Notice of Availability of a Risk Analysis for the Foot-and-Mouth Disease Status of the Republic of South Africa, 8844-8845 [E8-2912]
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Notices
Federal Register
Vol. 73, No. 32
Friday, February 15, 2008
This section of the FEDERAL REGISTER
contains documents other than rules or
proposed rules that are applicable to the
public. Notices of hearings and investigations,
committee meetings, agency decisions and
rulings, delegations of authority, filing of
petitions and applications and agency
statements of organization and functions are
examples of documents appearing in this
section.
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2008–0001]
Notice of Availability of a Risk Analysis
for the Foot-and-Mouth Disease Status
of the Republic of South Africa
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
rwilkins on PROD1PC63 with NOTICES
AGENCY:
SUMMARY: We are advising the public
that a risk analysis has been prepared by
the Animal and Plant Health Inspection
Service concerning the foot-and-mouth
disease status of the Republic of South
Africa and the related disease risks
associated with importing animals and
animal products into the United States
from the Republic of South Africa. This
risk analysis will be used as a basis for
determining whether to relieve certain
prohibitions and restrictions on the
importation of ruminants and swine and
the fresh meat and other animal
products of ruminants and swine into
the United States from the Republic of
South Africa. We are making this risk
analysis available to the public for
review and comment.
DATES: We will consider all comments
we receive on or before April 15, 2008.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/fdmspublic/
component/
main?main=DocketDetail&d=APHIS2008-0001 to submit or view comments
and to view supporting and related
materials available electronically.
• Postal Mail/Commercial Delivery:
Please send two copies of your comment
to Docket No. APHIS–2008–0001,
Regulatory Analysis and Development,
PPD, APHIS, Station 3A–03.8, 4700
River Road Unit 118, Riverdale, MD
20737–1238. Please state that your
VerDate Aug<31>2005
15:58 Feb 14, 2008
Jkt 214001
comment refers to Docket No. APHIS–
2008–0001.
Reading Room: You may read any
comments that we receive on the risk
analysis 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: Additional
information about APHIS and its
programs is available on the Internet at
https://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: Mr.
Javier Vargas, Animal Scientist,
Regionalization Evaluation Services
Staff, National Center for Import and
Export, VS, APHIS, 4700 River Road
Unit 38, Riverdale, MD 20737–1231;
(301) 734–0756.
SUPPLEMENTARY INFORMATION: The
regulations in 9 CFR part 94 (referred to
below as the regulations) govern the
importation of certain animals and
animal products into the United States
in order to prevent the introduction of
various animal diseases, including
rinderpest and foot-and-mouth disease
(FMD). These are dangerous and
destructive communicable diseases of
ruminants and swine. Section 94.1 of
the regulations lists regions of the world
that are considered free of rinderpest
and FMD. Section 94.11 lists regions of
the world considered free of rinderpest
and FMD but from which the
importation of meat and other animal
products into the United States is
subject to additional restrictions
because of those regions’ proximity to or
trading relationships with FMD-affected
regions.
In an interim rule effective November
6, 2000, and published in the Federal
Register on February 9, 2001 (66 FR
9641–9643, Docket No. 00–122–1), we
amended the regulations by removing
the Republic of South Africa from the
list of regions considered to be free of
rinderpest and FMD. We also removed
the Republic of South Africa from the
list of regions in § 94.11 that are
considered to be free of these diseases,
but are subject to certain restrictions
because of their proximity to or trading
relationships with rinderpest- or FMDaffected regions. These actions were
PO 00000
Frm 00001
Fmt 4703
Sfmt 4703
necessary because FMD had been
confirmed in two provinces in the
Republic of South Africa. The effect of
the interim rule was to prohibit or
restrict the importation of ruminants
and swine and the fresh meat and other
animal products of ruminants and swine
into the United States from the Republic
of South Africa.
Although we removed the Republic of
South Africa from the list of regions
considered to be free of rinderpest and
FMD, we recognized that the Republic
of South Africa’s National Department
of Agriculture responded immediately
to the detection of the disease by
imposing restrictions on the movement
of ruminants, swine, and ruminant and
swine products from the affected areas
and by initiating measures to eradicate
the disease. We stated that we intended
to reassess the situation in the region at
a future date in accordance with Office
International des Epizooties (OIE)
standards. We solicited comments
concerning our interim rule ending
April 10, 2001; we received no
comments by that date.
In this notice, we are announcing the
availability for review and comment of
a document entitled ‘‘Evaluation of the
Foot-and-Mouth Disease Status of the
Republic of South Africa’’ (October
2007). This risk analysis assesses the
FMD status of the Republic of South
Africa and the related disease risks
associated with importing animals and
animal products into the United States
from the Republic of South Africa. This
risk analysis will be considered as part
of our decisionmaking process regarding
whether to relieve certain prohibitions
and restrictions on the importation of
ruminants and swine and the fresh meat
and other animal products of ruminants
and swine into the United States from
the Republic of South Africa. The
importation of live swine and certain
swine products would continue to be
restricted because the Republic of South
Africa has not been evaluated by APHIS
for African swine fever, classical swine
fever, and swine vesicular disease. We
are making the risk analysis available
for public comment for 60 days.
