[Federal Register Volume 64, Number 140 (Thursday, July 22, 1999)]
[Notices]
[Pages 39514-39515]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-18688]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-2145]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products (VICH); 
VICH GL11 Draft Guidance on Impurities in New Veterinary Medicinal 
Products; 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availability for comment of a draft guidance developed by the 
International Cooperation on Harmonisation of Technical Requirements 
for Registration of Veterinary Medicinal Products (VICH). This VICH 
GL11 draft guidance for industry entitled ``Impurities in New 
Veterinary Medicinal Products'' provides guidance recommendations for 
applications for marketing authorizations on the content and 
qualification of impurities in new veterinary medicinal products 
produced from chemically synthesized new active substances not 
previously registered in a member state.

DATES: Submit written comments by August 23, 1999; FDA must receive 
comments before the deadline in order to ensure their consideration at 
the next VICH committee meeting, but the agency will accept comments 
after the deadline.

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of the draft guidance and the docket number found in brackets in the 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    Copies of the draft guidance entitled ``Impurities in New 
Veterinary Medicinal Products'' 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requests for single copies of the draft guidance to the Communications 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 the 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 ``[email protected]''.
    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 
``[email protected]''.

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 seeking 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 International Conference on 
Harmonisation of Technical Requirements for Registration of 
Pharmaceuticals for Human Use (ICH) for several years to develop 
harmonized technical requirements for the registration of human 
pharmaceutical 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 registration of veterinary medicinal 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. 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 U.S. FDA; the U.S. Department of Agriculture; the Animal Health 
Institute; the Japanese Veterinary Pharmaceutical Association; 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 MERCOSUR (Argentina, Brazil, Uruguay, 
and Paraguay), and one representative from Federacion Latino-Americana 
de la Industria para la Salud Animal. 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.
    At a meeting held on October 20 through 22, l998, the VICH Steering 
Committee agreed that the draft guidance entitled ``Impurities in New 
Veterinary Medicinal Products'' should be made available for public 
comment. Comments 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 draft guidance, developed under the VICH process, has been 
revised to conform to FDA's good guidance practices regulations (62 FR 
8961, February 27, l997) . For example, the document has been 
designated as a draft ``guidance'' rather than a draft ``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. Additionally, the term(s) 
``veterinary medicinal products'' and ``veterinary pharmaceutical 
products'' may require revision to be consistent with product terms 
used in other VICH guidance documents.
    This draft guidance represents the agency's current thinking on 
impurities

[[Page 39515]]

in new veterinary medicinal products. The document does not create or 
confer any rights for or on any person and will not operate to bind FDA 
or the public. Alternate approaches may be used if they satisfy the 
requirements of applicable statutes, regulations, or both.

II. Comments

    Interested persons should submit written comments on or before 
August 23, 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: July 15, 1999
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-18688 Filed 7-21-99; 8:45 am]
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