International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex on Residue on Ignition/Sulphated Ash General Chapter; Availability, 9576-9577 [E8-3187]
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Federal Register / Vol. 73, No. 35 / Thursday, February 21, 2008 / 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 the Federal Register of August 8,
2006 (71 FR 45059), FDA published a
notice announcing the availability of a
draft guidance entitled ‘‘Q4B Regulatory
Acceptance of Analytical Procedures
and/or Acceptance Criteria.’’ The notice
gave interested persons an opportunity
to submit comments by October 10,
2006.
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a final draft guidance entitled ‘‘Q4B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’’ was submitted to the ICH
Steering Committee and endorsed by the
three participating regulatory agencies
in November 2007.
The guidance provides information on
a Q4B process for evaluating
harmonization proposals for specific
pharmacopeial topics originating from
the three-party Pharmacopoeial
Discussion Group (PDG) or from
individual PDG pharmacopeias. The
PDG consists of representatives from the
European Directorate for the Quality of
Medicines in the Council of Europe; the
Japanese Ministry of Health, Labour and
Welfare, and the United States
Pharmacopeial Convention, Inc. The
results of the individual Q4B
evaluations will move forward as topicspecific annexes to the core Q4B
guidance. Each annex will be issued
separately following the ICH step
process, providing guidance to assist
industry and regulators in the
implementation of the specific topic
evaluated by the ICH Q4B process.
Following the receipt of comments on
the draft guidance, the Q4B EWG made
no substantive changes to the Q4B
process or the use of annexes to convey
the results of Q4B evaluations. The title
of the guidance, as well as some of the
VerDate Aug<31>2005
16:34 Feb 20, 2008
Jkt 214001
text, was revised to more closely reflect
the actual workings and process of the
Q4B EWG.
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 Q4B evaluation and
recommendation of pharmacopoeial
texts for use in the ICH regions. 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.
Food and Drug Administration
[Docket No. FDA–2008–D–0083 (formerly
Docket No. 2006D–0296)]
International Conference on
Harmonisation; Guidance on Q4B
Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the
ICH Regions; Annex on Residue on
Ignition/Sulphated Ash General
Chapter; Availability
AGENCY:
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 Web site transitioned to the
Federal Dockets Management System
(FDMS). FDMS is a Government-wide,
electronic docket management system.
Electronic submissions will be accepted
by FDA through FDMS only.
III. Electronic Access
Persons with access to the Internet
may obtain the document athttps://
www.fda.gov/ohrms/dockets/
default.htm, https://www.fda.gov/cder/
guidance/index.htm, or https://
www.fda.gov/cber/publications.htm.
Dated: February 12, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8–3186 Filed 2–20–08; 8:45 am]
BILLING CODE 4160–01–S
Food and Drug Administration,
HHS.
ACTION:
II. Comments
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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 1: Residue on
Ignition/Sulphated Ash 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
Residue on Ignition/Sulphated Ash
General Chapter harmonized text from
each of the three pharmacopeias (United
States, European, and Japanese)
represented by the Pharmacopoeial
Discussion Group (PDG). The guidance
conveys recognition of the three
pharmacopeial methods by the three
ICH regulatory regions and provides
specific information regarding the
recognition. The guidance is intended to
recognize the interchangeability among
these texts from the local regional
pharmacopeias, thus avoiding
redundant testing in favor of a common
testing strategy in each regulatory
region. Elsewhere in this issue of the
Federal Register, FDA is announcing
the availability of 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 guidance at any
time.
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),
ADDRESSES:
Frm 00061
Fmt 4703
Sfmt 4703
E:\FR\FM\21FEN1.SGM
21FEN1
Federal Register / Vol. 73, No. 35 / Thursday, February 21, 2008 / Notices
pwalker on PROD1PC71 with NOTICES
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. Requests and
comments should be identified with the
docket number found in brackets in the
heading of this document. 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. 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
Administration, 1401 Rockville
Pike, Rockville, MD 20852–1448,
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
VerDate Aug<31>2005
16:34 Feb 20, 2008
Jkt 214001
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 the Federal Register of August 8,
2006 (71 FR 45058), FDA published a
notice announcing the availability of a
draft guidance entitled ‘‘Q4B Regulatory
Acceptance of Analytical Procedures
and/or Acceptance Criteria; Annex 1:
Residue on Ignition/Sulphated Ash
General Chapter.’’ The notice gave
interested persons an opportunity to
submit comments by October 10, 2006.
