[Federal Register Volume 64, Number 196 (Tuesday, October 12, 1999)]
[Notices]
[Pages 55293-55294]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 99-26501]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0566]


International Cooperation on Harmonisation of Technical 
Requirements for Approval of Veterinary Medicinal Products (VICH); 
Final Guidances entitled ``Stability Testing of New Veterinary Drug 
Substances and Medicinal Products'' (VICH GL3); ``Stability Testing of 
New Veterinary Dosage Forms'' (VICH GL4); ``Stability Testing: 
Photostability Testing of New Veterinary Drug Substances and Medicinal 
Products'' (VICH GL5); 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 three final guidances for industry entitled ``Stability 
Testing of New Veterinary Drug Substances and Medicinal Products'' 
(VICH GL3), ``Stability Testing of New Veterinary Dosage Forms'' (VICH 
GL4), and ``Stability Testing: Photostability Testing of New Veterinary 
Drug Substances and Medicinal Products'' (VICH GL5). These guidances 
have been adapted for veterinary use by the International Cooperation 
on Harmonisation of Technical Requirements for Approval of Veterinary 
Medicinal Products (VICH) from guidances regarding pharmaceuticals for 
human use, which were adopted by the International Conference on 
Harmonisation of Technical Requirements for Approval of Pharmaceuticals 
for Human Use (ICH). These VICH documents provide guidance on stability 
testing of new animal drugs and new dosage forms of new animal drugs 
included as part of new animal drug applications (referred to as 
registration applications in the guidances) submitted to the European 
Union, Japan, and the United States.

DATES: You may submit written comments at anytime.

ADDRESSES: Copies of the final guidance documents entitled ``Stability 
Testing of New Veterinary Drug Substances and Medicinal Products'' 
(VICH GL3), ``Stability Testing of New Veterinary Dosage Forms'' (VICH 
GL4), and ``Stability Testing: Photostability Testing of New Veterinary 
Drug Substances and Medicinal Products'' (VICH GL5) may be obtained on 
the Internet from the CVM home page at http://www.fda.gov/cvm/fda/
mappgs/vich.html. Persons without Internet access may submit written 
requests for single copies of the final 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.
     You may submit written comments any time on the final guidance 
documents to the Policy and Regulations Team (HFV-6), Center for 
Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855.

FOR FURTHER INFORMATION CONTACT:
     Regarding VICH: Sharon 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 guidance documents: William G. Marnane, Center for 
Veterinary Medicine (HFV-140), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-6966. E-mail, 
``wmarnane@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

[[Page 55294]]

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 reduce the differences in technical 
requirements for drug development among regulatory agencies.
     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 veterinary 
pharmaceutical products. The VICH is concerned with developing 
harmonized technical requirements for the approval of veterinary 
pharmaceutical products 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 (OIE). During the initial phase of the 
VICH, an OIE representative chairs the VICH Steering Committee.
     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. 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 also participates 
in the VICH Steering Committee meetings.

 II. Guidance on Stability Testing

     These three guidances are entitled ``Stability Testing of New 
Veterinary Drug Substances and Medicinal Products'' (VICH GL3), 
``Stability Testing of New Veterinary Dosage Forms'' (VICH GL4), and 
``Stability Testing: Photostability Testing of New Veterinary Drug 
Substances and Medicinal Products'' (VICH GL5). They have been adapted 
for veterinary use by the VICH from guidances regarding pharmaceuticals 
for human use which were adopted by the ICH and published in the 
Federal Register of September 22, 1994 (59 FR 48753), May 9, 1997 (62 
FR 25634), and May 16, 1997 (62 FR 27115).
     In the Federal Register of July 30, 1998 (63 FR 40721), FDA 
published these VICH guidances in draft form, giving interested persons 
until August 31, 1998, to submit comments. After consideration of 
comments received, final draft guidances were submitted to the VICH 
steering committee. At a meeting held on May 20, 1999, the VICH 
Steering Committee endorsed the three final draft guidances for 
industry, VICH GL3, VICH GL4, and VICH GL5.
     VICH GL3 addresses the generation of stability information that 
should be included in submissions for new animal drug applications in 
the European Union, Japan, and the United States. VICH GL4 is an annex 
to VICH GL3 and supplements that document by providing specific 
guidance on what should be submitted regarding stability of new dosage 
forms by the new animal drug applicant, after the original submission 
of stability information made in a new animal drug application. VICH 
GL5 is also an annex to VICH GL3 and supplements that document by 
providing guidance on basic protocol for photostability testing for new 
animal drugs. These guidances will be implemented in May of 2000.
     These guidances represent the FDA's current thinking on stability 
testing of new animal drugs and new dosage forms of new animal drugs. 
They do not create or confer any rights for or on any person and does 
not operate to bind FDA or the public. You may use alternative methods 
as long as they satisfy the requirements of applicable statute and 
regulation.
     As with all of FDA's guidances, the public is encouraged to submit 
written comments with new data or other new information pertinent to 
these guidances. The comments in the docket will be periodically 
reviewed, and, where appropriate, the guidances will be amended. The 
public will be notified of any such amendments through a notice in the 
Federal Register.

    Dated: September 30, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-26501 Filed 10-8-99; 8:45 am]
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