[Federal Register Volume 66, Number 146 (Monday, July 30, 2001)]
[Notices]
[Pages 39317-39318]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-18864]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Announcement Number 01187]


Human Immunodeficiency Virus (HIV) Prevention Intervention 
Research Studies--Routinely Recommending HIV and Sexually Transmitted 
Disease (STD) Counseling and Testing in Ambulatory Care Clinics and 
Emergency Rooms; Notice of Availability of Funds; Amendment

    A notice announcing the availability of Fiscal Year 2001 funds for 
HIV Intervention Research Studies--Routinely Recommending HIV and STD 
Counseling and Testing in Ambulatory Care Clinics and Emergency Rooms 
was published in the Federal Register on July 20, 2001, (Vol. 66, No. 
140, pages 37966-37969). The notice is amended as follows:
    On page 37967, First Column, under Section B. Eligible Applicants, 
add the following paragraph immediately following paragraph number one:

Additional Eligibility Criteria

    1. Demonstrate ability to do testing for chlamydia, gonorrhea, 
and HIV by including a letter from a contract laboratory or facility 
administrator.
    2. Provide evidence of adequate available space for the testing 
program in the form of a letter from the responsible facility 
administrator.
    3. Provide evidence that at least 500 HIV-infected persons per 
year visit the ambulatory care facility or emergency room.

    On page 37967, 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 independent review group 
appointed by CDC.
    1. Background and Objectives (10 points): Demonstrate that the 
proposed study will identify persons who do not know they are 
infected with HIV.
    The application should include:
    a. A detailed review of the scientific literature pertinent to 
testing in ambulatory care clinics and emergency rooms;
    b. Clearly stated goals and objectives for the research; and
    c. A description of how the intervention would impact HIV and 
STD prevention in the community.
    2. Site Selection (15 points): Demonstrate high prevalence of 
HIV or AIDS in the study area.
    The application should include a description of:
    a. The current magnitude and characteristics of the HIV 
epidemic;
    b. STD disease burden;
    c. The number of persons served by the clinics; and
    d. The expected number of newly-identified HIV infections that 
will be detected.
    Letters of support from cooperating organizations should be 
included which clearly describe the nature and extent of such 
cooperation.
    3. Methods (30 points): Appropriateness of methods for 
implementing and evaluating the testing program.
    The application should describe the potential intervention and 
how it might impact on HIV and STD incidence in the study area. It 
should specify potential barriers to implementing the intervention 
and how they will be overcome. The methods for assessing the 
increase in number of persons tested, as well as the number of 
infected persons identified and successfully referred for treatment, 
should also be addressed. (25 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:

[[Page 39318]]

    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 other similar 
research collaboration with State and local health departments and 
availability of qualified and experienced personnel.
    The application should describe the capacity and experience of 
the research team and should include curriculum vitae and position 
descriptions for key staff. The percentage-time commitments, duties, 
and responsibilities of project personnel and involvement of state 
and local health department personnel should be sufficient to 
operationalize the proposed methodology. Letters of support from key 
collaborators, community groups, State and local health departments, 
should be included. The application should document that there is 
sufficient space available in the ambulatory care clinic or 
emergency room for the addition of the testing program.
    5. Sustainability of the intervention (15 points): Evidence of 
the health department and community planning group's commitment to 
sustain this program beyond the end of the project period and 
funding support, if it finds more infected persons at a lower cost 
than other existing outreach programs. Evidence includes letters of 
support from the community planning group and the health department, 
and the applicant's plan for encouraging the continuation of program 
activities.
    6. 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 increase in number of persons tested, the number of new 
infections identified, and the number of persons who access 
treatment.
    7. 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).
    8. 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. 01-18864 Filed 7-27-01; 8:45 am]
BILLING CODE 4163-18-P