[Federal Register Volume 61, Number 125 (Thursday, June 27, 1996)]
[Notices]
[Pages 33528-33530]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16386]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Announcement Number 664]


Primate Model for Studying the Pathogenesis of Measles Infections 
and for Development of Improved Measles Vaccines

Introduction

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1996 funds for a cooperative agreement

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program to support research into the pathogenesis of measles virus in a 
primate model. The goal of this program is to assist researchers in 
defining the mechanism of immune protection from measles virus and to 
use this information to develop improved vaccines for worldwide measles 
control efforts.
    The CDC is committed to achieving the health promotion and disease 
prevention objectives of Healthy People 2000, a 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 sections 301(a) and 317(k)(1) [42 
U.S.C. 241(a) and 247b(k)(1)] of the Public Health Service Act, as 
amended.

Smoke-Free Workplace

    CDC strongly encourages all grant recipients to provide a smoke-
free workplace and to promote the nonuse of all tobacco products, and 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities that receive Federal funds in which education, 
library, day care, health care, and early childhood development 
services are provided to children.

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 $200,000 is available in FY 1996 to fund one award. 
It is expected that the award will begin on or about September 30, 
1996, 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 the 
recipient in developing a primate model for measles infection and in 
conducting studies to: (1) improve the infection model, (2) 
characterize the immune response to natural disease and vaccination, 
(3) develop and test experimental measles vaccines, and (4) investigate 
the pathogenesis and epidemiology of measles infections.
    More specifically, the purpose of the program is to achieve the 
following research goals:
    1. Characterization of the immune response to natural disease and 
vaccination. Studies should attempt to measure differences between the 
immune response in animals receiving measles vaccination to those 
experiencing infection with a virulent strain. Efforts should be aimed 
at providing a complete description of the humoral and cellular immune 
responses and should also attempt to measure mucosal immunity.
    2. Development of a vaccine that will protect in the presence of 
maternal antibody. The goal of these studies should be to develop a 
vaccine that will protect newborns from measles infection during the 
first year of life and not interfere with subsequent vaccination using 
standard vaccines.
    3. Evaluation of immune response to individual measles virus 
antigens. Research should be designed to measure the immune response 
generated by experimental measles vaccines and the degree of protection 
provided. Measures of mucosal and cellular immunity as well as immune 
memory will be particularly important.

Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient shall be responsible for the activities under A., below, 
and CDC shall be responsible for conducting activities under B., below.

A. Recipient Activities

    1. Develop study design to accomplish the research goals described 
above.
    2. Perform all inoculations of animals. Maintain records of 
clinical observations and obtain samples for laboratory analysis.
    3. Perform laboratory analysis of samples obtained from study 
animals.
    4. Provide routine veterinary care, housing and other support for 
rhesus macaques to be used in experiments. Comply fully with PHS 
policies regarding research on animal subjects.
    5. Maintain sufficient numbers of seronegative animals so that 
experiments can be completed within an appropriate amount of time.
    6. Develop experimental measles vaccines and evaluate them in the 
animal model.
    7. Analyze data and prepare manuscripts describing results of 
research investigations.

B. CDC Activities

    1. Provide technical assistance and advice for design and conduct 
of the research.
    2. Provide assistance in development of various preparations of 
measles virus antigens for use as experimental vaccines. This material 
may consist of vaccines derived of recombinant DNA technology.
    3. Provide specialty reagents such as monoclonal and polyclonal 
antiserum and PCR primers as necessary.
    4. Assist in conducting specialized analysis of samples obtained 
from test animals. These may include special serological or immunologic 
assays, as well as assays to detect and measure measles virus or 
measles virus RNA in various tissue samples. Perform genetic 
characterization of viruses used in the study.
    5. Assist in data analysis.

Notice of Intent To Apply

    In order to assist CDC in planning for and executing the evaluation 
of applications submitted under this announcement, all parties 
intending to submit an application are requested to inform CDC of their 
intention to do so at their earliest convenience prior to the 
application due date. Notification should include: (1) name and address 
of institution, and (2) name, address, and telephone number of contact 
person. Notification should be provided by facsimile, postal mail, or 
E-mail to Paul Rota, Ph.D., National Center for Infectious Diseases, 
Centers for Disease Control and Prevention (CDC), 1600 Clifton Road, 
NE., Mailstop G-17, Atlanta, GA 30333, E-mail [email protected], 
facsimile (404) 639-1307.

