[Federal Register: January 18, 2007 (Volume 72, Number 11)]
[Page 2284-2285]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[[Page 2284]]



Food and Drug Administration

[Docket No. 2007N-0016]

Sentinel Network To Promote Medical Product Safety; Public 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.


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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.accessdata.fda.gov/scripts/oc/dockets/meetings/meetingdocket.cfm Submit electronic comments to http://.


Transcripts of the meeting will be available for review at the Division 
of Dockets Management and on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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 
    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: 
erik.mettler@fda.hhs.gov; or Nancy Stanisic, Office of the 

Commissioner, Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-0149, e-mail: nancy.stanisic@fda.hhs.gov.


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 
    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 
    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:


    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]