[Federal Register Volume 68, Number 113 (Thursday, June 12, 2003)]
[Notices]
[Pages 35234-35235]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-14822]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03D-0051]


International Cooperation on Harmonization of Technical 
Requirements for Registration of Veterinary Medicinal Products (VICH); 
Draft Guidance for Industry on ``Pre-Approval Information for 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); Request 
for Comments; 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availability of a draft guidance for industry ([numsign]144) entitled 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 This draft guidance has been developed for 
veterinary use by the International Cooperation on Harmonization of 
Technical Requirements for Registration of Veterinary Medicinal 
Products (VICH). This draft 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 The draft guidance 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DATES: Submit written or electronic comments on the draft guidance by 
July 14, 2003, to ensure their adequate consideration in preparation of 
the final document. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Communications Staff (HFV-12), Center for Veterinary 
Medicine (CVM), Food and Drug Administration, 7519 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 draft guidance 
document.
    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. Submit electronic comments to 
http://www.fda.gov/dockets/ecomments. Comments should be identified 
with the full title of the draft guidance and the docket number found 
in brackets in the heading of this 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 the Federal Register of September 13, 2002 (67 FR 58058), FDA 
announced the availability of a related draft guidance for industry 
([numsign]152) entitled ``Evaluating the Safety of Antimicrobial New 
Animal Drugs With Regard to Their Microbiological Effects on Bacteria 
of Human Health Concern.'' Draft guidance [numsign]152 represents FDA's 
current thinking on an approach for using data, such as that outlined 
in the VICH draft guidance, for completing an assessment on the safety 
of antimicrobial drugs that focuses on antimicrobial resistance 
concerns. The publication of the draft VICH guidance ([numsign]144) in 
the United States was delayed until FDA developed an understanding of 
how the outlined data could be incorporated into an assessment process 
such as that described in the FDA draft guidance [numsign]152.
    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

[[Page 35235]]

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. Draft Guidance on Antimicrobial Resistance

    The VICH Steering Committee held a meeting on June 28, 2001, and 
agreed that the draft guidance document entitled ``Pre-Approval 
Information for Registration of New Veterinary Medicinal Products for 
Food Producing Animals with Respect to Antimicrobial Resistance'' (VICH 
GL27) should be made available for public comment. However, subsequent 
to the June 2001 Steering Committee meeting, the FDA decided to delay 
the publication of the draft VICH guidance in the United States until 
the FDA draft guidance ([numsign]152) related to antimicrobial 
resistance was published. FDA believed that it was important to first 
develop its thinking on how data, such as that described in the draft 
VICH guidance, could be used for completing an assessment on 
antimicrobial resistance.
    The draft VICH guidance 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.
    This draft guidance 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.
    FDA and the VICH Expert Working Group on Antimicrobial Resistance 
will consider comments about the draft guidance document. Information 
collection is covered under the Office of Management and Budget control 
number 0910-0032.

III. Significance of Guidance

    This draft 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.'' 
Similarly, words such as ``require'' or ``requirement'' have been 
replaced by ``recommend'' or ``recommendation'' as appropriate to the 
context.
    The draft VICH guidance ([numsign]144) is consistent with the 
agency's current thinking, described in draft guidance [numsign]152, on 
the type of preapproval 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

    This draft guidance document is being distributed for comment 
purposes only and is not intended for implementation at this time. 
Interested persons may submit written or electronic comments regarding 
this draft guidance document to the Dockets Management Branch (see 
ADDRESSES). Submit written or electronic comments to ensure adequate 
consideration in preparation of the final guidance. Two copies of any 
mailed 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. A copy of the draft guidance 
and received comments are available for public examination in the 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

V. Electronic Access

    Electronic comments may also be submitted electronically on the 
Internet at http://www.fda.gov/dockets/ecomments. Once on this Internet 
site, select Docket No. 03D-0051 ``Pre-Approval Information for 
Registration of New Veterinary Medicinal Products for Food-Producing 
Animals with Respect to Antimicrobial Resistance'' and follow the 
directions.
    Copies of the draft guidance document entitled ``Pre-Approval 
Information for Registration of New Veterinary Medicinal Products for 
Food-Producing Animals with Respect to Antimicrobial Resistance'' (VICH 
GL27) may be obtained on the Internet from the CVM home page at http://www.fda.gov/cvm.

    Dated: June 4, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-14822 Filed 6-11-03; 8:45 am]
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