[Federal Register Volume 76, Number 212 (Wednesday, November 2, 2011)]
[Notices]
[Pages 67746-67747]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-28371]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-1999-D-2955]
Revised Guidance for Industry on Impurities: Residual Solvents in
New Veterinary Medicinal Products, Active Substances and Excipients
(Revision), VICH GL18(R); 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 (100) entitled
``Impurities: Residual Solvents in New Veterinary Medicinal Products,
Active Substances and Excipients (Revision)'' VICH GL18(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 guidance
is intended to recommend acceptable amounts of residual solvents in new
animal drugs (referred to as pharmaceuticals or veterinary medicinal
products in this guidance) for the safety of the target animal as well
as for the safety of human consumers of products derived from treated
food producing animals. It is intended to assist in developing new
animal drug applications (referred to as marketing applications in this
guidance) submitted to the European Union, Japan, and the United
States.
DATES: Submit either electronic or written 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 requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Mai Huynh, Center for Veterinary
Medicine (HFV-142), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, (240) 276-8273, [email protected].
SUPPLEMENTARY INFORMATION:
[[Page 67747]]
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
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. Food and Drug Administration, 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 Residual Solvents in New Veterinary Medicinal
Products, Active Substances and Excipients
In the Federal Register of August 17, 2010 (75 FR 50771), FDA
published a notice of availability for a draft revised guidance
entitled ``Residual Solvents in New Veterinary Medicinal Products,
Active Substances and Excipients (Revision) VICH GL18(R)'' giving
interested persons until October 18, 2010, to comment on the draft
revised guidance. This draft incorporated a lower permissible daily
exposure limit for N-Methypyrrolidone, which is still being kept in
Class 2, and placed tetrahydrofuran into Class 2 from Class 3. Based on
comments received from the draft revised guidance, additional
information was added in section 3.2 of this guidance to include
reference to the International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use
guideline entitled ``Impurities: Guideline for Residual Solvents
(Q3C(R4)).'' The revised guidance announced in this notice finalizes
the draft revised guidance announced on August 17, 2010. The revised
guidance is a product of the Quality Expert Working Group of the VICH.
III. Paperwork Reduction Act of 1995
This revised 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 this document 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 (GFI 100) is consistent with the
Agency's current thinking on this topic. 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 either electronic or
written comments regarding this revised guidance document to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. It is no longer necessary to send two copies
of mailed comments. Identify comments with the docket number found in
brackets in the heading of this document. 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
either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.
Dated: October 27, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-28371 Filed 11-1-11; 8:45 am]
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