The FDA is offering this grant to support efficient and innovative natural history studies. This grant is for the purpose of advancing medical product development in rare diseases and conditions where significant unmet needs exist. By funding natural history studies that yield high-quality, interpretable data, the FDA aims to fill critical knowledge gaps and remove major obstacles in the field. The initiative seeks to make a substantial impact on specific rare diseases or multiple diseases with similar underlying pathophysiology, ultimately facilitating the development of new medical products for these conditions.
Opportunity ID: 331560
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-22-001 |
| Funding Opportunity Title: | Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01) Clinical Trials Not Required |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | 5 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 3 |
| Posted Date: | Feb 17, 2021 |
| Last Updated Date: | Mar 07, 2024 |
| Original Closing Date for Applications: | – February 15, 2022 Two deadlines listed below: February 15, 2022,by 11:59 PM Eastern Time February 13, 2024; by 11:59 PM Eastern Time. |
| Current Closing Date for Applications: | Mar 11, 2024 This FOA has multiple close dates. February 15, 2022, by 11:59 PM Eastern Time and March 11, 2024, by 11:59 PM Eastern Time. |
| Archive Date: | – |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $2,500,000 |
| Award Floor: | $150,000 |
Eligibility
| Eligible Applicants: | County governments Independent school districts Private institutions of higher education State governments Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses For profit organizations other than small businesses Native American tribal governments (Federally recognized) Others (see text field entitled “Additional Information on Eligibility” for clarification) Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) |
| Additional Information on Eligibility: | Eligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education: o Hispanic-serving Institutionso Historically Black Colleges and Universities (HBCUs)o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutionso 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) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit OrganizationsSmall Businesses For-Profit Organizations (Other than Small Businesses) Governments State Governments County Governments City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) U.S. Territory or PossessionOtherIndependent School DistrictsPublic Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
The purpose of this funding opportunity announcement (FOA) is to support efficient and innovative natural history studies that advance medical product development in rare diseases/conditions with unmet needs. Through the support of natural history studies with high quality and interpretable data elements, FDA expects to address critical knowledge gaps, remove major barriers to progress in the field, exert a significant and broad impact on a specific rare disease or multiple rare diseases with similar pathophysiology, and facilitate rare disease product development. |
| Link to Additional Information: | Full Announcement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Shashi Malhotra
Grants Management Specialist Phone 2404027592 Email:shashi.malhotra@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Extended Due Date | Mar 07, 2024 | |
| Update close dates | Feb 17, 2021 | |
| Feb 17, 2021 |
DISPLAYING: Synopsis 3
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-22-001 |
| Funding Opportunity Title: | Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01) Clinical Trials Not Required |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | 5 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 3 |
| Posted Date: | Feb 17, 2021 |
| Last Updated Date: | Mar 07, 2024 |
| Original Closing Date for Applications: | – February 15, 2022 Two deadlines listed below: February 15, 2022,by 11:59 PM Eastern Time February 13, 2024; by 11:59 PM Eastern Time. |
| Current Closing Date for Applications: | Mar 11, 2024 This FOA has multiple close dates. February 15, 2022, by 11:59 PM Eastern Time and March 11, 2024, by 11:59 PM Eastern Time. |
| Archive Date: | – |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $2,500,000 |
| Award Floor: | $150,000 |
Eligibility
| Eligible Applicants: | County governments Independent school districts Private institutions of higher education State governments Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses For profit organizations other than small businesses Native American tribal governments (Federally recognized) Others (see text field entitled “Additional Information on Eligibility” for clarification) Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) |
| Additional Information on Eligibility: | Eligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education: o Hispanic-serving Institutionso Historically Black Colleges and Universities (HBCUs)o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutionso 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) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit OrganizationsSmall Businesses For-Profit Organizations (Other than Small Businesses) Governments State Governments County Governments City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) U.S. Territory or PossessionOtherIndependent School DistrictsPublic Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
The purpose of this funding opportunity announcement (FOA) is to support efficient and innovative natural history studies that advance medical product development in rare diseases/conditions with unmet needs. Through the support of natural history studies with high quality and interpretable data elements, FDA expects to address critical knowledge gaps, remove major barriers to progress in the field, exert a significant and broad impact on a specific rare disease or multiple rare diseases with similar pathophysiology, and facilitate rare disease product development. |
| Link to Additional Information: | Full Announcement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Shashi Malhotra
Grants Management Specialist Phone 2404027592 Email:shashi.malhotra@fda.hhs.gov |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-22-001 |
