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65752 Federal Register / Vol. 72, No.

225 / Friday, November 23, 2007 / Notices

III. Paperwork Reduction Act of 1995 DEPARTMENT OF HEALTH AND Administration, 7500 Standish Pl.,
This guidance refers to previously HUMAN SERVICES Rockville, MD 20855, 301–827–6956, e-
approved collections of information mail: dennis.bensley@fda.hhs.gov.
found in FDA regulations. These Food and Drug Administration SUPPLEMENTARY INFORMATION:
collections of information are subject to [Docket No. 1999D–2145] I. Background
review by the Office of Management and
Budget (OMB) under the Paperwork International Cooperation on In recent years, many important
Reduction Act of 1995 (44 U.S.C. 3501– Harmonisation of Technical initiatives have been undertaken by
3520). The collections of information in Requirements for Registration of regulatory authorities and industry
section 2 of the guidance have been Veterinary Medicinal Products; associations to promote the
approved under OMB Control No. 0910– Revised Guidance for Industry on international harmonization of
0032. Impurities in New Veterinary Medicinal regulatory requirements. FDA has
Products (Revision); Availability participated in efforts to enhance
IV. Significance of Guidance harmonization and has expressed its
This revised document, developed AGENCY: Food and Drug Administration, commitment to seek scientifically based
under the VICH process, has been HHS. harmonized technical procedures for the
revised to conform to FDA’s good ACTION: Notice. development of pharmaceutical
guidance practices regulation (21 CFR products. One of the goals of
SUMMARY: The Food and Drug
10.115). For example, the document has harmonization is to identify and then
Administration (FDA) is announcing the
been designated ‘‘guidance’’ rather than reduce differences in technical
availability of a revised guidance for
‘‘guideline.’’ In addition, guidance requirements for drug development
industry (#93) entitled ‘‘Impurities in
documents must not include mandatory among regulatory agencies in different
New Veterinary Medicinal Products
language such as ‘‘shall,’’ ‘‘must,’’ countries.
(Revision)’’ VICH GL11(R). This revised
‘‘require,’’ or ‘‘requirement,’’ unless FDA has actively participated for
guidance has been developed for
FDA is using these words to describe a several years in the International
veterinary use by the International
statutory or regulatory requirement. Conference on Harmonisation of
The revised VICH guidance (GFI #73) Cooperation on Harmonisation of
Technical Requirements for Registration Technical Requirements for Approval of
is consistent with the agency’s current Pharmaceuticals for Human Use to
thinking on the stability testing of new of Veterinary Medicinal Products
(VICH). This revised document is develop harmonized technical
veterinary drug substances and requirements for the approval of human
medicinal products. This guidance does intended to assist in developing
registration applications for approval of pharmaceutical and biological products
not create or confer any rights for or on among the European Union, Japan, and
any person and will not operate to bind veterinary medicinal products
submitted to the European Union, the United States. The VICH is a parallel
FDA or the public. An alternative initiative for veterinary medicinal
method may be used as long as it Japan, and the United States. The
revised guidance addresses only those products. The VICH is concerned with
satisfies the requirements of applicable developing harmonized technical
statutes and regulations. impurities in new veterinary medicinal
drug products classified as degradation requirements for the approval of
V. Comments products. veterinary medicinal products in the
European Union, Japan, and the United
Interested persons may submit to the DATES: Submit written or electronic
States, and includes input from both
Division of Dockets Management (see comments on agency guidances at any regulatory and industry representatives.
ADDRESSES) written or electronic time.
The VICH Steering Committee is
comments regarding this revised ADDRESSES: Submit written requests for composed of member representatives
guidance document. Submit a single single copies of the guidance to the from the European Commission,
copy of electronic comments or two Communications Staff (HFV–12), Center European Medicines Evaluation Agency,
paper copies of any mailed comments, for Veterinary Medicine (CVM), Food European Federation of Animal Health,
except that individuals may submit one and Drug Administration, 7519 Standish Committee on Veterinary Medicinal
paper copy. Comments are to be Pl., Rockville, MD 20855. Send one self- Products, the U.S. FDA, the U.S.
identified with the docket number addressed adhesive label to assist that Department of Agriculture, the Animal
found in brackets in the heading of this office in processing your request. See Health Institute, the Japanese Veterinary
document. A copy of the guidance and the SUPPLEMENTARY INFORMATION section Pharmaceutical Association, the
received comments may be seen in the for electronic access to the guidance Japanese Association of Veterinary
Division of Dockets Management document. Biologics, and the Japanese Ministry of
between 9 a.m. and 4 p.m., Monday Submit written comments to the Agriculture, Forestry, and Fisheries.
through Friday. Division of Dockets Management (HFA– Four observers are eligible to
VI. Electronic Access 305), Food and Drug Administration, participate in the VICH Steering
5630 Fishers Lane, rm. 1061, Rockville, Committee: One representative from the
Persons with access to the Internet
MD 20852. Comments should be government of Australia/New Zealand,
may obtain the guidance at CVM’s home
identified with the full title of the one representative from the industry in
page (http://www.fda.gov/cvm) and from
guidance and the docket number found Australia/New Zealand, one
the Division of Dockets Management
in brackets in the heading of this representative from the government of
Web site (http://www.fda.gov/ohrms/
document. Submit electronic comments Canada, and one representative from the
dockets/default.htm).
mstockstill on PROD1PC66 with NOTICES

