Opportunity ID: 351803
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-24-005 |
| Funding Opportunity Title: | Integrating Machine Learning with Computational Fluid Dynamics Models of Orally Inhaled Drug Products (U01) Clinical Trials Not Allowed |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 4 |
| Posted Date: | Jan 15, 2024 |
| Last Updated Date: | Apr 02, 2024 |
| Original Closing Date for Applications: | Mar 31, 2024 |
| Current Closing Date for Applications: | Apr 08, 2024 |
| Archive Date: | Apr 30, 2024 |
| Estimated Total Program Funding: | $300,000 |
| Award Ceiling: | $300,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | State governments City or township governments For profit organizations other than small businesses Private institutions of higher education Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” 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 Independent school districts Native American tribal governments (Federally recognized) Small businesses Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments Special district governments |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
Computational fluid dynamics (CFD) has played a crucial role in providing an alternative bioequivalence (BE) approach for generic orally inhaled drug products (OIDPs), in addition to comparative clinical endpoint or pharmacodynamic BE studies, as a relatively cost- and time-efficient complement to benchtop and clinical experiments that has been widely used in developing and assessing generic inhaler devices. However, despite the advances in the power of modern computers, there are still some bottlenecks in using CFD due to computational time, limited grid resolution, pre- and post-processing of large simulation data sets, model parameter estimations, and uncertainty quantifications. Machine learning (ML) has been gaining more attention as a potential tool to alleviate such limitations that arise in CFD. The purpose of this grant is to develop a methodology to integrate ML with CFD models of OIDPs to promote alternative BE studies to enhance and accelerate the development and approval of generic OIDPs. |
| Link to Additional Information: | RFA-FD-24-005 Funding Opportunity Announcement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Terrin Brown
Grantor Email:terrin.brown@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| The deadline has been extended to April 8, 2024. | Apr 02, 2024 | |
| The closing date was incorrect on grants.gov. | Jan 15, 2024 | |
| The link to the full announcement has been added. | Jan 15, 2024 | |
| Jan 15, 2024 |
DISPLAYING: Synopsis 4
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-24-005 |
| Funding Opportunity Title: | Integrating Machine Learning with Computational Fluid Dynamics Models of Orally Inhaled Drug Products (U01) Clinical Trials Not Allowed |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 4 |
| Posted Date: | Jan 15, 2024 |
| Last Updated Date: | Apr 02, 2024 |
| Original Closing Date for Applications: | Mar 31, 2024 |
| Current Closing Date for Applications: | Apr 08, 2024 |
| Archive Date: | Apr 30, 2024 |
| Estimated Total Program Funding: | $300,000 |
| Award Ceiling: | $300,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | State governments City or township governments For profit organizations other than small businesses Private institutions of higher education Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” 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 Independent school districts Native American tribal governments (Federally recognized) Small businesses Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments Special district governments |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
Computational fluid dynamics (CFD) has played a crucial role in providing an alternative bioequivalence (BE) approach for generic orally inhaled drug products (OIDPs), in addition to comparative clinical endpoint or pharmacodynamic BE studies, as a relatively cost- and time-efficient complement to benchtop and clinical experiments that has been widely used in developing and assessing generic inhaler devices. However, despite the advances in the power of modern computers, there are still some bottlenecks in using CFD due to computational time, limited grid resolution, pre- and post-processing of large simulation data sets, model parameter estimations, and uncertainty quantifications. Machine learning (ML) has been gaining more attention as a potential tool to alleviate such limitations that arise in CFD. The purpose of this grant is to develop a methodology to integrate ML with CFD models of OIDPs to promote alternative BE studies to enhance and accelerate the development and approval of generic OIDPs. |
| Link to Additional Information: | RFA-FD-24-005 Funding Opportunity Announcement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Terrin Brown
Grantor Email:terrin.brown@fda.hhs.gov |
DISPLAYING: Synopsis 3
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-24-005 |
| Funding Opportunity Title: | Integrating Machine Learning with Computational Fluid Dynamics Models of Orally Inhaled Drug Products (U01) Clinical Trials Not Allowed |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| 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: | Jan 15, 2024 |
| Last Updated Date: | Apr 01, 2024 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Apr 01, 2024 |
| Archive Date: | Apr 30, 2024 |
| Estimated Total Program Funding: | $300,000 |
| Award Ceiling: | $300,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | City or township governments Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Small businesses Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) County governments Independent school districts State governments For profit organizations other than small businesses Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
