[Federal Register Volume 64, Number 140 (Thursday, July 22, 1999)]
[Notices]
[Pages 39515-39516]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-18692]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-2249]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products (VICH); 
Draft Guidance on Stability Testing for Medicated Premixes; 
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availability for comment on the following draft guidance for industry 
document entitled ``Stability Testing for Medicated Premixes.'' This 
draft guidance document has been developed for veterinary use by the 
International Cooperation on Harmonisation of Technical Requirements 
for Registration of Veterinary Medicinal Products (VICH). This draft 
guidance document is an annex to the parent guidance VICH GL3 entitled 
``Stability Testing of New Drug Substances and Products in the 
Veterinary Field.'' This draft guidance document is the annex and 
addresses the recommendations for stability testing of veterinary 
medicinal Type A medicated articles (referred to as medicated premix 
drug products in the draft guidance) intended for submission for 
approval to the European Union, Japan, and the United States.

DATES: Written comments should be submitted by August 23, 1999. NOTE: 
FDA will accept comments after the deadline, but to assure 
consideration, we must receive them by August 23, 1999.

ADDRESSES: Submit written comments on the draft guidance to the Dockets 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the full title of the draft guidance document and the docket number 
found in the heading of this document. 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single copies of the draft guidance to the Communications Staff (HFV-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 Pl., Rockville, MD 20855. Send one self-addressed adhesive 
label to assist that office in processing your requests. See the 
Supplementary Information section of this document for electronic 
access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: 

    Regarding VICH: Sharon Thompson (HFV-3), Center for Veterinary 
Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, 
MD 20855, 301-594-1798, e-mail ``[email protected]''.
    Regarding the guidance document: William G. Marnane (HFV-140), 
Center for Veterinary Medicine, Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-6966, 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 approval 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 (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 October 20-22, 1998, the VICH Steering 
Committee agreed that the draft guidance document entitled ``Stability 
Testing for Medicated Premixes'' should be made available for public 
comment.
    This draft guidance addresses the generation of acceptable 
stability information for submission in new animal drug applications 
(referred to as registration applications in the draft guidance) for 
Type A medicated articles containing new molecular entities. Comments 
about this draft guidance document 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.

[[Page 39516]]

    This draft guidance has 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.'' 
Because guidance documents are not binding, mandatory words such as 
``must'' and ``shall,'' and ``will'' in the original VICH documents 
have been substituted with ``should.'' 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 document represents the FDA's current thinking 
on acceptable stability testing of Type A medicated articles. 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 may, on or before August 23, 1999, submit to the 
Dockets Management Branch (address above) written comments regarding 
this draft guidance document. 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 draft guidance 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.

III. Electronic Access

    Copies of the draft guidance document entitled ``Stability Testing 
for Medicated Premixes'' may be obtained on the internet within the CVM 
home page at ``http://www.fda.gov/cvm/fda/TOCs/guideline.html''.

    Dated: July 15, 1999
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-18692 Filed 7-21-99; 8:45 am]
BILLING CODE 4160-01-F