This grant, offered by the National Institutes of Health (NIH), is for supporting critical studies focused on rare neurodegenerative diseases affecting both children and adults. Its primary purpose is to fund efficient natural history studies, either alone or combined with the development and validation of clinical outcome assessments (COAs) and biomarker studies. The initiative aims to address significant unmet needs by generating high-quality, interpretable data. Through this support, the NIH seeks to bridge crucial knowledge gaps, dismantle major barriers to progress in the field, and profoundly impact specific or multiple rare neurodegenerative conditions, ultimately accelerating the development of new therapies and products for these challenging diseases.
Opportunity ID: 351426
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-24-024 |
| Funding Opportunity Title: | Natural History, Clinical Outcome Assessment, and Biomarker Studies of Rare Neurodegenerative Diseases (U01) Clinical Trials Optional |
| 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: | 3 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Dec 11, 2023 |
| Last Updated Date: | Dec 11, 2023 |
| Original Closing Date for Applications: | May 06, 2024 |
| Current Closing Date for Applications: | May 06, 2024 |
| Archive Date: | Jun 05, 2024 |
| Estimated Total Program Funding: | $2,000,000 |
| Award Ceiling: | $2,000,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Private institutions of higher education Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized) Small businesses Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled “Additional Information on Eligibility” for clarification) Independent school districts County governments Special district governments State governments |
| Additional Information on Eligibility: | Eligible OrganizationsHigher Education Institutions• Public/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 Organizations• Small Businesses• For-Profit Organizations (Other than Small Businesses)Local 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)Other• Independent School Districts• Public 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) Foreign InstitutionsNon-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the HHS Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
The purpose of this funding opportunity announcement (FOA) is to support efficient natural history studies alone or in conjunction with the development and validation of clinical outcome assessments (COAs) and/or biomarker studies to address the unmet needs in rare neurodegenerative diseases for children and adults. Through the support of 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 neurodegenerative disease or multiple rare neurodegenerative diseases with similar pathophysiology, and facilitate rare disease product development. |
| Link to Additional Information: | – |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Zahara Graves
Grantor Email:zahara.graves@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Corrected Posted Date | Dec 11, 2023 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-24-024 |
| Funding Opportunity Title: | Natural History, Clinical Outcome Assessment, and Biomarker Studies of Rare Neurodegenerative Diseases (U01) Clinical Trials Optional |
| 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: | 3 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Dec 11, 2023 |
| Last Updated Date: | Dec 11, 2023 |
| Original Closing Date for Applications: | May 06, 2024 |
| Current Closing Date for Applications: | May 06, 2024 |
| Archive Date: | Jun 05, 2024 |
| Estimated Total Program Funding: | $2,000,000 |
| Award Ceiling: | $2,000,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Private institutions of higher education Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized) Small businesses Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled “Additional Information on Eligibility” for clarification) Independent school districts County governments Special district governments State governments |
| Additional Information on Eligibility: | Eligible OrganizationsHigher Education Institutions• Public/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 Organizations• Small Businesses• For-Profit Organizations (Other than Small Businesses)Local 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)Other• Independent School Districts• Public 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) Foreign InstitutionsNon-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the HHS Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
The purpose of this funding opportunity announcement (FOA) is to support efficient natural history studies alone or in conjunction with the development and validation of clinical outcome assessments (COAs) and/or biomarker studies to address the unmet needs in rare neurodegenerative diseases for children and adults. Through the support of 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 neurodegenerative disease or multiple rare neurodegenerative diseases with similar pathophysiology, and facilitate rare disease product development. |
| Link to Additional Information: | – |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Zahara Graves
Grantor Email:zahara.graves@fda.hhs.gov |
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | Zahara Graves Grantor Email: zahara.graves@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-24-024 | FORM H | PKG00284120 | Mar 07, 2024 | May 06, 2024 | View |
Package 1
Mandatory forms
351426 RR_SF424_5_0-5.0.pdf
351426 PHS398_CoverPageSupplement_5_0-5.0.pdf
351426 RR_OtherProjectInfo_1_4-1.4.pdf
351426 PerformanceSite_4_0-4.0.pdf
351426 RR_KeyPersonExpanded_4_0-4.0.pdf
351426 RR_Budget_3_0-3.0.pdf
351426 PHS398_ResearchPlan_5_0-5.0.pdf
351426 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
351426 RR_SubawardBudget30_3_0-3.0.pdf
351426 PHS_AssignmentRequestForm_3_0-3.0.pdf
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