[Federal Register: November 23, 2007 (Volume 72, Number 225)]
[Notices]
[Page 65751-65752]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23no07-86]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D-0139]
International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products; Revised
Guidance for Industry on Stability Testing of New Veterinary Drug
Substances and Medicinal Products (Revision); Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a revised guidance for industry (73) entitled
``Stability Testing of New Veterinary Drug Substances and Medicinal
Products (Revision) VICH GL3(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 provide
guidance regarding the development of stability testing data for new
animal drug applications (referred to as registration applications in
the guidance) submitted to the European Union (EU), Japan, and United
States.
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 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. VICH
is a parallel initiative for veterinary medicinal products. 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. Revised Guidance on Stability Testing of New Veterinary Drug
Substances and Medicinal Products
In the Federal Register of April 14, 2006 (71 FR 19525), FDA
published a notice of availability for a draft revised guidance
entitled ``Stability Testing of New Veterinary Drug Substances and
Medicinal Products (Revision)'', VICH GL3(R) giving interested persons
until May 15, 2006, to comment on the draft revised guidance. No
comments were received. The revised guidance announced in this notice
finalizes the draft revised guidance announced on April 14, 2006. The
revised guidance is a product of the quality expert working group of
the VICH. The revised guidance seeks to exemplify the core stability
data package to be included in registration applications for new
veterinary drug substances and medicinal products.
[[Page 65752]]
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 section 2 of the guidance have been
approved under OMB Control No. 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 (GFI 73) is consistent with the
agency's current thinking on the stability testing of 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.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this revised
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
guidance and received comments may be seen 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 at
CVM's home page (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cvm) and from 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. E7-22900 Filed 11-21-07; 8:45 am]
BILLING CODE 4160-01-S