Food and Drug Administration

Description

Electronic data standards are needed for the animal efficacy studies and natural history studies for Animal Rule applications (see 21 CFR 314.600-650 for drugs and 21 CFR 601.90-95 for biological products). CDER is seeking organization(s) to refine and complete its preliminary work in this area and to publish a complete set of voluntary consensus standards for these studies, incorporating the relevant current electronic data standards from Standard for Exchange of Nonclinical Data (SEND) and Study Data Tabulation Model (SDTM) and creating any new standards needed to characterize data from these studies.

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

Contact

Eric Bozoian <br/>Grants Management Specialist <br/>Phone 2404027623
eric.bozoian@fda.hhs.gov