[Federal Register Volume 69, Number 84 (Friday, April 30, 2004)]
[Notices]
[Pages 23795-23796]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-9836]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0051]


International Cooperation on Harmonization of Technical 
Requirements for Registration of Veterinary Medicinal Products; 
Guidance for Industry on Pre-Approval Information for Registration of 
New Veterinary Medicinal Products for Food-Producing Animals With 
Respect to Antimicrobial Resistance (VICH GL27); 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 guidance for industry ([numsign]144) entitled ``Pre-
Approval Information for Registration of New Veterinary Medicinal 
Products for Food-Producing Animals With Respect to Antimicrobial 
Resistance'' (VICH GL27). This guidance has been developed for 
veterinary use by the International Cooperation on Harmonization of 
Technical Requirements for Registration of Veterinary Medicinal 
Products (VICH). This VICH guidance document is an initial step in 
developing harmonized technical guidance in the European Union, Japan, 
and the United States for approval of therapeutic antimicrobial 
veterinary medicinal products intended for use in food-producing 
animals with regard to characterization of antimicrobial resistance 
selection in bacteria of human health concern. The guidance outlines 
the types of studies and data which are recommended for assessing the 
potential for resistance to develop in association with the use of 
antimicrobial drugs in food-producing animals.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Communications Staff (HFV-12), Center for Veterinary Medicine, 
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. 
Send one self-addressed adhesive label to assist that office in 
processing your requests.
    Submit electronic or written comments at any time on the guidance 
to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://www.fda.gov/dockets/ecomments. 
Comments should be identified by the docket number found in brackets in 
the heading of this document. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: William T. Flynn, Center for 
Veterinary Medicine (HFV-2), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-4514, 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 
participated in efforts to enhance harmonization and has expressed its 
commitment to seek scientifically based harmonized technical procedures 
for the development of pharmaceutical products. One of the goals of 
harmonization is to identify and then reduce differences in technical 
requirements for drug development among regulatory agencies in 
different countries.
    FDA has actively participated in the International Conference on 
Harmonization of Technical Requirements for Approval of Pharmaceuticals 
for Human Use 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; Committee on Veterinary Medicinal 
Products; 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.
    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 the Government of Canada, and one 
representative from the industry of Canada. The VICH Secretariat, which 
coordinates the preparation of documentation, is provided by the 
Conf[eacute]d[eacute]ration Mondiale de L'Industrie de la Sant[eacute] 
Animale (COMISA). A COMISA representative also participates in the VICH 
Steering Committee meetings.

II. Guidance on Antimicrobial Resistance

    In the Federal Register of June 12, 2003 (68 FR 35234), FDA 
published the notice of availability of the VICH draft guidance, giving 
interested persons until July 14, 2003, to submit comments. After 
consideration of comments received, the draft guidance was changed in 
response to the comments and submitted to the VICH Steering Committee. 
At a meeting held on October 7 and 8, 2003, the VICH Steering Committee 
endorsed the guidance for industry, VICH GL27.
    The VICH guidance document is an initial step in developing 
harmonized

[[Page 23796]]

technical guidance in the European Union, Japan, and the United States 
for approval of therapeutic antimicrobial veterinary medicinal products 
intended for use in food-producing animals with regard to 
characterization of antimicrobial resistance selection in bacteria of 
human health concern.
    This guidance document outlines the types of studies and data that 
may be used to characterize the potential for resistance to develop in 
the target animal when an antimicrobial drug product is used under the 
proposed conditions. This includes information which describes the drug 
substance, drug product, nature of the resistance, and potential 
exposure of gut flora in the target animal species. This information 
may be used as part of an overall assessment of the potential impact of 
the product on human health. Information collection is covered under 
the Office of Management and Budget control number 0910-0032.

III. Significance of Guidance

    This guidance document, developed under the VICH process, has been 
revised to conform to FDA's good guidance practices regulation (21 CFR 
10.115). For example, the document has been designated ``guidance'' 
rather than ``guideline.'' Because guidance documents are not binding, 
mandatory words such as ``must,'' ``shall,'' and ``will'' in the 
original VICH document have been substituted with ``should'' or 
``recommend.''
    This VICH guidance document is consistent with the agency's current 
thinking, on the type of pre-approval information that should be 
considered for new veterinary medicinal products for food-producing 
animals with regard to characterization of antimicrobial resistance 
selection in bacteria of human health concern. This guidance does not 
create or confer any rights for or on any person and will not operate 
to bind FDA or the public. An alternative method may be used as long as 
it satisfies the requirements of applicable statutes and regulations.

IV. Comments

    As with all of FDA's guidances, the public is encouraged to submit 
written or electronic comments 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 submit written comments to the Division of 
Dockets Management (see ADDRESSES) regarding this guidance document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments should be identified with the docket number found in the 
brackets in the heading of this document. A copy of the guidance 
document and received comments are available for public examination in 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

V. Electronic Access

    Persons with Internet access may obtain a copy of the guidance 
document entitled ``Pre-Approval Information for Registration of New 
Veterinary Medicinal Products for Food-Producing Animals with Respect 
to Antimicrobial Resistance'' (VICH GL-27) may be obtained on the 
Internet from the CVM Home Page at http://www.fda.gov/cvm.

    Dated: April 19, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-9836 Filed 4-29-04; 8:45 am]
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