[Federal Register: April 14, 2006 (Volume 71, Number 72)]
[Notices]
[Page 19525-19526]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14ap06-55]
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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; Draft
Revised Guidance for Industry on Stability Testing of New Veterinary
Drug Substances and Medicinal Products (Revision); Request for
Comments; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability for comment of a draft revised guidance for industry
(73) entitled ``Stability Testing of New Veterinary Drug
Substances and Medicinal Products (Revision)'' VICH GL3(R). This draft
revised guidance, which updates a guidance on the same topic for which
a notice of availability was published in the Federal Register of
October 12, 1999 (64 FR 55293) (the 1999 guidance), has been developed
for veterinary use by the International Cooperation on Harmonisation of
Technical Requirements for Registration of Veterinary Medicinal
Products (VICH). This draft revised document is intended to provide
guidance regarding the development of stability testing data 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 by May 15, 2006 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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Communications Staff (HFV-12), Center for Veterinary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 (CVM), 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 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Submit written comments on the draft guidance to the Division of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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Comments should be identified
with the full title of the 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: 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.
[[Page 19526]]
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; 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. Draft Revised Guidance on Stability Testing of New Veterinary Drug
Substances and Medicinal Products
The draft revised guidance is entitled ``Stability Testing of New
Veterinary Drug Substances and Medicinal Products (Revision)'' VICH
GL3(R). It has been adapted for veterinary use by the VICH from
guidances regarding pharmaceuticals for human use which were adopted by
the ICH and for which notices of availability were published in the
Federal Register of November 7, 2001 (66 FR 56332), June 14, 2002 (67
FR 40951), and November 21, 2003 (68 FR 65717).
In October 2005, the VICH steering committee agreed that a draft
revised guidance entitled ``Stability Testing of New Veterinary Drug
Substances and Medicinal Products (Revision)'' VICH GL3(R) should be
made available for public comment. The draft revised guidance is a
revision of a guidance on the same topic for which a notice of
availability was published in the Federal Register of October 12, 1999.
The draft revised guidance clarifies the 1999 guidance, adds
information, and provides consistency with more recently published VICH
guidances. The draft revised guidance seeks to exemplify the core
stability data package to be included in registration applications for
new veterinary drug substances and medicinal products. The draft
revised guidance is the product of the Quality Expert Working Group of
the VICH. Comments about this draft will be considered by FDA and the
Quality Expert Working Group.
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 number 0910-0032.
IV. Significance of Guidance
This draft 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 draft 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 draft revised
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
This draft revised 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 written 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 revised 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
Electronic comments may also be submitted on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
Once on this Internet site, select
Docket No. 1999D-2215, entitled ``Draft Revised Guidance for Industry
on Stability Testing of New Veterinary Drug Substances and Medicinal
Products (Revision)'' VICH GL3(R) and follow the directions.
Copies of the draft guidance document entitled ``Draft Revised
Guidance for Industry on Stability Testing of New Veterinary Drug
Substances and Medicinal Products (Revision)'' VICH GL3(R) may be
obtained on the Internet from the CVM home page at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cvm
.
Dated: April 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-5525 Filed 4-13-06; 8:45 am]
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