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[Federal Register: May 7, 2003 (Volume 68, Number 88)]
[Notices]
[Page 24480-24483]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07my03-88]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Program Announcement 03068]
Primate Model for Studying the Pathogenesis of Measles Infections
and for Development of Improved Measles Vaccines; Notice of
Availability of Funds
Application Deadline: June 23, 2003.
A. Authority and Catalog of Federal Domestic Assistance Number
This program is authorized under the sections 301 and 317(k)(1) of
the Public Health Service Act, as amended, [42 U.S.C. 241 and
247b(k)(1)]. The Catalog of Federal Domestic Assistance number is
93.283.
B. Purpose
The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 2003 funds for a cooperative agreement
program for a Primate Model for Studying the Pathogenesis of Measles
Infections and for Development of Improved Measles Vaccines. This
program addresses the ``Healthy People 2010'' focus area of
Immunization and Infectious Diseases.
The purpose of the program is to define the genetic and immunologic
basis for the pathogenesis of measles virus and to use this information
to develop improved vaccines for worldwide measles control efforts.
Measurable outcomes of the program will be in alignment with one or
more of the following performance goals for the National Center for
Infectious Diseases (NCID): Protect Americans from infectious diseases.
Any research project involving the construction and/or handling of
recombinant deoxyribonucleic acid (DNA) molecules or organisms or
viruses containing recombinant DNA molecules will be subject to review
and approval by the CDC Institutional Biosafety Committee using the
National Institutes of Health (NIH) Guidelines: http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html
C. Eligible Applicants
Applications may be submitted by public and private nonprofit
organizations and by governments and their agencies, this includes:
[sbull] Universities
[sbull] Colleges
[sbull] Technical schools
[sbull] Research Institutions
[sbull] Hospitals
[sbull] Community-based organizations
[sbull] Faith-based organizations
[sbull] Federally recognized Indian tribal governments
[sbull] Indian Tribes
[sbull] Indian tribal organizations
[sbull] State and local governments or their bona fide agents (this
includes the District of Columbia, the Commonwealth of Puerto Rico, the
Virgin Islands, the Commonwealth of the Northern Mariana Islands,
American Samoa, Guam, the Federated States of Micronesia, the Republic
of the Marshall Islands, and the Republic of Palau)
[sbull] Political subdivisions of States (in consultation with States)
Note: Title 2 of the United States Code section 1611 states that
an organization described in section 501(c)(4) of the Internal
Revenue Code that engages in lobbying activities is not eligible to
receive Federal funds constituting an award, grant or loan.
D. Funding
Availability of Funds
Approximately $200,000 is available in FY 2003 to fund one award.
It is expected that the award will begin on or about September 15,
2003, and will be made for a 12-month budget period within a project
period of up to 3 years. The funding estimate may change.
[[Page 24481]]
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.
Recipient Financial Participation
Matching funds are not required for this program.
Funding Preferences
Applications for new studies are encouraged, however, funding
preference may 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 an improved vaccine.
E. Program Requirements
In conducting activities to achieve the purpose of this program,
the recipient will be responsible for the activities listed in 1.
Recipient Activities, and CDC will be responsible for the activities
listed in 2. CDC Activities.
1. Recipient Activities
(a) Develop a study design to accomplish the following research
goals:
(1) Use the rhesus macaque as a primate model for measles
infections. These studies which produce disease in rhesus that closely
resembles measles in humans will describe the pathogenesis of measles
in the primate model.
(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. These studies should include
and broaden our understanding of cell mediated immunity by mapping CD4
and CD8 T-cell reactive epitopes on measles antigens and by measuring
the cytokine/chemokine responses following infection or vaccination.
(3) Develop improved measles vaccines. Research efforts should be
directed at developing, testing and optimizing 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
newborn humans from measles infection or disease during their first
year of life. In addition, subunit or DNA vaccines that could be used
to stimulate or boost immunity in immunocompromized individuals should
also be considered. Using recombinant measles viruses as a vector to
present other antigens should also be considered.
