National Institutes of Health

Description

The goal of this Funding Opportunity Announcement (FOA) is to support any research activities required to advance candidate therapeutics through Investigational New Drug (IND), Investigational Device Exemption (IDE), or 510(K) submission to the Food and Drug Administration (FDA), and ready them for clinical testing for neurological disorders. Projects should include a strong biological rationale for the intended approach, supporting data from rigorously designed experiments, and proposed studies that exhibit methodological rigor. Such projects, if successful, should lead directly to or support another project (e.g. cooperative agreement in translational research) that will include all remaining activities for submission of an IND, IDE, or 510(k) application to the FDA. The scope includes only preclinical development activities for therapeutic drugs, devices, and biologics; development of diagnostics or rehabilitation strategies cannot be supported. Clinical research, basic research, and studies of disease mechanism are outside the program scope.

Who can apply

• State governments
• County governments
• City or township governments
• Special district governments
• Independent school districts
• Public and State controlled institutions of higher education
• Native American tribal governments (Federally recognized)
• Public housing authorities / Indian housing authorities
• Native American tribal organizations (other than Federally recognized)
• Nonprofits with 501(c)(3) status (other than higher education)
• Nonprofits without 501(c)(3) status (other than higher education)
• Private institutions of higher education
• For-profit organizations other than small businesses
• Small businesses
• Others

Contact

NIH OER Webmaster<br/>FBOWebmaster@OD.NIH.GOV<br/>
FBOWebmaster@OD.NIH.GOV