[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