International Conference on Harmonisation; Guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs; Availability, 61134-61135 [05-20971]
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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
Federal Register / Vol. 70, No. 202 / Thursday, October 20, 2005 / Notices
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.
In the Federal Register of September
13, 2004 (69 FR 55163), FDA published
a notice announcing the availability of
a draft tripartite guidance entitled ‘‘E14
Clinical Evaluation of QT/QTc Interval
Prolongation and Proarrhythmic
Potential for Non-Antiarrhythmic
Drugs.’’ 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). On April
11 and 12, 2005, FDA, the Drug
Information Association, and the Heart
Rhythm Society cosponsored a public
meeting to discuss the draft guidance.
Comments received at the meeting were
made available to the Efficacy Expert
Working Group. 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
the design, conduct, analysis and
interpretation of 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,
along with the collection of adverse
cardiac events related to arrhythmias, as
a standard part of drug development,
and to encourage the early discussion of
this assessment with the FDA. The goal
of such discussions is to reach a
common understanding of the effects as
early in development as practical, with
the goal of enhancing the efficiency of
data collection later in drug
development. The guidance
incorporates the following changes: (1)
A fuller discussion of the factors that
influence the clinical assessment of
drug effects on the QT interval and (2)
an adjustment in the statistical analysis
of QT interval data obtained as a part of
early thorough QT assessment.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the agency’s
current thinking on this topic. It does
not create or confer any rights for or on
VerDate Aug<31>2005
16:14 Oct 19, 2005
Jkt 208001
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 anytime.
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
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,
Assistant Commissioner for Policy.
[FR Doc. 05–20971 Filed 10–19–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0362]
Draft Guidance for Industry on
Recommendations for Implementing a
Collection Program for Source Plasma
Containing Disease-Associated and
Other Immunoglobulin Antibodies;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft document entitled
‘‘Guidance for Industry:
Recommendations for Implementing a
Collection Program for Source Plasma
Containing Disease-Associated and
Other Immunoglobulin (IgG)
Antibodies,’’ dated October 2005. The
draft guidance document is intended to
assist source plasma manufacturers in
submitting to FDA the appropriate
information when implementing an IgG
antibody collection program or when
adding a new IgG antibody collection to
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
61135
an existing program. The draft guidance,
when finalized, would supersede the
draft reviewers’ guide entitled ‘‘Disease
Associated Antibody Collection
Program,’’ dated October 1, 1995.
DATES: Submit written or electronic
comments on the draft guidance by
January 18, 2006 to ensure their
adequate consideration in preparation of
the final guidance. General comments
on agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for
single copies of the draft guidance to 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. Send one
self-addressed adhesive label to assist
the office in processing your requests.
The draft guidance may also be obtained
by mail by calling CBER at 1–800–835–
4709 or 301–827–1800. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
Submit written comments on the draft
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.
FOR FURTHER INFORMATION CONTACT:
Brenda R. Friend, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft document entitled ‘‘Guidance for
Industry: Recommendations for
Implementing a Collection Program for
Source Plasma Containing DiseaseAssociated and Other Immunoglobulin
(IgG) Antibodies’’ dated October 2005.
The draft guidance, when finalized,
would supersede the draft reviewers’
guide, ‘‘Disease Associated Antibody
Collection Program,’’ dated October 1,
1995. The document provides guidance
to source plasma manufacturers in
submitting the appropriate information
to FDA when implementing an IgG
antibody collection program or when
adding a new IgG antibody collection to
an existing program. The guidance
identifies changes in collection
programs that must be documented as
minor changes in an annual report to
FDA under § 601.12(d) (21 CFR
601.12(d)). These collection programs
include disease-associated IgG
E:\FR\FM\20OCN1.SGM
20OCN1
Agencies
[Federal Register Volume 70, Number 202 (Thursday, October 20, 2005)]
[Notices]
[Pages 61134-61135]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-20971]
-----------------------------------------------------------------------
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 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
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
[[Page 61135]]
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.
In the Federal Register of September 13, 2004 (69 FR 55163), FDA
published a notice announcing the availability of a draft tripartite
guidance entitled ``E14 Clinical Evaluation of QT/QTc Interval
Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic
Drugs.'' 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). On April 11 and 12, 2005, FDA, the
Drug Information Association, and the Heart Rhythm Society cosponsored
a public meeting to discuss the draft guidance. Comments received at
the meeting were made available to the Efficacy Expert Working Group.
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 the design, conduct, analysis and
interpretation of 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, along with the collection of adverse
cardiac events related to arrhythmias, as a standard part of drug
development, and to encourage the early discussion of this assessment
with the FDA. The goal of such discussions is to reach a common
understanding of the effects as early in development as practical, with
the goal of enhancing the efficiency of data collection later in drug
development. The guidance incorporates the following changes: (1) A
fuller discussion of the factors that influence the clinical assessment
of drug effects on the QT interval and (2) an adjustment in the
statistical analysis of QT interval data obtained as a part of early
thorough QT assessment.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The 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
anytime. 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 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,
Assistant Commissioner for Policy.
[FR Doc. 05-20971 Filed 10-19-05; 8:45 am]
BILLING CODE 4160-01-S