[Federal Register: September 13, 2004 (Volume 69, Number 176)]
[Notices]
[Page 55163-55164]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13se04-48]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0377]
International Conference on Harmonisation; Draft Guidance on E14
Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic
Potential for Non-Antiarrhythmic Drugs; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``E14 Clinical Evaluation of
QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-
Antiarrhythmic Drugs.'' The draft guidance was prepared under the
auspices of the International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use (ICH).
The draft guidance provides recommendations to sponsors concerning
clinical studies to assess the potential of a new drug to cause cardiac
arrhythmias, focusing on the assessment of changes in the QT/QTc
interval on the electrocardiogram as a predictor of risk. The draft
guidance is intended to encourage the assessment of drug effects on the
QT/QTc interval as a standard part of drug development and to encourage
the early discussion of this assessment with FDA.
DATES: Submit written or electronic comments on the draft guidance by
December 13, 2004.
ADDRESSES: Submit written comments on the draft guidance to the
Division of Dockets Management (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. Submit written
requests for single copies of the draft guidance to the Division of
Drug Information (HFD-240), Center for Drug Evaluation and Research,
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857;
or the Office of Communication, Training and Manufacturers Assistance
(HFM-40), Center for Biologics Evaluation and Research (CBER), Food and
Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. The
guidance may also be obtained by mail by calling the CBER Voice
Information System at 1-800-835-4709 or 301-827-
[[Page 55164]]
1800. Send two self-addressed adhesive labels to assist the office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Douglas C. Throckmorton, Center for Drug
Evaluation and Research (HFD-1), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857.
Regarding the ICH: Michelle Limoli, Office of International
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4480.
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for drug development among regulatory agencies.
ICH was organized to provide an opportunity for tripartite
harmonization initiatives to be developed with input from both
regulatory and industry representatives. FDA also seeks input from
consumer representatives and others. ICH is concerned with
harmonization of technical requirements for the registration of
pharmaceutical products among three regions: The European Union, Japan,
and the United States. The six ICH sponsors are the European
Commission, the European Federation of Pharmaceutical Industries
Associations, the Japanese Ministry of Health, Labour, and Welfare, the
Japanese Pharmaceutical Manufacturers Association, the Centers for Drug
Evaluation and Research and Biologics Evaluation and Research, FDA, and
the Pharmaceutical Research and Manufacturers of America. The ICH
Secretariat, which coordinates the preparation of documentation, is
provided by the International Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
The ICH Steering Committee includes representatives from each of
the ICH sponsors and the IFPMA, as well as observers from the World
Health Organization, Health Canada, and the European Free Trade Area.
In June 2004, the ICH Steering Committee agreed that a draft
guidance entitled ``E14 Clinical Evaluation of QT/QTc Interval
Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs''
should be made available for public comment. The draft guidance is the
product of the Efficacy Expert Working Group of the ICH. Comments about
this draft will be considered by FDA and the the Efficacy Expert
Working Group.
The draft guidance provides guidance on the design, conduct,
analysis and interpretation of clinical studies to assess the potential
of a new drug to cause cardiac arrhythmias, focusing on the assessment
of changes in the QT/QTc interval on the electrocardiogram as a
predictor of risk. The draft guidance is intended to encourage the
assessment of drug effects on the QT/QTc interval, along with the
collection of adverse cardiac events related to arrhythmias, as a
standard part of drug development, and to encourage the early
discussion of this assessment with the FDA. The goal of such
discussions is to reach a common understanding of the effects as early
in development as practical, with the goal of enhancing the efficiency
of data collection later in drug development.
This draft guidance, when finalized, will represent the agency's
current thinking on this topic. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the draft guidance.
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. The draft guidance and received
comments may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the document at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm, or http://www.fda.gov/cber/publications.htm.
Dated: September 3, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-20565 Filed 9-10-04; 8:45 am]
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