The risk analysis may be viewed on
the Regulations.gov Web site or in our
reading room (see ADDRESSES above for
a link to Regulations.gov and
information on the location and hours of
the reading room). You may request
paper copies of the risk analysis by
E:\FR\FM\15FEN1.SGM
15FEN1
Federal Register / Vol. 73, No. 32 / Friday, February 15, 2008 / Notices
calling or writing to the person listed
under FOR FURTHER INFORMATION
CONTACT. Please refer to the title of the
risk analysis when requesting copies.
Authority: 7 U.S.C. 450, 7701–7772, 7781–
7786, and 8301–8317; 21 U.S.C. 136 and
136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and
371.4.
Done in Washington, DC, this 11th day of
February 2008.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. E8–2912 Filed 2–14–08; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2008–0024]
Draft Guideline: Target Animal Safety
for Veterinary Live and Inactivated
Vaccines
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice of availability and
request for comments.
AGENCY:
SUMMARY: The International Cooperation
on Harmonization of Technical
Requirements for the Registration of
Veterinary Medicinal Products (VICH)
has developed a draft guideline titled
‘‘Target Animal Safety for Veterinary
Live and Inactivated Vaccines.’’ This
draft guideline provides guidance for
designing and executing studies to
evaluate the safety of the final
formulation of veterinary live and
inactivated vaccines in animals.
Because the draft guideline may have an
effect on the requirements for vaccines
that are regulated by the Animal and
Plant Health Inspection Service under
the Virus-Serum-Toxin Act, we are
requesting comments on the scope of
the guideline and its provisions so that
we may include any relevant public
input on the draft in the Agency’s
comments to the VICH Steering
Committee.
We will consider all comments
that we receive on or before April 15,
2008.
DATES:
You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/fdmspublic/
component/
main?main=DocketDetail&d=APHIS2008-0024 to submit or view comments
and to view supporting and related
materials available electronically.
rwilkins on PROD1PC63 with NOTICES
ADDRESSES:
VerDate Aug<31>2005
15:58 Feb 14, 2008
Jkt 214001
• Postal Mail/Commercial Delivery:
Please send two copies of your comment
to Docket No. APHIS–2008–0024,
Regulatory Analysis and Development,
PPD, APHIS, Station 3A–03.8, 4700
River Road Unit 118, Riverdale, MD
20737–1238. Please state that your
comment refers to Docket No. APHIS–
2008–0024.
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: Additional
information about APHIS and its
programs is available on the Internet at
https://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: Dr.
Albert P. Morgan, Center for Veterinary
Biologics-Policy Evaluation and
Licensing, VS, APHIS, 4700 River Road
Unit 148, Riverdale, MD 20737–1231;
(301) 734–8245.
SUPPLEMENTARY INFORMATION: The
International Cooperation on
Harmonization of Technical
Requirements for the Registration of
Veterinary Medicinal Products (VICH) is
a unique project conducted under the
auspices of the World Organization for
Animal Health 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
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 on 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
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Frm 00002
Fmt 4703
Sfmt 4703
8845
development of veterinary drugs and
biological products. 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.
The draft guideline ‘‘Target Animal
Safety for Veterinary Live and
Inactivated Vaccines’’ (VICH Topic
GL44) has been made available by the
VICH Steering Committee for comments
by interested parties. The guideline is
intended to provide guidance for
designing and executing studies to
evaluate the safety of the final
formulation of veterinary live and
inactivated vaccines prior to approval
for licensing/registration. Because the
draft guideline applies to some
veterinary vaccines regulated by APHIS
under the Virus-Serum-Toxin Act—
particularly with regard to the safety of
the dose of the vaccine on the health
and welfare of the target animal—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 guideline reflects current
APHIS thinking regarding designing and
executing studies to assess the safety of
the final formulation of live and
inactivated veterinary vaccines in target
animals. In accordance with the VICH
process, once a final draft of the
document 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,
each 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 applicable regulatory
requirements.
Ultimately, APHIS intends to consider
the VICH Steering Committee’s final
guideline for use by U.S. veterinary
biologics licensees, permittees, and
applicants. In addition, we may
consider using the final guideline as the
basis for proposed amendments to the
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
versions of ‘‘Target Animal Safety for
Veterinary Live and Inactivated
Vaccines’’ may be introduced into
APHIS’ veterinary biologics regulatory
program in the future, we encourage
your comments on the draft guideline.
E:\FR\FM\15FEN1.SGM
15FEN1
]]>Agencies
[Federal Register Volume 73, Number 32 (Friday, February 15, 2008)]
[Notices]
[Pages 8844-8845]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-2912]
========================================================================
Notices
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains documents other than rules
or proposed rules that are applicable to the public. Notices of hearings
and investigations, committee meetings, agency decisions and rulings,
delegations of authority, filing of petitions and applications and agency
statements of organization and functions are examples of documents
appearing in this section.
