International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Specifications: Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances; Request for Comments; Availability, 30761-30763 [05-10624]
Download as PDF
<![CDATA[
30761
Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Notices
TABLE 2.—Continued
Item No.
Title of Standard
Reference No. and Date
148
Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials
ASTM F2250–03
149
Standard Test Method for Thickness Measurement of Flexible Packaging Materials
ASTM F2251–03ε1
150
Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using
Tape
ASTM F2252–03
151
Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay
Method
ASTM F2338–04
IV. List of Recognized Standards
FDA maintains the agency’s current
list of FDA recognized consensus
standards in a searchable database that
may be accessed directly at FDA’s
Internet site at https://
www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfStandards/search.cfm.
FDA will incorporate the
modifications and minor revisions
described in this document into the
database and, upon publication in the
Federal Register, this recognition of
consensus standards will be effective.
FDA will announce additional
modifications and minor revisions to
the list of recognized consensus
standards, as needed, in the Federal
Register once a year, or more often, if
necessary.
V. Recommendation of Standards for
Recognition by FDA
Any person may recommend
consensus standards as candidates for
recognition under the new provision of
section 514 of the act by submitting
such recommendations, with reasons for
the recommendation, to the contact
person (see FOR FURTHER INFORMATION
CONTACT). To be properly considered,
such recommendations should contain,
at a minimum, the following
information: (1) Title of the standard, (2)
any reference number and date, (3)
name and address of the national or
international standards development
organization, (4) a proposed list of
devices for which a declaration of
conformity to this standard should
routinely apply, and (5) a brief
identification of the testing or
performance or other characteristics of
the device(s) that would be addressed
by a declaration of conformity.
VI. Electronic Access
In order to receive ‘‘Guidance on the
Recognition and Use of Consensus
Standards’’ via your fax machine, call
the Center for Devices and Radiological
Health (CDRH) Facts-On-Demand
system at 800–899–0381 or 301–827–
VerDate jul<14>2003
16:42 May 26, 2005
Jkt 205001
0111 from a touch-tone telephone. Press
1 to enter the system. At the second
voice prompt, press 1 to order a
document. Enter the document number
321 followed by the pound sign. Follow
the remaining voice prompts to
complete your request.
You may also obtain a copy of
‘‘Guidance on the Recognition and Use
of Consensus Standards’’ by using the
Internet. CDRH maintains a site on the
Internet for easy access to information
including text, graphics, and files that
you may download to a personal
computer with access to the Internet.
Updated on a regular basis, the CDRH
home page includes the guidance as
well as the current list of recognized
standards and other standards related
documents. After publication in the
Federal Register, this document
announcing ‘‘Modification to the List of
Recognized Standards, Recognition List
Number: 012’’ will be available on the
CDRH home page. You may access the
CDRH home page at https://www.fda.gov/
cdrh.
You may access ‘‘Guidance on the
Recognition and Use of Consensus
Standards,’’ and the searchable database
for FDA recognized consensus standards
through the hyperlink at https://
www.fda.gov/cdrh/stdsprog.html.
This Federal Register document on
modifications in FDA’s recognition of
consensus standards is available at
https://www.fda.gov/cdrh/fedregin.html.
VII. Submission of Comments and
Effective Date
Interested persons may submit to the
contact person (see FOR FURTHER
INFORMATION CONTACT) written or
electronic comments regarding this
document. Two copies of any mailed
comments are to be submitted, 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. FDA will consider any
comments received in determining
whether to amend the current listing of
PO 00000
Frm 00087
Fmt 4703
Sfmt 4703
modifications to the list of recognized
standards, Recognition List Number:
012. These modifications to the list or
recognized standards are effective upon
publication of this notice in the Federal
Register.
