The FDA’s Critical Path Initiative supports collaborations through cooperative agreements like the Coalition Against Major Disease Consortium (CAMD), Multiple Sclerosis Outcome Assessment Consortium (MSOAC), and others. These consortia focus on developing biomarkers and Clinical Outcome Assessment Tools to qualify under the FDA’s Drug Development Tool Qualification Program. This grant aims to maintain the infrastructure of the consortia efforts and supports new projects, such as a Neonatal Consortium, to advance the Critical Path Initiative. Closing date for applications is Jul 28, 2014.
Opportunity ID: 258034
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-14-089 |
| Funding Opportunity Title: | Critical Path Public Private Partnerships |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | CategoryExplanation |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Food and Nutrition Health |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Jun 19, 2014 |
| Last Updated Date: | Jul 02, 2014 |
| Original Closing Date for Applications: | Jul 28, 2014 |
| Current Closing Date for Applications: | Jul 28, 2014 |
| Archive Date: | Aug 27, 2014 |
| Estimated Total Program Funding: | $10,500,000 |
| Award Ceiling: | $10,500,000 |
| Award Floor: | $1,500,000 |
Eligibility
| Eligible Applicants: | Private institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having 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: | – |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | As part of its Critical Path Initiative, FDA recognizes the need for collaborations established under the terms and conditions of a cooperative agreement, whereby existing resources and expertise can be used to the fullest extent possible. The Critical Path Institute has developed 8 individual consortia the Coalition Against Major Disease Consortium (CAMD), the Multiple Sclerosis Outcome Assessment Consortium (MSOAC), the Patient Reported Outcomes Consortium (PRO), the Electronic Patient Reported Outcomes Consortium (ePRO), the Coalition for Accelerating Standards and Therapies (CFAST), the Predictive Safety Testing Consortium (PSTC), the Polycystic Kidney Disease Outcome Consortium (PKD), and the Critical Path to TB Drug Regimens Consortium (CPTR). These consortia have been active in developing biomarkers and Clinical Outcome Assessment Tools for Qualification under the FDAs Drug Development Tool Qualification Program. The goals of this program are to maintain the administrative and scientific infrastructure of these consortia efforts while continuing to support the creation and execution of ongoing and new projects (such as a Neonatal Consortium) under the FDA’s Critical Path Initiative. |
| Link to Additional Information: | Link to full annoucement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Daniel Lukash
Grants Management Specialist Phone 240-402-7596 Email:daniel.lukash@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Added attachment to clarify project period is maximum of 5 years | Jul 02, 2014 | |
| Jul 02, 2014 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-14-089 |
| Funding Opportunity Title: | Critical Path Public Private Partnerships |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | CategoryExplanation |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Food and Nutrition Health |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Jun 19, 2014 |
| Last Updated Date: | Jul 02, 2014 |
| Original Closing Date for Applications: | Jul 28, 2014 |
| Current Closing Date for Applications: | Jul 28, 2014 |
| Archive Date: | Aug 27, 2014 |
| Estimated Total Program Funding: | $10,500,000 |
| Award Ceiling: | $10,500,000 |
| Award Floor: | $1,500,000 |
Eligibility
| Eligible Applicants: | Private institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having 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: | – |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | As part of its Critical Path Initiative, FDA recognizes the need for collaborations established under the terms and conditions of a cooperative agreement, whereby existing resources and expertise can be used to the fullest extent possible. The Critical Path Institute has developed 8 individual consortia the Coalition Against Major Disease Consortium (CAMD), the Multiple Sclerosis Outcome Assessment Consortium (MSOAC), the Patient Reported Outcomes Consortium (PRO), the Electronic Patient Reported Outcomes Consortium (ePRO), the Coalition for Accelerating Standards and Therapies (CFAST), the Predictive Safety Testing Consortium (PSTC), the Polycystic Kidney Disease Outcome Consortium (PKD), and the Critical Path to TB Drug Regimens Consortium (CPTR). These consortia have been active in developing biomarkers and Clinical Outcome Assessment Tools for Qualification under the FDAs Drug Development Tool Qualification Program. The goals of this program are to maintain the administrative and scientific infrastructure of these consortia efforts while continuing to support the creation and execution of ongoing and new projects (such as a Neonatal Consortium) under the FDA’s Critical Path Initiative. |
| Link to Additional Information: | Link to full annoucement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Daniel Lukash
Grants Management Specialist Phone 240-402-7596 Email:daniel.lukash@fda.hhs.gov |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-14-089 |
| Funding Opportunity Title: | Critical Path Public Private Partnerships |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Food and Nutrition Health |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Jul 02, 2014 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jul 28, 2014 |
| Archive Date: | Aug 27, 2014 |
| Estimated Total Program Funding: | $10,500,000 |
| Award Ceiling: | $10,500,000 |
| Award Floor: | $1,500,000 |
Eligibility
| Eligible Applicants: | Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | As part of its Critical Path Initiative, FDA recognizes the need for collaborations established under the terms and conditions of a cooperative agreement, whereby existing resources and expertise can be used to the fullest extent possible. The Critical Path Institute has developed 8 individual consortia the Coalition Against Major Disease Consortium (CAMD), the Multiple Sclerosis Outcome Assessment Consortium (MSOAC), the Patient Reported Outcomes Consortium (PRO), the Electronic Patient Reported Outcomes Consortium (ePRO), the Coalition for Accelerating Standards and Therapies (CFAST), the Predictive Safety Testing Consortium (PSTC), the Polycystic Kidney Disease Outcome Consortium (PKD), and the Critical Path to TB Drug Regimens Consortium (CPTR). These consortia have been active in developing biomarkers and Clinical Outcome Assessment Tools for Qualification under the FDAs Drug Development Tool Qualification Program. The goals of this program are to maintain the administrative and scientific infrastructure of these consortia efforts while continuing to support the creation and execution of ongoing and new projects (such as a Neonatal Consortium) under the FDA’s Critical Path Initiative. |
| Link to Additional Information: | Link to full annoucement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Daniel Lukash
Grants Management Specialist Phone 240-402-7596 Email:daniel.lukash@fda.hhs.gov |
Related Documents
Folder 258034 Full Announcement-1 -> sf424_rr_guide_general_adobe_verc.pdf
Folder 258034 Full Announcement-1 -> RFA-FD-14-089.pdf
Folder 258034 Other Supporting Documents-clarify project period is maximum of 5 years 1 -> Note FD-14-014 Critical Path.pdf
Packages
| Agency Contact Information: | Daniel Lukash Grants Management Specialist Phone 240-402-7596 Email: daniel.lukash@fda.hhs.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| 93.103 | RFA-FD-14-089 | Adobe version c | PKG00199584 | Jun 24, 2014 | Jul 25, 2014 | View |
Package 1
Mandatory forms
258034 RR_SF424_2_0-2.0.pdf
258034 PHS398_ResearchPlan_2_0-2.0.pdf
258034 PHS398_CoverPageSupplement_2_0-2.0.pdf
258034 RR_Budget_1_3-1.3.pdf
258034 RR_KeyPersonExpanded_2_0-2.0.pdf
258034 RR_OtherProjectInfo_1_3-1.3.pdf
258034 PerformanceSite_2_0-2.0.pdf
Optional forms
258034 PlannedReport-1.0.pdf
258034 PHS398_CumulativeInclusionReport-1.0.pdf
258034 RR_SubawardBudget30_1_3-1.3.pdf
Share This Post, Choose Your Platform!
About the Author: osnqt
