International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Revised Guidance for Industry on Impurities in New Veterinary Drug Substances (Revision); Availability, 65753-65754 [E7-22902]

Download as PDF Federal Register / Vol. 72, No. 225 / Friday, November 23, 2007 / Notices V. Comments participates in the VICH Steering Committee meetings. II. Revised Guidance on Impurities in New Veterinary Medicinal Products In the Federal Register of January 10, 2006 (71 FR 1543), FDA published a notice of availability for a draft revised guidance entitled ‘‘Impurities in New Veterinary Medicinal Products (Revision)’’ VICH GL11(R), which gave interested persons until February 9, 2006, to comment on the draft revised guidance. No comments were received. The revised guidance announced in this document finalizes the draft revised guidance announced on January 10, 2006. The revised guidance is a product of the Quality Expert Working Group of the VICH. The document is intended to provide guidance for new animal drug applications on the content and qualification of impurities in new veterinary medicinal products produced from chemically synthesized new veterinary drug substances not previously registered in a country, region, or member State. III. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in sections II through VI of the guidance have been approved under OMB Control Number 0910–0032. mstockstill on PROD1PC66 with NOTICES IV. Significance of Guidance This revised 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.’’ In addition, guidance documents must not include mandatory language such as ‘‘shall,’’ ‘‘must,’’ ‘‘require,’’ or ‘‘requirement,’’ unless FDA is using these words to describe a statutory or regulatory requirement. The revised VICH guidance (guidance for industry #93) is consistent with the agency’s current thinking on impurities in new veterinary drug 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. VerDate Aug<31>2005 16:16 Nov 21, 2007 Jkt 214001 Interested persons may, at any time, submit written or electronic comments regarding the revised guidance document to the Division of Dockets Management (see ADDRESSES). Submit a single copy of electronic comments or two copies of written comments, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. A copy of the 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. VI. Electronic Access Persons with access to the Internet may obtain the guidance from either the CVM home page (https://www.fda.gov/ cvm) or the Division of Dockets Management Web site (https:// www.fda.gov/ohrms/dockets/ default.htm). Dated: November 12, 2007. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E7–22901 Filed 11–21–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 1999D–2215] International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Revised Guidance for Industry on Impurities in New Veterinary Drug Substances (Revision); Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry (#92) entitled ‘‘Impurities in New Veterinary Drug Substances (Revision)’’ VICH GL10(R). This revised guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The revised document is intended to provide guidance for registration applicants on the content and qualification of impurities in new veterinary drug substances produced by chemical syntheses and not previously PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 65753 registered in a country, region, or member state. DATES: Submit written or electronic comments on agency guidances at any time. ADDRESSES: Submit written requests for single copies of the 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 request. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Comments should be identified with the full title of the guidance and the docket number found in brackets in the heading of this document. Submit electronic comments on the guidance via the Internet at https://www.fda.gov/dockets/ecomments or https://www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Dennis Bensley, Center for Veterinary Medicine (HFV–140), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–6956, email: dennis.bensley@fda.hhs.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 for several years in the International Conference on Harmonisation of Technical Requirements for Approval of Pharmaceuticals for Human Use 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 E:\FR\FM\23NON1.SGM 23NON1 65754 Federal Register / Vol. 72, No. 225 / Friday, November 23, 2007 / Notices mstockstill on PROD1PC66 with NOTICES 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, the U.S. 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. Revised Guidance on Impurities in New Veterinary Drug Substances In the Federal Register of January 4, 2006 (71 FR 351), FDA published a notice of availability for a draft revised guidance entitled ‘‘Impurities in New Veterinary Drug Substances (Revision)’’ VICH GL10(R) giving interested persons until February 3, 2006, to comment on the draft revised guidance. No comments were received. The revised guidance announced in this document finalizes the draft revised guidance announced on January 4, 2006. The revised guidance has been amended to add to the glossary a definition for the term ‘‘Degradation Products’’. The document is intended to provide guidance for new animal drug applicants (referred to in the guidance as registration applicants) on the content and qualification of impurities in new veterinary drug substances intended to be used for new veterinary medicinal products produced by chemical synthesis and not previously registered in a country, region, or member state. The revised guidance is the product of the Quality Expert Working Group of the VICH. III. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These VerDate Aug<31>2005 16:16 Nov 21, 2007 Jkt 214001 collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in sections 2 through 7 of the guidance have been approved under OMB Control Number 0910–0032. IV. Significance of Guidance This revised 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.’’ In addition, guidance documents must not include mandatory language such as ‘‘shall,’’ ‘‘must,’’ ‘‘required,’’ or ‘‘requirement,’’ unless FDA is using these words to describe a statutory or regulatory requirement. The revised VICH guidance (guidance for industry #92) is consistent with the agency’s current thinking on impurities in new veterinary drug substances. 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. V. Comments Interested persons may, at any time, submit written or electronic comments regarding the revised guidance document to the Division of Dockets Management (see ADDRESSES). Submit a single copy of electronic comments or two copies of written comments, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. A copy of the 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. VI. Electronic Access Persons with access to the Internet may obtain the guidance from either the CVM home page (https://www.fda.gov/ cvm) or the Division of Dockets Management Web site (https:// www.fda.gov/ohrms/dockets/ default.htm). Dated: November 12, 2007. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E7–22902 Filed 11–21–07; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: SUMMARY: The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. ADDRESSES: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852–3804; telephone: 301/ 496–7057; fax: 301/402–0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. Inactivation of Enveloped Viruses and Tumor Cells for Infectious Disease and Cancer Vaccines Description of Invention: The current technology describes the inactivation of viruses, parasites, and tumor cells by the hydrophobic photoactivatable compound 1,5-iodoanpthylazide (INA). This non-toxic compound will diffuse into the lipid bilayer of biological membranes and upon irradiation with light will bind to proteins and lipids in this domain, thereby inactivating fusion of enveloped viruses with their corresponding target cells. Furthermore, the selective binding of INA to protein domains in the lipid bilayer preserves the structural integrity and therefore immunogenicity of proteins on the exterior of the inactivated virus. This technology is universally applicable to other microorganisms that are surrounded by biological membranes like parasites and tumor cells. The broad utility of the subject technology has been demonstrated using influenza virus, HIV, SIV, Ebola and equine encephalitis virus (VEE) as representative examples. The inactivation approach for vaccine development presented in this technology provides for a safe, non- E:\FR\FM\23NON1.SGM 23NON1

