This grant from NIH/NIAID, FDA/CDER, and BARDA aims to enhance clinical trial endpoints for new antivirals by improving enrollment of high-risk individuals with influenza-like-illness, particularly at the JHU Emergency Department. By utilizing advanced rapid diagnostic testing like Cepheid XPert Flu, early identification of influenza-positive patients can lead to prompt treatment and better monitoring of clinical response to antiviral therapy. The goal is to target a population that would benefit most from early intervention and effective management of influenza in emergency department settings.
Opportunity ID: 266128
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | EP-IDS-14-017 |
| Funding Opportunity Title: | Rapid influenza testing with Cepheid XPert Flu in Emergency Department Practice |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.360 — Biomedical Advanced Research and Development Authority (BARDA), Biodefense Medical Countermeasure Development |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Sep 19, 2014 |
| Last Updated Date: | Sep 19, 2014 |
| Original Closing Date for Applications: | Sep 24, 2014 Application Due Date: September 24, 2014 at 11:00pm EST |
| Current Closing Date for Applications: | Sep 24, 2014 Deadline Sept 24, 2014 at 11PM |
| Archive Date: | Oct 24, 2014 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $80,000 |
| Award Floor: | $20,000 |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) |
| Additional Information on Eligibility: | John Hopkins University, School of Medicine |
Additional Information
| Agency Name: | Assistant Secretary for Preparedness and Response |
| Description: | NIH/NIAID, FDA/CDER and BARDA coordinate efforts to improve endpoints for clinical trials with new antivirals. Using endpoints originally established for clinical efficacy with oseltamivir has forced manufacturers to engage outpatient locations for enrollment of individuals with influenza-like-illness in large numbers, with very few individuals having complicated influenza that would benefit from antiviral treatment. The PHEMCE coordination has the goal to improve enrollment of high risk individuals such as those who present to the JHU Emergency Department, are identified as influenza virus positive by advanced rapid diagnostic testing, many of which are subsequently hospitalized. These patients can be treated early; thus providing a target population that can be more effectively monitored for clinical response to treatment. |
| Link to Additional Information: | Rapid influenza testing with Cepheid XPert Flu in Emergency Department Practice |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Grants.gov Contact Center
Phone Number: 1-800-518-4726 Hours of operation are 24 hours a day, 7 days a week. The contact center is closed on federal holidays. Email:support@grants.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Deadline Sept 24, 2014 at 11PM | Sep 19, 2014 | |
| Sep 19, 2014 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | EP-IDS-14-017 |
| Funding Opportunity Title: | Rapid influenza testing with Cepheid XPert Flu in Emergency Department Practice |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.360 — Biomedical Advanced Research and Development Authority (BARDA), Biodefense Medical Countermeasure Development |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Sep 19, 2014 |
| Last Updated Date: | Sep 19, 2014 |
| Original Closing Date for Applications: | Sep 24, 2014 Application Due Date: September 24, 2014 at 11:00pm EST |
| Current Closing Date for Applications: | Sep 24, 2014 Deadline Sept 24, 2014 at 11PM |
| Archive Date: | Oct 24, 2014 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $80,000 |
| Award Floor: | $20,000 |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) |
| Additional Information on Eligibility: | John Hopkins University, School of Medicine |
Additional Information
| Agency Name: | Assistant Secretary for Preparedness and Response |
| Description: | NIH/NIAID, FDA/CDER and BARDA coordinate efforts to improve endpoints for clinical trials with new antivirals. Using endpoints originally established for clinical efficacy with oseltamivir has forced manufacturers to engage outpatient locations for enrollment of individuals with influenza-like-illness in large numbers, with very few individuals having complicated influenza that would benefit from antiviral treatment. The PHEMCE coordination has the goal to improve enrollment of high risk individuals such as those who present to the JHU Emergency Department, are identified as influenza virus positive by advanced rapid diagnostic testing, many of which are subsequently hospitalized. These patients can be treated early; thus providing a target population that can be more effectively monitored for clinical response to treatment. |
| Link to Additional Information: | Rapid influenza testing with Cepheid XPert Flu in Emergency Department Practice |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Grants.gov Contact Center
Phone Number: 1-800-518-4726 Hours of operation are 24 hours a day, 7 days a week. The contact center is closed on federal holidays. Email:support@grants.gov |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | EP-IDS-14-017 |
| Funding Opportunity Title: | Rapid influenza testing with Cepheid XPert Flu in Emergency Department Practice |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.360 — Biomedical Advanced Research and Development Authority (BARDA), Biodefense Medical Countermeasure Development |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Sep 19, 2014 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Sep 24, 2014 Application Due Date: September 24, 2014 at 11:00pm EST |
| Archive Date: | Oct 24, 2014 |
| Estimated Total Program Funding: | $80,000 |
| Award Ceiling: | $80,000 |
| Award Floor: | $80,000 |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) |
| Additional Information on Eligibility: | Sole Source Cooperative Agreement with Johns Hopkins University |
Additional Information
| Agency Name: | Assistant Secretary for Preparedness and Response |
| Description: | The current cooperative agreement between ASPR and Johns Hopkins University (JHU) integrates rapid influenza molecular testing into Emergency Department (ED) clinical practice with assessment of clinical course following antiviral treatment and adoption of electronic communications that can assist clinicians and public health practice with local management of influenza infections. The existing JHU cooperative agreement (IDSEP130014) successfully completed one season of a clinical study across four EDs, enrolling 1,997 adult patients at 4 sites with over one-third hospitalized (also 592 admitted pediatric patients from two of the sites). The rapid influenza molecular test identified more than fifty adult influenza patients during their ED visit at two of these sites, many of which were hospitalized. During the second influenza season, adult patients presenting to the ED with potential symptoms of influenza will receive a rapid molecular influenza test during the triage process. |
| Link to Additional Information: | – |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Brenda Cox
Grants Management Officer Phone 2028094144 Email:brenda.cox@hhs.gov |
Related Documents
Folder 266128 Full Announcement-1 -> JHU FOA FINAL 09-19-14.pdf
Packages
| Agency Contact Information: | Grants.gov Contact Center Phone Number: 1-800-518-4726 Hours of operation are 24 hours a day, 7 days a week. The contact center is closed on federal holidays. Email: support@grants.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| 93.360 | EP-IDS-14-017-049817 | Rapid Influenza testing with Cepheid XPert Flu Emergency Dept Practice | PKG00206483 | Sep 19, 2014 | Sep 24, 2014 | View |
Package 1
Mandatory forms
266128 SF424_2_1-2.1.pdf
266128 Project_Abstract-1.1.pdf
266128 SF424A-1.0.pdf
266128 SF424B-1.1.pdf
Optional forms
266128 Project-1.1.pdf
266128 Budget-1.1.pdf
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