
[Federal Register Volume 77, Number 25 (Tuesday, February 7, 2012)]
[Notices]
[Page 6127]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-2756]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0084]


Submission of Extended Digital Electrocardiogram Waveform Data; 
Notice of 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 consider changes in how digital electrocardiogram (ECG) data 
gathered to assess a drug's adverse effects on heart function should be 
submitted for review. At the meeting, an extension of the Health Level-
7 (HL7) Annotated ECG standard data format--used by the ECG warehouse--
will be presented. The new data format is intended to facilitate 
electronic submission and sharing of ECG data from continuous 
recordings. We encourage device manufacturers, ECG laboratories, 
investigators, industry, and academic researchers to offer advice on 
the proposed format and perspective on the collection, analysis, 
submission, and review of data from long-term continuous ECG recordings 
for assessing the safety of investigational drugs.
    Date and Time: The public meeting will be held on Wednesday, March 
14, 2012, from 8 a.m. to 5 p.m.
    Location: The public meeting will be held at FDA's White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 2, rm. 2031, Silver Spring, MD 
20993.
    Contact Person: Devi Kozeli, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
22, rm. 4183, Silver Spring, MD 20993-0002, (301) 796-1128, FAX: (301) 
796-9841, email: Devi.Kozeli@fda.hhs.gov.
    Attendance and Registration: The FDA Conference Center at the White 
Oak location is a Federal facility with security procedures and limited 
seating. Therefore, early arrival is encouraged. There is no fee to 
attend the meeting, and attendees who do not wish to make an oral 
presentation do not need to register. Seating will be on a first-come, 
first-served basis.
    If you would like to make an oral presentation during the meeting, 
you must register by sending an email to devi.kozeli@fda.hhs.gov by 
February 14, 2012. Your email should contain complete contact 
information for each attendee, including name, title, affiliation, 
address, email address, and phone number. We will try to accommodate 
all persons who wish to make a presentation. Registrants will receive 
confirmation after they have been selected. Persons registered to make 
an oral presentation should check in before the meeting. If you need 
special accommodations because of a disability, please contact Devi 
Kozeli (see Contact Person) at least 7 days before the meeting.
    Comments: Interested persons may submit either electronic or 
written comments regarding this document. Submit electronic comments to 
http://www.regulations.gov. Submit written comments to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday. To ensure consideration, all comments must 
be received by March 28, 2012.

SUPPLEMENTARY INFORMATION: 

I. Background

    Some drugs are known to interfere with the electrical function of 
the heart by delaying cardiac repolarization, and this delay may be 
associated with serious and sometimes fatal adverse events. Delay in 
cardiac repolarization can be assessed with an ECG, a recording of the 
cyclical changes in the heart's electrical activity. The delay is 
quantified as the increase in the Q wave and T wave (QT) interval, the 
length of time corresponding to the start of the Q wave and the end of 
the T wave on the ECG tracing. In 2005, FDA issued a guidance that was 
developed within the Expert Working Group of the International 
Conference on Harmonization of Technical Requirements (ICH) that made 
recommendations for the gathering and submission of ECG data, the 
clinical evaluation of the QT interval, and reporting of adverse 
events.
    In responding to this guidance (ICH E-14), investigators of the 
efficacy and safety of drugs typically submit digitized 10-second ECGs 
taken at key protocol time points to FDA's ECG Warehouse. These ECGs 
are often extracted from continuous ECG recordings collected on Holter, 
Telemetry, and other long-term monitoring devices. ECG information 
submitted through the ECG warehouse should be in a format that was 
jointly developed by FDA, sponsors, core laboratories, and device 
manufactures under the auspices of HL7, an international organization 
of information scientists who collaborate to create standards for the 
exchange of electronic healthcare information.
    Because effects on heart function that are only apparent in long-
term ECG data from continuous recordings have been shown to be 
important in the evaluation of drug efficacy and safety, FDA plans to 
request these data whenever they are collected in clinical trials. This 
will necessitate changes in the HL7 Annotated ECG.

II. Purpose and Scope of the Meeting

    The HL7 Annotated ECG data format will be discussed, and changes to 
it for handling long-term ECG data from continuous recordings will be 
proposed. The revised format is expected to proceed through the 
standard approval processes of HL7. Needed expansions to the hardware 
and software resources of FDA's ECG Warehouse and modifications to the 
upload process for ECG data are underway. FDA is interested in the 
perspective of manufacturers, ECG laboratories, investigators, 
industry, and academic researchers as it seeks to improve the 
collection, analysis, submission, and review of continuous ECG 
recordings for purposes of assessing drug safety.

    Dated: February 2, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-2756 Filed 2-6-12; 8:45 am]
BILLING CODE 4160-01-P


