National Institutes of Health

Description

This FOA issued by the National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health, will support investigator-initiated Phase I, II, III or IV clinical trial cooperative agreement applications or biomarker evaluation studies that require prospective collection of clinical outcomes and clinical specimens. All applicants must have received an NIDCR Clinical Trial Planning (R34) award to plan the proposed cooperative agreement study (see PAR-11-338 for information about NIDCR Clinical Trial or Biomarker Clinical Evaluation Study Planning Grants). NIDCR may consider an exception. A unique application is required for each proposed study, and must include a final draft of the study protocol, a Manual of Procedures and other supporting materials such as the Investigators Brochure. These documents must meet all National Institutes of Health (NIH), Food and Drug Administration (FDA), and Office of Human Research Protections (OHRP) requirements. All awards will be made as cooperative agreements.

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