Research on Laboratory Markers of Recent HIV Infection: Notice of Availability of Funds

[Federal Register Volume 64, Number 147 (Monday, August 2, 1999)]
[Notices]
[Pages 41937-41939]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-19675]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Program Announcement 00007]


Research on Laboratory Markers of Recent HIV Infection: Notice of 
Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of $500,000 of fiscal year (FY) 2000 funds for a 
cooperative agreement program for Research on Laboratory Markers for 
Recent HIV Infection. This program addresses the ``Healthy People 
2000'' priority area of HIV Infection. The purpose of the Program is to 
support research on laboratory markers that can be used to measure HIV 
infection incidence from cross-sectional samples and identify recently 
infected persons.
    One example of this approach is provided by a newly described 
testing algorithm using a modified enzyme immuno assay (EIA) for HIV-1 
antibody to identify persons who are in the early period of HIV 
infection (Janssen et al, JAMA 1998; 280:42-48). Specimens that are 
positive for HIV antibody by a standard EIA and Western blot are 
retested with a less sensitive EIA. The method was developed using the 
Abbott 3A11 EIA as the standard assay and a modified Abbott 3A11 EIA 
(employing a more dilute specimen and shorter incubation time) as the 
less sensitive assay. Persons who are HIV-positive on the sensitive 
assay, but negative on the less sensitive assay, are considered to be 
recently infected.
    The objective is to develop laboratory tests or algorithms for 
identifying recent HIV infection (e.g., 3-12 months). These might 
include modifying existing EIAs or developing new serologic assays or 
testing algorithms. These assays or algorithms should be of sufficient 
simplicity to permit routine use in public health surveillance and 
programs.

B. Eligible Applicants

    Applications may be submitted by public and private nonprofit and 
for-profit organizations and by governments and their agencies: that 
is, universities, colleges, research institutions, hospitals, other 
public and private nonprofit, and for-profit organizations, State and 
local governments or their bona fide agents, and federally recognized 
Indian tribal governments, Indian tribes, or Indian tribal 
organizations.

    Note: Public Law 104-65 specifies 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 $500,000 is available in FY 2000 to fund up to two 
(2) awards. It is expected that the average award will be $250,000. It 
is also expected that the awards will begin on or about January 2, 2000 
and will be made for a 12-month budget period within a project period 
of up to two (2) 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.

Funding Preferences

    Funding will be awarded to applicants proposing different 
approaches, in order to avoid funding more than one laboratory for the 
same or very similar research.

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 activities 
under 2. (CDC Activities).
1. Recipient Activities
    a. Develop an innovative testing methodology for identifying recent 
HIV infection, or adapt another commercially available HIV-1 serum EIA 
to detect early HIV-1 infection in individuals (e.g., 3-12 months), or 
adapt such methods to other body fluids (oral fluids, urine, etc.), or 
adapt such methods to rapid HIV testing.
    b. Validate methods in appropriate study populations or appropriate 
panels of specimens using appropriate statistical methods for analysis.
    c. Provide results and share data (individual & aggregate) with 
other collaborators in the field and with CDC.
2. CDC Activities
    a. If the research protocol involves human subjects, CDC will 
assist in the development of a research protocol for

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Institutional Review Board (IRB) review by each cooperating institution 
participating in the research project.
    The CDC Institutional Review Board (IRB) will review and approve 
the protocol initially and on at least an annual basis until the 
research project is completed.
    b. Provide assistance in the design and conduct of the research and 
statistical analysis.
    c. Provide assistance on selected laboratory tests, when requested.
    d. Coordinate research activities among diverse sites, when 
appropriate, as there may be identical samples that require testing by 
more than one venue.
    e. Assist in the analysis of research information and the 
presentation and publication of research findings.

E. Application Content

    Use the information in the Program Requirements, Other 
Requirements, and Evaluation Criteria Sections to develop the 
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 be no more than ten (10) double-spaced 
pages, printed on one side, with one inch margins, and unreduced font.