Evaluation Criteria

    All applications will be reviewed and evaluated according to the 
following criteria (100 total points):

1. Background and Need (10 total points)

    Extent to which applicant demonstrates a clear understanding of the 
purpose and objectives of this proposed cooperative agreement.

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2. Capacity (55 total points)

    a. Extent to which applicant describes adequate resources and 
facilities for conducting the project. Extent to which facilities for 
the safe handling of infectious agents are available. (10 points)
    b. 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. Extent 
to which the applicant demonstrates experience with virology, 
particularly the virology of measles virus. (10 points)
    c. Extent to which applicant demonstrates experience with viral 
pathogenesis/immunology in rhesus macaques or other primate system. 
Extent to which the applicant can demonstrate previous or ongoing 
experience with measles infections of primates. Extent to which the 
applicant can produce a measles infection that is similar to measles 
infections in humans in rhesus macaques following intranasal 
inoculation. (35 points)

3. Objectives and Technical Approach (35 total points)

    a. 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. 
(5 points)
    b. 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. (10 points)
    c. Extent to which applicant describes appropriate collaboration 
with CDC during various phases of the project. (10 points)
    d. Extent to which applicant provides a detailed plan for 
evaluating study results and for evaluating progress towards achieving 
project objectives. (10 points)

4. Budget (Not Scored)

    Extent to which the proposed budget is reasonable, clearly 
justifiable, and consistent with the intended use of cooperative 
agreement funds.

Executive Order 12372

    Applications are not subject to review under Executive Order 12372, 
Intergovernmental Review of Federal Programs.

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.

Other Requirements

Animal Subjects

    This proposed project involves research on animal subjects; 
therefore, the applicant must comply with the ``PHS Policy on Humane 
Care and Use of Laboratory Animals by Awardee Institutions.'' An 
applicant organization using vertebrate animals in PHS-supported 
activities must file an Animal Welfare Assurance with the Office for 
Protection from Research Risks at the National Institutes of Health, 
Bethesda, Maryland.

Application Submission and Deadline

    The original and two copies of application PHS Form 398 (Revised 5/
95, OMB Number 0925-0001) must be submitted to Sharron P. Orum, 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, 
Attention: Marsha Driggans, on or before August 12, 1996.
    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. An application 
package and business management and technical assistance may be 
obtained from Marsha Driggans, 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) 842-6523, E-mail 
[email protected], facsimile (404) 842-6513.
    Programmatic technical assistance may be obtained from Paul Rota, 
Ph.D., Supervisory Research Microbiologist, Measles Section, Division 
of Viral and Rickettsial Diseases, National Center for Infectious 
Diseases, Centers for Disease Control and Prevention (CDC), 1600 
Clifton Road, NE., Mailstop G-17, Atlanta, GA 30333, telephone (404) 
639-3308, E-mail [email protected], facsimile (404) 639-1307.
    Please refer to Announcement Number 664 when requesting information 
regarding this program.

    Important Notice: Atlanta, GA, will be the host of the 1996 
Summer Olympics Games, July 19 through August 4, 1996. As a result 
of this event, it is likely that the Procurement and Grants Office 
(PGO), CDC, may experience delays in the receipt of both regular and 
overnight mail deliveries. Contacting PGO employees during this time 
frame may also be hindered due to the possible telephone 
disruptions. To the extent authorized, please consider the use of 
voice mail, E-mail, and facsimile transmission to the maximum extent 
practicable. However, do not fax lengthy documents or grant 
applications.

    You may obtain this announcement from one of two Internet sites on 
the actual publication date: CDC's homepage at http://www.cdc.gov or at 
the Government Printing Office homepage (including free on-line access 
to the Federal Register at http://www.access.gpo.gov).
    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) 512-1800.

    Dated: June 21, 1996.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 96-16386 Filed 6-26-96; 8:45 am]
BILLING CODE 4163-18-P