Opportunity ID: 311854

General Information

Document Type: Grants Notice
Funding Opportunity Number: PAR-19-155
Funding Opportunity Title: NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional)
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Grant
Category of Funding Activity: Health
Category Explanation:
Expected Number of Awards:
Assistance Listings: 93.233 — National Center on Sleep Disorders Research
Cost Sharing or Matching Requirement: No
Version: Synopsis 2
Posted Date: Jan 08, 2019
Last Updated Date: Nov 18, 2020
Original Closing Date for Applications: Jan 07, 2021
Current Closing Date for Applications: Nov 18, 2020
Archive Date: Dec 18, 2020
Estimated Total Program Funding:
Award Ceiling: $225,000
Award Floor:

Eligibility

Eligible Applicants: Special district governments
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
For profit organizations other than small businesses
Independent school districts
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Native American tribal governments (Federally recognized)
State governments
City or township governments
Public and State controlled institutions of higher education
Native American tribal organizations (other than Federally recognized tribal governments)
County governments
Public housing authorities/Indian housing authorities
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Private institutions of higher education
Small businesses
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 eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Additional Information

Agency Name: National Institutes of Health
Description:

This Funding Opportunity Announcement (FOA) is to support studies that are scientifically essential, yet also sufficient, for investigators to make definitive decisions that inform the final designs of important Phase II and beyondclinical trials within NHLBI’s mission; that is, clinical trials with the primary intent of testing the efficacy, safety, clinical management, or implementation of intervention(s) in the prevention and treatment of heart, lung, blood, and sleep disorders. This mechanism may be used to test the feasibility of novel and efficient (pragmatic) trial designs, as well as determine the feasibility of an intervention, intervention parameters, subject availability, or other information essential to complete the design of a trial. Applications should demonstrate that the proposed studies are both necessary and sufficient to permit definitive decisions about the final design of the subsequent clinical trial. Applicants who propose solely to write a protocol or manual of operations,to develop infrastructure for a clinical trial, or implement a fully designed trialwill not be considered appropriate for this announcement. Please note that NHLBI supports other funding opportunities for clinical trials-see https://www.nhlbi.nih.gov/grants-and-training/funding-opportunities-and-contacts/clinical-trials-optimization for information on other NHLBI clinical trial funding opportunity announcements. In contrast to the planning or study start up phase of other NHLBI clinical trial FOAs, the R34 mechanism is intended to provide new i?n?f?o?r?m?a?t?i?o?n that answers a scientific question(s) which may be pragmatic in nature and, therefore, informs the final development of a Phase II-IV clinical trial.

Link to Additional Information: http://grants.nih.gov/grants/guide/pa-files/PAR-19-155.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
Expired and reissued as PAR-21-079 Nov 18, 2020
Jan 08, 2019

DISPLAYING: Synopsis 2

General Information

Document Type: Grants Notice
Funding Opportunity Number: PAR-19-155
Funding Opportunity Title: NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional)
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Grant
Category of Funding Activity: Health
Category Explanation:
Expected Number of Awards:
Assistance Listings: 93.233 — National Center on Sleep Disorders Research
Cost Sharing or Matching Requirement: No
Version: Synopsis 2
Posted Date: Jan 08, 2019
Last Updated Date: Nov 18, 2020
Original Closing Date for Applications: Jan 07, 2021
Current Closing Date for Applications: Nov 18, 2020
Archive Date: Dec 18, 2020
Estimated Total Program Funding:
Award Ceiling: $225,000
Award Floor:

Eligibility

Eligible Applicants: Special district governments
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
For profit organizations other than small businesses
Independent school districts
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Native American tribal governments (Federally recognized)
State governments
City or township governments
Public and State controlled institutions of higher education
Native American tribal organizations (other than Federally recognized tribal governments)
County governments
Public housing authorities/Indian housing authorities
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Private institutions of higher education
Small businesses
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 eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Additional Information

Agency Name: National Institutes of Health
Description:

This Funding Opportunity Announcement (FOA) is to support studies that are scientifically essential, yet also sufficient, for investigators to make definitive decisions that inform the final designs of important Phase II and beyondclinical trials within NHLBI’s mission; that is, clinical trials with the primary intent of testing the efficacy, safety, clinical management, or implementation of intervention(s) in the prevention and treatment of heart, lung, blood, and sleep disorders. This mechanism may be used to test the feasibility of novel and efficient (pragmatic) trial designs, as well as determine the feasibility of an intervention, intervention parameters, subject availability, or other information essential to complete the design of a trial. Applications should demonstrate that the proposed studies are both necessary and sufficient to permit definitive decisions about the final design of the subsequent clinical trial. Applicants who propose solely to write a protocol or manual of operations,to develop infrastructure for a clinical trial, or implement a fully designed trialwill not be considered appropriate for this announcement. Please note that NHLBI supports other funding opportunities for clinical trials-see https://www.nhlbi.nih.gov/grants-and-training/funding-opportunities-and-contacts/clinical-trials-optimization for information on other NHLBI clinical trial funding opportunity announcements. In contrast to the planning or study start up phase of other NHLBI clinical trial FOAs, the R34 mechanism is intended to provide new i?n?f?o?r?m?a?t?i?o?n that answers a scientific question(s) which may be pragmatic in nature and, therefore, informs the final development of a Phase II-IV clinical trial.

