International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 2 on Test for Extractable Volume of Parenteral Preparations General Chapter; Availability, 71417-71418 [E7-24434]
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Federal Register / Vol. 72, No. 241 / Monday, December 17, 2007 / Notices
ebenthall on PROD1PC69 with NOTICES
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.
In November 2007, the ICH Steering
Committee agreed that a draft guidance
entitled ‘‘Q4B Evaluation and
Recommendation of Pharmacopoeial
Texts for Use in the ICH Regions; Annex
3: Test for Particulate Contamination:
Subvisible Particles General Chapter’’
should be made available for public
comment. The draft guidance is the
product of the Q4B Expert Working
Group of the ICH. Comments about this
draft will be considered by FDA and the
Q4B Expert Working Group.
The draft guidance provides the
specific evaluation results from the ICH
Q4B process for the Test for Particulate
Contamination: Subvisible Particles
General Chapter harmonization
proposal originating from the threeparty PDG. This draft guidance is in the
form of an annex to the core ICH Q4B
guidance. Once finalized, the annex will
provide guidance to assist industry and
regulators in the implementation of the
specific topic evaluated by the ICH Q4B
process.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will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
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on the draft guidance. Submit
a single copy of electronic comments or
two paper copies of any mailed
VerDate Aug<31>2005
15:28 Dec 14, 2007
Jkt 214001
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. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Please note that in January 2008, the
FDA Web site is expected to transition
to the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. After the transition
date, electronic submissions will be
accepted by FDA through the FDMS
only. When the exact date of the
transition to FDMS is known, FDA will
publish a Federal Register notice
announcing that date.
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: December 7, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–24431 Filed 12–14–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D–0458]
International Conference on
Harmonisation; Draft Guidance on Q4B
Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the
International Conference on
Harmonisation Regions; Annex 2 on
Test for Extractable Volume of
Parenteral Preparations General
Chapter; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance entitled
‘‘Q4B Evaluation and Recommendation
of Pharmacopoeial Texts for Use in the
ICH Regions; Annex 2: Test for
Extractable Volume of Parenteral
Preparations General Chapter.’’ 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 the results
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
71417
of the ICH Q4B evaluation of the Test
for Extractable Volume of Parenteral
Preparations General Chapter
harmonized text from each of the three
pharmacopoeias (United States,
European, and Japanese) represented by
the Pharmacopoeial Discussion Group
(PDG). The draft guidance conveys
recognition of the three pharmacopoeial
methods by the three ICH regulatory
regions and provides specific
information regarding the recognition.
The draft guidance is intended to
recognize the interchangeability
between the local regional
pharmacopoeias, thus avoiding
redundant testing in favor of a common
testing strategy in each regulatory
region. This is the second annex to the
core Q4B guidance, which was made
available in draft in August 2006 (71 FR
45059, August 8, 2006).
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115 (g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by February 15, 2008.
ADDRESSES: 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),
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 CBER at 1–800–835–4709 or
301–827–1800. Send two self-addressed
adhesive labels to assist the office in
processing your requests. 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. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Robert H. King,
Sr., Center for Drug Evaluation and
Research (HFD–003), Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 21, rm. 3542, Silver Spring,
MD 20993–0002, 301–796–1242; or
Christopher Joneckis, Center for
Biologics Evaluation and Research
(HFM–20), Food and Drug
E:\FR\FM\17DEN1.SGM
17DEN1
71418
Federal Register / Vol. 72, No. 241 / Monday, December 17, 2007 / Notices
ebenthall on PROD1PC69 with NOTICES
Administration, 1401 Rockville Pike,
Rockville, MD 20852, 301–435–5681.
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.
In November 2007, the ICH Steering
Committee agreed that a draft guidance
entitled ‘‘Q4B Evaluation and
Recommendation of Pharmacopoeial
Texts for Use in the ICH Regions; Annex
2: Test for Extractable Volume of
Parenteral Preparations General
Chapter’’ should be made available for
public comment. The draft guidance is
the product of the Q4B Expert Working
VerDate Aug<31>2005
15:28 Dec 14, 2007
Jkt 214001
Group of the ICH. Comments about this
draft will be considered by FDA and the
Q4B Expert Working Group.
The draft guidance provides the
specific evaluation results from the ICH
Q4B process for the Test for Extractable
Volume of Parenteral Preparations
General Chapter harmonization
proposal originating from the threeparty PDG. This draft guidance is in the
form of an annex to the core ICH Q4B
guidance. Once finalized, the annex will
provide guidance to assist industry and
regulators in the implementation of the
specific topic evaluated by the ICH Q4B
process.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The 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
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on the draft guidance. 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. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Please note that in January 2008, the
FDA Web site is expected to transition
to the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. After the transition
date, electronic submissions will be
accepted by FDA through the FDMS
only. When the exact date of the
transition to FDMS is known, FDA will
publish a Federal Register notice
announcing that date.
