[Federal Register Volume 72, Number 11 (Thursday, January 18, 2007)]
[Notices]
[Pages 2284-2285]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-141]
[[Page 2284]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0016]
Sentinel Network To Promote Medical Product Safety; Public
Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting to explore opportunities to link private sector and public
sector postmarket safety efforts to create a virtual, integrated,
electronic ``Sentinel Network.'' Such a network would integrate
existing and planned efforts to collect, analyze, and disseminate
medical product safety information to health care practitioners and
patients at the point-of-care. It would be established through
multiple, broad-based, public-private partnerships. We are seeking
input on a number of specific questions regarding opportunities for
collaboration, the efficient use of information technology, and the
collection and analysis of medical product safety information.
Dates and Times: The public meeting will be held on March 7 and 8,
2007, from 8 a.m. to 5 p.m.
Location: The public meeting will be held at the University System
of Maryland Shady Grove Center, 8630 Gudelsky Dr., Rockville, MD 20850.
ADDRESSES: Submit written registration and written comments to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
registration to http://www.accessdata.fda.gov/scripts/oc/dockets/meetings/meetingdocket.cfm. Submit electronic comments to http://www.accessdata.fda.gov/scripts/oc/dockets/commentdocket.cfm.
Transcripts of the meeting will be available for review at the Division
of Dockets Management and on the Internet at http://www.fda.gov/ohrms/dockets approximately 21 days after the meeting.
For Registration to Attend and/or to Participate in the Meeting:
Seating at the meeting is limited. People interested in attending
should register at http://www.accessdata.fda.gov/scripts/oc/dockets/meetings/meetingdocket.cfm or submit written registration to the
Division of Dockets Management (see ADDRESSES) by close of business on
February 7, 2007. Registration is free and will be on a first-come,
first-serve basis. Written or electronic comments will be accepted
until April 5, 2007, at the Division of Dockets Management (see
ADDRESSES).
If you wish to make an oral presentation during the open session of
the meeting, you must state your intention on your registration
submission (see ADDRESSES). To speak, submit your name, title, business
affiliation, address, telephone number, fax number, and e-mail address.
FDA has identified questions and subject matters of special interest in
this notice. You should identify by number each question you intend to
address in your presentation, although presentations do not have to be
limited to those questions. FDA will do its best to accommodate
requests to speak. Individuals and organizations with common interests
are urged to consolidate or coordinate their presentations, and to
request time for a joint presentation. FDA may require joint
presentations by persons with common interests. FDA will determine the
amount of time allotted to each presenter and the approximate time that
each oral presentation is scheduled to begin.
If you require special accommodations due to a disability, please
inform Erik Mettler or Nancy Stanisic.
For Information On the Meeting Contact: Erik Mettler, Office of
Policy (HF-11), Food and Drug Administration, 5600 Fishers Lane, rm.
14-101, Rockville, MD 20857, 301-827-3360, FAX: 301-594-6777, e-mail:
[email protected]; or Nancy Stanisic, Office of the
Commissioner, Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-0149, e-mail: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Each year many Americans experience an adverse event due to the use
or misuse of a medical product. Medical products, for purposes of this
meeting, include human drugs, biological products, and medical devices.
Sometimes it is an adverse event known to be associated with the
product and sometimes it is not. Patients may experience an adverse
event because of errors in the prescribing, selection, or use of a
medical product, or because of the inherent properties of a medical
product or a problem with the product's manufacture.
When medical products are not used optimally, the public health can
be affected in many ways. First, there can be direct injuries to
patients. Second, the public's trust in the health care system and in
governmental oversight of medical products can be eroded. Finally,
patients and health care professionals can become overly cautious in
their use of treatments, thus diminishing the usefulness of effective
therapies.
To make informed decisions about how to use the products safely and
effectively, health care professionals need up-to-date and accurate
information about the medical products they may be prescribing. Without
this information, treatments, preventatives, and diagnostics may not be
utilized optimally. Efforts now underway to develop and harmonize
health information standards, such as for electronic health records,
and to make use of available health information technologies, are
giving the public and private sectors a new array of tools to help
improve the safe and effective use of medical products.
Premarket clinical trials cannot identify all potential risks from
a medical product. FDA and other Federal agencies conduct a variety of
postmarket surveillance efforts to monitor the safety of medical
products once they have been approved for marketing in the United
States. These include adverse event reporting systems used to assess
known risks and to identify potential previously unknown risks, and the
use of population-based data sets to help assess whether such risks are
related to specific medical products. However, the effectiveness of
these postmarket safety activities has been constrained due to
limitations in the quality, quantity, and timeliness of the available
data as well as limitations in the existing capacity to rapidly conduct
postmarket safety studies when needed. The development of new
information technology tools and the growing interest of the private
sector in creating the necessary capacity to conduct postmarket safety
assessments provide an opportunity to address these limitations through
better integration of the nation's postmarket medical product safety
activities.
