E9-14904. Convener of Active Medical Product Surveillance Discussion (U13)

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of a neutral, independent institution and/or organization that proposes appropriate methods and processes for convening a broad range of stakeholders with relevant expertise to manage and support conferences and meetings. The focus of the conferences and meetings is to explore and address methodological, data development, technical, and communication issues related to active medical product surveillance. The awardee would be expected to synthesize, summarize, and communicate findings from these conferences and meetings to a broad range of organizations and individuals who have the capability to use the information to further develop and create active medical product surveillance methods and systems.

DATES:

The application due date is July 15, 2009. The earliest start date is in September 2009.

FOR FURTHER INFORMATION AND ADDITIONAL REQUIREMENTS CONTACT:

Programmatic/Peer Review Contact: Melissa Robb, Office of Critical Path Programs, Office of the Commissioner, Food and Drug Administration, 5600 Fishers Lane, rm. 14B-45, Rockville, MD 20857, 301-827-1516, e-mail: [e-mail].

Financial or Grants Management Contact: Gladys M. Bohler, Office of Acquisitions and Grant Services, Food and Drug Administration, 5630 Fishers Lane, rm. 2105, Rockville, MD 20857, 301-827-7168, FAX: [phone], e-mail: [e-mail].

For more information on this funding opportunity announcement (FOA) and to obtain detailed requirements, please refer to the full FOA located at http://www.fda.gov/​Safety/​FDAsSentinelInitiative/​ucm149345.htm.

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

Request for Applications (RFA) Number: RFA-FD09-012

Catalog of Federal Domestic Assistance Number: 93.103

A. Background

In 2007, Congress enacted the Food and Drug Administration Amendments Act of 2007 (FDAAA). Section 905 of this statute calls for the Secretary of Health and Human Services (the Secretary) to develop methods to obtain access to disparate data sources and to establish an active postmarket risk identification and analysis system that links and analyzes safety data from multiple sources. The law sets a goal of access to data from 25 million patients by July 1, 2010, and 100 million patients by July 1, 2012. The law also requires FDA to work closely with partners from public, academic, and private entities.

In May 2008, the Secretary and the Commissioner of Food and Drugs announced the launch of the Sentinel Initiative, a long-term effort to create a national electronic system for monitoring regulated product safety. Once implemented, the Sentinel System is intended to augment FDA's existing postmarket (primarily passive) safety surveillance systems and to enable FDA to actively gather information about the postmarket safety and performance of its regulated products. FDA views its Sentinel Initiative as a mechanism through which some of the requirements mandated in FDAAA can be carried out.

As currently envisioned, the Sentinel System will enable FDA to capitalize on the capabilities of multiple, existing automated healthcare data systems (e.g. electronic health record systems, administrative claims databases, registries). The Sentinel System will enable queries of disparate data sources quickly and securely for relevant regulated product safety information. Data will continue to be managed by its owners, and only data of organizations who agree to participate in this system will be involved. FDA questions would be sent to appropriate, participating data holders, who would, in accordance with existing privacy and security safeguards, evaluate their data and send results summaries to FDA for review.

Following announcement of the Sentinel Initiative in May 2008, FDA's first step has been to create a broad public forum for discussion of issues related to developing and implementing the Sentinel System. During 2008, FDA sponsored a series of exploratory meetings with a broad variety of stakeholders to identify key issues that will need to be addressed before, during, and after implementation of the Sentinel System. Key questions include, for example, what level of collaboration between public and private entities would best ensure the success of the initiative; how a possible governance model could be identified and developed; what kind of methods and tools will be needed to facilitate the development and sharing of highly technical summary results derived from automated healthcare data in disparate systems; and what privacy and security safeguards will be needed and how will they be maintained.

B. Research Objectives

These initial discussions have focused on many of the policy and procedural needs of developing the Sentinel System. However, to proceed, additional meetings and working groups need to be formed to explore in greater depth the science of safety needed to support this initiative, as well as methods for communicating about the information learned from the system. Topics to be addressed include specific topics, issues, and questions related to the development of active medical product surveillance methodologies and tools. Subsequently, the information from these meetings and working groups must be described, managed, and made available to the public using a transparent and open approach.

C. Eligibility Information

The following organizations/institutions are eligible to apply: Non-profit organizations.

Foreign institutions are not eligible to apply for conference grant support. An international conference can be supported through the U.S. representative organization of an established international scientific or professional society.

II. Award Information/Funds Available

A. Award Amount

FDA anticipates providing up to $600,000 (direct cost only) during fiscal year (FY) 2009 to support efforts outlined in this FOA. One award will be made.

This Cooperative Agreement ensures substantial FDA involvement in this program and will include, but not be limited to, co-development of the meeting(s) priorities and agendas and providing feedback on reports and publications related to meeting proceedings on identified topics.

B. Length of Support

Subject to the availability of Federal funds and successful performance, and if the FOA stated objectives are met, an additional 4 years of support up to $600,000 (direct and indirect costs combined) per year may be available.

III. Electronic Application, Registration, and Submission

Only electronic applications will be accepted. To submit an electronic application in response to this FOA, applicants should first review the full announcement located at http://www.fda.gov/​Safety/​FDAsSentinelInitiative/​ucm149345.htm.

For all electronically submitted applications, the following steps are required.

• Step 1: Obtain a Dun and Bradstreet (DUNS) Number
• Step 2: Register With Central Contractor Registration
• Step 3: Obtain Username & Password
• Step 4: Authorized Organization Representative (AOR) Authorization
• Step 5: Track AOR Status
• Step 6: Register With Electronic Research Administration (eRA) Commons

Steps 1 through 5, in detail, can be found at http://www07.grants.gov/​applicants/​organization_​registration.jsp. Step 6, in detail, can be found at https://commons.era.nih.gov/​commons/​registration/​registrationInstructions.jsp. After you have followed these steps, submit electronic applications to http://www.grants.gov.

Dated: June 19, 2009.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.