The National Institute of Neurological Disorders and Stroke (NINDS) is offering a grant to support the preclinical development of therapeutic biotechnology products and biologics for disorders within the NINDS mission. This grant requires an identified clinical candidate with specific properties for entry, and aims to fund Investigational New Drug (IND)-enabling studies and potentially a Phase I clinical trial. Successful projects should have an IND application submitted to the FDA by the end of the funding period. Closing date for applications is May 07, 2021.
Opportunity ID: 299572
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-18-542 |
| Funding Opportunity Title: | NINDS CREATE Bio Development Track: Preclinical Development for Biotechnology Products and Biologics (U01 – Clinical Trial Optional) |
| 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: | Dec 20, 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: | $1,500,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Small businesses Special district governments Public housing authorities/Indian housing authorities Private institutions of higher education County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments For profit organizations other than small businesses Independent school districts Others (see text field entitled “Additional Information on Eligibility” for clarification) City or township governments Public and State controlled institutions of higher education Nonprofits having 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 development of therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene therapies, cell therapies, and novel emerging therapies) for disorders identified under the NINDS mission. An identified clinical candidate with sufficient bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and/or target engagement, and other favorable properties that are consistent with the desired clinical application, is required for entry to this CREATE Bio Development Track. Therefore, this FOA supports Investigational New Drug (IND)-enabling studies for a therapeutic candidate and the inclusion of an optional small delayed-onset first in human Phase I clinical trial. At the end of the funding period, a successful project should have at least an IND application submitted to the U.S. Food and Drug Administration (FDA). |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-18-542.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-20-055 | Apr 28, 2020 | |
| Dec 20, 2017 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-18-542 |
| Funding Opportunity Title: | NINDS CREATE Bio Development Track: Preclinical Development for Biotechnology Products and Biologics (U01 – Clinical Trial Optional) |
| 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: | Dec 20, 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: | $1,500,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Small businesses Special district governments Public housing authorities/Indian housing authorities Private institutions of higher education County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments For profit organizations other than small businesses Independent school districts Others (see text field entitled “Additional Information on Eligibility” for clarification) City or township governments Public and State controlled institutions of higher education Nonprofits having 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 development of therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene therapies, cell therapies, and novel emerging therapies) for disorders identified under the NINDS mission. An identified clinical candidate with sufficient bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and/or target engagement, and other favorable properties that are consistent with the desired clinical application, is required for entry to this CREATE Bio Development Track. Therefore, this FOA supports Investigational New Drug (IND)-enabling studies for a therapeutic candidate and the inclusion of an optional small delayed-onset first in human Phase I clinical trial. At the end of the funding period, a successful project should have at least an IND application submitted to the U.S. Food and Drug Administration (FDA). |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-18-542.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-18-542 |
| Funding Opportunity Title: | NINDS CREATE Bio Development Track: Preclinical Development for Biotechnology Products and Biologics (U01 – Clinical Trial Optional) |
| 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: | Dec 20, 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: | $1,500,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Special district governments County governments Independent school districts Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities 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) Private institutions of higher education Native American tribal governments (Federally recognized) For profit organizations other than small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) State governments Small businesses City or township governments 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 development of therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene therapies, cell therapies, and novel emerging therapies) for disorders identified under the NINDS mission. An identified clinical candidate with sufficient bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and/or target engagement, and other favorable properties that are consistent with the desired clinical application, is required for entry to this CREATE Bio Development Track. Therefore, this FOA supports Investigational New Drug (IND)-enabling studies for a therapeutic candidate and the inclusion of an optional small delayed-onset first in human Phase I clinical trial. At the end of the funding period, a successful project should have at least an IND application submitted to the U.S. Food and Drug Administration (FDA). |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-18-542.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 | PKG00237174 | Jan 20, 2018 | May 24, 2020 | View | |
| FORMS-F | Use for due dates on or after May 25, 2020 | PKG00259541 | Jan 20, 2018 | May 07, 2021 | View |
Package 1
Mandatory forms
299572 RR_SF424_2_0-2.0.pdf
299572 PHS398_CoverPageSupplement_4_0-4.0.pdf
299572 RR_OtherProjectInfo_1_4-1.4.pdf
299572 PerformanceSite_2_0-2.0.pdf
299572 RR_KeyPersonExpanded_2_0-2.0.pdf
299572 PHS398_ResearchPlan_4_0-4.0.pdf
Optional forms
299572 RR_Budget_1_4-1.4.pdf
299572 RR_SubawardBudget30_1_4-1.4.pdf
299572 PHS398_ModularBudget_1_2-1.2.pdf
299572 PHS_AssignmentRequestForm_2_0-2.0.pdf
Package 2
Mandatory forms
299572 RR_SF424_2_0-2.0.pdf
299572 PHS398_CoverPageSupplement_5_0-5.0.pdf
299572 RR_OtherProjectInfo_1_4-1.4.pdf
299572 PerformanceSite_2_0-2.0.pdf
299572 RR_KeyPersonExpanded_2_0-2.0.pdf
299572 PHS398_ResearchPlan_4_0-4.0.pdf
299572 PHSHumanSubjectsAndClinicalTrialsInfo_2_0-2.0.pdf
Optional forms
299572 RR_Budget_1_4-1.4.pdf
299572 RR_SubawardBudget30_1_4-1.4.pdf
299572 PHS398_ModularBudget_1_2-1.2.pdf
299572 PHS_AssignmentRequestForm_3_0-3.0.pdf
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