[Federal Register: November 23, 2007 (Volume 72, Number 225)]
[Notices]
[Page 65752-65753]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23no07-87]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 1999D-2145]
International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products; Revised
Guidance for Industry on Impurities in New Veterinary Medicinal
Products (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 (93) entitled
``Impurities in New Veterinary Medicinal Products (Revision)'' VICH
GL11(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).
This revised document is intended to assist in developing registration
applications for approval of veterinary medicinal products submitted to
the European Union, Japan, and the United States. The revised guidance
addresses only those impurities in new veterinary medicinal drug
products classified as degradation products.
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
(CVM), 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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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 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
[[Page 65753]]
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.
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.
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 (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cvm) or the Division of Dockets Management Web site (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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