[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this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by October 18, 2010.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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