[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] ----------------------------------------------------------------------- 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Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance on Validation of Analytical Procedures: Definition and Terminology (#63), and Validation of Analytical Procedures: Methodolgy (#64); Availability; Request for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. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability for comment of two draft guidance for industry (GFI) documents entitled ``Validation of Analytical Procedures: Definition and Terminology'' (number 63) and ``Validation of Analytical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 The draft guidance is intended to provide guidance on characteristics that should be considered during the validation of analytical procedures included as part of registration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