Therefore, FDA is exploring opportunities to link existing and
planned private and public sector postmarket safety efforts to create a
virtual, integrated, electronic network -- a ``Sentinel Network''. The
Network would foster the seamless, timely electronic flow of medical
product safety information from electronic databases and surveillance
reporting systems, through risk identification and analysis processes,
to health care practitioners and patients at the point-
[[Page 2285]]
of-care while protecting patient privacy. The Network would use
national and international standards adopted by the Department of
Health and Human Services, but would not involve health information
technology standards development. The Network would include three
principal types of activities: (1) Data collection, (2) risk
identification and analysis, and (3) risk communication.
As a first step in beginning a national dialogue regarding actions
that can be taken to assemble the Sentinel Network, FDA will hold a 2-
day public meeting to discuss the envisioned Network. At the meeting we
will engage the private sector in a discussion of opportunities for
public sector and private sector collaboration on activities to help
develop the data collection and risk identification and analysis
components of the Network. In particular, we would like to hear from
those who have established or have access to large, electronic,
population-based data sets that are, or could be, used for postmarket
safety activities. We also want to hear from those with experience in
risk identification and analysis.
The objectives of the Sentinel Network public meeting to be held in
March are to:
Evaluate current needs in postmarket medical product
adverse event data collection and risk identification and analysis;
Identify the obstacles to facilitators, and incentives for
developing the data collection and risk identification and analysis
components of the Sentinel Network; and
Identify opportunities for public-private collaborations
for building the data collection and risk identification and analysis
components of the Network.
To help achieve these objectives, FDA would like to focus the
meeting discussion on the following questions:
General
1. What are the obstacles to facilitators, and incentives for
developing the Sentinel Network?
2. How can postmarket medical product safety data collection be
integrated into the workflow of clinical practice at the point-of-care
while avoiding the imposition of undue burdens on health care
practitioners, patients, and health care institutions?
3. How can electronic health records serve as an effective data
collection tool for medical product safety data without imposing undue
burden on health care practitioners and patients at the point-of-care?
What would be needed to facilitate this effort?
4. What steps should be taken to ensure the privacy of patient
information used by the Network?
Current Needs
5. What are the current gaps in postmarket medical product safety
data collection and risk identification and analysis?
6. What are the existing data collection systems and methodologies
that could be used to fill these gaps in postmarket medical product
safety data collection and risk identification and analysis? Please
present a comprehensive description of the systems, including the types
of questions that they have and have not been able to address and that
they have the potential to address.
7. How readily can existing systems be used or be modified to serve
as dynamic surveillance loops (e.g., constant integration of data
collection from, analysis, and feedback of information to health care
practitioners and patients at the point-of-care)?
Future Opportunities
8. What are the opportunities for public-private collaborations for
building the data collection and risk identification and analysis
components of the Sentinel Network?
9. Given that building the Network will be a complex undertaking,
are there worthwhile small-scale projects that could be readily
achievable? If appropriate, please address what your organization can
contribute to these programs.
10. What types of opportunities are there for conducting
prospective testing of existing systems (e.g., in real time) to
determine their validity for medical product safety risk
identification? What benchmarks, both inside and outside the health
care environment, are optimal for comparison?
On the first day of the meeting, a panel of experts from Federal
agencies will provide an overview of the vision of the Sentinel Network
and the gaps they see that the Network might fill. Then a second panel
of invited private sector experts will make presentations on the
systems and programs they are involved in that are already in use or
under development, and will address the questions presented in this
notice. Afterwards, members of the public who registered to speak will
make their presentations. On the second day of the meeting there will
be a moderated discussion between the two panels about the questions
presented in this notice. There also will be an opportunity for
attendees to provide feedback on the presentations and any additional
thoughts during a designated open session. While we are interested in
learning about specific technologies being (or already) developed,
specific proprietary commercial products are not the focus of this
meeting. An opportunity to display such commercial products will be
provided in a separate, adjacent area that will be open for viewing on
both days of the meeting. Because of space limitations, any vendor
wishing to display its product should register (see ADDRESSES) to
reserve space. The display area will provide vendors an opportunity to
fully explain their products to interested parties. Descriptions or
materials regarding commercial products can be submitted in writing to
the Division of Dockets Management. Vendors are also welcome to comment
on the specific substantive questions raised at the meeting.
II. Request for Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic notices of participation and
comments for consideration. To permit time for all interested persons
to submit data, information, or views on this subject, the docket for
the meeting will open 14 days prior to the meeting and remain open for
30 days following the meeting. Persons who wish to provide additional
materials for consideration should file these materials with the
Division of Dockets Management (see ADDRESSES). You should annotate and
organize your comments to identify the specific numbered questions in
this notice to which they respond. Submit a single copy of electronic
comments or two paper copies of any mailed comments, except that
individuals may submit one paper copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the Divsion of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Transcripts of the meeting also will be available for review at the
Division of Dockets Management.
Dated: January 11, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-141 Filed 1-12-07; 8:45 am]
BILLING CODE 4160-01-S