[Federal Register Volume 63, Number 17 (Tuesday, January 27, 1998)]
[Notices]
[Pages 3907-3908]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-1848]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0017]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products (VICH); 
Draft Guidance on Validation of Analytical Procedures: Definition and 
Terminology (#63), and Validation of Analytical Procedures: Methodolgy 
(#64); 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availability for comment of two draft guidance for industry (GFI) 
documents entitled ``Validation of Analytical Procedures: Definition 
and Terminology'' (number 63) and ``Validation of Analytical 
Procedures: Methodology'' (number 64). These related draft GFI 
documents have been adapted for veterinary use by the International 
Cooperation on Harmonisation of Technical Requirements for Registration 
of Veterinary Medicinal Products (VICH) from two guidelines, Q2A and 
Q2B, that were adopted by the International Conference on Harmonisation 
(ICH) of Technical Requirements for Registration of Pharmaceuticals for 
Human Use. The draft guidance is intended to provide guidance on 
characteristics that should be considered during the validation of 
analytical procedures included as part of registration applications for 
approval of veterinary medicinal products submitted to the European 
Union, Japan, and the United States.
DATES: Submit written comments on these draft GFI documents by March 
30, 1998.

ADDRESSES: Submit written comments on the two draft GFI documents to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm 1-23, Rockville, MD 20857. Comments should be 
identified with the full title of the draft GFI document and the docket 
number found in the heading of this document.

[[Page 3908]]

 Submit written requests for single copies of these draft GFI documents 
to the Communications and Education Team (HFV-12), Center for 
Veterinary Medicine (CVM), Food and Drug Administration, 7500 Standish 
Place, Rockville, MD 20855. Send two self-addressed adhesive labels to 
assist that office in processing your requests. Copies of these draft 
guidance documents may be obtained on the Internet from the CVM Home 
Page (http://www.cvm.fda.gov).

FOR FURTHER INFORMATION CONTACT: 
    Regarding the GFI's: William G. Marnane, Center for Veterinary 
Medicine (HFV-140), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-0678. E-mail: [email protected].
    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: [email protected].

SUPPLEMENTARY INFORMATION: 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 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 registration of human 
pharmaceutical 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 registration 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; the European Medicines Evaluation Agency; the 
European Federation of Animal Health; the U.S. Food and Drug 
Administration; 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 also participates in the VICH Steering Committee 
meetings.
    At a meeting held on August 20 and 21, 1997, the VICH Steering 
Committee agreed that the draft GFI documents entitled ``Validation of 
Analytical Procedures: Definition and Terminology'' and ``Validation of 
Analytical Procedures: Methodology'' should be made available for 
public comment. These draft GFI documents were prepared by the VICH 
Quality Working Group and are based on the ICH Guidelines (Q2A and Q2B) 
that have already been adopted by FDA for human pharmaceuticals. With 
one exception, the deletion of the text ``(e.g. metered dose 
inhalers)'' included in the ICH guideline Q2B, Section 3, the documents 
are identical.
    The draft GFI document entitled, ``Validation of Analytical 
Procedures: Definition and Terminology,'' discusses the characteristics 
that should be considered during the validation of the analytical 
procedures included in an application for registration of veterinary 
medicinal products in the European Union, Japan, and the United States. 
This document pertaining to ``Definition and Terminology'' is not 
intended to cover testing requirements or procedures, rather it is 
intended to serve as a collection of terms and definitions. These 
common definitions such as ``analytical procedures,'' ``specificity,'' 
``precision,'' ``accuracy,'' etc., are meant to bridge the differences 
that often exist among various compendia and requirements of the 
European Union, Japan, and the United States. The draft GFI document 
entitled, ``Validation of Analytical Procedures: Methodology,'' 
discusses common analytical procedures and provides guidance and 
recommendations on how to consider various validation characteristics 
for each analytical procedure. It also indicates the data that should 
be included in an application for registration. Comments about these 
draft GFI documents will be considered by the FDA and the VICH Quality 
Working Group. Ultimately, FDA intends to adopt the VICH Steering 
Committee's final guidelines and publish them as future GFI documents.
    If finalized, these documents will represent current FDA thinking 
on characteristics for consideration during the validation of the 
analytical procedures included as part of applications. The draft GFI 
documents will 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.
    Interested persons may, on or before March 30, 1998, submit to the 
Dockets Management Branch (address above) written comments on the draft 
guidance document. Two copies of any comments are to be submitted, 
except that individuals may submit one copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document and with the full title of the guidance document. The 
comments are available for public examination in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday. After review 
of these comments, FDA will implement the guidance document with any 
appropriate changes. Thereafter, interested persons may submit written 
comment on the guidance document directly to the CVM Communications and 
Education Team (address above).

    Dated: January 20, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-1848 Filed 1-26-98; 8:45 am]
BILLING CODE 4160-01-F