on the guidance via the Internet at industry of Canada. The VICH


Dated: November 12, 2007. http://www.fda.gov/dockets/ecomments Secretariat, which coordinates the
Randall W. Lutter, or http://www.regulations.gov. preparation of documentation, is
Deputy Commissioner for Policy. FOR FURTHER INFORMATION CONTACT: provided by the International
[FR Doc. E7–22900 Filed 11–21–07; 8:45 am] Dennis Bensley, Center for Veterinary Federation for Animal Health (IFAH).
BILLING CODE 4160–01–S Medicine (HFV–140), Food and Drug An IFAH representative also

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Federal Register / Vol. 72, No. 225 / Friday, November 23, 2007 / Notices 65753

participates in the VICH Steering V. Comments registered in a country, region, or


Committee meetings. Interested persons may, at any time, member state.
submit written or electronic comments DATES: Submit written or electronic
II. Revised Guidance on Impurities in
New Veterinary Medicinal Products regarding the revised guidance comments on agency guidances at any
document to the Division of Dockets time.
In the Federal Register of January 10, Management (see ADDRESSES). Submit a ADDRESSES: Submit written requests for
2006 (71 FR 1543), FDA published a single copy of electronic comments or single copies of the guidance to the
notice of availability for a draft revised two copies of written comments, except Communications Staff (HFV–12), Center
guidance entitled ‘‘Impurities in New that individuals may submit one copy. for Veterinary Medicine, Food and Drug
Veterinary Medicinal Products Comments are to be identified with the Administration, 7519 Standish Pl.,
(Revision)’’ VICH GL11(R), which gave docket number found in brackets in the Rockville, MD 20855. Send one self-
interested persons until February 9, heading of this document. A copy of the addressed adhesive label to assist that
2006, to comment on the draft revised guidance and received comments are office in processing your request. See
guidance. No comments were received. available for public examination in the the SUPPLEMENTARY INFORMATION section
The revised guidance announced in this Division of Dockets Management for electronic access to the guidance
document finalizes the draft revised between 9 a.m. and 4 p.m., Monday document.
guidance announced on January 10, through Friday. Submit written comments to the
2006. The revised guidance is a product Division of Dockets Management (HFA–
of the Quality Expert Working Group of VI. Electronic Access 305), Food and Drug Administration,
the VICH. Persons with access to the Internet 5630 Fishers Lane, rm. 1061, Rockville,
The document is intended to provide may obtain the guidance from either the MD 20852. Comments should be
guidance for new animal drug CVM home page (http://www.fda.gov/ identified with the full title of the
applications on the content and cvm) or the Division of Dockets guidance and the docket number found
qualification of impurities in new Management Web site (http:// in brackets in the heading of this
veterinary medicinal products produced www.fda.gov/ohrms/dockets/ document. Submit electronic comments
from chemically synthesized new default.htm). on the guidance via the Internet at
veterinary drug substances not Dated: November 12, 2007. http://www.fda.gov/dockets/ecomments
previously registered in a country, Randall W. Lutter, or http://www.regulations.gov.
region, or member State. Deputy Commissioner for Policy. FOR FURTHER INFORMATION CONTACT:
Dennis Bensley, Center for Veterinary
III. Paperwork Reduction Act of 1995 [FR Doc. E7–22901 Filed 11–21–07; 8:45 am]
