Opportunity ID: 309783
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-20-001 |
| Funding Opportunity Title: | Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | 15 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 3 |
| Posted Date: | Oct 23, 2018 |
| Last Updated Date: | Jun 27, 2019 |
| Original Closing Date for Applications: | Jun 25, 2019 |
| Current Closing Date for Applications: | Jun 25, 2019 |
| Archive Date: | Jul 25, 2019 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities State governments For profit organizations other than small businesses City or township governments Small businesses Native American tribal governments (Federally recognized) County governments Special district governments Public and State controlled institutions of higher education Private institutions of higher education Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits that do not have 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: |
The purpose of this funding opportunity announcement (FOA) is to support clinical studies of products that address unmet needs in rare diseases or conditions or provide highly significant improvements in treatment or diagnosis. Through the support of efficient and innovative clinical studies evaluating safety and/or effectiveness, FDA expects to increase the number of treatments for rare diseases with an unmet medical need and support studies that will either result in market approval of these products or substantially contribute to the essential data needed for medical product development that will ultimately meet the needs of rare disease patients. |
| Link to Additional Information: | Full application announcement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Daniel Lukash
Grants Management Specialist Phone 240-402-7596 Email:daniel.lukash@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Update close date | Jun 27, 2019 | |
| update deadline date | Oct 23, 2018 | |
| Oct 23, 2018 |
DISPLAYING: Synopsis 3
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-20-001 |
| Funding Opportunity Title: | Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | 15 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 3 |
| Posted Date: | Oct 23, 2018 |
| Last Updated Date: | Jun 27, 2019 |
| Original Closing Date for Applications: | Jun 25, 2019 |
| Current Closing Date for Applications: | Jun 25, 2019 |
| Archive Date: | Jul 25, 2019 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities State governments For profit organizations other than small businesses City or township governments Small businesses Native American tribal governments (Federally recognized) County governments Special district governments Public and State controlled institutions of higher education Private institutions of higher education Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits that do not have 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: |
The purpose of this funding opportunity announcement (FOA) is to support clinical studies of products that address unmet needs in rare diseases or conditions or provide highly significant improvements in treatment or diagnosis. Through the support of efficient and innovative clinical studies evaluating safety and/or effectiveness, FDA expects to increase the number of treatments for rare diseases with an unmet medical need and support studies that will either result in market approval of these products or substantially contribute to the essential data needed for medical product development that will ultimately meet the needs of rare disease patients. |
| Link to Additional Information: | Full application announcement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Daniel Lukash
Grants Management Specialist Phone 240-402-7596 Email:daniel.lukash@fda.hhs.gov |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-20-001 |
| Funding Opportunity Title: | Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | 15 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Oct 23, 2018 |
| Last Updated Date: | Jun 27, 2019 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jun 27, 2019 |
| Archive Date: | Jul 25, 2019 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments State governments Special district governments City or township governments Small businesses Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) Independent school districts For profit organizations other than small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
The purpose of this funding opportunity announcement (FOA) is to support clinical studies of products that address unmet needs in rare diseases or conditions or provide highly significant improvements in treatment or diagnosis. Through the support of efficient and innovative clinical studies evaluating safety and/or effectiveness, FDA expects to increase the number of treatments for rare diseases with an unmet medical need and support studies that will either result in market approval of these products or substantially contribute to the essential data needed for medical product development that will ultimately meet the needs of rare disease patients. |
| Link to Additional Information: | Full application announcement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Daniel Lukash
Grants Management Specialist Phone 240-402-7596 Email:daniel.lukash@fda.hhs.gov |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-20-001 |
| Funding Opportunity Title: | Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | 15 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Oct 23, 2018 |
| Last Updated Date: | Oct 23, 2018 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jun 25, 2019 |
| Archive Date: | Jul 25, 2019 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments State governments Special district governments City or township governments Small businesses Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) Independent school districts For profit organizations other than small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
The purpose of this funding opportunity announcement (FOA) is to support clinical studies of products that address unmet needs in rare diseases or conditions or provide highly significant improvements in treatment or diagnosis. Through the support of efficient and innovative clinical studies evaluating safety and/or effectiveness, FDA expects to increase the number of treatments for rare diseases with an unmet medical need and support studies that will either result in market approval of these products or substantially contribute to the essential data needed for medical product development that will ultimately meet the needs of rare disease patients. |
| Link to Additional Information: | Full application announcement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Daniel Lukash
Grants Management Specialist Phone 240-402-7596 Email:daniel.lukash@fda.hhs.gov |
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