(4) Conduct studies to evaluate the safety and efficacy of standard
measles vaccines given by alternate routes. In particular, studies to
evaluate the safety and efficacy of measles vaccines given as aerosols
or dry powders via the intranasal route should be conducted in normal
and immunosuppressed animals. Evaluation of immune response to
individual measles virus antigens.
(5) Conduct studies to determine the genetic basis for virulence of
measles virus in the rhesus macaque. Studies should include
experimental infections with recombinant measles viruses that have
defined genetic characteristics. Another important goal will be the
maintenance and genetic characterization of viral stocks which can
reliably produce disease in rhesus by the intranasal route. Conduct
detailed analysis of these stocks to help understand the genetic basis
for the pathogenesis of measles virus.
(b) Perform all inoculations of research animals. Maintain records
of clinical observations and obtain samples for laboratory analysis.
(c) Perform specialized tests on specimens obtained from study
animals and coordinate shipment of specimens to CDC for additional
testing.
(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 in a timely manner.
(f) Develop experimental measles vaccines and evaluate them in the
animal model.
(g) Analyze data and manuscripts describing results of research
investigations.
2. CDC Activities
(a) Collaborate on the design and conduct of the research.
(b) Collaborate in the development of various preparations of
measles virus antigens, recombinant viruses, rescued viruses or
complementary DNA (cDNA) clones for use as experimental vaccines.
(c) Provide Direct Assistance for specialty reagents, such as
monoclonal and polyclonal antiserum, and PCR primers as needed.
(d) Conduct specialized analysis of samples obtained from test
animals and assist with genetic characterization of viruses used in the
study.
(e) Collaborate in data analysis, manuscript preparation and
presentation.
F. Content
Letter of Intent (LOI)
An LOI is optional for this program. The Program Announcement title
and number must appear in the LOI. The narrative should be no more than
two pages, single-spaced, printed on one side, with one-inch margins,
and unreduced 12-point font. Your letter of intent will be used to
enable CDC to determine the level of interest in the announcement and
should include the following information, a brief description of the
proposed study, the business address of the organization, and the name
and phone number of the Principal Investigator.
Applications
The Program Announcement title and number must appear in the
application. 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 ten pages, double-spaced,
printed on one side, with one-inch margins, and unreduced 12-point
font.
The narrative should consist of Background and Need, Capacity,
Objectives and Technical Approach, Measures of Effectiveness, Budget,
and Animal Subjects.
G. Submission and Deadline
Letter of Intent (LOI) Submission
On or before May 22, 2003, submit the LOI to the Grants Management
Specialist identified in the ``Where to Obtain Additional Information''
section of this announcement.
Application Forms
Submit the signed original and two copies of PHS 398 (OMB Number
0920-0001). Adhere to the instructions on the Errata Instruction Sheet
(posted on the CDC website) for PHS 398. Forms are available at the
following Internet address: www.cdc.gov/od/pgo/forminfo.htm
If you do not have access to the Internet, or if you have
difficulty accessing the forms on-line, you may contact the CDC
Procurement and Grants Office Technical Information Management Section
(PGO-TIM) at: 770-488-2700. Application forms can be mailed to you.
[[Page 24482]]
Submission Date, Time, and Address
The application must be received by 4 p.m. Eastern Time June 23,
2003. Submit the application to: Technical Information Management--
PA03068, CDC Procurement and Grants Office, 2920 Brandywine Road,
Atlanta, GA 30341-4146. Applications may not be submitted
electronically.
CDC Acknowledgment of Application Receipt
A postcard will be mailed by PGO-TIM, notifying you that CDC has
received your application.
Deadline
Applications shall be considered as meeting the deadline if they
are received before 4 p.m. Eastern Time on the deadline date. Any
applicant who sends their application by the United States Postal
Service or commercial delivery services must ensure that the carrier
will be able to guarantee delivery of the application by the closing
date and time. If an application is received after closing due to (1)
carrier error, when the carrier accepted the package with a guarantee
for delivery by the closing date and time, or (2)significant weather
delays or natural disasters, CDC will upon receipt of proper
documentation, consider the application as having been received by the
deadline.
Any application that does not meet the above criteria will not be
eligible for competition, and will be discarded. The applicant will be
notified of their failure to meet the submission requirements.
