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Notice Number: NOT-FD-13-001
Release Date: December 18, 2012
Response Date: January 11, 2013
Food and Drug Administration (FDA)
In September 2012, the US Food and Drug Administration (FDA) sponsored public workshops to present FDA’s draft National Postmarket Surveillance Plan for medical devices (http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/ucm301912.htm) and discuss various aspects of the Plan. As a part of these workshops, discussion was held regarding the development of a broad-based public-private partnership (PPP), the Medical Device Epidemiology Network (MDEpiNet, www.fda.gov/MDEpiNet). In order to assure the development and long-term success of the partnership, a centralized partnership management center needs to be established outside of FDA that is capable of building a sustainable business structure, managing relationships with a broad array of stakeholders, providing scientific leadership in medical device surveillance and epidemiology, and executing high-priority scientific projects with a diverse set of partners
This RFI seeks to gather information from potential collaborators about feasible structures, potential members, financial models, and projected costs for sustained management of the MDEpiNet PPP.
FDA initially proposed the development of the MDEpiNet PPP in a workshop held April 2010. Since that time, FDA has worked with partners on building several projects, and has developed a draft framework for the partnership and its management.
To date, FDA has provided support for individual projects through a variety of mechanisms, including two cooperative agreement FOAs, Developing Innovative Methodologies and Device-Specific Infrastructure through the Medical Device Epidemiology Network: Applications for Medical Countermeasure-Associated Devices (U01) RFA-FD-12-010, and Enhancing post-market surveillance through developing registries for medical device epidemiology (U01) RFA-FD-12-028. While the projects supported under these cooperative agreements support the mission of the FDA and program directives, there is not sufficient opportunity within this pathway for projects to be proposed, prioritized, coordinated, and supported by a wider stakeholder group, as can be accomplished through a public-private partnership. In order to best serve public health, the MDEpiNet PPP requires a centralized coordinating body that would be charged with:
It is assumed that for each of these functions, a multidisciplinary team will be built with membership from MDEpiNet partners. The partnership management center would thus be directly responsible for team management, providing open lines of communication among partners, and equitable means for scientific and operational decision-making.
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:
Responses to this RFI are voluntary. Any personal identifiers (e.g., names, addresses, email addresses, etc.) will be removed when responses are compiled. Please do not include proprietary, classified, confidential, or sensitive information in your response. Replies to individual topics are optional, and anonymous responses are permitted. The information provided will be analyzed and may appear in various reports. You will not receive individualized feedback on responses. The United States government may use any non-proprietary technical information in any resultant solicitation(s).
Responses to this RFI are due January 11, 2013 by 11:59 PM Eastern Time. Responses should be limited to ten pages and marked with this RFI identifier NOT-FD-13-001 in the subject line and if you are willing to do so, please also provide the following:
Responses must be submitted electronically to Lisa.Ko@fda.hhs.gov.
This RFI is for planning purposes only and is not a solicitation for applications or an obligation on the part of the U.S. Government to provide support for any ideas identified in response to it. Please note that the U.S. Government will not pay for the preparation of any comment submitted or for its use of that comment.
Please direct all inquiries to:
Benjamin C. Eloff, PhD
Senior Scientific Program Manager
Division of Epidemiology
Office of Surveillance and Biometrics
Center for Devices and Radiological Health
10903 New Hampshire Ave, WO66 RM 4210
Silver Spring, MD 20993
Grants Management Specialist
Division of Assistance and Service Agreements
Office of Acquisition and Grants Services
5630 Fishers Lane, Room 2027
Rockville, MD 20857
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Office of Extramural
National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
Department of Health
and Human Services (HHS)
NIH . . . Turning Discovery Into Health
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