The NIAID is offering a grant to Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) for investigator-initiated clinical trials. This program supports hypothesis-driven, milestone-driven clinical trials with a focus on high-risk studies involving non-routine interventions or administration of unlicensed products. Mechanistic studies are also encouraged within the program. The NIAID has a strong infrastructure for conducting clinical studies, and proposed trials may utilize this infrastructure. However, support will not be provided for studies using dedicated resources from NIAID-supported clinical trial networks. Applications for this grant must be submitted by Jan 23, 2018.
Opportunity ID: 283941
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-16-271 |
| Funding Opportunity Title: | NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.855 — Allergy and Infectious Diseases Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 4 |
| Posted Date: | May 18, 2016 |
| Last Updated Date: | Jan 24, 2018 |
| Original Closing Date for Applications: | May 13, 2019 |
| Current Closing Date for Applications: | Jan 23, 2018 |
| Archive Date: | Feb 22, 2018 |
| 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 County governments Small businesses Private institutions of higher education Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Public housing authorities/Indian housing authorities For profit organizations other than small businesses City or township governments Special district governments |
| 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; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | This Funding Opportunity Announcement (FOA) invites Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose to implement investigator-initiated clinical trials related to the research mission of the NIAID. This program provides support for hypothesis-driven, milestone-driven clinical trials. Although clinical trials not considered high-risk may be proposed, this program encourages high-risk clinical studies. High-risk does not imply human subject or patient risk, but rather defines a study that contains one or more of the following unique features: involves non-routine interventions, administration of an unlicensed product, or administration of a licensed product for an unapproved indication. Mechanistic studies are also encouraged and can be proposed under this program. However, not more than one clinical trial should be proposed within each application. The NIAID has a robust infrastructure for conducting clinical studies that includes independently managed resources provided through grants, cooperative agreements, and contracts, as well as resources that are integrated within existing NIAID-supported clinical trial networks. Proposed clinical trials may use NIAIDs independent infrastructure for clinical studies, however, support will not be provided for studies that propose to use dedicated resources that are part of a NIAID-supported clinical trial network. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-16-271.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 expiration date in accordance with NOT-AI-18-014 | Jan 24, 2018 | |
| Corrected expiration date | Jan 24, 2018 | |
| Updated expiration date in accordance with NOT-CA-18-040 | Jan 24, 2018 | |
| Jan 24, 2018 |
DISPLAYING: Synopsis 4
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-16-271 |
| Funding Opportunity Title: | NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.855 — Allergy and Infectious Diseases Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 4 |
| Posted Date: | May 18, 2016 |
| Last Updated Date: | Jan 24, 2018 |
| Original Closing Date for Applications: | May 13, 2019 |
| Current Closing Date for Applications: | Jan 23, 2018 |
| Archive Date: | Feb 22, 2018 |
| 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 County governments Small businesses Private institutions of higher education Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Public housing authorities/Indian housing authorities For profit organizations other than small businesses City or township governments Special district governments |
| 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; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | This Funding Opportunity Announcement (FOA) invites Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose to implement investigator-initiated clinical trials related to the research mission of the NIAID. This program provides support for hypothesis-driven, milestone-driven clinical trials. Although clinical trials not considered high-risk may be proposed, this program encourages high-risk clinical studies. High-risk does not imply human subject or patient risk, but rather defines a study that contains one or more of the following unique features: involves non-routine interventions, administration of an unlicensed product, or administration of a licensed product for an unapproved indication. Mechanistic studies are also encouraged and can be proposed under this program. However, not more than one clinical trial should be proposed within each application. The NIAID has a robust infrastructure for conducting clinical studies that includes independently managed resources provided through grants, cooperative agreements, and contracts, as well as resources that are integrated within existing NIAID-supported clinical trial networks. Proposed clinical trials may use NIAIDs independent infrastructure for clinical studies, however, support will not be provided for studies that propose to use dedicated resources that are part of a NIAID-supported clinical trial network. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-16-271.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 3
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-16-271 |
| Funding Opportunity Title: | NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.855 — Allergy and Infectious Diseases Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 3 |
| Posted Date: | Jan 24, 2018 |
| Last Updated Date: | Jan 24, 2018 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | May 13, 2019 |
