FDA Request for Information (RFI) on MDEpiNET PPP Operations

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FDA is seeking input on the management of the MDEpiNet PPP to enhance postmarket surveillance. Stakeholders are invited to provide insights on partnership roles, governance, financial models, and funding sources. The RFI aims to ensure the PPP’s alignment with multiple sectors’ missions for maximum public health impact. Questions include partnership representation, governance efficiency, financial sustainability, and cost breakdown. Responses are crucial for shaping the operations of the MDEpiNet PPP. Submission deadline: Jan 11, 2013.

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Opportunity ID: 211773

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General Information

Document Type:: Grants Notice
Funding Opportunity Number:: NOT-FD-13-001
Funding Opportunity Title:: Request for Information (RFI): MDEpiNET PPP
Opportunity Category:: Discretionary
Opportunity Category Explanation:: CategoryExplanation
Funding Instrument Type::
Category of Funding Activity:: Consumer Protection
Category Explanation::
Expected Number of Awards::
Assistance Listings Number(s):: 93.103 — Food and Drug Administration_Research
Cost Sharing or Matching Requirement:: No
Version:: Synopsis 1
Posted Date:: Dec 18, 2012
Last Updated Date::
Original Closing Date for Applications:: Jan 11, 2013
Current Closing Date for Applications:: Jan 11, 2013
Archive Date:: Feb 10, 2013
Estimated Total Program Funding::
Award Ceiling:: $0
Award Floor:: $0

Eligibility

Eligible Applicants:: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility”
Additional Information on Eligibility::

Additional Information

Agency Name:: Food and Drug Administration
Description:: FDA is interested in obtaining multi stakeholder input related to the operations of the MDEpiNet PPP, to ensure that it is developed in a way that supports not only FDA, but the missions of other participating partners, thus providing the maximum impact on public health. This RFI is focused on better understanding of capabilities and approaches for the management of the MDEpiNet PPP to support the national postmarket surveillance plan. Specifically, FDA requires input related to the following questions:

What role is envisioned for partners representing the patient, government, medical device industry, academia, health care providers, professional organizations, health care payer, and other sectors, and what are the parameters for their membership in the MDEpiNet PPP?

Which additional partnership sectors should be represented, if any, and are there specific groups without whom the MDEpiNet PPP would not meet its mission?

How would governance balance the desire for a comprehensive representative body against the need for nimble operations, usually accomplished through a small empowered team?

What financial model(s) would best support the startup and sustained management of the PPP through the partnership management center?

What are the ideal project proposal, selection, funding, and management models that would allow for appropriate buy-in and coordination, while allowing for scientific independence of investigators?

What is the projected annual cost of operations, and what would be the ideal breakdown of federal and private funding to meet those needs?

Link to Additional Information::
Grantor Contact Information:: If you have difficulty accessing the full announcement electronically, please contact:

Version History

Version Modification Description Updated Date
Synopsis 1

Package Status

Package No: 1

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