Computational fluid dynamics (CFD) has played a crucial role in providing an alternative bioequivalence (BE) approach for generic orally inhaled drug products (OIDPs), in addition to comparative clinical endpoint or pharmacodynamic BE studies, as a relatively cost- and time-efficient complement to benchtop and clinical experiments that has been widely used in developing and assessing generic inhaler devices. However, despite the advances in the power of modern computers, there are still some bottlenecks in using CFD due to computational time, limited grid resolution, pre- and post-processing of large simulation data sets, model parameter estimations, and uncertainty quantifications. Machine learning (ML) has been gaining more attention as a potential tool to alleviate such limitations that arise in CFD. The purpose of this grant is to develop a methodology to integrate ML with CFD models of OIDPs to promote alternative BE studies to enhance and accelerate the development and approval of generic OIDPs. |
| Link to Additional Information: | RFA-FD-24-005 Funding Opportunity Announcement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Terrin Brown
Grantor Email:terrin.brown@fda.hhs.gov |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-24-005 |
| Funding Opportunity Title: | Integrating Machine Learning with Computational Fluid Dynamics Models of Orally Inhaled Drug Products (U01) Clinical Trials Not Allowed |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| 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: | Jan 15, 2024 |
| Last Updated Date: | Mar 14, 2024 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Mar 31, 2024 |
| Archive Date: | Apr 30, 2024 |
| Estimated Total Program Funding: | $300,000 |
| Award Ceiling: | $300,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | City or township governments Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Small businesses Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) County governments Independent school districts State governments For profit organizations other than small businesses Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
Computational fluid dynamics (CFD) has played a crucial role in providing an alternative bioequivalence (BE) approach for generic orally inhaled drug products (OIDPs), in addition to comparative clinical endpoint or pharmacodynamic BE studies, as a relatively cost- and time-efficient complement to benchtop and clinical experiments that has been widely used in developing and assessing generic inhaler devices. However, despite the advances in the power of modern computers, there are still some bottlenecks in using CFD due to computational time, limited grid resolution, pre- and post-processing of large simulation data sets, model parameter estimations, and uncertainty quantifications. Machine learning (ML) has been gaining more attention as a potential tool to alleviate such limitations that arise in CFD. The purpose of this grant is to develop a methodology to integrate ML with CFD models of OIDPs to promote alternative BE studies to enhance and accelerate the development and approval of generic OIDPs. |
| Link to Additional Information: | RFA-FD-24-005 Funding Opportunity Announcement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Terrin Brown
Grantor Email:terrin.brown@fda.hhs.gov |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-24-005 |
| Funding Opportunity Title: | Integrating Machine Learning with Computational Fluid Dynamics Models of Orally Inhaled Drug Products (U01) Clinical Trials Not Allowed |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| 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: | Jan 15, 2024 |
| Last Updated Date: | Jan 15, 2024 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Mar 31, 2024 |
| Archive Date: | Apr 30, 2024 |
| Estimated Total Program Funding: | $300,000 |
| Award Ceiling: | $300,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | City or township governments Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Small businesses Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) County governments Independent school districts State governments For profit organizations other than small businesses Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
Computational fluid dynamics (CFD) has played a crucial role in providing an alternative bioequivalence (BE) approach for generic orally inhaled drug products (OIDPs), in addition to comparative clinical endpoint or pharmacodynamic BE studies, as a relatively cost- and time-efficient complement to benchtop and clinical experiments that has been widely used in developing and assessing generic inhaler devices. However, despite the advances in the power of modern computers, there are still some bottlenecks in using CFD due to computational time, limited grid resolution, pre- and post-processing of large simulation data sets, model parameter estimations, and uncertainty quantifications. Machine learning (ML) has been gaining more attention as a potential tool to alleviate such limitations that arise in CFD. The purpose of this grant is to develop a methodology to integrate ML with CFD models of OIDPs to promote alternative BE studies to enhance and accelerate the development and approval of generic OIDPs. |
| Link to Additional Information: | – |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Terrin Brown
Grantor Phone 2404027610 Email:terrin.brown@fda.hhs.gov |
Related Documents
Packages
| Agency Contact Information: | Terrin Brown Grantor Email: terrin.brown@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-24-005 | FORM H | PKG00284418 | Jan 15, 2024 | Apr 08, 2024 | View |
Package 1
Mandatory forms
Optional forms
Share This Post, Choose Your Platform!
About the Author: osnqt
