[Federal Register Volume 67, Number 115 (Friday, June 14, 2002)]
[Notices]
[Pages 40950-40951]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-15000]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0232]


International Conference on Harmonisation; Draft Guidance on S7B 
Safety Pharmacology Studies for Assessing 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availability of a draft guidance entitled ``S7B Safety Pharmacology 
Studies for Assessing the Potential for Delayed Ventricular 
Repolarization (QT Interval Prolongation) by Human Pharmaceuticals.'' 
The draft guidance was prepared under the auspices of the International 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 The draft guidance provides 
general principles and information on currently available nonclinical 
methodologies to identify the potential risk of QT interval 
prolongation by a pharmaceutical and recommends study types and timing 
of studies in relation to clinical development of a pharmaceutical. The 
draft guidance is intended to protect clinical trial participants and 
patients receiving marketed products from delayed repolarization-
associated ventricular tachycardia, torsade de pointes, and lethal 
arrhythmias resulting from administration of pharmaceuticals.

DATES: Submit written or electronic comments on the draft guidance by 
August 1, 2002.

ADDRESSES: Submit written comments on the draft guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 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single copies of the draft guidance to the Division of Drug Information 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), Food 
and Drug Administration, Center for Biologics Evaluation and Research 
(CBER), 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-3844, 
FAX: 888-CBERFAX. 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: John Koerner, Center for Drug Evaluation 
and Research (HFD-110), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 301-594-5338, or David Green, Center for 
Biologics Evaluation and Research (HFM-579), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448.
    Regarding the ICH: Janet J. Showalter, Office of International 
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-

[[Page 40951]]

0864.

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's Health Products and Food Branch, 
and the European Free Trade Area.
    In accordance with FDA's good guidance practices (GGPs) regulation 
(21 CFR 10.115), this document is being called a guidance, rather than 
a guideline.
    To facilitate the process of making ICH guidances available to the 
public, the agency has changed its procedure for publishing ICH 
guidances. As of April 2000, we no longer include the text of ICH 
guidances in the Federal Register. Instead, we publish a notice in the 
Federal Register announcing the availability of an ICH guidance. The 
ICH guidance will be placed in the docket and can be obtained through 
regular agency sources (see ADDRESSES). Draft guidances are left in the 
original ICH format. The final guidance is reformatted to conform to 
the GGP style before publication.
    In February 2002, the ICH Steering Committee agreed that a draft 
guidance entitled ``S7B Safety Pharmacology Studies for Assessing the 
Potential for Delayed Ventricular Repolarization (QT Interval 
Prolongation) by Human Pharmaceuticals'' should be made available for 
public comment. The draft guidance is the product of the Safety Expert 
Working Group of the ICH. Comments about this draft will be considered 
by FDA and the Safety Expert Working Group.
    The draft guidance provides general principles and information on 
currently available nonclinical methodologies to identify the potential 
risk of QT interval prolongation by a pharmaceutical and recommends 
study types and timing of studies in relation to clinical development 
of a pharmaceutical. The draft guidance is intended to protect clinical 
trial participants and patients receiving marketed products from 
delayed repolarization-associated ventricular tachycardia, torsade de 
pointes, and lethal arrhythmias resulting from administration of 
pharmaceuticals.
    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 Dockets Management Branch (see 
ADDRESSES) written or electronic comments on the draft guidance by 
August 1, 2002. Two copies of any comments are to be submitted, except 
that individuals may submit one 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 
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 document at 
http://www.fda.gov/ohrms/dockets/default.htm, http://www.fda.gov/cder/guidance/index.htm, or http://www.fda.gov/cber/publications.htm.

    Dated: June 6, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-15000 Filed 6-13-02; 8:45 am]
BILLING CODE 4160-01-S