This funding opportunity from the National Heart, Lung, and Blood Institute aims to support U01 applications for pragmatic clinical trials focusing on chronic pulmonary diseases in adults. The Pulmonary Trials Cooperative (PTC) initiative will involve multiple Protocol Leadership Groups (PLGs) and a Network Management Core (NEMO) to conduct various Phase 2 and Phase 3 trials evaluating the efficacy of new therapies. Applicants will lead the development of protocols and oversee trial activities in both inpatient and outpatient settings for diseases such as interstitial lung disease, pulmonary hypertension, COPD, and sarcoidosis. Excluded conditions are asthma and acute lung injury and critical care. Applications for NEMO are also encouraged through a companion FOA (RFA-HL-15-016). Closing date for submissions is October 20, 2014.
Opportunity ID: 261989
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-HL-15-015 |
| Funding Opportunity Title: | Multi-Site Clinical Trials for the Pulmonary Trials Cooperative (PTC) (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: | 93.233 — National Center on Sleep Disorders Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Aug 14, 2014 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Oct 20, 2014 |
| Current Closing Date for Applications: | Oct 20, 2014 |
| Archive Date: | Nov 20, 2014 |
| Estimated Total Program Funding: | $1,000,000 |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities Private institutions of higher education Small businesses 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 For profit organizations other than small businesses Native American tribal governments (Federally recognized) State governments Special district governments City or township governments Public and State controlled institutions of higher education County governments Independent school districts 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 not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | This funding opportunity announcement (FOA) requests U01 applications proposing a single, pragmatic clinical trial in adults with chronic pulmonary diseases. Each successful applicant will serve as a Protocol Leadership Group (PLG) for a new type of clinical research network: the Pulmonary Trials Cooperative (PTC). The PTC is a cooperative program that includes multiple PLGs and a Network Management Core (NEMO). The PTC is designed to conduct multiple clinical trials in both inpatient and outpatient settings in adults with a variety of chronic pulmonary diseases, including but not limited to interstitial lung disease (ILD), pulmonary hypertension (PH), chronic obstructive pulmonary disease (COPD), sarcoidosis, and obstructive sleep apnea, but excluding asthma and acute lung injury and critical care. Studies, which may include both Phase 2 and Phase 3 simple, pragmatic clinical trials, will evaluate the efficacy or effectiveness of promising new or existing therapies. This FOA solicits applications for PLGs, which will have primary responsibility for developing a protocol and supporting a Lead Investigator for that protocol in the conduct and analyses of the related trial. A companion FOA (RFA-HL-15-016) requests applications for NEMO. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-15-015.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 |
|---|---|---|
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-C | FORMS-C | PKG00203404 | Sep 20, 2014 | Oct 20, 2014 | View |
Package 1
Mandatory forms
261989 RR_SF424_2_0-2.0.pdf
261989 PHS398_ResearchPlan_2_0-2.0.pdf
261989 PHS398_CoverPageSupplement_2_0-2.0.pdf
261989 RR_KeyPersonExpanded_2_0-2.0.pdf
261989 RR_OtherProjectInfo_1_3-1.3.pdf
261989 PerformanceSite_2_0-2.0.pdf
Optional forms
261989 RR_SubawardBudget30_1_3-1.3.pdf
261989 PlannedReport-1.0.pdf
261989 PHS398_CumulativeInclusionReport-1.0.pdf
261989 PHS398_ModularBudget_1_2-1.2.pdf
261989 RR_Budget_1_3-1.3.pdf
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