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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