Dated: May 16, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. 05–10626 Filed 5–26–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0199]
International Cooperation on
Harmonization of Technical
Requirements for Registration of
Veterinary Medicinal Products (VICH);
Draft Guidance for Industry on
Specifications: Test Procedures and
Acceptance Criteria for New Veterinary
Drug Substances and New Medicinal
Products: Chemical Substances;
Request for Comments; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability for comments of a draft
guidance document for industry (#176)
entitled ‘‘Specifications: Test
Procedures and Acceptance Criteria for
New Veterinary Drug Substances and
New Medicinal Products: Chemical
Substances’’ (VICH GL39). This draft
guidance has been developed for
veterinary use by the International
Cooperation on Harmonization of
Technical Requirements for Registration
of Veterinary Medicinal Products
(VICH). This draft VICH guidance
document is intended to assist to the
extent possible, in the establishment of
a single set of recommended global
E:\FR\FM\27MYN1.SGM
27MYN1
30762
Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Notices
specifications for new veterinary drug
substances and medicinal products. It
provides guidance through
recommendations on the setting and
justification of acceptance criteria and
the selection of test procedures for new
drug substances of synthetic chemical
origin, and new medicinal products
produced from them, which have not
been registered previously in the United
States, the European Union, or Japan.
DATES: Submit written or electronic
comments on the draft guidance by June
27, 2005, to ensure their adequate
consideration in preparation of the final
document. General comments on agency
guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Communications Staff (HFV–12), Center
for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. 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.
Comments should be identified with the
full title of the draft guidance and the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Dennis Bensley, Center for Veterinary
Medicine, (HFV–143), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–6956, email: dbensley@cvm.fda.gov.
SUPPLEMENTARY INFORMATION:
Harmonization of Technical
Requirements for Approval of
Pharmaceuticals for Human Use for
several years to develop harmonized
technical requirements for the approval
of human pharmaceutical and biological
products among the European Union,
Japan, and the United States. The VICH
is a parallel initiative for veterinary
medicinal products. The VICH is
concerned with developing harmonized
technical requirements for the approval
of veterinary medicinal products in the
European Union, Japan, and the United
States, and includes input from both
regulatory and industry representatives.
The VICH Steering Committee is
composed of member representatives
from the European Commission;
European Medicines Evaluation Agency;
European Federation of Animal Health;
Committee on Veterinary Medicinal
Products; FDA; the U.S. Department of
Agriculture; the Animal Health
Institute; the Japanese Veterinary
Pharmaceutical Association; the
Japanese Association of Veterinary
Biologics; and the Japanese Ministry of
Agriculture, Forestry, and Fisheries.
Four observers are eligible to
participate in the VICH Steering
Committee: One representative from the
government of Australia/New Zealand,
one representative from the industry in
Australia/New Zealand, one
representative from the government of
Canada, and one representative from the
industry of Canada. The VICH
Secretariat, which coordinates the
preparation of documentation, is
provided by the International
Federation for Animal Health (IFAH).
An IFAH representative also
participates in the VICH Steering
Committee meetings.
I. Background
In recent years, many important
initiatives have been undertaken by
regulatory authorities and industry
associations to promote the
international harmonization of
regulatory requirements. FDA has
participated in efforts to enhance
harmonization and has expressed its
commitment to seek scientifically based
harmonized technical procedures for the
development of pharmaceutical
products. One of the goals of
harmonization is to identify and then
reduce differences in technical
requirements for drug development
among regulatory agencies in different
countries.
FDA has actively participated in the
International Conference on
The VICH Steering Committee held a
meeting in August 2004 and agreed that
the draft guidance document entitled
‘‘Specifications: Test Procedures and
Acceptance Criteria for New Veterinary
Drug Substances and New Medicinal
Products: Chemical Substances’’ (VICH
GL39) should be made available for
public comment. This draft VICH
guidance addresses specifications, i.e.,
those tests, procedures, and acceptance
criteria which play a major role in
assuring the quality of the new
veterinary drug substance and
medicinal product at release and during
shelf life. FDA and the VICH Safety
Working Group will consider comments
about the draft guidance document.
Information collection is covered under
OMB control number 0910–0032.
VerDate jul<14>2003
16:42 May 26, 2005
Jkt 205001
II. Draft Guidance on Chemical
Substance
PO 00000
Frm 00088
Fmt 4703
Sfmt 4703
III. Significance of Guidance
This draft document, developed
under the VICH process, has been
revised to conform to FDA’s good
guidance practices regulation (21 CFR
10.115). For example, the document has
been designated ‘‘guidance’’ rather than
‘‘guideline.’’ Because guidance
documents are not binding, mandatory
words such as ‘‘must,’’ ‘‘shall,’’ and
‘‘will’’ in the original VICH document
have been substituted with ‘‘should.’’
