International Conference on Harmonisation; Draft Guidance on Q8 Pharmaceutical Development; Availability, 6888-6889 [05-2449]
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Federal Register / Vol. 70, No. 26 / Wednesday, February 9, 2005 / Notices
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[FR Doc. 05–2512 Filed 2–8–05; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0021]
International Conference on
Harmonisation; Draft Guidance on Q8
Pharmaceutical Development;
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availability of a draft guidance entitled
VerDate jul<14>2003
16:49 Feb 08, 2005
Jkt 205001
‘‘Q8 Pharmaceutical Development.’’ 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draft guidance was prepared under the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).
This draft guidance describes the
suggested contents for the
pharmaceutical development section in
the quality module of a regulatory
submission in the ICH M4 Common
Technical Document (CTD) format. The
draft guidance is intended to assist in
the development of pharmaceutical
studies that provide scientific
understanding to support the
establishment of specifications and
manufacturing controls and serve as the
basis for evaluating risk management
over the life cycle of the product.
DATES: Submit written or electronic
comments on the draft guidance by
April 11, 2005.
ADDRESSES: 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on the draft guidance to the Division of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.
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 The draft
guidance may also be obtained by mail
by calling the CBER Voice Information
System 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. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Ajaz
Hussain, Center for Drug Evaluation
and Research (HFD–3), Food and
Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–
594–2847; or Christopher Joneckis,
Center for Biologics Evaluation and
Research (HFM–20), Food and Drug
Administration, 1401 Rockville
Pike, Rockville, MD 20852, 301–
435–5681.
Regarding the ICH: Michelle Limoli,
Office of International Programs
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
(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 Center for Drug
Evaluation and Research and the Center
for 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.
During the July 2003 ICH meeting in
Brussels, agreement was reached on a
common vision and approach for
developing an international plan for a
harmonized pharmaceutical quality
system that would be applicable across
the life cycle of a product. This plan
emphasizes an integrated approach to
review (assessment) and inspection
based on scientific risk management.
One aspect of the plan was the
establishment of an expert working
E:\FR\FM\09FEN1.SGM
09FEN1
Federal Register / Vol. 70, No. 26 / Wednesday, February 9, 2005 / Notices
group to develop guidance for
pharmaceutical development
throughout the life cycle of a product.
In November 2004, the ICH Steering
Committee agreed that a draft guidance
entitled ‘‘Q8 Pharmaceutical
Development’’ should be made available
for public comment. The draft guidance
is the product of the Quality Expert
Working Group of the ICH. Comments
about this draft will be considered by
FDA and the Quality Expert Working
Group.
This document is a significant
element in FDA’s initiative,
‘‘Pharmaceutical Current Good
Manufacturing Practices for the 21
Century,’’ which encourages review of
current manufacturing science practices.
Scientific information obtained during
the design of a product and from the
pharmaceutical development studies is
important for the development and
selection of a product formulation that
meets the purpose specified in the
product application.
The draft guidance describes the
suggested contents for the
pharmaceutical development section
(section 3.2.P.2 of module 3: Quality) of
a regulatory submission in the CTD
format. The draft guidance is intended
to assist in the development of
pharmaceutical studies that provide
scientific understanding to support the
establishment of specifications and
manufacturing controls and serve as the
basis for evaluating risk management
over the life cycle of the product.
This draft guidance applies to
pharmaceutical studies as defined in
section 3.2.P.2 of module 3 of the CTD.
The draft guidance does not apply to
submissions for drug products during
the clinical research stages. However,
the principles described in the draft
guidance are important to consider
during product development.
This 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 this 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
VerDate jul<14>2003
16:49 Feb 08, 2005
Jkt 205001
heading of this document. The draft
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: February 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–2449 Filed 2–8–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
New Mexico State University/Food and
Drug Administration Food Labeling;
Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
SUMMARY: The Food and Drug
Administration (FDA), Office of
Regulatory Affairs (ORA), Southwest
Regional Small Business Representative
Program (SWR SBR), in collaboration
with New Mexico State University
(NMSU), Department of Extension
Home Economics is announcing a
public workshop entitled ‘‘NMSU/FDA
Food Labeling Workshop.’’ This public
workshop is intended to provide
information about FDA food labeling
regulations and other related subjects to
the regulated industry, particularly
small businesses and startups.
Date and Time: The public workshop
will be held on March 21, 2005, from 8
a.m. to 5 p.m. and on March 22, 2005,
from 8 a.m. to 3 p.m.
Location: The public workshop will
be held at NMSU, Las Cruces, NM
88003, Gerald Thomas Hall, rm. 337.
Directions to the facility are available at
https://www.nmsu.edu/General/Maps/.1
Contact: Gloria Hernandez, New
Mexico State University, P.O. Box
30003, MSC 3AE, Las Cruces, NM
88003, 505–646–2198, FAX 505–646–
1889, or e-mail: glorhern@nmsu.edu.
Registration: Registration by March
11, 2005, is encouraged. NMSU has an
$89 registration fee to cover the cost of
1FDA has verified the Web site address but is not
responsible for subsequent changes to the Web site
after this document publishes in the Federal
Register.
