[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Draft Guidance on Validation of Analytical Procedures: Definition and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availability for comment of two draft guidance for industry (GFI)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 The draft guidance is intended to provide guidance on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: wmarnane@bangate.fda.gov.
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@bangate.fda.gov.
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
