2284 Federal Register / Vol. 72, No. 11 / Thursday, January 18, 2007 / Notices 

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. 

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, broadbased, 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: 

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. 

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 

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Federal Register / Vol. 72, No. 11 / Thursday, January 18, 2007 / Notices 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 publicprivate 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 pointof-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 


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