Similarly, words such as ‘‘require’’ or
‘‘requirement’’ have been replaced by
‘‘recommend’’ or ‘‘recommendation’’ as
appropriate to the context. The draft
VICH guidance (#176) is consistent with
the agency’s current thinking on the
new veterinary drug substances and
medicinal products. This guidance does
not create or confer any rights for or on
any person and will not operate to bind
FDA or the public. An alternative
method may be used as long as it
satisfies the requirements of applicable
statutes and regulations.
IV. Comments
This draft guidance document is being
distributed for comment purposes only
and is not intended for implementation
at this time. Interested persons may
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments regarding this draft
guidance 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. A copy of the draft guidance
and received comments are available for
public examination in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
V. Electronic Access
Comments may be submitted
electronically on the Internet at https://
www.fda.gov/dockets/ecomments. Once
on this Internet site, select Docket No.
2005D–0199 entitled ‘‘Specifications:
Test Procedures and Acceptance Criteria
for New Veterinary Drug Substances and
New Medicinal Products: Chemical
Substances’’ (VICH GL39), and follow
the directions.
Copies of the draft guidance
document entitled ‘‘Specifications: Test
Procedures and Acceptance Criteria for
New Veterinary Drug Substances and
New Medicinal Products: Chemical
Substances’’ (VICH GL39) may be
obtained on the Internet from the Center
for Veterinary Medicine’s home page at
https://www.fda.gov/cvm.
E:\FR\FM\27MYN1.SGM
27MYN1
Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Notices
Dated: May 23, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–10624 Filed 5–24–05; 11:50 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0200]
International Cooperation on
Harmonization of Technical
Requirements for Registration of
Veterinary Medicinal Products (VICH);
Draft Guidance for Industry on
Specifications: Test Procedures and
Acceptance Criteria for New
Biotechnological/Biological Veterinary
Medicinal Products; Request for
Comments; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance
document for industry (#177) entitled
‘‘Specifications: Test Procedures and
Acceptance Criteria for New
Biotechnological/Biological Veterinary
Medicinal Products’’ (VICH GL40). This
draft guidance has been developed for
veterinary use by the International
Cooperation on Harmonization of
Technical Requirements for Registration
of Veterinary Medicinal Products
(VICH). This draft VICH guidance
document is intended to provide general
principles through recommendations on
the setting and justification, to the
extent possible, of a uniform set of
international specifications for
biotechnological and biological
products to support new marketing
applications.
Submit written or electronic
comments on the draft guidance by June
27, 2005, to ensure their adequate
consideration in preparation of the final
document. General comments on agency
guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Communications Staff (HFV–12), Center
for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
DATES:
VerDate jul<14>2003
16:42 May 26, 2005
Jkt 205001
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.
Comments should be identified with the
full title of the draft guidance and the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Dennis Bensley, Center for Veterinary
Medicine (HFV–143), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–6956, email: dbensley@cvm.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, many important
initiatives have been undertaken by
regulatory authorities and industry
associations to promote the
international harmonization of
regulatory requirements. FDA has
participated in efforts to enhance
harmonization and has expressed its
commitment to seek scientifically based
harmonized technical procedures for the
development of pharmaceutical
products. One of the goals of
harmonization is to identify and then
reduce differences in technical
requirements for drug development
among regulatory agencies in different
countries.
FDA has actively participated in the
International Conference on
Harmonisation of Technical
Requirements for Approval of
Pharmaceuticals for Human Use for
several years to develop harmonized
technical requirements for the approval
of human pharmaceutical and biological
products among the European Union,
Japan, and the United States. The VICH
is a parallel initiative for veterinary
medicinal products. The VICH is
concerned with developing harmonized
technical requirements for the approval
of veterinary medicinal products in the
European Union, Japan, and the United
States, and includes input from both
regulatory and industry representatives.
