International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex on Test for Extractable Volume of Parenteral Preparations General Chapter; Availability, 908-909 [E9-155]
Download as PDF
<![CDATA[
908
Federal Register / Vol. 74, No. 6 / Friday, January 9, 2009 / Notices
evaluation. In table 1 of this document,
row 1 shows that for 20 evaluations, the
total burden for these 4 data
components is 80 hours.
Two data components ask for original
data to be generated. One data
component consists of a bioinformatics
analysis which can be performed using
publicly available databases. The other
data component involves ‘‘wet’’ lab
work to assess the new protein’s
stability and the resistance of the
protein to enzymatic degradation using
appropriate in vitro assays (protein
digestibility study). The paperwork
burden of these two data components
consists of the time it takes the company
to assemble the information on these
two data components to submit to FDA.
We estimate that these two data
components will take 16 hours to
complete (8 hours for each component).
In table 1 of this document, row 2 shows
that for 20 evaluations, the total burden
for these two data components is 320
hours.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
Dated: December 30, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–213 Filed 1–8–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0081] (formerly
Docket No. 2006D–0297)
International Conference on
Harmonisation; Guidance on Q4B
Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the
International Conference on
Harmonisation Regions; Annex on
Test for Extractable Volume of
Parenteral Preparations General
Chapter; Availability
mstockstill on PROD1PC66 with NOTICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance entitled ‘‘Q4B
Evaluation and Recommendation of
VerDate Nov<24>2008
16:16 Jan 08, 2009
Jkt 217001
Pharmacopoeial Texts for Use in the
ICH Regions; Annex 2: Test for
Extractable Volume of Parenteral
Preparations General Chapter.’’ 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 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 guidance conveys
recognition of the three pharmacopoeial
methods by the three ICH regulatory
regions and provides specific
information regarding the recognition.
The 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. In the Federal Register of
February 21, 2008 (73 FR 9575), FDA
made available a guidance on the Q4B
process entitled ‘‘Q4B Evaluation and
Recommendation of Pharmacopoeial
Texts for Use in the ICH Regions.’’
DATES: Submit written or electronic
comments on agency guidances at any
time.
ADDRESSES: 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, 10903 New Hampshire
Ave., Bldg. 51, rm. 2201, Silver Spring,
MD 20993–0002; 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,
suite 200N, 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 selfaddressed adhesive labels to assist the
office in processing your requests.
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.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Robert H.
King, Sr., Center for Drug
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
Evaluation and Research (HFD–
003), Food and Drug
Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 4150,
Silver Spring, MD 20993–0002,
301–796–1242; or
Christopher Joneckis, Center for
Biologics Evaluation and Research
(HFM–1), Food and Drug
Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD
20852–1448, 301–827–0373.
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
E:\FR\FM\09JAN1.SGM
09JAN1
Federal Register / Vol. 74, No. 6 / Friday, January 9, 2009 / Notices
mstockstill on PROD1PC66 with NOTICES
Organization, Health Canada, and the
European Free Trade Area.
In the Federal Register of December
17, 2007 (72 FR 71417), FDA published
a notice announcing the availability of
a draft tripartite 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
notice gave interested persons an
opportunity to submit comments by
February 15, 2008.
After consideration of the comments
received and revisions to the guidance,
a final 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’’ was
submitted to the ICH Steering
Committee and endorsed by the three
participating regulatory agencies in June
2008.
The guidance provides the specific
evaluation outcome from the ICH Q4B
process for the Test for Extractable
Volume of Parenteral Preparations
General Chapter harmonization
proposal originating from the threeparty PDG. This guidance is in the form
of an annex to the core ICH Q4B
guidance. When implemented, the
annex will provide guidance for
industry and regulators on the use of the
specific pharmacopoeial texts evaluated
by the ICH Q4B process. Following
receipt of comments on the draft, no
substantive changes were made to the
annex.
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 regarding this document.
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.
VerDate Nov<24>2008
16:16 Jan 08, 2009
Jkt 217001
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.regulations.gov, https://
www.fda.gov/cder/guidance/index.htm,
or https://www.fda.gov/cber/
guidelines.htm.
