[Federal Register Volume 68, Number 88 (Wednesday, May 7, 2003)]
[Notices]
[Pages 24480-24483]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-11261]


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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.

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    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: 
[email protected].

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    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: 
[email protected].

    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