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
6889
facilities, materials, speakers, and
breaks. Seats are limited to 80 people,
please submit your registration as soon
as possible. Course space will be filled
in order of receipt of registration. Those
accepted into the course will receive
confirmation. Registration will close
after the course is filled. Registration at
the site is not guaranteed but may be
possible on a space available basis on
the day of the public workshop
beginning at 8 a.m. The cost of
registration at the site is $99 payable to
New Mexico State University. If you
need special accommodations due to a
disability, please contact Gloria
Hernandez (see Contact) at least 7 days
in advance.
Registration Form Instructions: To
register, please complete the form below
and send along with a check or money
order for $89 payable to the New
Mexico State University. Mail to: New
Mexico State University, P.O. Box
30003, MSC 3AE, Las Cruces, NM
88003–8003. After March 11, 2005, the
registration cost is $99. Credit card
payment is not available.
Name: ____________________
Affiliation: ____________________
Mailing address: ____________________
City: ____________________
State:_______ Zip Code: ____________
Phone: (
) _______________________
Fax: (
) _______________________
E-mail: (
) ____________________
Special Accommodations Required:
________________________________
Transcripts: Transcripts of the public
workshop will not be available due to
the format of this workshop. Course
handouts may be requested at cost
through the Freedom of Information
Office (HFI–35), Food and Drug
Administration, 5600 Fishers Lane, rm.
12A–16, Rockville, MD 20857,
approximately 15 working days after the
public workshop at a cost of 10 cents
per page.
SUPPLEMENTARY INFORMATION: The FDA
Southwest Regional Small Business
Representative previously presented
this workshop in Kansas City, MO on
December 21, 2001 (66 FR 65976), and
in Dallas, TX on March 29, 2002 (67 FR
15211).
This public workshop is being held in
response to the large volume of food
labeling inquiries from small food
manufacturers and startups originating
from the area covered by the FDA
Denver District Office. The Southwest
Regional Small Business Representative
presents these workshops to help
achieve objectives set forth in section
406 of the Food and Drug
Administration Modernization Act of
1997 (21 U.S.C. 393), which include
E:\FR\FM\09FEN1.SGM
09FEN1
]]>Agencies
[Federal Register Volume 70, Number 26 (Wednesday, February 9, 2005)]
[Notices]
[Pages 6888-6889]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-2449]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0021]
International Conference on Harmonisation; Draft Guidance on Q8
Pharmaceutical Development; 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 ``Q8 Pharmaceutical
Development.'' 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). This draft
guidance describes the suggested contents for the pharmaceutical
development section in the quality module of a regulatory submission in
the ICH M4 Common Technical Document (CTD) format. The draft guidance
is intended to assist in the development of pharmaceutical studies that
provide scientific understanding to support the establishment of
specifications and manufacturing controls and serve as the basis for
evaluating risk management over the life cycle of the product.
DATES: Submit written or electronic comments on the draft guidance by
April 11, 2005.
ADDRESSES: 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. 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
draft guidance may also be obtained by mail by calling the CBER Voice
Information System 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. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Ajaz Hussain, Center for Drug Evaluation
and Research (HFD-3), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-594-2847; or Christopher Joneckis, Center for
Biologics Evaluation and Research (HFM-20), Food and Drug
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 Center for Drug
Evaluation and Research and the Center for 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.
During the July 2003 ICH meeting in Brussels, agreement was reached
on a common vision and approach for developing an international plan
for a harmonized pharmaceutical quality system that would be applicable
across the life cycle of a product. This plan emphasizes an integrated
approach to review (assessment) and inspection based on scientific risk
management. One aspect of the plan was the establishment of an expert
working
[[Page 6889]]
group to develop guidance for pharmaceutical development throughout the
life cycle of a product.
In November 2004, the ICH Steering Committee agreed that a draft
guidance entitled ``Q8 Pharmaceutical Development'' should be made
available for public comment. The draft guidance is the product of the
Quality Expert Working Group of the ICH. Comments about this draft will
be considered by FDA and the Quality Expert Working Group.
This document is a significant element in FDA's initiative,
``Pharmaceutical Current Good Manufacturing Practices for the 21
Century,'' which encourages review of current manufacturing science
practices. Scientific information obtained during the design of a
product and from the pharmaceutical development studies is important
for the development and selection of a product formulation that meets
the purpose specified in the product application.
The draft guidance describes the suggested contents for the
pharmaceutical development section (section 3.2.P.2 of module 3:
Quality) of a regulatory submission in the CTD format. The draft
guidance is intended to assist in the development of pharmaceutical
studies that provide scientific understanding to support the
establishment of specifications and manufacturing controls and serve as
the basis for evaluating risk management over the life cycle of the
product.
This draft guidance applies to pharmaceutical studies as defined in
section 3.2.P.2 of module 3 of the CTD. The draft guidance does not
apply to submissions for drug products during the clinical research
stages. However, the principles described in the draft guidance are
important to consider during product development.
This 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 this 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. The draft 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: February 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-2449 Filed 2-8-05; 8:45 am]
BILLING CODE 4160-01-S
