[Federal Register: April 30, 2004 (Volume 69, Number 84)]
[Notices]
[Page 23795-23796]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30ap04-74]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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:
wflynn@cvm.fda.gov.
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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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