[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
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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
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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, gcg4@cdc.gov.
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, par1@cdc.gov.
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
