Opportunity ID: 231020
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-13-029 |
| Funding Opportunity Title: | In vitro-In vivo Correlations of Ocular Implants |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Business and Commerce Education |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 3 |
| Posted Date: | Apr 18, 2013 |
| Last Updated Date: | Jun 03, 2013 |
| Original Closing Date for Applications: | Jun 01, 2013 |
| Current Closing Date for Applications: | Jun 03, 2013 |
| Archive Date: | – |
| Estimated Total Program Funding: | $500,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | $5,000 |
Eligibility
| Eligible Applicants: | County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) State governments Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Private institutions of higher education Special district governments For profit organizations other than small businesses |
| Additional Information on Eligibility: | Higher Education Institutions
Public/State Controlled Institutions of Higher Education Hispanic-serving Institutions Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Small Businesses State Governments Independent School Districts |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | The purpose of this study is to investigate in vitro-in vivo correlations of ophthalmic intravitreal implants. Specifically, an in vitro dissolution test which correlates with in vivo ocular absorption should be investigated. In vivo studies should be conducted in an appropriate animal model.Suitable bioequivalence methods are lacking for generic ophthalmic implants. The results from this project will help to understand the relationship between in vitro release and in vivo release, and the findings will be used to help determine bioequivalence study recommendations for generic ophthalmic intravitreal implants. |
| Link to Additional Information: | NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Jennerfer Torres-Hernandez
Grants Management Specialist Phone 301-827-9607 Email:Jennerfer.Torres-Hernandez@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| update in closing date for June 3, 2013 until 11:59pm eastern time. | Jun 03, 2013 | |
| update URL. | Jun 03, 2013 | |
| Apr 18, 2013 |
DISPLAYING: Synopsis 3
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-13-029 |
| Funding Opportunity Title: | In vitro-In vivo Correlations of Ocular Implants |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Business and Commerce Education |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 3 |
| Posted Date: | Apr 18, 2013 |
| Last Updated Date: | Jun 03, 2013 |
| Original Closing Date for Applications: | Jun 01, 2013 |
| Current Closing Date for Applications: | Jun 03, 2013 |
| Archive Date: | – |
| Estimated Total Program Funding: | $500,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | $5,000 |
Eligibility
| Eligible Applicants: | County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) State governments Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Private institutions of higher education Special district governments For profit organizations other than small businesses |
| Additional Information on Eligibility: | Higher Education Institutions
Public/State Controlled Institutions of Higher Education Hispanic-serving Institutions Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Small Businesses State Governments Independent School Districts |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | The purpose of this study is to investigate in vitro-in vivo correlations of ophthalmic intravitreal implants. Specifically, an in vitro dissolution test which correlates with in vivo ocular absorption should be investigated. In vivo studies should be conducted in an appropriate animal model.Suitable bioequivalence methods are lacking for generic ophthalmic implants. The results from this project will help to understand the relationship between in vitro release and in vivo release, and the findings will be used to help determine bioequivalence study recommendations for generic ophthalmic intravitreal implants. |
| Link to Additional Information: | NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Jennerfer Torres-Hernandez
Grants Management Specialist Phone 301-827-9607 Email:Jennerfer.Torres-Hernandez@fda.hhs.gov |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-13-029 |
| Funding Opportunity Title: | In vitro-In vivo Correlations of Ocular Implants |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Business and Commerce Education |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Jun 03, 2013 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jun 01, 2013 |
| Archive Date: | – |
| Estimated Total Program Funding: | $500,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | $5,000 |
Eligibility
| Eligible Applicants: | County governments State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Native American tribal governments (Federally recognized) For profit organizations other than small businesses Independent school districts Others (see text field entitled “Additional Information on Eligibility” for clarification) Public and State controlled institutions of higher education Special district governments City or township governments Small businesses 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 |
| Additional Information on Eligibility: | Higher Education Institutions
Public/State Controlled Institutions of Higher Education Hispanic-serving Institutions Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Small Businesses State Governments Independent School Districts |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | The purpose of this study is to investigate in vitro-in vivo correlations of ophthalmic intravitreal implants. Specifically, an in vitro dissolution test which correlates with in vivo ocular absorption should be investigated. In vivo studies should be conducted in an appropriate animal model.Suitable bioequivalence methods are lacking for generic ophthalmic implants. The results from this project will help to understand the relationship between in vitro release and in vivo release, and the findings will be used to help determine bioequivalence study recommendations for generic ophthalmic intravitreal implants. |
| Link to Additional Information: | NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Jennerfer Torres-Hernandez
Grants Management Specialist Phone 301-827-9607 Email:Jennerfer.Torres-Hernandez@fda.hhs.gov |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-13-029 |
| Funding Opportunity Title: | In vitro-In vivo Correlations of Ocular Implants |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Business and Commerce Education |
| 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 18, 2013 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jun 01, 2013 |
| Archive Date: | – |
| Estimated Total Program Funding: | $500,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | $5,000 |
Eligibility
| Eligible Applicants: | County governments State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Native American tribal governments (Federally recognized) Independent school districts For profit organizations other than small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) Public and State controlled institutions of higher education Special district governments City or township governments Small businesses 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 |
| Additional Information on Eligibility: | Higher Education Institutions
Public/State Controlled Institutions of Higher Education Hispanic-serving Institutions Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Small Businesses State Governments Independent School Districts |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | The purpose of this study is to investigate in vitro-in vivo correlations of ophthalmic intravitreal implants. Specifically, an in vitro dissolution test which correlates with in vivo ocular absorption should be investigated. In vivo studies should be conducted in an appropriate animal model.
Suitable bioequivalence methods are lacking for generic ophthalmic implants. The results from this project will help to understand the relationship between in vitro release and in vivo release, and the findings will be used to help determine bioequivalence study recommendations for generic ophthalmic intravitreal implants. |
| Link to Additional Information: | NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Jennerfer Torres-Hernandez
Grants Management Specialist Phone 301-827-9607 Email:Jennerfer.Torres-Hernandez@fda.hhs.gov |
Related Documents
Packages
| Agency Contact Information: | Jennerfer Torres-Hernandez Grants Management Specialist Phone 301-827-9607 Email: Jennerfer.Torres-Hernandez@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 | PKG00174232 | May 01, 2013 | Jun 04, 2013 | View |
Package 1
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