CBER is offering a grant to advance gene therapies for rare diseases impacting small populations through enhancing the manufacturing of Adeno-associated virus (AAV) vectors. The goal is to support innovations in AAV vector production to address the needs of even single individuals with these conditions. Application deadline: May 28, 2021.
Opportunity ID: 332471
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-21-034 |
| Funding Opportunity Title: | AAV Vector manufacturing for diseases affecting very small populations (R01) Clinical Trials Not Allowed |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| Category Explanation: | – |
| Expected Number of Awards: | 5 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 4 |
| Posted Date: | Mar 30, 2021 |
| Last Updated Date: | May 19, 2021 |
| Original Closing Date for Applications: | May 28, 2021 |
| Current Closing Date for Applications: | May 28, 2021 |
| Archive Date: | Jun 27, 2021 |
| Estimated Total Program Funding: | $3,000,000 |
| Award Ceiling: | $600,000 |
| Award Floor: | $0 |
Eligibility
| Eligible Applicants: | Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) 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) Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses County governments Independent school districts Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” State governments City or township governments Public housing authorities/Indian housing authorities Private institutions of higher education Public and State controlled institutions of higher education For profit organizations other than small businesses |
| Additional Information on Eligibility: | Higher 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 EducationNonprofits 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) GovernmentsState 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 Possession OtherIndependent 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 |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
CBER seeks to advance the development of gene therapies for diseases affecting very small populations, potentially even single individuals, by enhancing innovations in the manufacture of Adeno-associated virus (AAV) vectors. |
| Link to Additional Information: | Full Announcement for RFA-FD-21-034 in NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Gordana Zuber
Grant Management Specialist Phone 301-348-1747 Email:gordana.zuber@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| updated link | May 19, 2021 | |
| . | Mar 30, 2021 | |
| Mar 30, 2021 |
DISPLAYING: Synopsis 4
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-21-034 |
| Funding Opportunity Title: | AAV Vector manufacturing for diseases affecting very small populations (R01) Clinical Trials Not Allowed |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| Category Explanation: | – |
| Expected Number of Awards: | 5 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 4 |
| Posted Date: | Mar 30, 2021 |
| Last Updated Date: | May 19, 2021 |
| Original Closing Date for Applications: | May 28, 2021 |
| Current Closing Date for Applications: | May 28, 2021 |
| Archive Date: | Jun 27, 2021 |
| Estimated Total Program Funding: | $3,000,000 |
| Award Ceiling: | $600,000 |
| Award Floor: | $0 |
Eligibility
| Eligible Applicants: | Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) 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) Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses County governments Independent school districts Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” State governments City or township governments Public housing authorities/Indian housing authorities Private institutions of higher education Public and State controlled institutions of higher education For profit organizations other than small businesses |
| Additional Information on Eligibility: | Higher 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 EducationNonprofits 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) GovernmentsState 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 Possession OtherIndependent 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 |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
CBER seeks to advance the development of gene therapies for diseases affecting very small populations, potentially even single individuals, by enhancing innovations in the manufacture of Adeno-associated virus (AAV) vectors. |
| Link to Additional Information: | Full Announcement for RFA-FD-21-034 in NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Gordana Zuber
Grant Management Specialist Phone 301-348-1747 Email:gordana.zuber@fda.hhs.gov |
DISPLAYING: Synopsis 3
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-21-034 |
| Funding Opportunity Title: | AAV Vector manufacturing for diseases affecting very small populations (R01) Clinical Trials Not Allowed |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| 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: | Mar 30, 2021 |
| Last Updated Date: | May 19, 2021 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | May 28, 2021 |
| Archive Date: | Jun 27, 2021 |
| Estimated Total Program Funding: | $3,000,000 |
| Award Ceiling: | $600,000 |
| Award Floor: | $0 |
Eligibility
| Eligible Applicants: | Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” City or township governments Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Public and State controlled institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) For profit organizations other than small businesses County governments State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Independent school districts |
| Additional Information on Eligibility: | Higher 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 EducationNonprofits 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) GovernmentsState 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 Possession OtherIndependent 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 |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
CBER seeks to advance the development of gene therapies for diseases affecting very small populations, potentially even single individuals, by enhancing innovations in the manufacture of Adeno-associated virus (AAV) vectors. |
| Link to Additional Information: | Full Announcement for RFA-FD-21-034 in NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Gordana Zuber
Grant Management Specialist Phone 301-348-1747 Email:gordana.zuber@fda.hhs.gov |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-21-034 |
| Funding Opportunity Title: | AAV Vector manufacturing for diseases affecting very small populations (R01) Clinical Trials Not Allowed |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| 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: | Mar 30, 2021 |
| Last Updated Date: | Mar 30, 2021 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | May 28, 2021 |
| Archive Date: | Jun 27, 2021 |
| Estimated Total Program Funding: | $3,000,000 |
| Award Ceiling: | $600,000 |
| Award Floor: | $0 |
Eligibility
| Eligible Applicants: | Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” City or township governments Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Public and State controlled institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) For profit organizations other than small businesses County governments State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Independent school districts |
| Additional Information on Eligibility: | Higher 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 EducationNonprofits 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) GovernmentsState 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 Possession OtherIndependent 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 |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
CBER seeks to advance the development of gene therapies for diseases affecting very small populations, potentially even single individuals, by enhancing innovations in the manufacture of Adeno-associated virus (AAV) vectors. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-21-034.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Gordana Zuber
Grant Management Specialist Phone 301-348-1747 Email:gordana.zuber@fda.hhs.gov |
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | Gordana Zuber Grant Management Specialist Phone 301-348-1747 Email: gordana.zuber@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-21-034 | FORM F | PKG00266249 | Mar 30, 2021 | May 28, 2021 | View |
Package 1
Mandatory forms
332471 RR_SF424_2_0-2.0.pdf
332471 PHS398_CoverPageSupplement_5_0-5.0.pdf
332471 RR_OtherProjectInfo_1_4-1.4.pdf
332471 PerformanceSite_2_0-2.0.pdf
332471 RR_KeyPersonExpanded_2_0-2.0.pdf
332471 RR_Budget_1_4-1.4.pdf
332471 PHS398_ResearchPlan_4_0-4.0.pdf
332471 PHSHumanSubjectsAndClinicalTrialsInfo_2_0-2.0.pdf
Optional forms
332471 RR_SubawardBudget30_1_4-1.4.pdf
332471 PHS_AssignmentRequestForm_3_0-3.0.pdf
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