Link to Additional Information: http://grants.nih.gov/grants/guide/pa-files/PAR-19-155.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-19-155
Funding Opportunity Title: NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional)
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Grant
Category of Funding Activity: Health
Category Explanation:
Expected Number of Awards:
Assistance Listings: 93.233 — National Center on Sleep Disorders Research
Cost Sharing or Matching Requirement: No
Version: Synopsis 1
Posted Date: Jan 08, 2019
Last Updated Date: Jan 08, 2019
Original Closing Date for Applications:
Current Closing Date for Applications: Jan 07, 2021
Archive Date: Feb 12, 2021
Estimated Total Program Funding:
Award Ceiling: $225,000
Award Floor:

Eligibility

Eligible Applicants: City or township governments
Native American tribal governments (Federally recognized)
Public housing authorities/Indian housing authorities
Independent school districts
Public and State controlled institutions of higher education
Others (see text field entitled “Additional Information on Eligibility” for clarification)
State governments
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
For profit organizations other than small businesses
Small businesses
Special district governments
Native American tribal organizations (other than Federally recognized tribal governments)
Private institutions of higher education
County governments
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; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Additional Information

Agency Name: National Institutes of Health
Description: This Funding Opportunity Announcement (FOA) is to support studies that are scientifically essential, yet also sufficient, for investigators to make definitive decisions that inform the final designs of important Phase II and beyondclinical trials within NHLBI’s mission; that is, clinical trials with the primary intent of testing the efficacy, safety, clinical management, or implementation of intervention(s) in the prevention and treatment of heart, lung, blood, and sleep disorders. This mechanism may be used to test the feasibility of novel and efficient (pragmatic) trial designs, as well as determine the feasibility of an intervention, intervention parameters, subject availability, or other information essential to complete the design of a trial. Applications should demonstrate that the proposed studies are both necessary and sufficient to permit definitive decisions about the final design of the subsequent clinical trial. Applicants who propose solely to write a protocol or manual of operations,to develop infrastructure for a clinical trial, or implement a fully designed trialwill not be considered appropriate for this announcement. Please note that NHLBI supports other funding opportunities for clinical trials-see https://www.nhlbi.nih.gov/grants-and-training/funding-opportunities-and-contacts/clinical-trials-optimization for information on other NHLBI clinical trial funding opportunity announcements. In contrast to the planning or study start up phase of other NHLBI clinical trial FOAs, the R34 mechanism is intended to provide new i?n?f?o?r?m?a?t?i?o?n that answers a scientific question(s) which may be pragmatic in nature and, therefore, informs the final development of a Phase II-IV clinical trial.
Link to Additional Information: http://grants.nih.gov/grants/guide/pa-files/PAR-19-155.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

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 PKG00247399 Jan 16, 2019 May 24, 2020 View
FORMS-F Use for due dates on or after May 25, 2020 PKG00260101 Jan 16, 2019 Dec 10, 2020 View

Package 1

Mandatory forms

311854 RR_SF424_2_0-2.0.pdf

311854 PHS398_CoverPageSupplement_4_0-4.0.pdf

311854 RR_OtherProjectInfo_1_4-1.4.pdf

311854 PerformanceSite_2_0-2.0.pdf

311854 RR_KeyPersonExpanded_2_0-2.0.pdf

311854 PHS398_ResearchPlan_4_0-4.0.pdf

Optional forms

311854 RR_Budget_1_4-1.4.pdf

311854 RR_SubawardBudget30_1_4-1.4.pdf

311854 PHS398_ModularBudget_1_2-1.2.pdf

311854 PHS_AssignmentRequestForm_2_0-2.0.pdf

Package 2

Mandatory forms

311854 RR_SF424_2_0-2.0.pdf

311854 PHS398_CoverPageSupplement_5_0-5.0.pdf

311854 RR_OtherProjectInfo_1_4-1.4.pdf

311854 PerformanceSite_2_0-2.0.pdf

311854 RR_KeyPersonExpanded_2_0-2.0.pdf

311854 PHS398_ResearchPlan_4_0-4.0.pdf

311854 PHSHumanSubjectsAndClinicalTrialsInfo_2_0-2.0.pdf

Optional forms

311854 RR_Budget_1_4-1.4.pdf

311854 RR_SubawardBudget30_1_4-1.4.pdf

311854 PHS398_ModularBudget_1_2-1.2.pdf

311854 PHS_AssignmentRequestForm_3_0-3.0.pdf

2025-07-09T10:48:28-05:00

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