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 1: Residue on
Ignition/Sulphated Ash General
Chapter’’ was submitted to the ICH
Steering Committee and endorsed by the
three participating regulatory agencies
in November 2007.
The guidance provides the specific
evaluation outcome from the ICH Q4B
process for the Residue on Ignition/
Sulphated Ash 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 pharmacopeial texts evaluated
by the ICH Q4B process. Following
receipt of comments on the draft, no
substantive changes were made to the
annex. The title of the core Q4B
guidance was changed to more closely
reflect the actual workings and process
of the Q4B EWG.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
9577
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, at any time,
submit to the Division of Dockets
Management (see ADDRESSES) written
comments on the 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 office above between 9 a.m.
and 4 p.m., Monday through Friday.
Please note that on January 15, 2008,
the FDA Web site transitioned to the
Federal Dockets Management System
(FDMS). FDMS is a Government-wide,
electronic docket management system.
Electronic submissions will be accepted
by FDA through FDMS only.
III. Electronic Access
Persons with access to the Internet
may obtain the document athttps://
www.fda.gov/ohrms/dockets/
default.htm, https://www.fda.gov/cder/
guidance/index.htm, or https://
www.fda.gov/cber/publications.htm.
Dated: February 12, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8–3187 Filed 2–20–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; Process Evaluation
of the Global Health Research Initiative
Program for New Foreign Investigators
(GRIP)
SUMMARY: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Fogarty
International Center (FIC), the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request to review and approve
the information collection listed below.
This proposed information collection
was previously published in the Federal
Register on November 30, 2007, and
allowed 60 days for public comment. No
public comments were received. The
E:\FR\FM\21FEN1.SGM
21FEN1
Agencies
[Federal Register Volume 73, Number 35 (Thursday, February 21, 2008)]
[Notices]
[Pages 9576-9577]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-3187]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0083 (formerly Docket No. 2006D-0296)]
International Conference on Harmonisation; Guidance on Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the
ICH Regions; Annex on Residue on Ignition/Sulphated Ash 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 1: Residue on
Ignition/Sulphated Ash 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 Residue on Ignition/Sulphated Ash General Chapter harmonized
text from each of the three pharmacopeias (United States, European, and
Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The
guidance conveys recognition of the three pharmacopeial methods by the
three ICH regulatory regions and provides specific information
regarding the recognition. The guidance is intended to recognize the
interchangeability among these texts from the local regional
pharmacopeias, thus avoiding redundant testing in favor of a common
testing strategy in each regulatory region. Elsewhere in this issue of
the Federal Register, FDA is announcing the availability of 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 guidance 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, 5600 Fishers Lane,
Rockville, MD 20857, or the Office of Communication, Training and
Manufacturers Assistance (HFM-40),
[[Page 9577]]
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. Requests and comments should be
identified with the docket number found in brackets in the heading of
this document. 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. 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 Administration, 1401 Rockville Pike, Rockville,
MD 20852-1448, 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 the Federal Register of August 8, 2006 (71 FR 45058), FDA
published a notice announcing the availability of a draft guidance
entitled ``Q4B Regulatory Acceptance of Analytical Procedures and/or
Acceptance Criteria; Annex 1: Residue on Ignition/Sulphated Ash General
Chapter.'' The notice gave interested persons an opportunity to submit
comments by October 10, 2006.
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 1: Residue on Ignition/Sulphated Ash General Chapter'' was
submitted to the ICH Steering Committee and endorsed by the three
participating regulatory agencies in November 2007.
The guidance provides the specific evaluation outcome from the ICH
Q4B process for the Residue on Ignition/Sulphated Ash 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 pharmacopeial texts evaluated by
the ICH Q4B process. Following receipt of comments on the draft, no
substantive changes were made to the annex. The title of the core Q4B
guidance was changed to more closely reflect the actual workings and
process of the Q4B EWG.
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, at any time, submit to the Division of
Dockets Management (see ADDRESSES) written comments on the 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
office above between 9 a.m. and 4 p.m., Monday through Friday.
Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will
be accepted by FDA through FDMS only.
III. Electronic Access
Persons with access to the Internet may obtain the document
athttps://www.fda.gov/ohrms/dockets/default.htm, https://www.fda.gov/
cder/guidance/index.htm, or https://www.fda.gov/cber/publications.htm.
Dated: February 12, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-3187 Filed 2-20-08; 8:45 am]
BILLING CODE 4160-01-S