[Federal Register Volume 65, Number 147 (Monday, July 31, 2000)]
[Notices]
[Pages 46718-46720]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-19212]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 000147]


Innovative HIV Testing: Operational Research Among People of 
Color Notice of Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2000 funds for a cooperative agreement 
program to conduct Human Immunodeficiency Virus (HIV) related 
operational research for the control and prevention of HIV. The purpose 
of this program is to: (1) Encourage studies of using the new rapid HIV 
tests in different settings (Operational Research), specifically 
focused on African American, Latino, and other racial and ethnic 
minorities that are underserved and/or disproportionally affected by 
the HIV epidemic, and conducted by researchers who have experience 
working with these populations; (2) learn more about the effects of 
rapid HIV testing on motivators and barriers to HIV testing at the 
individual, provider and system levels; and (3) foster collaborations 
between organizations serving minority communities and their respective 
state and local health departments in the design and implementation of 
innovative practical strategies using rapid HIV tests to increase 
knowledge of HIV serostatus and facilitate entry into prevention and 
care systems.
    For the purpose of this announcement, operational research is 
defined as the design, implementation, and systematic observation of 
model health service delivery systems to evaluate their performance and 
improve their effectiveness.
    For the purpose of this program announcement, research studies 
should specifically focus on racial and ethnic minorities that are 
underserved and/or disproportionally affected by the HIV epidemic 
(African Americans, Hispanics, American Indians, Asian and Pacific 
Islanders). Applicants should demonstrate access to and experience 
working with the selected minority population(s). Applications are 
encouraged from research organizations involving minority researchers 
as principal investigators (PIs) or major co-investigators.
    This program addresses the ``Healthy People 2010'' focus area of 
HIV. For the conference copy of ``Healthy People 2010'' visit the 
internet site: http://www.health.gov/healthypeople>.

B. Eligible Applicants

    Applications may be submitted by public and private non-profit 
organizations, community-based, national, and regional organizations, 
State and local governments or their bona fide agents or 
instrumentalities, federally recognized Indian Tribal governments, 
Indian tribes or organizations.

    Note: Public Law 104-65 states that an organization described in 
section 501(c)(4) of the Internal Revenue Code of 1986 that 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 $800,000 is available in FY 2000 to fund 
approximately four awards. It is expected that the average award will 
be $200,000, ranging from $100,000--$300,000. It is expected that 
awards will begin September 30, 2000, 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 are based on 
the availability of funds and success in demonstrating progress toward 
achievement of objectives.

Funding Preferences

    Preference for awards will be given to: (1) Ensuring geographic and 
risk group diversity; and (2) applicants with at least two years of 
demonstrated experience conducting operational research with minority 
populations that are underserved and/or disproportionally affected by 
the HIV epidemic.

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 and draft a research protocol.
    b. Implement activities according to the approved research 
protocol.
    c. Share study-related data with CDC as appropriate, with the 
frequency and in the format agreed upon after protocol development.
    d. Compile and disseminate findings of the operational research.
2. CDC Activities
    a. Assist as needed in the development of a research 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, telephone calls, and 
review of technical reports and interim data analysis.
    c. Assist as needed in facilitating the planning and implementation 
of the necessary linkages with local or State health departments, and 
with the logistics of using investigational rapid HIV tests in 
operational research projects.
    d. Facilitate the technological and methodological dissemination of 
successful prevention and intervention models to appropriate target 
audiences 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, and ongoing consultation and 
technical assistance for effective program planning and management.
    f. Convene meetings annually or as necessary for protocol 
development, information sharing, problem solving, and training.

E. Application Content

Application

    Use the information in the Program Requirements, Other 
Requirements, and Evaluation Criteria sections to develop your 
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 should consist of:
    1. Abstract (Not to exceed 1 page): An executive summary of the 
program proposed under this announcement.
    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.

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    3. Budget: Submit an itemized budget and supporting justification 
that is consistent with your proposed program plan.

F. Submission and Deadlines

Application

    Submit the original and five copies of the application on Form PHS 
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/. . . Forms, or in the application kit. 
On or before September 8, 2000, submit your application to the Grants 
Management Specialist listed in the ``Where to Obtain Additional 
Information'' section of this announcement. Eligible applicants are 
encouraged to call the contact person for program technical assistance, 
also listed in the ``Where to Obtain Additional Information'' section 
of this announcement, before developing and submitting their 
applications.
    Deadline: Applications shall be considered as meeting the deadline 
if they are either:
    (a) Received on or before the deadline date, or
    (b) 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 
(a) or (b) 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.
    1. Background and Need: Inclusion of a brief review of the 
scientific literature related to the use of rapid HIV testing and 
pertinent to the study being proposed; statement of specific research 
questions or hypotheses and techniques that will guide the operational 
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. 
(15 points)
    2. Scientific Merit: The quality of the research design and plans 
to develop and implement the study, including identification of the 
rapid HIV tests to be used and a statement as to whether the design of 
the study is adequate to measure outcomes, including sample size 
calculations, when warranted. (25 points)
    3. Collaboration and Minority Participation: Plans and supporting 
evidence for:
    (a) Established and proposed linkages with community-based 
organizations serving racial and ethnic minorities that are underserved 
and/or disproportionately affected by the HIV epidemic, and the health 
department with jurisdiction for the proposed project area. This should 
include a description of the demographics of clients served by the CBO, 
evidence of past cooperative projects, and/or letters of intent which 
describe the relationship, roles, and responsibilities under the 
planned collaboration.
    (b) 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 the proposed plan for 
the inclusion of both sexes and racial and ethnic minority populations 
for appropriate representation, the proposed justification when 
representation is limited or absent, and 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. (20 points)
    4. Operational Feasibility. Extent to which the proposed 
activities, if well executed, support attaining project objectives and, 
if successful, lend themselves to replication in similar program 
settings to facilitate diffusion of innovation in rapid HIV testing to 
other communities. (20 points)
    5. Project Management, Implementation Plan and Schedule.
    (a) Extent to which personnel involved in this project are 
qualified, with realistic and sufficient time commitments. This should 
include curriculum vitae and evidence of past achievements appropriate 
to the project.
    (b) Evidence of access to sufficient numbers of potential 
participants, and for the adequacy of facilities and other resources 
necessary to carry out the project.
    (c) Inclusion of a time line with realistic and measurable 
milestones for major project activities (20 points)
    6. 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. A quarterly 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 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-7--Executive Order 12372 Review
AR-8--Public Health System Reporting Requirements
AR-9--Paperwork Reduction Act Requirements
AR-10--Smoke-Free Workplace Requirements
AR-11--Healthy People 2010
AR-12--Lobbying Restrictions

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 
Internet address--http://www.cdc.gov. Click on ``Funding'' then 
``Grants and Cooperative Agreements.''
    To receive additional written information and to request an

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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: Roslyn Currington, Grants Management Specialist, Grants 
Management Branch, Procurement and Grants Office, Centers for Disease 
Control and Prevention (CDC), Room 3000, 2920 Brandywine Road, Atlanta, 
GA 30341-4146, Telephone number: (770) 488-2720, Facsimile at (770) 
488-2777, Email address:http://[email protected]
    For program technical assistance, contact: Bernard Branson, M.D. 
National Center for HIV, STD and TB Prevention, Centers for Disease 
Control and Prevention (CDC), 1600 Clifton Road, NE, MS E46, Atlanta, 
GA 30333, Telephone (404) 639-6166, Email address: 
HTTP:\\[email protected]

    Dated: July 25, 2000.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 00-19212 Filed 7-28-00; 8:45 am]
BILLING CODE 4163-18-P