[Federal Register Volume 59, Number 132 (Tuesday, July 12, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-16808]
[[Page Unknown]]
[Federal Register: July 12, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Announcement Number 491]
Hantavirus Pulmonary Syndrome (HPS)/Immunology Cooperative
Agreement
Introduction
The Centers for Disease Control and Prevention (CDC) announces a
program for competitive fiscal year (FY) 1994 funds to conduct
Hantavirus Pulmonary Syndrome (HPS) Immunologic Investigations. These
activities are intended to focus on the role of immunopathology and its
role in induction of HPS. These investigations will provide the basis
for further work in understanding the pathogenesis of HPS and provide
additional avenues for progress in clinical management, treatment, and
vaccine development.
The Public Health Service (PHS) is committed to achieving the
health promotion and disease prevention objectives of Healthy People
2000, a PHS-led national activity to reduce morbidity and mortality and
improve the quality of life. This announcement is related to the
priority area of Immunization and Infectious Diseases. (To order a copy
of Healthy People 2000, see the section Where to Obtain Additional
Information.)
Authority: This program is authorized under Section 301(a) [42
U.S.C. 241(a)], 311 [42 U.S.C. 243], and 317(k)(3) [42 U.S.C.
247b(k)(3)] of the Public Health Service Act, as amended.
Application program regulations are found in 42 CFR Part 52--Grants
for Research Projects.
Smoke-Free Workplace
The Public Health Service strongly encourages all grant recipients
to provide a smoke-free workplace and promote the non-use of all
tobacco products. This is consistent with the PHS mission to protect
and advance the physical and mental health of the American people.
Eligible Applicants
Applications may be submitted by public and private, nonprofit and
for-profit organizations and governments and their agencies. Thus,
universities, colleges, research institutions, hospitals, other public
and private organizations, including State and local governments or
their bona fide agents, federally recognized Indian tribal governments,
Indian tribes or Indian tribal organizations, and small, minority- and/
or women-owned businesses are eligible to apply.
Availability of Funds
Approximately $250,000 is available in FY 1994 to fund one award.
It is expected that the award will begin on or about September 30,
1994, and will be made for a 12-month budget period within a project
period of up to 3 years. Funding estimates may vary and are subject to
change.
Continuation awards within the approved project period will be made
on the basis of satisfactory progress and availability of funds.
Purpose
The purpose of this cooperative agreement is to assist researchers
in studies of the immunology and immunopathology of hantavirus
infections that focus on the role of cellular immune response. The
overall goals of this program are to facilitate: (1) Development of
information that can guide future strategies for vaccine development,
and (2) Identification of immunopathologic disease processes which can
lead to the development of therapeutic approaches for blocking these
processes.
Program Requirements
In conducting activities to achieve the purpose of this agreement,
the recipients shall be responsible for the activities under A., below,
and CDC shall be responsible for conducting activities under B., below:
A. Recipient Activities
1. Prepare and evaluate bulk cultures of specific T lymphocytes and
T cell clones from humans and/or non-human primates. Include evaluation
of functional capabilities, phenotype, major histocompatibility complex
restriction, and epitope specificity. Focus on understanding the role
of T cells in protection against HPS.
2. Investigate the relative roles of cellular and humoral immunity
in recovery from hantaviral disease in general and HPS in particular.
Investigate the ongoing antibody response, T cell infiltrates in the
alveolar septae of the lung in deceased patients, and the non-
cytopathic replication of HPS viruses in causing disease.
3. In accordance with current hantavirus biosafety procedures,
perform studies in appropriate BSL-3 and BSL-4 containment facilities.
4. Analyze all results in collaboration with CDC. Present/publish
all significant findings.
B. CDC Activities
1. Until commercially available, provide inactivated antigens,
expression vectors containing viral genes, and sera from HPS patients.
2. Provide access to CDC's BSL-4 laboratory facilities and BSL-3
laboratory as necessary (CDC has one of only two BSL-4 laboratories in
the United States).
3. Provide fresh or appropriately frozen lymphocytes from immune
humans or nonhuman primates, as available.
4. Provide technical support as necessary.
Evaluation Criteria
All applications will be reviewed and evaluated according to the
following criteria:
A. Background and Need
Extent to which applicant demonstrates a clear understanding of the
purpose and objectives of this proposed cooperative agreement. Extent
to which applicant demonstrates a clear understanding of the
requirements, responsibilities, interactions, problems, constraints,
complexities, etc., that may be encountered in conducting the project
and performing the studies. (30 points)
B. Capacity
Extent to which applicant describes adequate resources and
facilities (both technical and administrative) for conducting the
project. Extent to which applicant documents that professional
personnel involved in the project are qualified and have past
experience and achievements in research related to that proposed in
this cooperative agreement as evidenced by curriculum vitae,
publications, etc. (35 points)
C. Objectives and Technical Approach
Extent to which applicant describes objectives of the proposed
project which are consistent with the purpose and program requirements
of this cooperative agreement and which are measurable and time-phased.
