OpportunityTitle: Advancing Regulatory Science through Novel Biomarker Research and Science-Based Technologies
AdditionalInformationOnEligibility: PLEASE NOTE:  The synopsis is being revised to reflect a change in eligibility requirements as follows:  The entities eligible to enter into partnerships with FDA are governed by Section 566 of the FD&amp;C [21 U.S.C. 360bbb-5&quot;.    Higher Education Institutions as defined in Section 101 of the Higher Education Act of 1965(or a consortium of such institutions).    An eligible organization that wishes to enter into a collaborative agreement must provide an assurance that the entity will not accept funding for a Critical Path Public-Private Partnership project from any organization that manufactures or distributes products regulated by the Food and Drug Administration unless the entity provides assurances in its agreement with the Food and Drug Administration that the results of the Critical Path Public-Private Partnership project will not be influenced by and source of funding.
Description: As a key component of FDA&apos;s Advancing Regulatory Science Initiative, the Office of Critical Path Programs (OCPP) supports innovation in the development, evaluation, and manufacture of new safe and effective medical/veterinary products for diagnosing, treating, and preventing diseases. This Funding Opportunity Announcement (FOA) invites applications that propose applying novel technologies and approaches to developing new biomarkers for well defined human or veterinary diseases and toxicity in areas where an unmet need exists, particularly where such biomarkers show substantial promise to enable or speed product development and evaluation or improve patient effectiveness and healthcare outcomes as well as ensure product availability to patients in a timely manner.Applications should address the Critical Path Initiative mission to facilitate the development of new safe and effective products for diagnosing, treating, and preventing disease.
GrantorContactEmailDescription: FDA work e-mail
GrantorContactText: gladys Bohler &lt;br/&gt;Grants Management Officer/Specialist &lt;br/&gt;Phone 301-827-7175