CDER is offering a grant to refine, complete, and publish electronic data standards for animal efficacy studies and natural history studies for Animal Rule applications. The aim is to create a complete set of voluntary consensus standards, incorporating existing standards like SEND and SDTM, and developing new standards if necessary. Organizations can help advance this work and improve data characterization for these studies. Grant applications are accepted until June 3, 2016.
Opportunity ID: 282682
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-16-008 |
| Funding Opportunity Title: | Refine, Complete, and Publish Data Standards for Animal Efficacy Studies and Natural History Studies for Animal Rule Applications (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Food and Nutrition Health |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Apr 01, 2016 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Jun 03, 2016 |
| Current Closing Date for Applications: | Jun 03, 2016 |
| Archive Date: | Jul 03, 2016 |
| Estimated Total Program Funding: | $250,000 |
| Award Ceiling: | $250,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Small businesses State governments County governments Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Independent school districts Native American tribal governments (Federally recognized) Private institutions of higher education For profit organizations other than small businesses |
| Additional Information on Eligibility: | Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the HHS Grants Policy Statement, are not allowed. |
Additional Information
| Agency Name: | 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. |
| Link to Additional Information: | Full Announcement of RFA-FD-16-008 |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Eric Bozoian
Grants Management Specialist Phone 2404027623 Email:eric.bozoian@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | Eric Bozoian Grants Management Specialist Phone 2404027623 Email: eric.bozoian@fda.hhs.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| 93.103 | PKG00222276 | Apr 04, 2016 | Jun 03, 2016 | View |
Package 1
Mandatory forms
282682 RR_SF424_2_0-2.0.pdf
282682 PHS398_CoverPageSupplement_3_0-3.0.pdf
282682 RR_OtherProjectInfo_1_3-1.3.pdf
282682 PerformanceSite_2_0-2.0.pdf
282682 RR_KeyPersonExpanded_2_0-2.0.pdf
282682 RR_Budget_1_3-1.3.pdf
282682 PHS398_ResearchPlan_3_0-3.0.pdf
Optional forms
282682 RR_SubawardBudget30_1_3-1.3.pdf
282682 PHS_Inclusion_Enrollment_Report-1.0.pdf
282682 PHS_AssignmentRequestForm-1.0.pdf
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