[Federal Register Volume 64, Number 66 (Wednesday, April 7, 1999)]
[Notices]
[Pages 16974-16976]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-8567]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Program Announcement 99066]


Primate Model for Studying the Pathogenesis of Measles Infections 
and for Development of Improved Measles Vaccines; Notice of 
Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1999 funds for a cooperative agreement 
program to support research into the pathogenesis of measles virus in a 
primate model. This program addresses the ``Healthy People 2000'' 
priority area of Immunization and Infectious Diseases. 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.
    Specifically, the purpose of the program is to achieve the 
following research goals:
    1. Use the rhesus macaque as a primate model for measles 
infections. Studies should attempt to reproduce disease in rhesus that 
closely resembles measles in humans. It will be important to develop 
viral stocks which can reliably produce disease in rhesus by the 
intranasal route and to describe the pathogenesis of this disease in 
the animal host.
    2. Characterize the immune response to natural measles disease and 
measles vaccination. Studies should attempt to measure differences 
between the immune response in animals receiving measles vaccines to 
those experiencing infection with a virulent strain. Efforts should be 
aimed at providing a complete description of the humoral, and 
especially, the cellular immune responses.
    3. Development of improved measles vaccines. Research efforts 
should be directed at developing and testing novel vaccine formulations 
that could be used to stimulate an immune response in the presence of 
maternal antibody. Such vaccines would be used to protect newborns from 
measles infection or disease during their first year of life. Vaccines 
that could be used to stimulate or boost immunity in immunocompromized 
individuals should also be considered.
    4. Evaluation of immune response to individual measles virus 
antigens. Research should be designed to measure the immune response 
generated by experimental measles vaccines and individual measles 
antigens. Efforts should be made to identify epitopes on measles 
proteins which are the most effective in inducing humoral and cellular 
immune responses in an outbred population.

B. Eligible Applicants

    Applications may be submitted by public and private nonprofit 
organizations and by governments and their agencies; that is, 
universities, colleges, research institutions, hospitals, other public 
and private nonprofit 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 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 $300,000 is available in FY 1999 to fund 
approximately two awards. It is expected that the average award will be 
$150,000, ranging from $100,000 to $200,000. It is expected that the 
awards will begin on or about

[[Page 16975]]

September 30, 1999 and will be made for a 12-month budget period within 
a project period of up to three years. The funding estimate 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

    Although applications for new studies are encouraged, funding 
preference will be given to the competing continuation application over 
applications for programs not already receiving support under the 
existing program. The current awardee has implemented vaccine research 
that requires continued support to become fully developed and to 
realize the benefits of continued vaccine development (see Background 
Information Attachment II).

D. Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient shall be responsible for the activities under 1., below, 
and CDC shall be responsible for conducting activities under 2., below:

1. Recipient Activities
    a. Develop study design to accomplish the research goals described 
above.
    b. Perform all inoculations of research animals. Maintain records 
of clinical observations and obtain samples for laboratory analysis.
    c. Perform laboratory analysis of samples obtained from study 
animals.
    d. 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.
    e. Maintain sufficient numbers of rhesus macaques so that 
experiments can be completed within an appropriate amount of time.
    f. Develop experimental measles vaccines and evaluate them in the 
animal model.
    g. Analyze data and prepare manuscripts describing results of 
research investigations.
2. CDC Activities
    a. Provide technical assistance and advice for design and conduct 
of the research.
    b. Provide assistance in development of various preparations of 
measles virus antigens, recombinant viruses, rescued viruses or cDNA 
clones for use as experimental vaccines.
    c. Provide specialty reagents such as monoclonal and polyclonal 
antiserum and PCR primers as necessary.
    d. Assist in conducting specialized analysis of samples obtained 
from test animals. These may include special serological or 
immunological assays, as well as assays to detect and measure measles 
virus or measles virus RNA in various tissue samples. Assist with 
genetic characterization of viruses used in the study.
    e. Assist in data analysis and presentation.

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 10 double-spaced pages, 
printed on one side, with one inch margins, and unreduced font.

F. Submission and Deadline

Application
    Submit the original and two copies of PHS-5161-1 (OMB Number 0937-
0189). Forms are in the application kit. On or before June 2, 1999, 
submit the application to: Gladys Gissentanna, Grants Management 
Specialist, Grants Management Branch, Procurement and Grants Office, 
Announcement 99066, Centers for Disease Control and Prevention (CDC), 
2920 Brandywine Road, Room 3000, Atlanta, Georgia 30341-4146.
    Deadline: Applications shall be considered as meeting the deadline 
if they are either:
    1. Received on or before the deadline date; or
    2. Sent on or before the deadline date and received in time for 
orderly processing. (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 (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.
2. Capacity (45 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. (5 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 and 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. (30 points)
3. Objectives and Technical Approach (45 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 (also see Attachment III). (20 points)
    c. Extent to which applicant provides a detailed plan for 
evaluating study results and for evaluating progress towards achieving 
project objectives. (20 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.
5. Animal Subjects (Not Scored)
    Extent to which the application adequately address the

[[Page 16976]]

requirements of Public Health Policy on Humane Care and Use of 
Laboratory Animals.

H. Other Requirements

    Technical Reporting Requirements Provide CDC with original plus two 
copies of:
    1. progress reports (annual);
    2. financial status report, 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: Gladys T. Gissentanna, Grants Management 
Specialist, Grants Management Branch, Procurement and Grants Office, 
Centers for Disease Control and Prevention (CDC), 2920 Brandywine Road, 
Room 3000, Atlanta, GA 30341-4146.
    The following additional requirements are applicable to this 
program. For a complete description of each, see Attachment I in the 
application kit.

AR-3 Animal Subjects Requirements
AR-10 Smoke-Free Workplace Requirements
AR-11 Healthy People 2000
AR-12 Lobbying Restrictions
AR-15 Proof of Non-Profit Status

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under the Public Health Service Act 
Sections 301(a)[42 U.S.C. 241(a)], 311 [42 U.S.C. 243], and 317(k) (1) 
and (2)[42 U.S.C. 247b(k) (1)and (2)], as amended. The Catalog of 
Federal Domestic Assistance number is 93.283.

J. Where to Obtain Additional Information

    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. Please refer to Program Announcement 
99066. You will receive a complete program description, information on 
application procedures, an application package. If you have any 
questions after reviewing the contents of all the documents, business 
management technical assistance may be obtained from Gladys T. 
Gissentanna, Grants Management Specialist, Grants Management Branch, 
Procurement and Grants Office, Centers for Disease Control and 
Prevention (CDC), 2920 Brandywine Road, Room 3000, Atlanta, GA 30341-
4146, telephone (770) 488-2753, e-mail address, [email protected].
    See also the CDC home page on the Internet: http://www.cdc.gov.
    For program technical assistance, contact Paul A. Rota, Ph.D., 
Supervisory Microbiologist, Measles Section, National Center For 
Infectious Diseases, Centers for Disease Control and Prevention, 1600 
Clifton Road, Mailstop C-22, Atlanta, GA 30333, telephone (404) 639-
3308, fax (404) 639-4187, e-mail address, [email protected].

    Dated: April 1, 1999.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 99-8567 Filed 4-6-99; 8:45 am]
BILLING CODE 4163-18-P