The National Institute of Neurological Disorders and Stroke (NINDS) is offering a grant to optimize potential therapeutic Biotechnology Products and Biologics for disorders within the NINDS mission. Successful projects will develop and optimize a therapeutic candidate with demonstrated bioactivity, stability, manufacturability, and in vivo efficacy. This grant aims to prepare projects for entry into the CREATE Bio Development track, which focuses on IND-enabling studies and FDA submission.
Opportunity ID: 296484
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-17-456 |
| Funding Opportunity Title: | NINDS CREATE Bio Optimization Track for Biologics (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.853 — Extramural Research Programs in the Neurosciences and Neurological Disorders |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Aug 14, 2017 |
| Last Updated Date: | Apr 28, 2020 |
| Original Closing Date for Applications: | Sep 07, 2020 |
| Current Closing Date for Applications: | May 07, 2021 |
| Archive Date: | Jun 06, 2021 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $500,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) Special district governments County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses State governments Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Small businesses Private institutions of higher education City or township governments Public housing authorities/Indian housing authorities Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: |
This Funding Opportunity Announcement (FOA) supports the optimization of potential therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene and cell therapies) for disorders identified under the NINDS mission. This track supports the further characterization and optimization of therapeutic lead(s) that showed promise as a potential therapeutic agent as evidenced by convincing animal proof-of-concept studies. Therefore, at the end of this funding period, successful projects will have delivered and optimized therapeutic candidate with demonstrated bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and should be eligible for entry into the CREATE Bio Development track. The CREATE Bio Development track is a later stage program focused on the development of optimized therapeutic candidates through Investigational New Drug (IND)-enabling studies and submission of an IND package to the Food and Drug Administration (FDA). |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-17-456.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV Email:FBOWebmaster@OD.NIH.GOV |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| updated close date as per NOT-NS-20-053 | Apr 28, 2020 | |
| Aug 14, 2017 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-17-456 |
| Funding Opportunity Title: | NINDS CREATE Bio Optimization Track for Biologics (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.853 — Extramural Research Programs in the Neurosciences and Neurological Disorders |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Aug 14, 2017 |
| Last Updated Date: | Apr 28, 2020 |
| Original Closing Date for Applications: | Sep 07, 2020 |
| Current Closing Date for Applications: | May 07, 2021 |
| Archive Date: | Jun 06, 2021 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $500,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) Special district governments County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses State governments Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Small businesses Private institutions of higher education City or township governments Public housing authorities/Indian housing authorities Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: |
This Funding Opportunity Announcement (FOA) supports the optimization of potential therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene and cell therapies) for disorders identified under the NINDS mission. This track supports the further characterization and optimization of therapeutic lead(s) that showed promise as a potential therapeutic agent as evidenced by convincing animal proof-of-concept studies. Therefore, at the end of this funding period, successful projects will have delivered and optimized therapeutic candidate with demonstrated bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and should be eligible for entry into the CREATE Bio Development track. The CREATE Bio Development track is a later stage program focused on the development of optimized therapeutic candidates through Investigational New Drug (IND)-enabling studies and submission of an IND package to the Food and Drug Administration (FDA). |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-17-456.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV Email:FBOWebmaster@OD.NIH.GOV |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-17-456 |
| Funding Opportunity Title: | NINDS CREATE Bio Optimization Track for Biologics (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.853 — Extramural Research Programs in the Neurosciences and Neurological Disorders |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Aug 14, 2017 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Sep 07, 2020 |
| Archive Date: | Oct 13, 2020 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $500,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | City or township governments County governments State governments Independent school districts Others (see text field entitled “Additional Information on Eligibility” for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses Small businesses Native American tribal governments (Federally recognized) |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | This Funding Opportunity Announcement (FOA) supports the optimization of potential therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene and cell therapies) for disorders identified under the NINDS mission. This track supports the further characterization and optimization of therapeutic lead(s) that showed promise as a potential therapeutic agent as evidenced by convincing animal proof-of-concept studies. Therefore, at the end of this funding period, successful projects will have delivered and optimized therapeutic candidate with demonstrated bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and should be eligible for entry into the CREATE Bio Development track. The CREATE Bio Development track is a later stage program focused on the development of optimized therapeutic candidates through Investigational New Drug (IND)-enabling studies and submission of an IND package to the Food and Drug Administration (FDA). |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-17-456.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV Email:FBOWebmaster@OD.NIH.GOV |
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | NIH OER Webmaster FBOWebmaster@OD.NIH.GOV Email: FBOWebmaster@OD.NIH.GOV |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-E | Use for due dates on or before May 24, 2020 | PKG00235402 | Oct 27, 2017 | May 24, 2020 | View | |
| FORMS-F | Use for due dates on or after May 25, 2020 | PKG00259538 | Jan 13, 2018 | May 07, 2021 | View |
Package 1
Mandatory forms
296484 RR_SF424_2_0-2.0.pdf
296484 PHS398_CoverPageSupplement_4_0-4.0.pdf
296484 RR_OtherProjectInfo_1_4-1.4.pdf
296484 PerformanceSite_2_0-2.0.pdf
296484 RR_KeyPersonExpanded_2_0-2.0.pdf
296484 PHS398_ResearchPlan_4_0-4.0.pdf
Optional forms
296484 RR_Budget_1_4-1.4.pdf
296484 RR_SubawardBudget30_1_4-1.4.pdf
296484 PHS398_ModularBudget_1_2-1.2.pdf
296484 PHS_AssignmentRequestForm_2_0-2.0.pdf
Package 2
Mandatory forms
296484 RR_SF424_2_0-2.0.pdf
296484 PHS398_CoverPageSupplement_5_0-5.0.pdf
296484 RR_OtherProjectInfo_1_4-1.4.pdf
296484 PerformanceSite_2_0-2.0.pdf
296484 RR_KeyPersonExpanded_2_0-2.0.pdf
296484 PHS398_ResearchPlan_4_0-4.0.pdf
296484 PHSHumanSubjectsAndClinicalTrialsInfo_2_0-2.0.pdf
Optional forms
296484 RR_Budget_1_4-1.4.pdf
296484 RR_SubawardBudget30_1_4-1.4.pdf
296484 PHS398_ModularBudget_1_2-1.2.pdf
296484 PHS_AssignmentRequestForm_3_0-3.0.pdf
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