[Federal Register Volume 74, Number 120 (Wednesday, June 24, 2009)]
[Notices]
[Pages 30097-30098]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-14904]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0275]
Convener of Active Medical Product Surveillance Discussion (U13)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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: [email protected].
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: 301-
827-7101, e-mail: [email protected].
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
[[Page 30098]]
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.
[FR Doc. E9-14904 Filed 6-23-09; 8:45 am]
BILLING CODE 4160-01-S