Extent to which applicant presents a detailed plan for initiating and
conducting the project. Extent to which the plan clearly describes
applicant's technical approach/methods for conducting the proposed
studies. Extent to which applicant describes specific study protocols
or plans for the development of study protocols that are appropriate
for achieving project objectives. Extent to which applicant describes
adequate collaboration with CDC during various phases of the project.
Extent to which applicant provides a detailed plan for evaluating study
results and for evaluating progress towards achieving project
objectives. (35 points)
D. Budget
Extent to which the proposed budget is reasonable, clearly
justifiable, and consistent with the intended use of cooperative
agreement funds. (Not Weighted)
Executive Order 12372
Applications are subject to Intergovernmental Review of Federal
Programs as governed by Executive Order (E.O.) 12372. E.O. 12372 sets
up a system for State and local government review of proposed Federal
assistance applications. Applicants (other than federally recognized
Indian tribal governments) should contact their State Single Point of
Contact (SPOC) as early as possible to alert them to the prospective
applications and receive any necessary instructions on the State
process. For proposed projects serving more than one State, the
applicant is advised to contact the SPOC for each State. A current list
of SPOCs is included in the application kit. If SPOCs have any State
process recommendations on applications submitted to CDC, they should
send them to Edwin L. Dixon, Grants Management Officer, Grants
Management Branch, Procurement and Grants Office, Centers for Disease
Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Room 314,
Mailstop E-18, Atlanta, GA 30305. The due date for State process
recommendations is 30 days after the application deadline date for new
and competing continuation awards. (A waiver for the 60 day requirement
has been requested.) The granting agency does not guarantee to
``accommodate or explain'' for State process recommendations it
receives after that date. Indian tribes are strongly encouraged to
request tribal government review of the proposed application. If tribal
governments have any tribal process recommendations on applications
submitted to CDC, they should forward them to Edwin L. Dixon, Grants
Management Officer, Grants Management Branch, Procurement and Grants
Office, Centers for Disease Control and Prevention (CDC), 255 East
Paces Ferry Road, NE., Room 314, Mailstop E-18, Atlanta, GA 30305. This
should be done no later than 30 days after the application deadline
date for new and competing continuation awards. The granting agency
does not guarantee to ``accommodate or explain'' for tribal process
recommendations it receives after that date.
Public Health System Reporting Requirements
This program is not subject to the Public Health System Reporting
Requirements.
Catalog of Federal Domestic Assistance Number
The Catalog of Federal Domestic Assistance Number is 93.283.
Application Submission and Deadline
The original and two copies of the application, Form PHS-5161-1
(Revised 7/92), must be submitted to Edwin L. Dixon, Grants Management
Officer, Grants Management Branch, Procurement and Grants Office,
Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry
Road, NE., Room 314, Mailstop E-18, Atlanta, GA 30305, on or before
August 22, 1994.
1. 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 should 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 proof of timely mailing.)
2. Late Applications: Applications which do not meet the criteria
in 1.a. or 1.b. above are considered late applications. Late
applications shall not be considered in the current competition for
funding and will be returned to the applicant.
Where To Obtain Additional Information
A complete program description and information on application
procedures are contained in the application package. Business
management technical assistance may be obtained from Gordon R. Clapp,
Grants Management Specialist, Grants Management Branch, Procurement and
Grants Office, Centers for Disease Control and Prevention (CDC), 255
East Paces Ferry Road, NE., Room 314, Mailstop E-18, Atlanta, GA 30305,
telephone (404) 842-6508.
Programmatic technical assistance may be obtained from Kathleen F.
Cavallaro, Operations and Management, Hantavirus Task Force, National
Center for Infectious Diseases, Centers for Disease Control and
Prevention (CDC), 1600 Clifton Road, NE., Mailstop A-26, Atlanta, GA
30333, telephone (404) 639-1511.
Please refer to Announcement Number 491 when requesting information
regarding this program.
Potential applicants may obtain a copy of Healthy People 2000 (Full
Report: Stock No. 017-001-00474-0) or Healthy People 2000 (Summary
Report: Stock No. 017-001-00473-1), referenced in the Introduction,
through the Superintendent of Documents, Government Printing Office,
Washington, DC 20402-9325, telephone (202) 783-3238.
Dated: July 6, 1994.
Martha Katz,
Acting Associate Director for Management and Operations, Centers for
Disease Control and Prevention (CDC).
[FR Doc. 94-16808 Filed 7-11-94; 8:45 am]
BILLING CODE 4163-18-P