========================================================================
Federal Register / Vol. 73, No. 32 / Friday, February 15, 2008 /
Notices
[[Page 8844]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2008-0001]
Notice of Availability of a Risk Analysis for the Foot-and-Mouth
Disease Status of the Republic of South Africa
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: We are advising the public that a risk analysis has been
prepared by the Animal and Plant Health Inspection Service concerning
the foot-and-mouth disease status of the Republic of South Africa and
the related disease risks associated with importing animals and animal
products into the United States from the Republic of South Africa. This
risk analysis will be used as a basis for determining whether to
relieve certain prohibitions and restrictions on the importation of
ruminants and swine and the fresh meat and other animal products of
ruminants and swine into the United States from the Republic of South
Africa. We are making this risk analysis available to the public for
review and comment.
DATES: We will consider all comments we receive on or before April 15,
2008.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to https://
www.regulations.gov/fdmspublic/component/
main?main=DocketDetail&d=APHIS-2008-0001 to submit or view comments and
to view supporting and related materials available electronically.
Postal Mail/Commercial Delivery: Please send two copies of
your comment to Docket No. APHIS-2008-0001, Regulatory Analysis and
Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118,
Riverdale, MD 20737-1238. Please state that your comment refers to
Docket No. APHIS-2008-0001.
Reading Room: You may read any comments that we receive on the risk
analysis 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: Additional information about APHIS and its
programs is available on the Internet at https://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: Mr. Javier Vargas, Animal Scientist,
Regionalization Evaluation Services Staff, National Center for Import
and Export, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-
1231; (301) 734-0756.
SUPPLEMENTARY INFORMATION: The regulations in 9 CFR part 94 (referred
to below as the regulations) govern the importation of certain animals
and animal products into the United States in order to prevent the
introduction of various animal diseases, including rinderpest and foot-
and-mouth disease (FMD). These are dangerous and destructive
communicable diseases of ruminants and swine. Section 94.1 of the
regulations lists regions of the world that are considered free of
rinderpest and FMD. Section 94.11 lists regions of the world considered
free of rinderpest and FMD but from which the importation of meat and
other animal products into the United States is subject to additional
restrictions because of those regions' proximity to or trading
relationships with FMD-affected regions.
In an interim rule effective November 6, 2000, and published in the
Federal Register on February 9, 2001 (66 FR 9641-9643, Docket No. 00-
122-1), we amended the regulations by removing the Republic of South
Africa from the list of regions considered to be free of rinderpest and
FMD. We also removed the Republic of South Africa from the list of
regions in Sec. 94.11 that are considered to be free of these
diseases, but are subject to certain restrictions because of their
proximity to or trading relationships with rinderpest- or FMD-affected
regions. These actions were necessary because FMD had been confirmed in
two provinces in the Republic of South Africa. The effect of the
interim rule was to prohibit or restrict the importation of ruminants
and swine and the fresh meat and other animal products of ruminants and
swine into the United States from the Republic of South Africa.
Although we removed the Republic of South Africa from the list of
regions considered to be free of rinderpest and FMD, we recognized that
the Republic of South Africa's National Department of Agriculture
responded immediately to the detection of the disease by imposing
restrictions on the movement of ruminants, swine, and ruminant and
swine products from the affected areas and by initiating measures to
eradicate the disease. We stated that we intended to reassess the
situation in the region at a future date in accordance with Office
International des Epizooties (OIE) standards. We solicited comments
concerning our interim rule ending April 10, 2001; we received no
comments by that date.
In this notice, we are announcing the availability for review and
comment of a document entitled ``Evaluation of the Foot-and-Mouth
Disease Status of the Republic of South Africa'' (October 2007). This
risk analysis assesses the FMD status of the Republic of South Africa
and the related disease risks associated with importing animals and
animal products into the United States from the Republic of South
Africa. This risk analysis will be considered as part of our
decisionmaking process regarding whether to relieve certain
prohibitions and restrictions on the importation of ruminants and swine
and the fresh meat and other animal products of ruminants and swine
into the United States from the Republic of South Africa. The
importation of live swine and certain swine products would continue to
be restricted because the Republic of South Africa has not been
evaluated by APHIS for African swine fever, classical swine fever, and
swine vesicular disease. We are making the risk analysis available for
public comment for 60 days.
The risk analysis may be viewed on the Regulations.gov Web site or
in our reading room (see ADDRESSES above for a link to Regulations.gov
and information on the location and hours of the reading room). You may
request paper copies of the risk analysis by
[[Page 8845]]
calling or writing to the person listed under FOR FURTHER INFORMATION
CONTACT. Please refer to the title of the risk analysis when requesting
copies.
Authority: 7 U.S.C. 450, 7701-7772, 7781-7786, and 8301-8317; 21
U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.
Done in Washington, DC, this 11th day of February 2008.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E8-2912 Filed 2-14-08; 8:45 am]
BILLING CODE 3410-34-P