Medicine (HFV–140), Food and Drug
BILLING CODE 4160–01–S
This guidance refers to previously Administration, 7500 Standish Pl.,
approved collections of information Rockville, MD 20855, 301–827–6956, e-
found in FDA regulations. These DEPARTMENT OF HEALTH AND mail: dennis.bensley@fda.hhs.gov.
collections of information are subject to HUMAN SERVICES SUPPLEMENTARY INFORMATION:
review by the Office of Management and I. Background
Budget (OMB) under the Paperwork Food and Drug Administration
Reduction Act of 1995 (44 U.S.C. 3501– In recent years, many important
[Docket No. 1999D–2215] initiatives have been undertaken by
3520). The collections of information in
sections II through VI of the guidance regulatory authorities and industry
International Cooperation on
have been approved under OMB Control associations to promote the
Harmonisation of Technical
Number 0910–0032. international harmonization of
Requirements for Registration of
regulatory requirements. FDA has
IV. Significance of Guidance Veterinary Medicinal Products;
participated in efforts to enhance
Revised Guidance for Industry on
harmonization and has expressed its
This revised document, developed Impurities in New Veterinary Drug
commitment to seek scientifically based
under the VICH process, has been Substances (Revision); Availability
harmonized technical procedures for the
revised to conform to FDA’s good development of pharmaceutical
AGENCY: Food and Drug Administration,
guidance practices regulation (21 CFR products. One of the goals of
HHS.
10.115). For example, the document has harmonization is to identify and then
been designated ‘‘guidance’’ rather than ACTION: Notice.
reduce differences in technical
‘‘guideline.’’ In addition, guidance SUMMARY: The Food and Drug requirements for drug development
documents must not include mandatory Administration (FDA) is announcing the among regulatory agencies in different
language such as ‘‘shall,’’ ‘‘must,’’ availability of a revised guidance for countries.
‘‘require,’’ or ‘‘requirement,’’ unless industry (#92) entitled ‘‘Impurities in FDA has actively participated for
FDA is using these words to describe a New Veterinary Drug Substances several years in the International
statutory or regulatory requirement. (Revision)’’ VICH GL10(R). This revised Conference on Harmonisation of
The revised VICH guidance (guidance guidance has been developed for Technical Requirements for Approval of
for industry #93) is consistent with the veterinary use by the International Pharmaceuticals for Human Use to
agency’s current thinking on impurities Cooperation on Harmonisation of develop harmonized technical
in new veterinary drug medicinal Technical Requirements for Registration requirements for the approval of human
products. This guidance does not create of Veterinary Medicinal Products pharmaceutical and biological products
mstockstill on PROD1PC66 with NOTICES

or confer any rights for or on any person (VICH). The revised document is among the European Union, Japan, and
and will not operate to bind FDA or the intended to provide guidance for the United States. The VICH is a parallel
public. An alternative method may be registration applicants on the content initiative for veterinary medicinal
used as long as it satisfies the and qualification of impurities in new products. The VICH is concerned with
requirements of applicable statutes and veterinary drug substances produced by developing harmonized technical
regulations. chemical syntheses and not previously requirements for the approval of

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