CLARIFICATION: PARTNERSHIPS FOR VACCINE AND DIAGNOSTIC DEVELOPMENT 
(RFA-AI-03-028)

RELEASE DATE:  July 16, 2003

NOTICE: NOT-AI-03-050

National Institute of Allergy and Infectious Diseases (NIAID)
 (http://www.niaid.nih.gov)

PURPOSES OF THIS NOTICE

This notice is intended to provide additional information and guidance 
to investigators to enable them to prepare better, more responsive 
applications for RFA AI-03-028 
(http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-03-028.html) and 
to clarify what is meant by point-of-care (POC) diagnostics for Group A 
Streptococci in Part D and Group B Streptococci in Part E of the RFA. 

ADDITIONAL GUIDANCE UNDER SPECIAL REQUIREMENTS

Each application must propose a milestone-driven, timeline-based 
project whose goal is to further the development of a product as 
described in RFA AI-03-028.  Annual funding will be tied to the 
successful attainment of research objectives.  Initial release of funds 
will be to support achievement of the first objective(s)/milestone(s).  
Release of each successive annual funding increment will be based on 
the achievement of the previous milestone(s) as determined by NIAID 
staff.  

Applicants submitting proposals for the development of products under 
this program must provide the following information in a separate 
section of the application entitled response to special requirements:

1.  A clear description the goal(s) of the project, including one (or 
more) final product(s) or stage(s) of development to be completed 
during the award period.  This section must also state all interim 
milestones to be achieved during the course of the project and identify 
any impediments that could require a revision in the work plan or 
milestones with alternative approaches.  It is suggested that an 
applicant propose no more than two or three interim 
objectives/milestones and a final objective.  An example of an interim 
milestone could be the production of a GMP vaccine candidate.  This 
section should include information that demonstrates that the applicant 
understands the steps that are required for advancing a candidate 
product that span this proposed project.  For example, the relevant 
benchmarks required for the licensure of a vaccine or 
clearance/approval of a diagnostic device.  
-  For additional details on vaccines, see: 
http://www.fda.gov/cber/vaccine/vacappr.htm
-  For additional details on diagnostics, see: http://www.fda.gov/cdrh.

a.  Provide a detailed schedule or timeline for the anticipated 
attainment of each milestone and the overall goal(s) that is linked to 
annual funding increments.  

b.  Provide criteria that clearly describe how decisions will be made 
to advance a product through the proposed product development pathway. 
In other words, provide criteria by which "go" or "no go" decisions 
will be made throughout the project as applicable.  

c.  Provide a detailed budget justification as a separate section of 
the application.  This should also include a justification of all key 
personnel, equipment, consultant costs and travel expenses.

Also note that applications must address any safety issues related to 
the further clinical development of the candidate product(s) as 
appropriate.

DEVELOPMENT OF POINT-OF-CARE DIAGNOSTICS FOR GROUP A STREPTOCOCCI AND 
GROUP B STREPTOCOCCI

RFA AI-03-028 solicits applications for the development of POC 
diagnostics for detection of group A streptococci (GAS) and group B 
streptococci (GBS) in clinical specimens.  There are many potential 
sites where POC testing can occur including near the patient; at field 
stations; and in emergency rooms, physician office laboratories, and 
clinics and hospitals. Personnel performing point-of-care-testing 
include both those with and without healthcare backgrounds.  In 
proposing POC diagnostics for GAS and GBS, applicants should 
demonstrate their understanding of the different public health needs 
for each organism.

D.  Development of point-of-care diagnostics for GAS

As described in the RFA, improved point-of-care diagnostics for 
detection of GAS are needed to obtain burden of disease data in sites 
where bacterial culture is not routinely performed.  It is anticipated 
that testing would be performed at a field site, or in a clinic or 
hospital.  The diagnostic test would optimally be easy to operate, 
require minimal or no training to perform, and involve a simple test 
procedure without complex sample handling and preparation.  In 
addition, components would require little or no maintenance or 
calibration, and the test system would be compact or portable and be 
able to withstand wide temperature variations. The results would be 
easy to read and interpret.  Only diagnostic tests for GAS intending to 
meet these criteria will be considered responsive to this RFA.

E.  Development of point-of-care diagnostics for GBS

Detection of GBS colonization in pregnant women is needed to determine 
whether an antibiotic should be administered at the time of labor and 
delivery to prevent GBS disease in the neonate.  This RFA solicits 
point of care diagnostics that could be performed in a variety of 
settings to replace culture-based methods.  Testing at the onset of 
labor and delivery would generally occur in a hospital setting where a 
more complex test may be acceptable; in developing countries a simple 
test (with the criteria cited above for GAS)is preferable.  Complex 
tests often involve specialized technical knowledge and training. The 
performance and interpretation of these tests may not be automatic and 
involve decision making and direct intervention.  Both simple and 
complex diagnostics for GBS will be considered responsive to this RFA. 

ADDITIONAL CLARIFICATION RELATED TO POINT-OF-CARE DIAGNOSTICS

o  Applications proposing diagnostics for both GAS and GBS in a single 
application must be responsive to the testing site and complexity 
considerations described in this notice.

o  Discussions with FDA are recommended to develop milestones related 
to the clinical evaluation of the diagnostic.  

INQUIRIES

Inquiries are strongly encouraged.  Opportunities to clarify any issues 
or questions from potential applicants are welcome.

Direct inquiries concerning this notice to:

Fran A. Rubin, Ph.D.
Program Officer
Division of Microbiology and Infectious Diseases
NIAID
6610 Rockledge Drive
Room 5055
Bethesda, MD 20892
Telephone: (301) 496-5305
Email: fr28f@nih.gov


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