[Federal Register Volume 64, Number 196 (Tuesday, October 12, 1999)]
[Notices]
[Pages 55296-55297]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 99-26503]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-4071]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products (VICH); 
VICH GL18 Draft Guidance on ``Impurities: Residual Solvents;'' 
Availability; Request for Comments

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availability for comment of the following VICH GL18 draft guidance for 
industry entitled ``Impurities: Residual Solvents.'' This draft 
guidance has been adapted for veterinary use by the International 
Cooperation on Harmonisation of Technical Requirements for Registration 
of Veterinary Medicinal Products (VICH) from an identically titled 
guidance regarding pharmaceuticals for human use, which was adopted by 
the International Conference on Harmonisation of Technical Requirements 
for Registration of Pharmaceuticals for Human Use (ICH). This draft 
guidance is intended to recommend acceptable amounts of residual 
solvents in new animal drugs (referred to as pharmaceuticals or 
veterinary medicinal products in the draft guidance) for the safety of 
the target animal as well as for the safety of residues in products 
derived from treated food-producing animals. It is intended to assist 
in developing new animal drug applications (referred to as marketing 
applications in the draft guidance) submitted to the European Union, 
Japan, and the United States.

DATES: Submit written comments by November 12, 1999.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Comments should be identified with the full title 
of the draft guidance and the docket number found in brackets in the 
heading of this document.
    Copies of the draft guidance entitled ``Impurities: Residual 
Solvents'' may be obtained on the internet from the CVM home page at 
http://www.fda.gov/cvm/fda/TOCs/guideline.html. Persons without 
internet access may submit written requests for single copies of the 
draft guidance to the Communications Staff (HFV-12), Center for 
Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855. Send one self-addressed adhesive label to assist 
that office in processing your requests.
FOR FURTHER INFORMATION CONTACT:
    Regarding VICH: Sharon R. Thompson, Center for Veterinary Medicine 
(HFV-3), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 
20855, 301-594-1798, e-mail: ``sthompso@cvm.fda.gov'', or
    Robert C. Livingston, Center for Veterinary Medicine (HFV-1), Food 
and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-
594-5903, e-mail: ``rlivings@cvm.fda.gov''.
    Regarding the draft guidance: Kevin J. Greenlees, Center for 
Veterinary Medicine (HFV-150), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-6977, e-mail: 
``kgreenle@cvm.fda.gov''.
SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by 
regulatory authorities, industry associations, and individual sponsors 
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 requirements for the development of pharmaceutical products. 
One of the goals of harmonization is to identify and reduce the 
differences in technical requirements for drug development among 
regulatory agencies in different countries.
    FDA has actively participated in the ICH 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 new animal 
drugs. The VICH is concerned with developing harmonized technical 
requirements for the approval of new animal drugs in the European 
Union, Japan, and the United States, and includes input from both 
regulatory and industry representatives.
    The VICH meetings are held under the auspices of the Office 
International des Epizooties. The VICH Steering Committee is composed 
of member representatives from the European Commission; the European 
Medicines Evaluation Agency; the European Federation of Animal Health; 
the 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.
    Two observers are eligible to participate in the VICH Steering 
Committee: One representative from the Government of Australia/New 
Zealand, and one representative from the industry in Australia/New 
Zealand. The VICH Secretariat, which coordinates the preparation of 
documentation, is provided by the Confederation Mondiale de L'Industrie 
de la Sante Animale (COMISA). A COMISA representative participates in 
the VICH Steering Committee meetings.

II. Guidance on Acceptable Amounts for Residual Solvents

    This VICH GL18 draft guidance entitled ``Impurities: Residual 
Solvents'' has been adapted for veterinary use by the VICH from a 
guidance regarding pharmaceuticals for human use which was adopted by 
the ICH and published in the Federal Register of December 24, 1997 (62 
FR 67377). At a meeting held on May 18 through 20, 1999, the VICH 
Steering Committee agreed that VICH GL18 should be made available for 
public comment.
    This draft guidance is intended to recommend acceptable amounts for 
residual solvents in new animal drugs for the safety of the target 
animal as well as for the safety of residues in products derived from 
treated food-producing animals. Comments about this draft guidance will 
be considered by FDA and the VICH Quality Working Group. Ultimately, 
FDA intends to adopt the VICH Steering Committee's final guidance and 
publish it as a future guidance.
    This document, developed under the VICH process, has been revised 
to conform to FDA's good guidance practice regulations (62 FR 8961, 
February 27, l997). For example, the document has been designated 
``guidance'' rather than ``guideline.'' Since guidance documents are 
not binding, mandatory words such as ``must,'' ``shall,'' and ``will'' 
in the original VICH document have been substituted with ``should'' 
unless the reference is to a statutory or regulatory requirement.
     This draft guidance represents the agency's current thinking on 
acceptable amounts of residual solvents in new animal drugs. The 
document does not

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create or confer any rights for or on any person and will not operate 
to bind FDA or the public. You may use alternative methods as long as 
they satisfy the requirements of the applicable statute and regulation.

III. Comments

    General comments are welcome at any time, however, in order to 
ensure consideration at the next meeting, interested persons should 
submit written comments by November 12, 1999, to the Dockets Management 
Branch (address above) regarding this draft guidance. Two copies of any 
comments are to be submitted, except that individuals may submit one 
copy. Comments should be identified with the docket number found in 
brackets in the heading of this document. A copy of the document and 
received comments are available for public examination in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: September 30, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-26503 Filed 10-8-99; 8:45 am]
BILLING CODE 4160-01-F