The FDA is offering a grant to expand the program focusing on strengthening regulatory systems in the Americas by adding a Medical Device Module for secure information exchange among participants. This extension aims to enhance collaboration and data-sharing in regulatory decision-making, particularly in audits and assessments related to medical devices, ensuring traceable and secure exchanges. The grant seeks to develop an international portal to facilitate the exchange of crucial information while conforming to data transmission standards. Closing date for application submission is on Jul 17, 2015.
Opportunity ID: 276597
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-15-040 |
| Funding Opportunity Title: | Program Expansion for Fostering Cooperation and Strengthening Medical Product Regulatory Systems in the Americas to add a Medical Device Module for Secure Regulatory Information Exchange (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection 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: | May 14, 2015 |
| Last Updated Date: | Jul 10, 2015 |
| Original Closing Date for Applications: | Jul 01, 2015 |
| Current Closing Date for Applications: | Jul 17, 2015 |
| Archive Date: | Jul 31, 2015 |
| Estimated Total Program Funding: | $1,000,000 |
| Award Ceiling: | $1,000,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) |
| Additional Information on Eligibility: | Only the following organization is eligible to apply: The Pan American Health Organization (PAHO) |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | The primary objective of the original RFA-FD-15-002 funding opportunity was to foster regulatory collaboration and strengthen regulatory capacity throughout the Americas in ways that provide benefit and contribution to the FDA regulatory and public health mission. One specific area of collaboration is to enable and/or further strengthen the development of data/information systems as sources of inputs for evidence-based regulatory decisions and actions.The scope of this area of collaboration is being expanded to support an international, collaborative portal for sharing and analyzing medical device information, including audits of device manufacturers and assessments of auditing organizations. Additionally, this development should ensure effective, traceable, and secure information exchanges among intended participants and be scalable to accommodate existing and future needs and conform to appropriate data transmission standards. |
| Link to Additional Information: | – |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Kimberly Pendleton Chew
Chief Grants Management Officer Email:kimberly.pendleton@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| The application deadline date has been extended to July 17, 2015. | Jul 10, 2015 | |
| Jul 10, 2015 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-15-040 |
| Funding Opportunity Title: | Program Expansion for Fostering Cooperation and Strengthening Medical Product Regulatory Systems in the Americas to add a Medical Device Module for Secure Regulatory Information Exchange (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection 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: | May 14, 2015 |
| Last Updated Date: | Jul 10, 2015 |
| Original Closing Date for Applications: | Jul 01, 2015 |
| Current Closing Date for Applications: | Jul 17, 2015 |
| Archive Date: | Jul 31, 2015 |
| Estimated Total Program Funding: | $1,000,000 |
| Award Ceiling: | $1,000,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) |
| Additional Information on Eligibility: | Only the following organization is eligible to apply: The Pan American Health Organization (PAHO) |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | The primary objective of the original RFA-FD-15-002 funding opportunity was to foster regulatory collaboration and strengthen regulatory capacity throughout the Americas in ways that provide benefit and contribution to the FDA regulatory and public health mission. One specific area of collaboration is to enable and/or further strengthen the development of data/information systems as sources of inputs for evidence-based regulatory decisions and actions.The scope of this area of collaboration is being expanded to support an international, collaborative portal for sharing and analyzing medical device information, including audits of device manufacturers and assessments of auditing organizations. Additionally, this development should ensure effective, traceable, and secure information exchanges among intended participants and be scalable to accommodate existing and future needs and conform to appropriate data transmission standards. |
| Link to Additional Information: | – |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Kimberly Pendleton Chew
Chief Grants Management Officer Email:kimberly.pendleton@fda.hhs.gov |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-15-040 |
| Funding Opportunity Title: | Program Expansion for Fostering Cooperation and Strengthening Medical Product Regulatory Systems in the Americas to add a Medical Device Module for Secure Regulatory Information Exchange (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection 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 10, 2015 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jul 01, 2015 |
| Archive Date: | Jul 31, 2015 |
| Estimated Total Program Funding: | $1,000,000 |
| Award Ceiling: | $1,000,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) |
| Additional Information on Eligibility: | Only the following organization is eligible to apply: The Pan American Health Organization (PAHO) |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | The primary objective of the original RFA-FD-15-002 funding opportunity was to foster regulatory collaboration and strengthen regulatory capacity throughout the Americas in ways that provide benefit and contribution to the FDA regulatory and public health mission. One specific area of collaboration is to enable and/or further strengthen the development of data/information systems as sources of inputs for evidence-based regulatory decisions and actions.
The scope of this area of collaboration is being expanded to support an international, collaborative portal for sharing and analyzing medical device information, including audits of device manufacturers and assessments of auditing organizations. Additionally, this development should ensure effective, traceable, and secure information exchanges among intended participants and be scalable to accommodate existing and future needs and conform to appropriate data transmission standards. |
| Link to Additional Information: | – |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Kimberly Pendleton Chew
Chief Grants Management Officer Email:kimberly.pendleton@fda.hhs.gov |
Related Documents
Folder 276597 Full Announcement-1 -> rfa-fd-15-040 program expansion paho final 5.14.15.pdf
Folder 276597 Full Announcement-1 -> sf424_rr_guide_general_adobe_verc.pdf
Packages
| Agency Contact Information: | Kimberly Pendleton Chew Chief Grants Management Officer Email: kimberly.pendleton@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 | PKG00216914 | May 14, 2015 | Jul 17, 2015 | View |
Package 1
Mandatory forms
276597 RR_SF424_2_0-2.0.pdf
276597 PHS398_ResearchPlan_2_0-2.0.pdf
276597 PHS398_CoverPageSupplement_2_0-2.0.pdf
276597 RR_Budget_1_3-1.3.pdf
276597 RR_KeyPersonExpanded_2_0-2.0.pdf
276597 RR_OtherProjectInfo_1_3-1.3.pdf
276597 PerformanceSite_2_0-2.0.pdf
Optional forms
276597 PlannedReport-1.0.pdf
276597 PHS398_CumulativeInclusionReport-1.0.pdf
276597 RR_SubawardBudget30_1_3-1.3.pdf
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