Agencies

[Federal Register Volume 72, Number 225 (Friday, November 23, 2007)]
[Notices]
[Pages 65753-65754]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-22902]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1999D-2215]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products; Revised 
Guidance for Industry on Impurities in New Veterinary Drug Substances 
(Revision); Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a revised guidance for industry (92) entitled 
``Impurities in New Veterinary Drug Substances (Revision)'' VICH 
GL10(R). This revised guidance has been developed for veterinary use by 
the International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products (VICH). 
The revised document is intended to provide guidance for registration 
applicants on the content and qualification of impurities in new 
veterinary drug substances produced by chemical syntheses and not 
previously registered in a country, region, or member state.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of the 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 request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.
    Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Comments should be identified with the full title 
of the guidance and the docket number found in brackets in the heading 
of this document. Submit electronic comments on the guidance via the 
Internet at https://www.fda.gov/dockets/ecomments or https://
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Dennis Bensley, Center for Veterinary 
Medicine (HFV-140), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-6956, e-mail: dennis.bensley@fda.hhs.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 for several years in the 
International Conference on Harmonisation of Technical Requirements for 
Approval of Pharmaceuticals for Human Use 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

[[Page 65754]]

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, the U.S. 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. Revised Guidance on Impurities in New Veterinary Drug Substances

    In the Federal Register of January 4, 2006 (71 FR 351), FDA 
published a notice of availability for a draft revised guidance 
entitled ``Impurities in New Veterinary Drug Substances (Revision)'' 
VICH GL10(R) giving interested persons until February 3, 2006, to 
comment on the draft revised guidance. No comments were received. The 
revised guidance announced in this document finalizes the draft revised 
guidance announced on January 4, 2006. The revised guidance has been 
amended to add to the glossary a definition for the term ``Degradation 
Products''.
    The document is intended to provide guidance for new animal drug 
applicants (referred to in the guidance as registration applicants) on 
the content and qualification of impurities in new veterinary drug 
substances intended to be used for new veterinary medicinal products 
produced by chemical synthesis and not previously registered in a 
country, region, or member state. The revised guidance is the product 
of the Quality Expert Working Group of the VICH.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in sections 2 through 7 of the guidance have 
been approved under OMB Control Number 0910-0032.

IV. Significance of Guidance

    This revised 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.'' In addition, guidance documents must not 
include mandatory language such as ``shall,'' ``must,'' ``required,'' 
or ``requirement,'' unless FDA is using these words to describe a 
statutory or regulatory requirement.
    The revised VICH guidance (guidance for industry 92) is 
consistent with the agency's current thinking on impurities in new 
veterinary drug substances. 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.

V. Comments

    Interested persons may, at any time, submit written or electronic 
comments regarding the revised guidance document to the Division of 
Dockets Management (see ADDRESSES). Submit a single copy of electronic 
comments or two copies of written comments, except that individuals may 
submit one copy. Comments are to be identified with the docket number 
found in brackets in the heading of this document. A copy of the 
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.

VI. Electronic Access

    Persons with access to the Internet may obtain the guidance from 
either the CVM home page (https://www.fda.gov/cvm) or the Division of 
Dockets Management Web site (https://www.fda.gov/ohrms/dockets/
default.htm).

    Dated: November 12, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-22902 Filed 11-21-07; 8:45 am]
BILLING CODE 4160-01-S

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