Funds; Amendment

    A notice announcing the availability of Fiscal Year 2001 funds for 
HIV Intervention Research Studies--Prevention for HIV-Positive Persons 
was published in the Federal Register on July 19, 2001, [Vol. 66, No. 
139, pages 37694-37696]. The notice is amended as follows:
    On page 37694, First Column, under section B. Eligible Applicants, 
add the following paragraph immediately following paragraph number one:

Additional Eligibility Criteria

    Eligible applicants must have:
    1. A minimum of three participating clinics in the project. 
Provide evidence of this by including letters from each 
participating clinic signed by the responsible facility 
administrator; and
    2. Each participating clinic must be currently serving a minimum 
of 300 HIV infected persons. Provide a statement signed by the 
responsible facility administrator certifying the number of HIV 
infected persons served.

    On page 37695, Third Column, Under Section G. Evaluation Criteria, 
change to read:

    The quality of each application will be evaluated individually 
against the following criteria by an objective review group 
appointed by CDC.
    1. Background, understanding of problem and objectives (10 
points):
    a. Demonstrates knowledge of literature pertinent to the 
proposed program and its goals. Demonstrates an understanding of how 
prevention models developed for high-risk individuals should be 
adapted, as suggested by theory or research, to customize the 
service for HIV infected persons. (5 points)
    b. Provides a compelling argument for justifying the care 
setting in which program will be implemented (patient load, lack of 
available prevention services, etc.). (5 points)
    2. Demonstrating the quality of proposed prevention program. (15 
points)
    a. Exceeds the minimum number of 900 clients served by the 
clinics participating in the study (minimum three (3) clinics X 
minimum 300 clients per clinic). One point will be given for every 
200 additional HIV infected clients, up to a maximum of 5 points. (5 
points)
    b. Demonstrates adequacy of proposed program to address the 
purpose stated in the background section: reduction in unprotected 
sex and/or needle sharing with HIV negative partners and partners of 
unknown status. (Disclosure of serostatus and adherence to therapy 
are acceptable but not required as additional outcomes). (5 points)
    c. Presents a program which adequately incorporates into the 
prevention model organizational and personnel factors which 
accelerate adoption and proper implementation by the care 
organizations specified in the application. (5 points)
    3. Demonstrating the appropriateness of research design to 
evaluate the proposed program. (35 points)
    a. Presents an overall research design which can generate 
reasonably certain conclusions about the effects of the proposed 
program; and which includes appropriate design elements such as: 
outcome measures taken at pre-intervention, post-intervention and 
follow-up; process measures; control or comparison group(s). (20 
points)
    b. Presents reliable and valid measures to gauge effectiveness 
at three levels: Organizational adoption (ability and willingness of 
the service organization to provide sustained support); adoption by 
care personnel (acceptance and use by the individual service 
providers); reduction in risk behaviors by clients. (10 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.

[[Page 39320]]

    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. Demonstrating the ability to implement the intervention and 
the research design. (40 points)
    a. Demonstrates the extent to which the applicant has the 
necessary skills and resources needed for both program and research 
design implementation. In cases where a collaboration is necessary 
between different organizations, demonstrates the ability to put 
together the collaboration necessary for adequately implementing the 
program and the research design. Demonstrates the degree of 
commitment from non-lead organizations to the project and explains 
how the lead organization intends to maintain this commitment. 
Letters of support from all collaborating organizations are the 
required minimum.(10 points)
    b. Identifies the technical assistance and training needs 
required for the proper implementation of the prevention service and 
the research protocol, and presents a plan that ensures that these 
needs will be met. (5 points)
    c. Specifies methods for careful verification that the proposed 
intervention is actually being implemented. (5 points)
    d. Specifies a plan for tracking participants and ensuring 
successful follow-up. (5 points)
    e. Presents a plan for carrying out the program and research 
activities. (5 points)
    f. Demonstrates experience and expertise in conducting similar 
prevention programs and research. (10 points)
    5. 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 two 
members of the study team to meet with CDC staff and other 
investigators).
    6. 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. 01-18866 Filed 7-27-01; 8:45 am]
BILLING CODE 4163-18-P