[Federal Register: October 24, 2001 (Volume 66, Number 206)]
[Notices]
[Page 53801-53802]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24oc01-67]
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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:
stockbridgen@cder.fda.gov; 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: levinr@cder.fda.gov.
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 (lailw@cder.fda.gov)
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