Opportunity ID: 324689
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-21-001 |
| Funding Opportunity Title: | Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Other (see text field entitled “Explanation of Other Category of Funding Activity” for clarification) |
| Category Explanation: | Eligible Organizations Higher Education Institutions Public/State Controlled Institutions of Higher Education o Hispanic-serving Institutions o Historically Black Colleges and Universities (HBCUs) o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutions o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Small Businesses State Governments Independent School Districts |
| Expected Number of Awards: | 8 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Feb 21, 2020 |
| Last Updated Date: | Feb 21, 2020 |
| Original Closing Date for Applications: | Oct 05, 2021 Two deadlines listed below:
October 6, 2020,by 11:59 PM Eastern Time |
| Current Closing Date for Applications: | Oct 05, 2021 Two deadlines listed below:October 6, 2020,by 11:59 PM Eastern TimeOctober 5, 2021; by 11:59 PM Eastern Time. |
| Archive Date: | Nov 04, 2021 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $10,000,000 |
| Award Floor: | $10,000 |
Eligibility
| Eligible Applicants: | Native American tribal governments (Federally recognized) City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities County governments Special district governments Private institutions of higher education Independent school districts State governments |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
The purpose of this funding opportunity announcement (FOA) is to fund well-controlled studies in support of a new indication or change in labeling of products to address unmet needs in rare diseases or conditions. Through the funding of efficient and innovative clinical studies evaluating safety and/or efficacy, FDA expects to increase the number of treatments for rare diseases with an unmet medical need and exert a broad and positive impact on rare disease drug development. |
| Link to Additional Information: | full 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 |
|---|---|---|
| Full list of eligible applicants | Feb 21, 2020 | |
| Feb 21, 2020 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-21-001 |
| Funding Opportunity Title: | Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Other (see text field entitled “Explanation of Other Category of Funding Activity” for clarification) |
| Category Explanation: | Eligible Organizations Higher Education Institutions Public/State Controlled Institutions of Higher Education o Hispanic-serving Institutions o Historically Black Colleges and Universities (HBCUs) o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutions o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Small Businesses State Governments Independent School Districts |
| Expected Number of Awards: | 8 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Feb 21, 2020 |
| Last Updated Date: | Feb 21, 2020 |
| Original Closing Date for Applications: | Oct 05, 2021 Two deadlines listed below:
October 6, 2020,by 11:59 PM Eastern Time |
| Current Closing Date for Applications: | Oct 05, 2021 Two deadlines listed below:October 6, 2020,by 11:59 PM Eastern TimeOctober 5, 2021; by 11:59 PM Eastern Time. |
| Archive Date: | Nov 04, 2021 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $10,000,000 |
| Award Floor: | $10,000 |
Eligibility
| Eligible Applicants: | Native American tribal governments (Federally recognized) City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities County governments Special district governments Private institutions of higher education Independent school districts State governments |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
The purpose of this funding opportunity announcement (FOA) is to fund well-controlled studies in support of a new indication or change in labeling of products to address unmet needs in rare diseases or conditions. Through the funding of efficient and innovative clinical studies evaluating safety and/or efficacy, FDA expects to increase the number of treatments for rare diseases with an unmet medical need and exert a broad and positive impact on rare disease drug development. |
| Link to Additional Information: | full 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-21-001 |
| Funding Opportunity Title: | Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Health |
| Category Explanation: | – |
| Expected Number of Awards: | 8 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Feb 21, 2020 |
| Last Updated Date: | Feb 21, 2020 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Oct 05, 2021 Two deadlines listed below:
October 6, 2020,by 11:59 PM Eastern Time |
| Archive Date: | Nov 04, 2021 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $10,000,000 |
| Award Floor: | $10,000 |
Eligibility
| Eligible Applicants: | Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Independent school districts Public and State controlled institutions of higher education County governments Native American tribal organizations (other than Federally recognized tribal governments) Small businesses Private 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 Special district governments State governments For profit organizations other than small businesses |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
The purpose of this funding opportunity announcement (FOA) is to fund well-controlled studies in support of a new indication or change in labeling of products to address unmet needs in rare diseases or conditions. Through the funding of efficient and innovative clinical studies evaluating safety and/or efficacy, FDA expects to increase the number of treatments for rare diseases with an unmet medical need and exert a broad and positive impact on rare disease drug development. |
| Link to Additional Information: | full 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 |
Related Documents
Packages
| Agency Contact Information: | Daniel Lukash Grants Management Specialist Phone 240-402-7596 Email: daniel.lukash@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-21-001 | FORMS-F Use for due dates on or after May 25, 2020 | PKG00258465 | Feb 21, 2020 | Oct 05, 2021 | View |
Package 1
Mandatory forms
Optional forms
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