[Federal Register Volume 75, Number 158 (Tuesday, August 17, 2010)]
[Notices]
[Pages 50771-50772]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-20235]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-1999-D-2955] (formerly Docket No. 1999D-4071)
Draft Revised Guidance for Industry on Residual Solvents in New
Veterinary Medicinal Products, Active Substances and Excipients
(Revision) VICH GL18(R); Request for Comments; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability for comments of a draft revised guidance for industry
(100) entitled ``Residual Solvents in New Veterinary Medicinal
Products, Active Substances and Excipients (Revision) VICH GL18(R).''
This draft revised guidance, which updates a final guidance on the same
topic for which a notice of availability was published in the Federal
Register of May 22, 2001 (66 FR 28182) (the 2001 final 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
[[Page 50772]]
to the European Union, Japan, and the United States.
DATES: Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by October 18, 2010.
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 draft guidance document.
Submit electronic comments on the draft 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:
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. Draft Revised Guidance on Residual Solvents in New Veterinary
Medicinal Products, Active Substances and Excipients
In April 2010, the VICH Steering Committee agreed that a draft
revised guidance entitled ``Residual Solvents in New Veterinary
Medicinal Products, Active Substances and Excipients (Revision) VICH
GL18(R)'' should be made available for public comment. The draft
revised guidance is a revision of the 2001 final guidance on the same
topic. The draft revised guidance revises the lower PDE (permissible
daily exposure) for N-Methylpyrrolidone being kept in Class 2 (Table 2
of the draft revised guidance) and for Tetrahydrofuran being placed
into Class 2 from Class 3 (Table 3 of the draft revised guidance). The
draft revised guidance is a product of the Quality Expert Working Group
of the VICH. Comments about this draft will be considered by FDA and
the VICH Quality Expert Working Group.
III. Paperwork Reduction Act of 1995
This draft 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 sections II-VI of this
document have been approved under OMB Control No. 0910-0032.
IV. Significance of Guidance
This draft guidance developed under the VICH process, includes
mandatory language that does not describe a statutory or regulatory
requirement, as permitted by good guidance practices regulation (21 CFR
10.115(i)(3)). Mandatory language that does not describe a statutory or
regulatory requirement will be revised in the final guidance document.
The draft 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 submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. 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 draft guidance
at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.
Dated: August 9, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-20235 Filed 8-16-10; 8:45 am]
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