[Federal Register: January 5, 2005 (Volume 70, Number 3)]
[Notices]               
[Page 823-824]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05ja05-84]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 2004D-0377 and 2004D-0378]

 
International Conference on Harmonisation; Draft Guidances on E14 
Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic 
Potential for Non-Antiarrhythmic Drugs and S7B Nonclinical Evaluation 
of the Potential for Delayed Ventricular Repolarization (QT Interval 
Prolongation) by Human Pharmaceuticals; Availability; Reopening of 
Comment Periods

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment periods.

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SUMMARY: The Food and Drug Administration (FDA) is reopening until 
February 18, 2005, the comment periods for the draft guidances entitled 
``E14 Clinical Evaluation of QT/QTc Interval Prolongation and 
Proarrhythmic Potential for Non-Antiarrhythmic Drugs'' and ``S7B 
Nonclinical Evaluation of the Potential for Delayed Ventricular 
Repolarization (QT Interval Prolongation) by Human Pharmaceuticals.'' 
The draft guidances were prepared under the auspices of the 
International Conference on Harmonisation (ICH) of Technical 
Requirements for Registration of Pharmaceuticals for Human Use. FDA 
published notices of availability of the draft guidances in the Federal 
Register of September 13, 2004 (69 FR 55163 and 69 FR 55164, 
respectively). FDA is taking this action in response to requests to 
extend the comment periods for both draft guidances.

DATES: Submit written or electronic comments on the draft guidances by 
February 18, 2005. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written comments on the draft guidances 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 guidances 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, Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. 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 guidances.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance entitled ``E14 Clinical Evaluation of QT/QTc 
Interval Prolongation and Proarrhythmic Potential for Non-
Antiarrhythmic Drugs'': Douglas C. Throckmorton, Center for Drug 
Evaluation and Research (HFD-1), Food and Drug Administration, 5600 
Fishers Lane,Rockville MD, 20857, 301-594-5400.
    Regarding the guidance entitled ``S7B Nonclinical Evaluation of the 
Potential for Delayed Ventricular Repolarization (QT Interval 
Prolongation) by Human Pharmaceuticals'': John Koerner, Center for Drug 
Evaluation and Research (HFD-110), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5338.
    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 the Federal Register of September 13, 2004, FDA announced the 
availability of the following two draft guidances prepared under the 
auspices of the ICH:

[[Page 824]]

     ``E14 Clinical Evaluation of QT/QTc Interval Prolongation 
and Proarrhythmic Potential for Non-Antiarrhythmic Drugs'' (69 FR 
55163; Docket No. 2004D-0377) 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.
     ``S7B Nonclinical Evaluation of the Potential for Delayed 
Ventricular Repolarization (QT Interval Prolongation) by Human 
Pharmaceuticals'' (69 FR 55164; Docket No. 2004D-0378) describes a 
nonclinical testing strategy for assessing the potential of a test 
substance to delay ventricular repolarization and includes information 
concerning nonclinical assays and an integrated risk assessment.
    Interested persons were given until December 13, 2004, to submit 
comments on the draft guidances.
    On December 13, 2004, FDA received letters from Wyeth 
Pharmaceuticals requesting that the agency extend the comment periods 
for the draft guidances.
    In response to these requests, FDA has decided to reopen the 
comment period on the draft guidances until February 18, 2005, to allow 
the public more time to review and comment on the contents.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the draft guidances 
on or before February 18, 2005. Submit a single copy of electronic 
comments or two paper copies of any mailed comments, except that 
individuals may submit one paper copy. Identify comments with the 
corresponding docket number of the draft guidance as follows: Docket 
No. 2004D-0377 ``E14 Clinical Evaluation of QT/QTc Interval 
Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs'' 
and Docket No. 2004D-0378 ``S7B Nonclinical Evaluation of the Potential 
for Delayed Ventricular Repolarization (QT Interval Prolongation) by 
Human Pharmaceuticals.'' The draft guidances and received comments are 
available for public examination 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 draft guidance 
documents 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: December 28, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 05-110 Filed 1-4-05; 8:45 am]

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