The FDA is offering a grant to develop an in-vitro assay to determine labile iron levels in parenteral iron complex products. The goal is to predict non-transferrin bound iron (NTBI) formation in vivo, comparing generic formulations with the reference listed drug. This method aims to correlate FDA standards with in vivo outcomes, potentially impacting oxidative stress and inflammation from NTBI. Applications are open until May 24, 2013.
Opportunity ID: 228878
General Information
| Document Type:: | Grants Notice |
| Funding Opportunity Number:: | RFA-FD-13-017 |
| Funding Opportunity Title:: | Development of Bio-relevant In-vitro Assay to Determine Labile Iron in the Parenteral Iron Complex Product (U01) |
| Opportunity Category:: | Discretionary |
| Opportunity Category Explanation:: | |
| Funding Instrument Type:: | |
| Category of Funding Activity:: | Consumer Protection |
| Category Explanation:: | |
| Expected Number of Awards:: | 1 |
| Assistance Listings Number(s):: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement:: | No |
| Version:: | Synopsis 1 |
| Posted Date:: | Apr 02, 2013 |
| Last Updated Date:: | |
| Original Closing Date for Applications:: | May 24, 2013 |
| Current Closing Date for Applications:: | May 24, 2013 |
| Archive Date:: | Jun 23, 2013 |
| Estimated Total Program Funding:: | $ 500,000 |
| Award Ceiling:: | $500,000 |
| Award Floor:: | $ |
Eligibility
| Eligible Applicants:: | Public and State controlled institutions of higher education |
| Additional Information on Eligibility:: | Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the HHS Grants Policy Statement, are allowed. |
Additional Information
| Agency Name:: | Food and Drug Administration |
| Description:: | It has been suggested that generic iron complex formulations could have higher levels of labile iron, leading to the formation of a greater amount of non-transferrin bound iron (NTBI) in vivo than the reference listed drug (RLD) that would potentiate oxidative stress and inflammation, then resulting in direct cellular damage. The objectives of this study are to evaluate various in-vitro methods of determining labile iron in the parenteral iron complex formulations and develop a bio-relevant in-vitro method to predict the amount of NTBI in vivo. Such a predictive in-vitro method will allow for linkage of FDA’s equivalence standards to in vivo performance. |
| Link to Additional Information:: | |
| Grantor Contact Information:: | If you have difficulty accessing the full announcement electronically, please contact: |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Synopsis 1 |
Package Status
Below are CLOSED Opportunity Package(s) no longer available for this Funding Opportunity:
Package No: 1
| Assistance Listings: | 93.103 |
| Competition ID: | |
| Competition Title: | |
| Opportunity Package ID: | PKG00172095 |
| Opening Date: | Apr 15, 2013 |
| Closing Date: | May 24, 2013 |
| Agency Contact Information:: | Lisa Ko |
| Who Can Apply:: | Organization Applicants |
| mendatory_forms |
SF424 (R & R) [V1.2] Project/Performance Site Location(s) [V1.4] Research And Related Other Project Information [V1.3] Research And Related Senior/Key Person Profile (Expanded) [V1.2] Research & Related Budget [V1.1] PHS 398 Cover Page Supplement [V1.4] PHS 398 Research Plan [V1.3] PHS 398 Checklist [V1.3] |
| optional_forms |
R & R Subaward Budget Attachment(s) Form 5 YR 30 ATT [V1.2] PHS Cover Letter [V1.2] |
Packages
| Assistance Listings | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions | Who Can Apply: | |
|---|---|---|---|---|---|---|---|---|
| 93.103 | PKG00172095 | Apr 15, 2013 | May 24, 2013 | View | Lisa Ko | Organization Applicants |