H. Evaluation Criteria
Applicants are required to provide Measures of Effectiveness that
will demonstrate the accomplishment of the various identified
objectives of the [grant or cooperative agreement]. Measures of
Effectiveness must relate to the performance goals stated in the
purpose section of this announcement. Measures must be objective and
quantitative and must measure the intended outcome. These measures of
effectiveness must be submitted with the application and will be an
element of evaluation.
An independent review group appointed by CDC will evaluate each
application against the following criteria:
1. Capacity (45 total points). (a) 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)
(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 describes adequate resources and
facilities for conducting the project. Extent to which facilities for
the safe handling of infectious agents are available. (5 points)
2. Objectives and Technical Approach (40 total points). (a) 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.
(20 points)
(b) Extent to which applicant provides a detailed plan for
evaluating study results and for evaluating progress towards achieving
project objectives. (15 points)
(c) 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)
3. Background and Need (10 points). Extent to which applicant
demonstrates a clear understanding of the purpose and objectives of
this proposed cooperative agreement.
4. Measures of Effectiveness (5 points). Does the applicant provide
Measures of Effectiveness that will demonstrate the accomplishment of
the various identified objectives of the grant? Are the measures
objective/quantitative and do they adequately measure the intended
outcome?
5. Budget (Not Scored). Extent to which the proposed budget is
reasonable, clearly justifiable, and consistent with the intended use
of cooperative agreement funds.
6. Animal Subjects (Not Scored). Extent to which the application
adequately addresses the requirements of Public Health Policy on Humane
Care and Use of Laboratory Animals.
I. Other Requirements
Technical Reporting Requirements
Provide CDC with original plus two copies of:
1. Interim progress report, no less than 90 days before the end of
the budget period. The progress report will serve as your non-competing
continuation application, and must contain the following elements:
a. Current Budget Period Activity Objectives.
b. Current Budget Period Financial Progress.
c. New Budget Period Program Proposed Activity Objectives.
d. Detailed Line-Item Budget and Justification.
e. Additional Requested Information.
2. Financial status report, no more than 90 days after the end of
the budget period.
3. Final financial and performance reports, no more than 90 days
after the end of the project period.
Send all reports to the Grants Management Specialist identified in
the ``Where to Obtain Additional Information'' section of this
announcement.
Additional Requirements
The following additional requirements are applicable to this
program. For a complete description of each, see Attachment I of the
program announcement, as posted on the CDC website.
AR-3--Animal Subjects Requirements
AR-7--Executive Order 12372
AR-10--Smoke Free Work Place Requirements
AR-11--Healthy People 2010
AR-12--Lobbying Restrictions
AR-15--Proof of Non-Profit Status
AR-22--Research Integrity
J. Where To Obtain Additional Information
This and other CDC announcements, the necessary applications, and
associated forms can be found on the CDC web site, Internet address:
http://www.cdc.gov Click on ``Funding'' then ``Grants and Cooperative
Agreements.''
For general questions about this announcement, contact: Technical
Information Management, CDC Procurement and Grants Office, 2920
Brandywine Road, Atlanta, GA 30341-4146, Telephone: 770-488-2700.
For business management and budget assistance, contact: Jeff
Napier, Grants Management Specialist, Procurement and Grants Office,
Centers for Disease Control and Prevention, 2920 Brandywine Road,
Atlanta, GA 30341-4146, Telephone: 770-488-2861, E-mail Address:
jkn7@cdc.gov.
[[Page 24483]]
For program technical assistance, contact: Paul A. Rota, Ph.D.,
Supervisory Microbiologist, National Center for Infectious Diseases,
Centers for Disease Control and Prevention, MS-C-22, 1600 Clifton Road,
NE., Atlanta, GA 30333, Telephone: (404) 639-4181, E-mail:
Prota@cdc.gov.
Dated: May 1, 2003.
Edward Schultz,
Acting Director, Procurement and Grants Office, Centers for Disease
Control and Prevention.
[FR Doc. 03-11261 Filed 5-6-03; 8:45 am]
BILLING CODE 4163-18-P
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