This grant, offered by the Food and Drug Administration’s (FDA) Office of Critical Path Programs (OCPP), is for research into developing and qualifying alternative methodologies in reproductive toxicology. Part of the FDA’s Advancing Regulatory Science initiative, it aims to foster innovation that improves the development and evaluation of safe and effective medical products. This funding supports methods with the potential to be more predictive than current tests, while also reducing, refining, or replacing animal testing. Applicants should align with the Critical Path Initiative’s mission to accelerate the creation of new products for diagnosing, treating, and preventing diseases, leveraging new science and technologies to achieve these critical regulatory science goals.
Opportunity ID: 91474
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-11-017 |
| Funding Opportunity Title: | Innovation in Development and Qualification of Alternative Testing Methodologies for Reproductive Toxicology (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 20 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | May 03, 2011 |
| Last Updated Date: | May 05, 2011 |
| Original Closing Date for Applications: | Jun 16, 2011 |
| Current Closing Date for Applications: | Jun 16, 2011 |
| Archive Date: | Jul 16, 2011 |
| Estimated Total Program Funding: | $1,000,000 |
| Award Ceiling: | $350,000 |
| Award Floor: | $250,000 |
Eligibility
| Eligible Applicants: | Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education |
| Additional Information on Eligibility: | PLEASE Note: The entities eligible to enter into partnerships with FDA are governed by Section 566 of the FD&C Act [21 U.S.C. 360bbb-5].
An eligible organization that wishes to enter into a collaborative agreement must provide an assurance that the entity will not accept funding for a Crtical Path Public-Private Partnership Project from any organization that manufactures or distributes products regulated by the Food and Drug Administration (FDA)unless the entity provides assurances in its agreement with FDA that the results of the Critical Path Public-Private Partnership Project will not be influenced by any source of funding. |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | As part of Food and Drug Administration’s Advancing Regulatory Science initiative the Office of Critical Path Programs (OCPP) supports innovation to improve the development and evaluation of new safe and effective medical products for diagnosing, treating, and preventing conditions and diseases. OCPP is working to harness new science and new technologies to further this goal.This Funding Opportunity Announcement (FOA) will provide resources for research into the development and qualification of alternative methodologies in the area of reproductive toxicology, which have the potential to be more predictive than the currently required testing, and which will reduce, refine, or replace animal testing.Applications should address the Critical Path Initiative’s mission to facilitate the development of new safe and effective products for diagnosing, treating, and preventing disease. |
| Link to Additional Information: | NIH Guide published April 28, 2011 |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Gladys M. Bohler
Grants Management Officer/Specialist Phone 301-827-7175 Email:gmbohler@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| The synopsis has been changed to reflect the following eligibility criteria.
The entities eligible to enter into partnerships with FDA are governed by Section 566 of the FD&C Act [21 U.S.C. 360bbb-5]. |
May 05, 2011 | |
| May 05, 2011 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-11-017 |
| Funding Opportunity Title: | Innovation in Development and Qualification of Alternative Testing Methodologies for Reproductive Toxicology (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 20 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | May 03, 2011 |
| Last Updated Date: | May 05, 2011 |
| Original Closing Date for Applications: | Jun 16, 2011 |
| Current Closing Date for Applications: | Jun 16, 2011 |
| Archive Date: | Jul 16, 2011 |
| Estimated Total Program Funding: | $1,000,000 |
| Award Ceiling: | $350,000 |
| Award Floor: | $250,000 |
Eligibility
| Eligible Applicants: | Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education |
| Additional Information on Eligibility: | PLEASE Note: The entities eligible to enter into partnerships with FDA are governed by Section 566 of the FD&C Act [21 U.S.C. 360bbb-5].
An eligible organization that wishes to enter into a collaborative agreement must provide an assurance that the entity will not accept funding for a Crtical Path Public-Private Partnership Project from any organization that manufactures or distributes products regulated by the Food and Drug Administration (FDA)unless the entity provides assurances in its agreement with FDA that the results of the Critical Path Public-Private Partnership Project will not be influenced by any source of funding. |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | As part of Food and Drug Administration’s Advancing Regulatory Science initiative the Office of Critical Path Programs (OCPP) supports innovation to improve the development and evaluation of new safe and effective medical products for diagnosing, treating, and preventing conditions and diseases. OCPP is working to harness new science and new technologies to further this goal.This Funding Opportunity Announcement (FOA) will provide resources for research into the development and qualification of alternative methodologies in the area of reproductive toxicology, which have the potential to be more predictive than the currently required testing, and which will reduce, refine, or replace animal testing.Applications should address the Critical Path Initiative’s mission to facilitate the development of new safe and effective products for diagnosing, treating, and preventing disease. |
| Link to Additional Information: | NIH Guide published April 28, 2011 |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Gladys M. Bohler
Grants Management Officer/Specialist Phone 301-827-7175 Email:gmbohler@fda.hhs.gov |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-11-017 |
| Funding Opportunity Title: | Innovation in Development and Qualification of Alternative Testing Methodologies for Reproductive Toxicology (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 20 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | May 05, 2011 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jun 16, 2011 |
| Archive Date: | Jul 16, 2011 |
| Estimated Total Program Funding: | $1,000,000 |
| Award Ceiling: | $350,000 |
| Award Floor: | $250,000 |
Eligibility
| Eligible Applicants: | Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education |
| Additional Information on Eligibility: | An eligible organization that wishes to enter into a collaborative agreement must provide an assurance that the entity will not accept funding for a Crtical Path Public-Private Partnership Project from any organization that manufactures or distributes products regulated by the Food and Drug Administration (FDA)unless the entity provides assurances in its agreement with FDA that the results of the Critical Path Public-Private Partnership Project will not be influenced by any source of funding. |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | As part of Food and Drug Administration’s Advancing Regulatory Science initiative the Office of Critical Path Programs (OCPP) supports innovation to improve the development and evaluation of new safe and effective medical products for diagnosing, treating, and preventing conditions and diseases. OCPP is working to harness new science and new technologies to further this goal.
This Funding Opportunity Announcement (FOA) will provide resources for research into the development and qualification of alternative methodologies in the area of reproductive toxicology, which have the potential to be more predictive than the currently required testing, and which will reduce, refine, or replace animal testing. Applications should address the Critical Path Initiative’s mission to facilitate the development of new safe and effective products for diagnosing, treating, and preventing disease. |
| Link to Additional Information: | NIH Guide published April 28, 2011 |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Gladys M. Bohler
Grants Management Officer/Specialist Phone 301-827-7175 Email:gmbohler@fda.hhs.gov |
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | Gladys M. Bohler Grants Management Officer/Specialist Phone 301-827-7175 Email: gmbohler@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 | RFA-FD-11-017 | ADOBE FORMS B1 | PKG00051530 | May 15, 2011 | Jun 16, 2011 | View |
Package 1
Mandatory forms
91474 RR_SF424_1_2-1.2.pdf
91474 RR_OtherProjectInfo_1_3-1.3.pdf
91474 RR_KeyPersonExpanded_1_2-1.2.pdf
91474 RR_Budget-1.1.pdf
91474 PerformanceSite_1_4-1.4.pdf
91474 PHS398_ResearchPlan_1_3-1.3.pdf
91474 PHS398_CoverPageSupplement_1_4-1.4.pdf
91474 PHS398_Checklist_1_3-1.3.pdf
Optional forms
91474 RR_SubawardBudget-1.2.pdf
91474 PHS_CoverLetter_1_2-1.2.pdf
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