[Federal Register Volume 64, Number 140 (Thursday, July 22, 1999)]
[Notices]
[Pages 39516-39517]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-18697]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-2215]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products (VICH); 
VICH GL10 Draft Guidance on ``Impurities in New Veterinary Drug 
Substances;'' 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availability for comment of a draft guidance developed for veterinary 
use by the International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products (VICH). 
This VICH GL10 draft guidance for industry entitled ``Impurities in New 
Veterinary Drug Substances'' is intended to assist in developing 
registration applications for approval of veterinary medicinal products 
submitted to the European Union, Japan, and the United States.

DATES: Submit written comments 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of the draft guidance and the docket number found in the heading of 
this document.
    Copies of the draft guidance entitled ``Impurities in New 
Veterinary Drug Substances'' 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copies of the draft guidance to the Communications Staff (HFV-12), 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 Place, Rockville, MD 20855. Send one self-addressed adhesive 
label to assist that office in processing your requests.

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 ``[email protected]''.
    Regarding the guidance document: Kevin 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

[[Page 39517]]

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 document entitled ``Impurities 
in New Drug Substances'' should be made available for public comment.
    This draft guidance is intended to provide guidance for 
registration applications on the content and qualification of 
impurities in new drug substances intended to be used for new 
veterinary medicinal products produced by chemical syntheses and not 
previously registered in a region or member state. Comments about this 
draft guidance will be considered by the FDA and the VICH Quality 
Working Group. Ultimately, FDA intends to adopt the VICH Steering 
Committee's final guidance and publish it as future guidance.
    This draft guidance, 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,'' and ``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 the 
regulation of impurities in new animal drug substances. 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. 99-18697 Filed 7-21-99; 8:45 am]
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