Dated: December 30, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–155 Filed 1–8–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0306] (formerly
Docket No. 2007D–0459)
International Conference on
Harmonisation; Guidance on Q4B
Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the
International Conference on
Harmonisation Regions; Annex on
Test for Particulate Contamination:
Subvisible Particles General Chapter;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a 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.’’ 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 the results of the
ICH Q4B evaluation of the Test for
Particulate Contamination: Subvisible
Particles General Chapter harmonized
text from each of the three
pharmacopoeias (United States,
European, and Japanese) represented by
the Pharmacopoeial Discussion Group
(PDG). The guidance conveys
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
909
recognition of the three pharmacopoeial
methods by the three ICH regulatory
regions and provides specific
information regarding the recognition.
The 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. In the Federal Register of
February 21, 2008 (73 FR 9575), FDA
made available a guidance on the Q4B
process entitled ‘‘Q4B Evaluation and
Recommendation of Pharmacopoeial
Texts for Use in the ICH Regions.’’
DATES: Submit written or electronic
comments on agency guidances at any
time.
ADDRESSES: 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, 10903 New Hampshire
Ave., Bldg. 51, rm. 2201, Silver Spring,
MD 20993–0002; 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,
suite 200N, 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 selfaddressed adhesive labels to assist the
office in processing your requests.
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.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the 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. 51, rm. 4150,
Silver Spring, MD 20993–0002,
301–796–1242; or
Christopher Joneckis, Center for
Biologics Evaluation and Research
(HFM–1), Food and Drug
Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD
20852–1448, 301–827–0373.
Regarding the ICH: Michelle Limoli,
Office of International Programs
(HFG–1), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–
4480.
E:\FR\FM\09JAN1.SGM
09JAN1
]]>Agencies
[Federal Register Volume 74, Number 6 (Friday, January 9, 2009)]
[Notices]
[Pages 908-909]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-155]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0081] (formerly Docket No. 2006D-0297)
International Conference on Harmonisation; Guidance on Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the
International Conference on Harmonisation Regions; Annex 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 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
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 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 guidance
conveys recognition of the three pharmacopoeial methods by the three
ICH regulatory regions and provides specific information regarding the
recognition. The 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. In the Federal Register of February 21, 2008
(73 FR 9575), FDA made available a guidance on the Q4B process entitled
``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in
the ICH Regions.''
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: 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, 10903 New Hampshire Ave.,
Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002; 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, suite 200N, 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 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.regulations.gov. See the SUPPLEMENTARY INFORMATION section for
electronic access to the 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. 51, rm. 4150, Silver Spring, MD 20993-0002,
301-796-1242; or
Christopher Joneckis, Center for Biologics Evaluation and Research
(HFM-1), Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852-1448, 301-827-0373.
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
[[Page 909]]
Organization, Health Canada, and the European Free Trade Area.
In the Federal Register of December 17, 2007 (72 FR 71417), FDA
published a notice announcing the availability of a draft tripartite
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 notice gave
interested persons an opportunity to submit comments by February 15,
2008.
After consideration of the comments received and revisions to the
guidance, a final 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'' was submitted to the ICH Steering Committee and endorsed by
the three participating regulatory agencies in June 2008.
The guidance provides the specific evaluation outcome 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 guidance is in the form of an annex to the
core ICH Q4B guidance. When implemented, the annex will provide
guidance for industry and regulators on the use of the specific
pharmacopoeial texts evaluated by the ICH Q4B process. Following
receipt of comments on the draft, no substantive changes were made to
the annex.
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 regarding this document.
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 on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at https://www.regulations.gov.
III. Electronic Access
Persons with access to the Internet may obtain the document at
https://www.regulations.gov, https://www.fda.gov/cder/guidance/index.htm,
or https://www.fda.gov/cber/guidelines.htm.
Dated: December 30, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-155 Filed 1-8-09; 8:45 am]
BILLING CODE 4160-01-S
