The Department of Health and Human Services is offering this grant to address concerns that generic parenteral iron complex formulations may contain higher levels of labile iron compared to reference listed drugs. This excess labile iron can lead to increased non-transferrin bound iron (NTBI) in vivo, potentially causing oxidative stress, inflammation, and cellular damage. The primary purpose of this grant is to evaluate existing in-vitro methods for determining labile iron and, critically, to develop a new bio-relevant in-vitro assay. This innovative method aims to accurately predict in vivo NTBI levels, thereby establishing a crucial link between FDA’s equivalence standards and the actual in vivo performance of these iron products. This research is vital for ensuring the safety and efficacy of generic parenteral iron complexes.
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: | 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 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: | Special district governments For profit organizations other than small businesses Native American tribal governments (Federally recognized) Independent school districts Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) County governments City or township governments Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Native American tribal organizations (other than Federally recognized tribal governments) State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than 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: | Link to Full Announcement of RFA-FD-13-017 on NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Lisa Ko
Grants Management Specialist Email:lisa.ko@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | Lisa Ko Grants Management Specialist Email: lisa.ko@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 | PKG00172095 | Apr 15, 2013 | May 24, 2013 | View |
Package 1
Mandatory forms
228878 RR_SF424_1_2-1.2.pdf
228878 PerformanceSite_1_4-1.4.pdf
228878 RR_OtherProjectInfo_1_3-1.3.pdf
228878 RR_KeyPersonExpanded_1_2-1.2.pdf
228878 RR_Budget-1.1.pdf
228878 PHS398_CoverPageSupplement_1_4-1.4.pdf
228878 PHS398_ResearchPlan_1_3-1.3.pdf
228878 PHS398_Checklist_1_3-1.3.pdf
Optional forms
228878 RR_SubawardBudget30-1.2.pdf
228878 PHS_CoverLetter_1_2-1.2.pdf
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