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.
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
Dated: December 7, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–24434 Filed 12–14–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0330]
Guidance for Industry and Food and
Drug Administration Review Staff:
Collection of Platelets by Automated
Methods; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a document entitled
‘‘Guidance for Industry and FDA
Review Staff: Collection of Platelets by
Automated Methods,’’ dated December
2007. The guidance document provides
to blood establishments and FDA staff
revised recommendations for the
collection of Platelets by automated
methods (plateletpheresis). The
guidance is intended to help blood
establishments ensure donor safety and
the safety, purity, and potency of
Platelets collected by an automated
blood cell separator device. For the
purpose of this document, Platelets
collected by automated methods will be
referred to by the product name
‘‘Platelets, Pheresis.’’ The document
contains recommendations for
appropriate criteria for a biologics
license application or supplement for
manufacturing Platelets, Pheresis. The
guidance announced in this notice
finalizes the draft guidance of the same
title dated September 2005, and
supersedes the guidance entitled
‘‘Revised Guideline for the Collection of
Platelets, Pheresis,’’ dated October 1988.
DATES: Submit written or electronic
comments on agency guidances at any
time.
Submit written requests for
single copies of the 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,
suite 200N, Rockville, MD 20852–1448.
Send one self-addressed adhesive label
to assist the office in processing your
requests. The guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 301–827–1800. See
ADDRESSES:
E:\FR\FM\17DEN1.SGM
17DEN1
]]>Agencies
[Federal Register Volume 72, Number 241 (Monday, December 17, 2007)]
[Notices]
[Pages 71417-71418]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-24434]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D-0458]
International Conference on Harmonisation; Draft Guidance on Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the
International Conference on Harmonisation Regions; Annex 2 on Test for
Extractable Volume of Parenteral Preparations General Chapter;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Q4B Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions;
Annex 2: Test for Extractable Volume of Parenteral Preparations General
Chapter.'' 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 the results of the ICH Q4B evaluation of the Test for
Extractable Volume of Parenteral Preparations General Chapter
harmonized text from each of the three pharmacopoeias (United States,
European, and Japanese) represented by the Pharmacopoeial Discussion
Group (PDG). The draft guidance conveys recognition of the three
pharmacopoeial methods by the three ICH regulatory regions and provides
specific information regarding the recognition. The draft guidance is
intended to recognize the interchangeability between the local regional
pharmacopoeias, thus avoiding redundant testing in favor of a common
testing strategy in each regulatory region. This is the second annex to
the core Q4B guidance, which was made available in draft in August 2006
(71 FR 45059, August 8, 2006).
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115 (g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by February 15, 2008.
ADDRESSES: 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), 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 CBER at 1-800-835-4709 or 301-827-1800. Send two self-addressed
adhesive labels to assist the office in processing your requests.
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. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Robert H.
King, Sr., Center for Drug Evaluation and Research (HFD-003), Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 21, rm. 3542,
Silver Spring, MD 20993-0002, 301-796-1242; or Christopher Joneckis,
Center for Biologics Evaluation and Research (HFM-20), Food and Drug
[[Page 71418]]
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-435-5681.
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.
In November 2007, the ICH Steering Committee agreed that a draft
guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial
Texts for Use in the ICH Regions; Annex 2: Test for Extractable Volume
of Parenteral Preparations General Chapter'' should be made available
for public comment. The draft guidance is the product of the Q4B Expert
Working Group of the ICH. Comments about this draft will be considered
by FDA and the Q4B Expert Working Group.
The draft guidance provides the specific evaluation results from
the ICH Q4B process for the Test for Extractable Volume of Parenteral
Preparations General Chapter harmonization proposal originating from
the three-party PDG. This draft guidance is in the form of an annex to
the core ICH Q4B guidance. Once finalized, the annex will provide
guidance to assist industry and regulators in the implementation of the
specific topic evaluated by the ICH Q4B process.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The 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 Division of Dockets Management
(see ADDRESSES) written or electronic comments on the draft guidance.
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. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Please note that in January 2008, the FDA Web site is expected to
transition to the Federal Dockets Management System (FDMS). FDMS is a
Government-wide, electronic docket management system. After the
transition date, electronic submissions will be accepted by FDA through
the FDMS only. When the exact date of the transition to FDMS is known,
FDA will publish a Federal Register notice announcing that date.
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: December 7, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-24434 Filed 12-14-07; 8:45 am]
BILLING CODE 4160-01-S
