[Federal Register: December 23, 2004 (Volume 69, Number 246)]
[Notices]
[Page 76903-76904]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23de04-34]
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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
regulations@aphis.usda.gov. 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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