International Conference on Harmonisation; Guidance on S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals; Availability, 61133-61134 [05-20959]
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Federal Register / Vol. 70, No. 202 / Thursday, October 20, 2005 / Notices
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Jason Brodsky,
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Relations.
[FR Doc. 05–20970 Filed 10–19–05; 8:45 am]
BILLING CODE 4160–01–S
VerDate Aug<31>2005
16:14 Oct 19, 2005
Jkt 208001
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.
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 https://
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-
ADDRESSES:
Frm 00021
Fmt 4703
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:
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.
PO 00000
61133
Sfmt 4703
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.
E:\FR\FM\20OCN1.SGM
20OCN1
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 https://
www.fda.gov/ohrms/dockets/
default.htm, https://www.fda.gov/cder/
guidance/index.htm, or https://
www.fda.gov/cber/publications.htm.
VerDate Aug<31>2005
16:14 Oct 19, 2005
Jkt 208001
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.
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 https://
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
ADDRESSES:
PO 00000
Frm 00022
Fmt 4703
Sfmt 4703
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
E:\FR\FM\20OCN1.SGM
20OCN1
Agencies
[Federal Register Volume 70, Number 202 (Thursday, October 20, 2005)]
[Notices]
[Pages 61133-61134]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-20959]
-----------------------------------------------------------------------
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 https://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
https://www.fda.gov/ohrms/dockets/default.htm, https://www.fda.gov/cder/
guidance/index.htm, or https://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