Translational Centers Using Microphysiologic Systems for Infectious Diseases

The National Institute of Allergy and Infectious Diseases (NIAID) seeks to advance its mission by supporting the development of human microphysiologic systems (MPS) for infectious disease research and the development of therapeutics or biological products. MPS are in vitro platforms composed of cells or tissues maintained in a microenvironment designed to mimic the physiological aspects of in vivo tissue or organ function. There is growing support for the development of MPS for basic research at NIH and regulatory pathways at the FDA with the aim of reducing the use of animals in research and generating human tissue models that can be used to study human physiological processes. However, MPS development has not focused on their use in studies of infectious diseases or for product development. The goal of this program is to accelerate the use of MPS for infectious diseases and product development, promoting adoption for use by developers of drugs and biological products and their regulatory acceptance. Grant authorities that allow NIAID to forecast this opportunity are as follows: Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.

Other Eligible ApplicantsIndian/Native American Tribal Governments (Other than Federally Recognized);Eligible Agencies of the Federal Government;U.S. Territory or Possession;Faith-based or Community-based Organizations;Regional Organizations;Non-domestic (non-U.S.) Entities (Foreign Institutions).

The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the...

This program has no statutory formula. Matching requirements are not applicable to this assistance listing. MOE requirements are not applicable to this assistance listing.

Not Applicable.