[Federal Register Volume 69, Number 246 (Thursday, December 23, 2004)]
[Notices]
[Pages 76903-76904]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E4-3782]



[[Page 76903]]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 04-129-1]


Draft Guideline on Target Animal Safety: Examination of Live 
Veterinary Vaccines in Target Animals for Absence of Reversion to 
Virulence (VICH Topic GL41)

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice of availability and request for comments.

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SUMMARY: A draft guideline titled ``Target Animal Safety: Examination 
of Live Veterinary Vaccines in Target Animals for Absence of Reversion 
to Virulence'' has been developed by the International Cooperation on 
Harmonization of Technical Requirements for Registration of Veterinary 
Medicinal Products (VICH). The draft guideline is intended to establish 
criteria and requirements for the conduct of studies that examine the 
potential for reversion to or increase in virulence of live veterinary 
vaccines in target animals. Because the draft guideline applies, in 
part, to veterinary biological products regulated by the Animal and 
Plant Health Inspection Service under the Virus-Serum-Toxin Act, we are 
requesting comments on its provisions so that we may include any 
relevant input on the draft in the Agency's comments to the VICH 
Steering Committee.

DATES: We will consider all comments that we receive on or before 
February 22, 2005.

ADDRESSES: You may submit comments by any of the following methods:
     EDOCKET: Go to http://www.epa.gov/feddocket to submit or 
view public comments, access the index listing of the contents of the 
official public docket, and to access those documents in the public 
docket that are available electronically. Once you have entered 
EDOCKET, click on the ``View Open APHIS Dockets'' link to locate this 
document.
     Postal Mail/Commercial Delivery: Please send four copies 
of your comment (an original and three copies) to Docket No. 04-129-1, 
Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 
River Road Unit 118, Riverdale, MD 20737-1238. Please state that your 
comment refers to Docket No. 04-129-1.
     E-mail: Address your comment to 
[email protected]. Your comment must be contained in the body 
of your message; do not send attached files. Please include your name 
and address in your message and ``Docket No. 04-129-1'' on the subject 
line.
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the instructions for locating this 
docket and submitting comments.
    Reading Room: You may read any comments that we receive on this 
docket in our reading room. The reading room is located in room 1141 of 
the USDA South Building, 14th Street and Independence Avenue SW., 
Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., 
Monday through Friday, except holidays. To be sure someone is there to 
help you, please call (202) 690-2817 before coming.
    Other Information: You may view APHIS documents published in the 
Federal Register and related information, including the names of groups 
and individuals who have commented on APHIS dockets, on the Internet at 
http://www.aphis.usda.gov/ppd/rad/webrepor.html.
    You may request a copy of the draft guideline by writing to Dr. 
Donna M. Gatewood, Center for Veterinary Biologics, VS, APHIS, 510 
South 17th Street, Suite 104, Ames, IA 50010, or by calling (515) 232-
5785. The draft guideline is also available on the Internet at http://www.aphis.usda.gov/vs/cvb/pel/notices.

FOR FURTHER INFORMATION CONTACT: Dr. Albert P. Morgan, Chief of 
Operational Support, Center for Veterinary Biologics, Policy, 
Evaluation and Licensing, VS, APHIS, 4700 River Road Unit 148, 
Riverdale, MD 20737-1231; (301) 734-8245.

SUPPLEMENTARY INFORMATION:

Background

    The International Cooperation on Harmonization of Technical 
Requirements for the Registration of Veterinary Medicinal Products 
(VICH) is a unique project that brings together the regulatory 
authorities of the European Union, Japan, and the United States and 
representatives from the animal health industry in the three regions. 
The purpose of VICH is to harmonize technical requirements for 
veterinary products (both drugs and biologics). Regulatory authorities 
and industry experts from Australia and New Zealand participate in an 
observer capacity. The VICH initiative is conducted under the auspices 
of the International Office of Epizootics. The World Federation of the 
Animal Health Industry (COMISA, the Confederation Mondiale de 
L'Industrie de la Sante Animale) provides the secretarial and 
administrative support for VICH activities.
    The United States Government is represented in VICH by the Food and 
Drug Administration (FDA) and the Animal and Plant Health Inspection 
Service (APHIS). The FDA provides expertise regarding veterinary drugs, 
while APHIS fills a corresponding role for veterinary biological 
products. As VICH members, APHIS and FDA participate in efforts to 
enhance harmonization and have expressed their commitment to seeking 
scientifically based harmonized technical requirements for the 
development of veterinary drugs and biologics. One of the goals of 
harmonization is to identify and reduce the differences in technical 
requirements for veterinary drugs and biologics among regulatory 
agencies in different countries.
    This notice informs the public that the draft document ``Target 
Animal Safety: Examination of Live Veterinary Vaccine in Target Animals 
for Absence of Reversion to Virulence'' (VICH Topic GL41) has been made 
available by the VICH Steering Committee for comments by interested 
parties. The draft guideline is intended to provide a unified standard 
for regulatory bodies to facilitate the mutual acceptance of reversion 
to virulence data. Because the draft guideline applies to some 
veterinary biological products regulated by APHIS under the Virus-
Serum-Toxin Act, particularly with regard to reversion to virulence 
testing, we are requesting comments on its provisions so that we may 
include any relevant public input on the draft in the Agency's comments 
to the VICH Steering Committee.
    The draft document reflects current APHIS thinking on examining 
veterinary vaccines in target animals for absence of reversion to 
virulence. In accordance with the VICH process, once a final draft of 
``Target Animal Safety: Examination of Live Veterinary Vaccine in 
Target Animals for Absence of Reversion to Virulence'' has been 
approved, the guideline will be recommended for adoption by the 
regulatory bodies of the European Union, Japan, and the United States. 
As with all VICH documents, the final guideline will not create or 
confer any rights for or on any person and will not operate to bind 
APHIS or the public. Further, the VICH guidelines specifically provide 
for the use of alternative approaches if those approaches satisfy 
regulatory requirements.
    Ultimately, APHIS intends to consider the VICH Steering Committee's 
final guidance document for use by U.S.

[[Page 76904]]

veterinary biologics licensees, permittees, and applicants. In 
addition, APHIS may also consider the use of the final guidance 
document as the basis for proposed additions or amendments to its 
regulations in 9 CFR chapter I, subchapter E (Viruses, Serums, Toxins, 
and Analogous Products; Organisms and Vectors). Because we anticipate 
that applicable provisions of the final version of ``Target Animal 
Safety: Examination of Live Veterinary Vaccines in Target Animals for 
Absence of Reversion to Virulence'' may be introduced into APHIS' 
veterinary biologics regulatory program in the future, we encourage 
your comments on the draft version.

    Authority: 21 U.S.C. 151 et seq.

    Done in Washington, DC, this 16th day of December 2004.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant Health Inspection Service.
 [FR Doc. E4-3782 Filed 12-22-04; 8:45 am]
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