[Federal Register Volume 66, Number 206 (Wednesday, October 24, 2001)]
[Notices]
[Pages 53801-53802]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-26821]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0476]


Electronic Interchange Standard for Digital ECG and Similar Data; 
Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting to collect information regarding the content and format of 
electrocardiographic (ECG) data to be submitted to the agency in 
support of applications. The agency is interested in obtaining ECG 
waveform data in digital format from the full spectrum of ECG devices 
(i.e., standard 12-lead ECGs, Holter monitors, transtelephonic 
monitors, and implanted devices) along with annotations for events 
(e.g., standard ECG interval measurements, arrhythmic events).

DATES: The public meeting will be held on November 19, 2001, from 10 
a.m. to 4 p.m. Submit registration requests by November 6, 2001. 
Written or electronic comments on ECG data standards are welcome at any 
time.

ADDRESSES: The public meeting will be held at FDA's Center for Drug 
Evaluation and Research Advisory Committee Conference Room, 5630 
Fishers Lane, rm. 1066, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Norman L. Stockbridge, Center for Drug

[[Page 53802]]

Evaluation and Research (HFD-110), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5329, e-mail: 
[email protected]; or Randy Levin, Center for Drug Evaluation 
and Research (HFD-001), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 301-594-5400, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: FDA is holding a public meeting to discuss 
potential data standards for digital ECG waveform data to be submitted 
in support of applications to FDA. Topics for discussion will include: 
(1) Scope of ECG datasets (i.e, what information should be included); 
(2) logical organization of a dataset supporting multiple recording 
sessions, multiple recording epochs within a session, and multiple 
leads; (3) logical organization supporting the annotation of data in 
one or more leads with the submitter's assessment of the locations of 
events of interest, including standard ECG intervals, arrhythmic 
events, and other information; and (4) realization of the data in 
extensible markup language (XML) or other open formats.
    Although the agency is considering updating guidance documents on 
related drug evaluation standards (i.e., arrhythmic potential, 
electronic submission of clinical trial data, including electronic ECG 
data), the use of ECG data in support of applications will not be the 
topic for this meeting. The purpose of this meeting is to get public 
input on the following questions related to the technical issues of 
transmitting digital ECG data:
      What information is needed to make ECG datasets easy to 
interpret?
      Is the data structure complex enough that the standard 
should be implemented in XML or some other format?
      Are the datasets so large that the data standards should 
be implemented in binary format?
      What tools can be used to review digital ECG data?
    An agenda and other materials, including a proposed data standard, 
will be available on the Internet at http://www.fda.gov/cder/regulatory/ersr/default.htm before the meeting. Although there is no 
registration fee, preregistration by November 6, 2001, is recommended 
for those individuals who wish to attend this meeting. Participation is 
limited to the first 100 registrants. To accommodate the greatest 
number of interested parties, registration is limited to people outside 
FDA, and no more than two individuals from a company should attend. To 
register, send an e-mail message to Wendy Lail ([email protected]) 
with the names of one or two individuals who wish to attend and the 
name of their company.
    The location of the meeting is 5630 Fishers Lane, Rockville, MD 
(next to the Parklawn Bldg). Registrants should use the lower entrance, 
which faces Parklawn Dr. Visitors' badges will be held at the guards' 
station at the entrance to the building, and participants will need 
picture identification to pick up their badges. Public parking is not 
available at the 5630 Fishers Lane location. A public parking lot (for 
a fee) is available on Fishers Lane across from the Parklawn Bldg. 
Additional public parking (for a fee) is available at the Twinbrook 
Metro Station, which is located several blocks west of the meeting 
location.
    Interested persons may submit to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, written comments on standards for digital ECG 
data. Two copies of mailed comments are to be submitted, except that 
individuals may submit one copy. Submit electronic comments to http://www.fda.gov/dockets/ecomments. Comments are to be identified with the 
docket number found in brackets in the heading of this document. 
Comments are available for public examination in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: October 19, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-26821 Filed 10-19-01; 4:12 pm]
BILLING CODE 4160-01-S