Budget

    1. Submit line-item descriptive justification for personnel, 
travel, supplies, and other services. Be precise about the purpose of 
each budget item as it relates to the project.
    2. If you request funding for contracts, include the name of the 
person or firm to receive the contract, the method of selection, the 
period of performance, the reason for using a contract, and a 
description of the contracted service requested.
    3. Funding levels for year two (2) should be estimated.

Supporting Materials

    1. Curriculum vitae and job description of critical staff.
    2. Letters of endorsement or collaboration of participating 
centers, agencies or State or local public health departments.

F. Submission and Deadline

Application

    Submit the original and two copies of PHS 5161-1 (OMB Number 0937-
0189). Forms are available at the following internet address: 
www.CDC.gov...forms or in the application kit. On or before October 4, 
1999, 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:
    (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 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. The applicant demonstrates the knowledge, ability, and 
experience necessary to conduct laboratory research on measures of 
recent HIV infection. (20 points)
    2. The applicant demonstrates the ability to obtain and examine 
appropriate numbers and types of laboratory specimens. (20 points)
    3. The applicant presents a sound plan for conducting and 
evaluating the research, including appropriate statistical analysis. 
(20 points)
    4. The applicant's proposed objectives are measurable, specific, 
time-phased, and related to required recipient activities and program 
purpose. (20 points)
    5. The applicant demonstrates willingness to cooperate in a study 
with CDC and other collaborating institutions. (10 points)
    6. The size, qualifications, and other time allocation of the 
proposed staff and the availability of facilities are adequate for the 
study. (10 points)
    7. The budget is reasonable, clearly justified, consistent with the 
intended use of funds, and allowable. All budget categories should be 
itemized. (not scored)
    8. Does the application adequately address the requirements of 
Title 45 CFR Part 46 for the protection of human subjects?
    9. 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; and (c) A 
statement as to whether the design of the study is adequate to measure 
differences when warranted. (not scored)

H. Other Requirements

Technical Reporting Requirements

    Provide CDC with original plus two copies of:
    1. Progress Reports (semi annual);
    2. Financial Status Report (FSR), no more than 90 days after the 
end of the budget period; and
    3. Final financial status and performance reports, no more than 90 
days after the end of the project period.
    Send all reports to: Van Malone, Grants Management Specialist, 
Procurement and Grants Office, Centers for Disease Control and 
Prevention (CDC), 2920 Brandywine Road, Room 3000, Atlanta, GA 30341.
    The following additional requirements are applicable to this 
program: For a complete description of each, see Attachment I in the 
application kit.

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 2000
AR-12  Lobbying Restrictions

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under Section 301 of the Public Health 
Service Act, [42 U.S.C. 241, Section 311, 42 U.S.C. 243], as amended. 
The Catalog of Federal Domestic Assistance number is 93.943.

J. Where To Obtain Additional Information

    Please refer to Program Announcement 00007 when you request 
information. For a complete program description, information on 
application procedures, an application package, and business management 
technical assistance, contact: Van Malone, Grants Management 
Specialist, Procurement and Grants Office, Announcement

[[Page 41939]]

00007, Centers for Disease Control and Prevention (CDC), 2920 
Brandywine Road, Room 3000, Atlanta, GA 30341, Telephone: (770) 488-
2733, Email address: Vxm7@cdc.gov.
    For program technical assistance, contact: Donald Ruberti, Senior 
Public Health Advisor, Prevention Services Research Branch, Division of 
HIV/AIDS Prevention, Centers for Disease Control and Prevention (CDC), 
1600 Clifton Road, NE, Mail Stop E46, Atlanta, Georgia 30333, 
Telephone: (404) 639-2098, Email address: http:www.dor1@cdc.gov">//www.dor1@cdc.gov. See 
also the CDC Home Page on the Internet: http://www.cdc.gov
    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.

    Dated: July 27, 1999.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 99-19675 Filed 7-30-99; 8:45 am]
BILLING CODE 4163-18-P