| Archive Date: | Jun 12, 2019 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Special district governments City or township governments Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses Public housing authorities/Indian housing authorities State governments Independent school districts Native American tribal governments (Federally recognized) County governments Private institutions of higher education Small businesses 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) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled 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; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | This Funding Opportunity Announcement (FOA) invites Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose to implement investigator-initiated clinical trials related to the research mission of the NIAID. This program provides support for hypothesis-driven, milestone-driven clinical trials. Although clinical trials not considered high-risk may be proposed, this program encourages high-risk clinical studies. High-risk does not imply human subject or patient risk, but rather defines a study that contains one or more of the following unique features: involves non-routine interventions, administration of an unlicensed product, or administration of a licensed product for an unapproved indication. Mechanistic studies are also encouraged and can be proposed under this program. However, not more than one clinical trial should be proposed within each application. The NIAID has a robust infrastructure for conducting clinical studies that includes independently managed resources provided through grants, cooperative agreements, and contracts, as well as resources that are integrated within existing NIAID-supported clinical trial networks. Proposed clinical trials may use NIAIDs independent infrastructure for clinical studies, however, support will not be provided for studies that propose to use dedicated resources that are part of a NIAID-supported clinical trial network. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-16-271.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 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-16-271 |
| Funding Opportunity Title: | NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.855 — Allergy and Infectious Diseases Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Jan 24, 2018 |
| Last Updated Date: | Jan 24, 2018 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jan 23, 2018 |
| Archive Date: | Feb 22, 2018 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Special district governments City or township governments Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses Public housing authorities/Indian housing authorities State governments Independent school districts Native American tribal governments (Federally recognized) County governments Private institutions of higher education Small businesses 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) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled 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; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | This Funding Opportunity Announcement (FOA) invites Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose to implement investigator-initiated clinical trials related to the research mission of the NIAID. This program provides support for hypothesis-driven, milestone-driven clinical trials. Although clinical trials not considered high-risk may be proposed, this program encourages high-risk clinical studies. High-risk does not imply human subject or patient risk, but rather defines a study that contains one or more of the following unique features: involves non-routine interventions, administration of an unlicensed product, or administration of a licensed product for an unapproved indication. Mechanistic studies are also encouraged and can be proposed under this program. However, not more than one clinical trial should be proposed within each application. The NIAID has a robust infrastructure for conducting clinical studies that includes independently managed resources provided through grants, cooperative agreements, and contracts, as well as resources that are integrated within existing NIAID-supported clinical trial networks. Proposed clinical trials may use NIAIDs independent infrastructure for clinical studies, however, support will not be provided for studies that propose to use dedicated resources that are part of a NIAID-supported clinical trial network. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-16-271.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-16-271 |
| Funding Opportunity Title: | NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.855 — Allergy and Infectious Diseases Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Jan 24, 2018 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | May 13, 2019 |
| Archive Date: | Jun 13, 2019 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Special district governments City or township governments Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses Public housing authorities/Indian housing authorities State governments Independent school districts Native American tribal governments (Federally recognized) County governments Private institutions of higher education Small businesses 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) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled 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; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | This Funding Opportunity Announcement (FOA) invites Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose to implement investigator-initiated clinical trials related to the research mission of the NIAID. This program provides support for hypothesis-driven, milestone-driven clinical trials. Although clinical trials not considered high-risk may be proposed, this program encourages high-risk clinical studies. High-risk does not imply human subject or patient risk, but rather defines a study that contains one or more of the following unique features: involves non-routine interventions, administration of an unlicensed product, or administration of a licensed product for an unapproved indication. Mechanistic studies are also encouraged and can be proposed under this program. However, not more than one clinical trial should be proposed within each application. The NIAID has a robust infrastructure for conducting clinical studies that includes independently managed resources provided through grants, cooperative agreements, and contracts, as well as resources that are integrated within existing NIAID-supported clinical trial networks. Proposed clinical trials may use NIAIDs independent infrastructure for clinical studies, however, support will not be provided for studies that propose to use dedicated resources that are part of a NIAID-supported clinical trial network. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-16-271.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-D | Use for due dates on or after May 25, 2016 | PKG00223594 | Aug 12, 2016 | Jan 25, 2018 | View |
Package 1
Mandatory forms
283941 RR_SF424_2_0-2.0.pdf
283941 PHS398_CoverPageSupplement_3_0-3.0.pdf
283941 RR_OtherProjectInfo_1_3-1.3.pdf
283941 PerformanceSite_2_0-2.0.pdf
283941 RR_KeyPersonExpanded_2_0-2.0.pdf
283941 RR_Budget_1_3-1.3.pdf
283941 PHS398_ResearchPlan_3_0-3.0.pdf
283941 SBIR_STTR_Information_1_1-1.1.pdf
Optional forms
283941 RR_SubawardBudget30_1_3-1.3.pdf
283941 PHS_Inclusion_Enrollment_Report-1.0.pdf
283941 PHS_AssignmentRequestForm-1.0.pdf
Share This Post, Choose Your Platform!
About the Author: osnqt