The VICH Steering Committee is
composed of member representatives
from the European Commission;
European Medicines Evaluation Agency;
European Federation of Animal Health;
Committee on Veterinary Medicinal
Products; FDA; the U.S. Department of
Agriculture; the Animal Health
Institute; the Japanese Veterinary
Pharmaceutical Association; the
Japanese Association of Veterinary
Biologics; and the Japanese Ministry of
Agriculture, Forestry and Fisheries.
PO 00000
Frm 00089
Fmt 4703
Sfmt 4703
30763
Four observers are eligible to
participate in the VICH Steering
Committee: One representative from the
government of Australia/New Zealand,
one representative from the industry in
Australia/New Zealand, one
representative from the government of
Canada, and one representative from the
industry of Canada. The VICH
Secretariat, which coordinates the
preparation of documentation, is
provided by the International
Federation for Animal Health (IFAH).
An IFAH representative also
participates in the VICH Steering
Committee meetings.
II. Draft Guidance on Biotechnological/
Biological Veterinary Medicinal
Products
The VICH Steering Committee held a
meeting in August 2004 and agreed that
the draft guidance document entitled
‘‘Specifications: Test Procedures and
Acceptance Criteria for New
Biotechnological/Biological Veterinary
Medicinal Products,’’ (VICH GL40)
should be made available for public
comment. This draft VICH guidance
document provides general principles
through recommendations on the setting
and justification, to the extent possible,
of a uniform set of international
specifications for biotechnological and
biological products to support new
marketing applications. The
recommendations in this document
apply to products composed of wellcharacterized proteins and
polypeptides, and their derivatives
which are isolated from tissues, body
fluids, cell cultures, or produced using
recombinant deoxyribonucleic acid (rDNA) technology. Thus, the document
covers the generation and submission of
specifications for products such as
cytokines, growth hormones and growth
factors, insulins, and monoclonal
antibodies. This document does not
cover antibiotics, heparins, vitamins,
cell metabolites, DNA products,
allergenic extracts, vaccines, cells,
whole blood, and cellular blood
components.
FDA and the VICH Safety Working
Group will consider comments about
the draft guidance document.
Information collection is covered under
OMB control number 0910–0032.
III. Significance of Guidance
The draft guidance document,
developed under the VICH process, has
been revised to conform to FDA’s good
guidance practices regulation (21 CFR
10.115). For example, the document has
been designated ‘‘guidance’’ rather than
‘‘guideline.’’ Because guidance
documents are not binding, mandatory
E:\FR\FM\27MYN1.SGM
27MYN1
]]>Agencies
[Federal Register Volume 70, Number 102 (Friday, May 27, 2005)]
[Notices]
[Pages 30761-30763]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-10624]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0199]
International Cooperation on Harmonization of Technical
Requirements for Registration of Veterinary Medicinal Products (VICH);
Draft Guidance for Industry on Specifications: Test Procedures and
Acceptance Criteria for New Veterinary Drug Substances and New
Medicinal Products: Chemical Substances; Request for Comments;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability for comments of a draft guidance document for industry
(176) entitled ``Specifications: Test Procedures and
Acceptance Criteria for New Veterinary Drug Substances and New
Medicinal Products: Chemical Substances'' (VICH GL39). This draft
guidance has been developed for veterinary use by the International
Cooperation on Harmonization of Technical Requirements for Registration
of Veterinary Medicinal Products (VICH). This draft VICH guidance
document is intended to assist to the extent possible, in the
establishment of a single set of recommended global
[[Page 30762]]
specifications for new veterinary drug substances and medicinal
products. It provides guidance through recommendations on the setting
and justification of acceptance criteria and the selection of test
procedures for new drug substances of synthetic chemical origin, and
new medicinal products produced from them, which have not been
registered previously in the United States, the European Union, or
Japan.
DATES: Submit written or electronic comments on the draft guidance by
June 27, 2005, to ensure their adequate consideration in preparation of
the final document. General comments on agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Communications Staff (HFV-12), Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville,
MD 20855. Send one self-addressed adhesive label to assist that office
in processing your requests. 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. Comments should be identified
with the full title of the draft guidance and the docket number found
in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Dennis Bensley, Center for Veterinary
Medicine, (HFV-143), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-6956, e-mail: dbensley@cvm.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote the
international harmonization of regulatory requirements. FDA has
participated in efforts to enhance harmonization and has expressed its
commitment to seek scientifically based harmonized technical procedures
for the development of pharmaceutical products. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for drug development among regulatory agencies in
different countries.
