Document ID: FDA-1999-D-2955-0005
Agency: fda
Document Type: Notice
Title: Guidance for Industry; Availability: Impurities; Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients  FINAL #100
Posted Date: 2011-11-02T04:00Z

[Federal Register Volume 76, Number 212 (Wednesday, November 2, 2011)]
[Notices]
[Pages 67746-67747]
From the Federal Register Online via the Government Printing 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, mai.huynh@fda.hhs.gov.

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]
BILLING CODE 4160-01-P