[Federal Register Volume 63, Number 146 (Thursday, July 30, 1998)]
[Notices]
[Pages 40721-40722]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20310]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0566]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products (VICH); 
Draft Guidance on Stability Testing of New Animal Drug Substances and 
Products (#73), Stability Testing for New Dosage Forms of New Animal 
Drugs (#74), and Stability Testing: Photostability Testing of New 
Animal Drug Substances and Products (#75); 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availability for comment of three draft guidance for industry documents 
entitled ``Stability Testing of New Animal Drug Substances and 
Products,'' ``Stability Testing for New Drug Dosage Forms of New Animal 
Drugs,''and ``Stability Testing: Photostability Testing of New Animal 
Drug Substances and Products.'' These related draft guidance documents 
have been adapted for veterinary use by the International Cooperation 
on Harmonisation of Technical Requirements for Registration of 
Veterinary Medicinal Products (VICH) from guidelines that were adopted 
by the International Conference on Harmonisation of Technical 
Requirements for Registration of Pharmaceuticals for Human Use (ICH). 
The draft guidance is intended to provide guidance on stability testing 
of new drug substances and products and new dosage forms included as 
part of registration applications for approval of veterinary medicinal 
products submitted to the European Union, Japan, and the United States.

DATES: Written comments should be submitted by August 31, 1998.
    Note: FDA will accept comments after the deadline, but to assure 
consideration at the next VICH Committee meeting, we must receive 
them by August 31, 1998.

ADDRESSES: Submit written requests for single copies of these draft 
guidance documents to the Communications Staff (HFV-12), Center for 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. Submit written comments to the 
Dockets Management Branch (HFA-

[[Page 40722]]

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 document and the docket number found in brackets 
in the heading of this document. See the SUPPLEMENTARY INFORMATION 
section of this document for electronic access to the draft guidance 
documents.

FOR FURTHER INFORMATION CONTACT:
     Regarding the guidance documents: 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 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: 

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 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 it includes input 
from both regulatory and industry representatives.
     The VICH meetings are held under the auspices of the Office 
International des Epizooties (OIE). 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 participates in the VICH Steering Committee 
meetings.
     At a meeting held on February 26 and 27, l998, the VICH Steering 
Committee agreed that the draft guidance documents entitled ``Stability 
Testing of New Animal Drug Substances and Products,'' ``Stability 
Testing for New Dosage Forms of New Animal Drugs,'' and ``Stability 
Testing: Photostability Testing of New Animal Drug Substances and 
Products'' should be made available for public comment. These draft 
guidance documents were prepared by the VICH Quality Working Group and 
are based on ICH Guidelines that have already been adopted by FDA for 
human pharmaceuticals.
     The draft guidance entitled ``Stability Testing of New Animal Drug 
Substances and Products'' addresses the generation of stability 
information that should be included in submissions for applications for 
registration or approval of new molecular entities and associated drug 
products in the European Union, Japan, and the United States. In this 
guidance's discussion of ``stress testing'' for both new drug 
substances and drug products, the comment states that ``light testing'' 
should be an integral part of stress testing and will be considered in 
a separate annexed VICH document. That separate draft document is 
entitled ``Stability Testing: Photostability Testing of New Animal Drug 
Substances and Products,'' and sets out a basic testing protocol for 
photostability. The third draft guidance entitled ``Stability Testing 
for New Dosage Forms of New Animal Drugs'' is also an annex to 
``Stability Testing of New Animal Drug Substances and Products.'' It 
addresses the generation of stability information for new dosage forms 
for submission by the owner of the original application for 
registration, after the original application for new drug substances 
and products has been submitted. Comments about these draft guidance 
documents will be considered by FDA and the VICH Quality Working Group. 
Ultimately, FDA intends to adopt the VICH Steering Committee's final 
guidance and to publish as future guidance documents.
    These draft guidance documents, developed under the VICH process, 
have been revised to conform to FDA's Good Guidance Practices (62 FR 
8961, February 27, l997) . For example, the documents have been 
designated ``guidance'' rather than ``guideline.'' Since guidance 
documents are not binding, mandatory words such as ``must,'' ``shall,'' 
and ``will'' in the original VICH documents have been substituted with 
``should.''
    These draft guidance documents represent current FDA thinking on 
stability testing of new animal drug substances and products and new 
dosage forms of new animal drugs. The documents do 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 may, on or before August 31, 1998, submit to the 
Dockets Management Branch (address above) written comments regarding 
the guidance documents. 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 guidance documents and received comments 
are available for public examination in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

     Persons with access to the Internet may obtain the guidance 
documents using the World Wide Web (WWW). For WWW access, connect to 
CVM at ``http://www.fda.gov/cvm''.

    Dated: July 23, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-20310 Filed 7-29-98; 8:45 am]
BILLING CODE 4160-01-F