FDA has actively participated in the International Conference on
Harmonization of Technical Requirements for Approval of Pharmaceuticals
for Human Use for several years to develop harmonized technical
requirements for the approval of human pharmaceutical and biological
products among the European Union, Japan, and the United States. The
VICH is a parallel initiative for veterinary medicinal products. The
VICH is concerned with developing harmonized technical requirements for
the approval of veterinary medicinal products in the European Union,
Japan, and the United States, and includes input from both regulatory
and industry representatives.
The VICH Steering Committee is composed of member representatives
from the European Commission; European Medicines Evaluation Agency;
European Federation of Animal Health; Committee on Veterinary Medicinal
Products; FDA; the U.S. Department of Agriculture; the Animal Health
Institute; the Japanese Veterinary Pharmaceutical Association; the
Japanese Association of Veterinary Biologics; and the Japanese Ministry
of Agriculture, Forestry, and Fisheries.
Four observers are eligible to participate in the VICH Steering
Committee: One representative from the government of Australia/New
Zealand, one representative from the industry in Australia/New Zealand,
one representative from the government of Canada, and one
representative from the industry of Canada. The VICH Secretariat, which
coordinates the preparation of documentation, is provided by the
International Federation for Animal Health (IFAH). An IFAH
representative also participates in the VICH Steering Committee
meetings.
II. Draft Guidance on Chemical Substance
The VICH Steering Committee held a meeting in August 2004 and
agreed that the draft guidance document entitled ``Specifications: Test
Procedures and Acceptance Criteria for New Veterinary Drug Substances
and New Medicinal Products: Chemical Substances'' (VICH GL39) should be
made available for public comment. This draft VICH guidance addresses
specifications, i.e., those tests, procedures, and acceptance criteria
which play a major role in assuring the quality of the new veterinary
drug substance and medicinal product at release and during shelf life.
FDA and the VICH Safety Working Group will consider comments about the
draft guidance document. Information collection is covered under OMB
control number 0910-0032.
III. Significance of Guidance
This draft document, developed under the VICH process, has been
revised to conform to FDA's good guidance practices regulation (21 CFR
10.115). For example, the document has been designated ``guidance''
rather than ``guideline.'' Because guidance documents are not binding,
mandatory words such as ``must,'' ``shall,'' and ``will'' in the
original VICH document have been substituted with ``should.''
Similarly, words such as ``require'' or ``requirement'' have been
replaced by ``recommend'' or ``recommendation'' as appropriate to the
context. The draft VICH guidance (176) is consistent with the
agency's current thinking on the new veterinary drug substances and
medicinal products. This guidance does not create or confer any rights
for or on any person and will not operate to bind FDA or the public. An
alternative method may be used as long as it satisfies the requirements
of applicable statutes and regulations.
IV. Comments
This draft guidance document is being distributed for comment
purposes only and is not intended for implementation at this time.
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this draft
guidance 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. A copy of the draft
guidance and received comments are available for public examination in
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
V. Electronic Access
Comments may be submitted electronically on the Internet at https://
www.fda.gov/dockets/ecomments. Once on this Internet site, select
Docket No. 2005D-0199 entitled ``Specifications: Test Procedures and
Acceptance Criteria for New Veterinary Drug Substances and New
Medicinal Products: Chemical Substances'' (VICH GL39), and follow the
directions.
Copies of the draft guidance document entitled ``Specifications:
Test Procedures and Acceptance Criteria for New Veterinary Drug
Substances and New Medicinal Products: Chemical Substances'' (VICH
GL39) may be obtained on the Internet from the Center for Veterinary
Medicine's home page at https://www.fda.gov/cvm.
[[Page 30763]]
Dated: May 23, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-10624 Filed 5-24-05; 11:50 am]
BILLING CODE 4160-01-S
