Federal Register / Vol. 70, No. 202 / Thursday, October 20, 2005 / Notices 61133 

3014512529. Please call the Information 

Line for up-to-date information on this 

meeting. When available, background 

materials for this meeting will be posted 

one business day prior to the meeting on 

the FDA Web site at http://www.fda.gov/ 

ohrms/dockets/ac/acmenu.htm. (Click 

on the year 2005 and scroll down to 

Anesthetic and Life Support Drugs 

Advisory Committee). 

Agenda: The meeting will be open to 

the public from 9 a.m. to 10 a.m., unless 

public participation does not last that 

long, from 10 a.m. to 5 p.m., the meeting 

will be closed to permit discussion and 

review of trade secret and/or 

confidential information. 

Procedure: On November 10, 2005, 

from 9 a.m. to 10 a.m., the meeting is 

open to the public. Interested persons 

may present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person by November 3, 2005. Oral 

presentations from the public will be 

scheduled between approximately 9:15 

a.m. to 10:15 a.m. Time allotted for each 

presentation may be limited. Those 

desiring to make formal oral 

presentations should notify the contact 

person before November 3, 2005, and 

submit a brief statement of the general 

nature of the evidence or arguments 

they wish to present, the names and 

addresses of proposed participants, and 

an indication of the approximate time 

requested to make their presentation. 

Closed Presentation of Data: On 

November 10, 2005, from 10 a.m. to 5 

p.m., the meeting will be closed to 

permit discussion and review of trade 

secret and/or confidential information 

(5 U.S.C. 552b(c)(4)). 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Victoria 

Ferretti-Aceto at least 7 days in advance 

of the meeting. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: October 12, 2005. 

Jason Brodsky, 

Acting Associate Commissioner for External 

Relations. 

[FR Doc. 05–20970 Filed 10–19–05; 8:45 am] 

BILLING CODE 4160–01–S 

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. 

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:// 

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 selfaddressed 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. 

61134 Federal Register / Vol. 70, No. 202 / Thursday, October 20, 2005 / Notices 

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:// 

www.fda.gov/ohrms/dockets/ 

default.htm, http://www.fda.gov/cder/ 

guidance/index.htm, or http:// 

www.fda.gov/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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2004D–0377] 

International Conference on 

Harmonisation; 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. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance entitled ‘‘E14 

Clinical Evaluation of QT/QTc Interval 

Prolongation and Proarrhythmic 

Potential for Non-Antiarrhythmic 

Drugs.’’ 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 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 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 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:// 

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 (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–

1800. Send one self-addressed adhesive 

label to assist the office in processing 

your request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the 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, 301–594–5400. 

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