[Federal Register: April 29, 2003 (Volume 68, Number 82)]
[Page 22719]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 03N-0158]

Specification for Annotated Electrocardiographic Waveform Data in 
Electronic Format; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.


SUMMARY: The Food and Drug Administration (FDA) is requesting comments 
on proposed specifications for annotated electrocardiographic (ECG) 
waveform data in electronic format. The proposed specifications are 
described in a Health Level Seven (HL7) informative document.

DATES: Submit written or electronic comments on the specifications by 
May 29, 2003. General comments on agency guidance documents are welcome 
at any time.

ADDRESSES: Copies of the specifications are available on the Internet 
at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.hl7.org/V3AnnECG/index.htm. Submit written comments on 
the specifications to the Dockets Management Branch (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Norman Stockbridge, Center for Drug 
Evaluation and Research (HFD-110), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5329, or e-mail: 

I. Background

    FDA considers the results of ECG tests in evaluating the safety and 
efficacy of certain new drugs, biologics, and devices. Traditionally, 
FDA has reviewed only summary representations of ECG data for the 
analysis of the safety and efficacy of products. The agency is 
interested in improving the evaluation of specific drug induced cardiac 
toxicity by reviewing ECG waveform data with detailed, sponsor 
generated annotations from the full spectrum of ECG devices, including 
12-lead standard ECG, holter monitors, and implanted devices. On 
November 19, 2001, FDA held a public meeting to collect information 
regarding the content and format of annotated ECG waveform data that 
could be submitted to the agency in support of product applications.
    Following the meeting, the Regulated Clinical Research Information 
Management Technical Committee (RCRIM) in HL7\1\, in association with 
the Clinical Data Interchange Standards Consortium (CDISC)\2\,  
investigated the technology necessary for the submission and review of 
this ECG data. The RCRIM then developed a model electronic format for 
the transportation of digital ECG waveform data, including annotations 
in the data message. The specifications on this annotated ECG waveform 
data message are provided in a proposed HL7 informative document. The 
document can be found on the HL7 Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.hl7.org/V3AnnECG/index.htm

    \1\Founded in 1987, Health Level Seven, Inc., (HL7) 
(http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=www.HL7.org), is a nonprofit, ANSI-Accredited Standards Developing 
Organization that provides standards for the exchange, management 
and integration of data that supports clinical patient care and the 
management, delivery and evaluation of healthcare services. Its 
2,200 members represent over 400 corporate members, including 90 
percent of the largest information systems vendors serving 
healthcare. HL7 international affiliates are active in Europe, 
Japan, Australia, Canada, New Zealand, and Southern Africa.
    \2\CDISC, (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=www.cdisc.org), is an open, multidisciplinary, 
nonprofit organization committed to the development of worldwide 
industry standards to support the electronic acquisition, exchange, 
submission and archiving of clinical trials data and metadata for 
medical and biopharmaceutical product development.

II. Comments

    We are interested in comments on the use of the proposed HL7 
electronic format in providing annotated waveform ECG data to FDA in 
support of submissions for regulated products. Specifically, does the 
proposed message capture the appropriate level of detail about ECGs for 
assessment? Are there additions needed to the proposed controlled 
terminology? What are the issues concerning the creation of the HL7 
    After FDA reviews any such comments concerning the HL7 proposal, 
the agency intends to issue a draft guidance setting forth its 
recommended electronic format for the submission of digital ECG 
waveform data. In those instances when the agency requests that a 
regulated entity submit ECG data electronically concerning a product, 
the draft guidance would describe an appropriate electronic format for 
the submission. Interested parties would have an opportunity to submit 
comments on this recommended format in response to the draft guidance. 
FDA would consider any such comments before publishing a guidance.
    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments on the proposed 
specification. Two paper copies of any mailed comments are to be 
submitted, 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. The proposed specifications and received 
comments are available for public examination in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the proposed 
specifications at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.hl7.org/V3AnnECG/index.htm.

    Dated: April 21, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-10475 Filed 4-28-03; 8:45 am]