[Federal Register Volume 66, Number 139 (Thursday, July 19, 2001)]
[Notices]
[Pages 37694-37696]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-18049]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 01190]


Human Immunodeficiency Virus (HIV) Prevention Intervention 
Research Studies--Prevention for HIV-Positive Persons; 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 the prevention for HIV-positive persons. This program 
addresses the ``Healthy People 2010'' focus area of HIV.
    The purpose of the activity is to generate effective prevention 
service models designed for HIV-infected persons, to be delivered at 
HIV care settings.

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, including the District of Columbia, the 
Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of 
Northern Mariana Islands, American Samoa, Guam, the Federated States of 
Micronesia, the Republic of the Marshall Islands, and the Republic of 
Palau, and federally recognized Indian tribal governments, Indian 
tribes, or Indian tribal organizations.


    Note: Title 2 of the United States Code, chapter 26, section 
1611 states that an organization described in section 501(c)(4) of 
the Internal Revenue Code of 1986 that

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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

    Approximately $750,000 is available in FY 2001 to fund 
approximately three to five awards. It is expected that the average 
award will be $250,000, ranging from $150,000 to $350,000. It is 
expected that the awards will begin on or about September 30, 2001, and 
will be made for a 12-month budget period within a project period of up 
to three 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.

1. Use of Funds

    Funds are awarded for a specifically defined purpose and may not be 
used for any other purpose or program. Funds may be used to support 
personnel and to purchase equipment, supplies, and services directly 
related to project activities. Funds may not be used to supplant State 
or local funds available for HIV Prevention. Funds may not be used to 
provide direct medical care.

2. Funding Preferences

    Preference will be given to applicants with geographic and 
population risk group diversity.

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 
listed under 2. (CDC Activities).

1. Recipient Activities

    a. Develop the prevention intervention, research study protocol and 
data collection forms.
    b. Plan and conduct project activities such as, enrolling care 
sites into comparison (or control) and intervention groups; 
implementing the prevention intervention; and collecting and analyzing 
data to evaluate the prevention intervention.
    c. Where necessary, build and maintain a coalition to adequately 
implement the program and research design.
    d. Where appropriate, obtain the participation of state and local 
professional associations and healthcare providers and institutions in 
serving, diagnosing, or providing treatment and care for persons with 
HIV/AIDS.
    e. Promote the adoption of effective prevention services for HIV-
infected persons in care settings other than those participating in the 
study by: (1) Providing data and ongoing assistance to community 
planning groups; (2) disseminating data through publications and 
presentations.
    f. Participate in project planning and implementation meetings with 
other collaborators, when appropriate.
    g. Establish procedures to maintain the rights and confidentiality 
of all study participants.
    h. Identify, recruit, obtain informed consent from participants 
(when appropriate), and enroll an adequate number of study participants 
as determined by study protocol and the program requirements. The 
protocol must be submitted to the local Institutional Review Boards 
(IRB) for approval.
    i. Share data and specimens (when appropriate) with other 
collaborators to answer specific research questions.
    j. Participate in multi-site data analysis and presentation and 
publication of research findings with collaborators, when appropriate.

2. CDC Activities

    a. Provide technical assistance, as needed, in refining the 
proposed intervention.
    b. As needed, assist in designing a data management system and data 
analysis and dissemination of findings.
    c. The CDC IRB will review and approve the protocol initially and 
on at least an annual basis until the research project is completed.

E. Application Content

    Use the information in the Program Requirements, Other 
Requirements, and Evaluation Criteria sections to follow them in laying 
out your program plan. The narrative should be no more than 25 pages 
double-spaced, printed on one side, with one inch margins, and 
unreduced font.
    The narrative should consist of, at a minimum, a Plan, Objectives, 
Methods, Evaluation and Budget.

F. Submission and Deadline

    Submit the original and five copies of PHS form 398 (OMB Number 
0925-0001) (adhere to the instructions on the Errata Instruction Sheet 
for PHS 398). Forms are available at the following Internet address: 
www.cdc.gov/od/pgo/forminfo.htm
    On or before August 27, 2001, submit the 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 which do not meet the criteria in 1. or 2. above 
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 objective review group appointed by CDC.

1. Background, Understanding of Problem and Objectives (10 Points)

    To the extent to which the applicant--
    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.). In addition, provide information on high 
HIV prevalence and incidence, and opportunities for evaluating 
prevention services designed for HIV infected persons in various HIV 
care settings. (5 points)

2. Demonstrating the Quality of Proposed Prevention Program (15 Points)

    To the extent to which the applicant--
    a. 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). (8 points)
    b. Presents a program which adequately incorporates into the 
prevention model organizational and personnel factors which accelerate 
adoption and proper implementation by

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the care organizations specified in the application. (7 points)

3. Demonstrating the Appropriateness of Research Design To Evaluate the 
Proposed Program (30 points):

    To the extent to which the applicant--
    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). (10 
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)
    c. In addition, 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: (10 points)
    1. The proposed plan for the inclusion of both sexes and 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.

4. Demonstrating the Ability To Implement the Intervention and the 
Research Design (45 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. (15 points)

6. Budget (Not Scored)

    The extent to which the budget is reasonable, clearly justified, 
and consistent with the intent of the announcement.

7. Human Subjects (Not Scored)

    Does the application adequately address the requirements of 45 CFR 
part 46 for the protection of human subjects? (Not scored; however, an 
application can be disapproved if the research risks are sufficiently 
serious and protection against risks are so inadequate as to make the 
entire application unacceptable.)

H. Other Requirements

Technical Reporting Requirements

    Provide CDC with the original and two copies of:
    1. Annual progress reports to be submitted with subsequent 
continuation applications;
    2. Financial status report, no more than 90 days after the end of 
the budget period;
    3. Final financial 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 I of the 
announcement.

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-7  Executive Order 12372 Review
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 
sections 317 (42 U.S.C. 241(a) and 247b); 301 (42 U.S.C. 241); and 311 
(42 U.S.C. 243), as amended. The Catalog of Federal Domestic Assistance 
number is 93.941.

J. Where To Obtain Additional Information

    This and other CDC announcements can be found on the CDC home page 
Internet address http://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 the 
documentation, business management technical assistance may be obtained 
from: James Masone, Grants Management Specialist, Grants Management 
Branch, Procurement and Grants Office, Centers for Disease Control and 
Prevention (CDC), 2920 Brandywine Road, Room 3000, Mailstop E-15, 
Atlanta, GA 30341-4146 Telephone: (770) 488-2736, Email address: 
[email protected].
    For program technical assistance, contact: Cassandra Walker, MPH, 
Acting Deputy Chief, Prevention Services Research Branch, Division of 
HIV/AIDS Prevention, Surveillance & Epidemiology, National Center for 
HIV, STD, TB Prevention, Centers for Disease Control and Prevention, 
1600 Clifton Road, Mailstop E-46, Atlanta, GA 30333, Telephone: (404) 
639-6191, Email address: [email protected].

    Dated: July 13, 2001.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 01-18049 Filed 7-18-01; 8:45 am]
BILLING CODE 4163-18-P