This grant from the FDA aims to fund studies that focus on understanding the natural history of rare diseases with unmet needs. By supporting innovative research efforts, the FDA intends to fill knowledge gaps, stimulate progress in the field, and influence the development of medical products for these conditions. The ultimate goal is to improve patient outcomes and address the specific challenges faced by individuals with rare diseases. The closing date for applications is January 10, 2019.
Opportunity ID: 309556
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-19-001 |
| Funding Opportunity Title: | Natural History Studies Addressing Unmet Needs of Rare Diseases: Orphan Products Research Project Grant (R01) |
| 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: | Oct 12, 2018 |
| Last Updated Date: | Oct 15, 2018 |
| Original Closing Date for Applications: | Jan 10, 2019 |
| Current Closing Date for Applications: | Jan 10, 2019 |
| Archive Date: | Feb 09, 2019 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal governments) Small businesses State governments Special district governments Independent school districts County governments 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 studies that advance medical product development through the characterization of the natural history of rare diseases/conditions with unmet needs. Through the support of efficient and innovative natural history studies, FDA expects to address critical knowledge gaps, to remove major barrier(s) to progress in the field, to exert a significant and broad impact on a specific rare disease or multiple rare diseases with similar pathophysiology, and to inform current or future product development including the design of clinical trial(s) and to ultimately inform the development of medical products that meet patient needs. |
| 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 |
|---|---|---|
| Corrected "Funding Instrument Type" to be – grant | Oct 15, 2018 | |
| Revised incorrect entry for expected number of award. The expected number is 5 | Oct 15, 2018 | |
| Oct 12, 2018 |
DISPLAYING: Synopsis 3
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-19-001 |
| Funding Opportunity Title: | Natural History Studies Addressing Unmet Needs of Rare Diseases: Orphan Products Research Project Grant (R01) |
| 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: | Oct 12, 2018 |
| Last Updated Date: | Oct 15, 2018 |
| Original Closing Date for Applications: | Jan 10, 2019 |
| Current Closing Date for Applications: | Jan 10, 2019 |
| Archive Date: | Feb 09, 2019 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal governments) Small businesses State governments Special district governments Independent school districts County governments 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 studies that advance medical product development through the characterization of the natural history of rare diseases/conditions with unmet needs. Through the support of efficient and innovative natural history studies, FDA expects to address critical knowledge gaps, to remove major barrier(s) to progress in the field, to exert a significant and broad impact on a specific rare disease or multiple rare diseases with similar pathophysiology, and to inform current or future product development including the design of clinical trial(s) and to ultimately inform the development of medical products that meet patient needs. |
| 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-19-001 |
| Funding Opportunity Title: | Natural History Studies Addressing Unmet Needs of Rare Diseases: Orphan Products Research Project Grant (R01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| 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: | Oct 15, 2018 |
| Last Updated Date: | Oct 12, 2018 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jan 10, 2019 |
| Archive Date: | Feb 09, 2019 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Independent school districts State governments Private institutions of higher education Special district governments Native American tribal governments (Federally recognized) 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 Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Public and State controlled institutions of higher education Small businesses County governments Native American tribal organizations (other than Federally recognized tribal governments) |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | The purpose of this funding opportunity announcement (FOA) is to support studies that advance medical product development through the characterization of the natural history of rare diseases/conditions with unmet needs. Through the support of efficient and innovative natural history studies, FDA expects to address critical knowledge gaps, to remove major barrier(s) to progress in the field, to exert a significant and broad impact on a specific rare disease or multiple rare diseases with similar pathophysiology, and to inform current or future product development including the design of clinical trial(s) and to ultimately inform the development of medical products that meet patient needs. |
| 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-19-001 |
| Funding Opportunity Title: | Natural History Studies Addressing Unmet Needs of Rare Diseases: Orphan Products Research Project Grant (R01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | 50 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Oct 12, 2018 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jan 10, 2019 |
| Archive Date: | Feb 09, 2019 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Independent school districts State governments Private institutions of higher education Special district governments Native American tribal governments (Federally recognized) 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 Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Public and State controlled institutions of higher education Small businesses County governments Native American tribal organizations (other than Federally recognized tribal governments) |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | The purpose of this funding opportunity announcement (FOA) is to support studies that advance medical product development through the characterization of the natural history of rare diseases/conditions with unmet needs. Through the support of efficient and innovative natural history studies, FDA expects to address critical knowledge gaps, to remove major barrier(s) to progress in the field, to exert a significant and broad impact on a specific rare disease or multiple rare diseases with similar pathophysiology, and to inform current or future product development including the design of clinical trial(s) and to ultimately inform the development of medical products that meet patient needs. |
| 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 |
Related Documents
There are no related documents on this grant.
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-19-001 | Form E | PKG00245546 | Nov 10, 2018 | Jan 10, 2019 | View |
Package 1
Mandatory forms
309556 RR_SF424_2_0-2.0.pdf
309556 PHS398_CoverPageSupplement_4_0-4.0.pdf
309556 RR_OtherProjectInfo_1_4-1.4.pdf
309556 PerformanceSite_2_0-2.0.pdf
309556 RR_KeyPersonExpanded_2_0-2.0.pdf
309556 RR_Budget_1_4-1.4.pdf
309556 PHS398_ResearchPlan_4_0-4.0.pdf
Optional forms
309556 RR_SubawardBudget30_1_4-1.4.pdf
309556 PHS_AssignmentRequestForm_2_0-2.0.pdf
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