[Federal Register Volume 66, Number 99 (Tuesday, May 22, 2001)]
[Notices]
[Pages 28182-28183]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-12770]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-4071]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products (VICH); 
Final Guidance for Industry on ``Impurities: Residual Solvents in New 
Veterinary Medicinal Products, Active Substances and Excipients'' (VICH 
GL18); Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a final guidance for industry (#100) entitled 
``Impurities: Residual Solvents in New Veterinary Medicinal Products, 
Active Substances and Excipients'' (VICH GL18). This guidance has been 
adapted for veterinary use by the International Cooperation on 
Harmonisation of Technical Requirements for Registration of Veterinary 
Medicinal Products (VICH) from a similarly titled guidance regarding 
pharmaceuticals for human use, which was adopted by the International 
Conference on Harmonisation of Technical Requirements for Registration 
of Pharmaceuticals for Human Use (ICH). The guidance is intended to 
recommend acceptable amounts of residual solvents in new animal drugs 
(referred to as pharmaceuticals or veterinary medicinal products in the 
final guidance) for the safety of the target animal as well as for the 
safety of human consumers of products derived from treated food 
producing animals. It is intended to assist in developing new animal 
drug applications (referred to as marketing applications in the final 
guidance) submitted to the European Union, Japan, and the United 
States.

DATES: You may submit written comments at any time.

ADDRESSES: You may submit written requests for a single copy of the 
final guidance entitled ``Impurities: Residual Solvents in New 
Veterinary Medicinal Products, Active Substances and Excipients'' (VICH 
GL18) 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 
for electronic access to the guidance document.
    You may submit written comments on the guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kevin J. Greenlees (HFV-150), Center 
for Veterinary Medicine, Food and Drug Administration, 7500 Standish 
Pl., Rockville, MD 20855, 301-827-6977, e-mail, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by 
regulatory authorities and industry associations to promote the 
international harmonization of regulatory requirements. FDA has

[[Page 28183]]

participated in efforts to enhance harmonization and has expressed its 
commitment to seek scientifically based harmonized technical 
requirements for the development of pharmaceutical products. One of the 
goals of harmonization is to identify and then 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 approval of human 
pharmaceutical and biological 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 Steering Committee is composed of member representatives 
from the: European Commission; European Medicines Evaluation Agency; 
European Federation of Animal Health; the U.S. FDA; the U.S. Department 
of Agriculture; the Animal Health Institute; the Japanese Veterinary 
Pharmaceutical Association; the Japanese Association of Veterinary 
Biologics; and the Japanese Ministry of Agriculture, Forestry and 
Fisheries.
    Two observers are eligible to participate in the VICH Steering 
Committee: One representative from the Government of Australia/New 
Zealand, and one representative from the industry in Australia/New 
Zealand. 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.

II. Guidance on Impurities: Residual Solvents

    In the Federal Register of October 12, 1999 (64 FR 55296), FDA 
published the notice of availability of the draft guidance entitled 
``Impurities: Residual Solvents'' (VICH GL18) giving interested persons 
until November 12, 1999, to submit comments. FDA received no comments. 
The final guidance was submitted to the VICH Steering Committee. At a 
meeting held on June 14 through 16, 2000, the VICH Steering Committee 
endorsed the final guidance for industry, VICH GL18.
    This guidance is intended to recommend acceptable amounts of 
residual solvents in new animal drugs (referred to as pharmaceuticals 
or veterinary medicinal products in the final guidance) for the safety 
of the target animal as well as for the safety of human consumers of 
products derived from treated food-producing animals. The guidance is 
intended to assist in developing new animal drug applications (referred 
to as marketing applications in the final guidance) submitted to the 
European Union, Japan, and the United States.
    This final level 1 guidance is being issued consistent with FDA's 
good guidance practices regulation (65 FR 56468, September 19, 2000). 
It does not create or confer any rights for or on any person and does 
not operate to bind FDA or the public. An alternative approach may be 
used if such approach satisfies the requirements of applicable statutes 
and regulations. Information collected is covered under OMB control 
number 0910-0032.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/cvm.

IV. Comments

    As with all of FDA's guidances, the public is encouraged to submit 
written comments with new data or other new information pertinent to 
this guidance. FDA will periodically review the comments in the docket 
and, where appropriate, will amend the guidance. The agency will notify 
the public of any such amendments through a notice in the Federal 
Register.
    Interested persons may, at any time, submit written or electronic 
comments regarding this guidance. Written comments should be submitted 
to the Dockets Management Branch (address above). Two copies of any 
comments are to be submitted, except individuals may submit one copy. 
Comments should be identified with the docket number found in the 
brackets in the heading of this document. A copy of the 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. 
Comments may also be submitted electronically on the Internet at http://www.fda.gov/dockets/ecomments. Once on this Internet site, select 
``99D-4071 Impurities: Residual Solvents in New Veterinary Medicinal 
Products'' and follow the directions.

    Dated: May 11, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-12770 Filed 5-21-01; 8:45 am]
BILLING CODE 4160-01-S