[Federal Register: October 20, 2005 (Volume 70, Number 202)]
[Notices]               
[Page 61133-61134]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20oc05-53]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0378]

 
International Conference on Harmonisation; Guidance on S7B 
Nonclinical Evaluation of the Potential for Delayed Ventricular 
Repolarization (QT Interval Prolongation) by Human Pharmaceuticals; 
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 guidance entitled ``S7B Nonclinical Evaluation of the 
Potential for Delayed Ventricular Repolarization (QT Interval 
Prolongation) by Human Pharmaceuticals.'' The guidance was prepared 
under the auspices of the International Conference on Harmonisation of 
Technical Requirements for Registration of Pharmaceuticals for Human 
Use (ICH). The guidance 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. The guidance is intended to 
facilitate the nonclinical assessment of the effects of pharmaceuticals 
on ventricular repolarization and proarrhythmic risk.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written comments on the 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 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, Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. The 
guidance may also be obtained by mail by calling the Center for 
Biologics Evaluation and Research (CBER) Voice Information System at 1-
800-835-4709 or 301-827-1800. Send one self-addressed adhesive label to 
assist the office in processing your requests.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: 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 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.

[[Page 61134]]

    In the Federal Register of September 13, 2004 (69 FR 55163), FDA 
published a notice announcing the availability of a draft tripartite 
guidance entitled ``S7B Nonclinical Evaluation of the Potential for 
Delayed Ventricular Repolarization (QT Interval Prolongation) by Human 
Pharmaceuticals.'' The notice gave interested persons an opportunity to 
submit comments by December 13, 2004. In response to a request for 
additional time to comment, FDA reopened the comment period until 
February 18, 2005 (70 FR 823, January 5, 2005).
    After consideration of the comments received and revisions to the 
guidance, a final draft of the guidance was submitted to the ICH 
Steering Committee and endorsed by the three participating regulatory 
agencies in May 2005.
    The guidance provides guidance on nonclinical assessment of the 
effects of pharmaceuticals on ventricular repolarization and 
proarrhythmic risk. The guidance 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.
    This guidance represents 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 guidance at any 
time. 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 guidance and received 
comments may be seen in the Division of Dockets Management above 
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.
v/cber/publications.htm.

    Dated: October 12, 2005.
Jeffrey Shuren,
Assisstant Commissioner for Policy.
[FR Doc. 05-20959 Filed 10-19-05; 8:45 am]

BILLING CODE 4160-01-S