The purpose of this Notice of Funding Opportunity (NOFO) is to leverage NICHD clinical research Network infrastructure relevant to infants, children, women, pregnant and lactating women, and persons with disabilities to conduct innovative, multisite, investigator-initiated clinical trials and observational studies. This NOFO will utilize a bi-phasic (UG3/UH3), milestone-driven mechanism consisting of a start-up phase (UG3) and a full enrollment and clinical trial implementation phase (UH3). Applications submitted in response to this NOFO must address specific aims and milestones for both the UG3 and UH3 phases. A UG3 project (phase I) that meets its milestones will be administratively considered by NICHD and prioritized for transition to the UH3 award (phase II). This NOFO provides an opportunity to leverage NICHD clinical research Network infrastructure as a platform for investigator-initiated innovative hypotheses by any investigator in the extramural community. Applications must be submitted as investigator-initiated, multi-Project Director/Principal Investigator (PD/PI) grant applications in conjunction with the respective NICHD-supported Network Data Coordinating Center (DCC), or equivalent as determined by the NICHD.

Government

• State governments
• Federally recognized Native American tribal governments
• Public and Indian housing authorities
• City or township governments
• Special district governments
• County governments

Education

• Independent school districts
• Public and state institutions of higher education
• Private institutions of higher education

Business

• For-profit organizations other than small businesses
• Small businesses

Miscellaneous

• Other

Nonprofit

• Other Native American tribal organizations
• Nonprofits non-higher education without 501(c)(3)
• Nonprofits non-higher education with 501(c)(3)