| Funding Opportunity Title: | Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01) Clinical Trials Not Required |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | 5 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Feb 17, 2021 |
| Last Updated Date: | Nov 12, 2021 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Feb 13, 2024 This FOA has multiple close dates. February 15, 2022, by 11:59 PM Eastern Time and February 13, 2024, by 11:59 PM Eastern Time. |
| Archive Date: | – |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $2,500,000 |
| Award Floor: | $150,000 |
Eligibility
| Eligible Applicants: | For profit organizations other than small businesses Private institutions of higher education City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) County governments Special district governments Public and State controlled institutions of higher education State governments 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 Small businesses |
| Additional Information on Eligibility: | Eligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education: o Hispanic-serving Institutionso Historically Black Colleges and Universities (HBCUs)o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutionso 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) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit OrganizationsSmall Businesses For-Profit Organizations (Other than Small Businesses) Governments State Governments County Governments City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) U.S. Territory or PossessionOtherIndependent School DistrictsPublic Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
The purpose of this funding opportunity announcement (FOA) is to support efficient and innovative natural history studies that advance medical product development in rare diseases/conditions with unmet needs. Through the support of natural history studies with high quality and interpretable data elements, FDA expects to address critical knowledge gaps, remove major barriers to progress in the field, exert a significant and broad impact on a specific rare disease or multiple rare diseases with similar pathophysiology, and facilitate rare disease product development. |
| Link to Additional Information: | Full Announcement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Shashi Malhotra
Grants Management Specialist Phone 2404027592 Email:shashi.malhotra@fda.hhs.gov |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-22-001 |
| Funding Opportunity Title: | Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01) Clinical Trials Not Required |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | 5 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Feb 17, 2021 |
| Last Updated Date: | Feb 17, 2021 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | – February 15, 2022 Two deadlines listed below: February 15, 2022,by 11:59 PM Eastern Time February 13, 2024; by 11:59 PM Eastern Time. |
| Archive Date: | – |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $2,500,000 |
| Award Floor: | $150,000 |
Eligibility
| Eligible Applicants: | For profit organizations other than small businesses Private institutions of higher education City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) County governments Special district governments Public and State controlled institutions of higher education State governments 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 Small businesses |
| Additional Information on Eligibility: | Eligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education: o Hispanic-serving Institutionso Historically Black Colleges and Universities (HBCUs)o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutionso 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) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit OrganizationsSmall Businesses For-Profit Organizations (Other than Small Businesses) Governments State Governments County Governments City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) U.S. Territory or PossessionOtherIndependent School DistrictsPublic Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
The purpose of this funding opportunity announcement (FOA) is to support efficient and innovative natural history studies that advance medical product development in rare diseases/conditions with unmet needs. Through the support of natural history studies with high quality and interpretable data elements, FDA expects to address critical knowledge gaps, remove major barriers to progress in the field, exert a significant and broad impact on a specific rare disease or multiple rare diseases with similar pathophysiology, and facilitate rare disease product development. |
| Link to Additional Information: | Full Announcement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Shashi Malhotra
Grants Management Specialist Phone 2404027592 Email:shashi.malhotra@fda.hhs.gov |
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | Shashi Malhotra Grants Management Specialist Phone 2404027592 Email: shashi.malhotra@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-22-001 | FORMS G – For due dates on or after January 25, 2022 | PKG00265491 | Feb 17, 2021 | Nov 24, 2022 | View |
| 93.103 | RFA-FD-22-001-FORMS-H | FORMS H – For due dates on or after January 25, 2023 | PKG00278673 | Nov 24, 2022 | Mar 11, 2024 | View |
Package 1
Mandatory forms
331560 RR_SF424_5_0-5.0.pdf
331560 PHS398_CoverPageSupplement_5_0-5.0.pdf
331560 RR_OtherProjectInfo_1_4-1.4.pdf
331560 PerformanceSite_4_0-4.0.pdf
331560 RR_KeyPersonExpanded_4_0-4.0.pdf
331560 RR_Budget_3_0-3.0.pdf
331560 PHS398_ResearchPlan_4_0-4.0.pdf
331560 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
331560 RR_SubawardBudget30_3_0-3.0.pdf
331560 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 2
Mandatory forms
331560 RR_SF424_5_0-5.0.pdf
331560 PHS398_CoverPageSupplement_5_0-5.0.pdf
331560 RR_OtherProjectInfo_1_4-1.4.pdf
331560 PerformanceSite_4_0-4.0.pdf
331560 RR_KeyPersonExpanded_4_0-4.0.pdf
331560 RR_Budget_3_0-3.0.pdf
331560 PHS398_ResearchPlan_5_0-5.0.pdf
331560 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
331560 RR_SubawardBudget30_3_0-3.0.pdf
331560 PHS_AssignmentRequestForm_3_0-3.0.pdf
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