Viruses, Serums, Toxins, and Analogous Products; Standard Requirements for Bovine Virus Diarrhea and Bovine Rhinotracheitis Vaccines, 12814 [05-5156]
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12814
Federal Register / Vol. 70, No. 50 / Wednesday, March 16, 2005 / Proposed Rules
Veterinary Biologics, Policy, Evaluation,
and Licensing, VS, APHIS, 4700 River
Road, Unit 148, Riverdale, MD 20737–
1231; (301) 734–8245.
On
October 11, 1994, we published in the
Federal Register (59 FR 51390–51392,
Docket No. 93–039–1) a proposed rule
to amend the regulations in 9 CFR part
113 to include a Standard Requirement
for Escherichia coli bacterins. We
solicited comments on the proposed
rule for 60 days ending on December 12,
1994. We subsequently reopened the
comment period, then extended the
comment period again: The first notice,
published in the Federal Register on
May 17, 1995 (60 FR 26384, Docket No.
93–039–2), reopened the comment
period until August 15, 1995, and the
second notice, published in the Federal
Register on August 22, 1995 (60 FR
43573–43574, Docket No. 93–039–3),
extended the comment period until
September 14, 1995.
We received a total of nine comments
by the close of the extended comment
period. The comments were from
veterinary biologics manufacturers and
a trade association representing
veterinary biologics manufacturers. One
commenter supported the concept of a
standard test procedure for E. coli
bacterin, but remarked that the
proposed standard lacked sufficient
detail concerning the test method.
Another commenter identified
provisions in the proposed rule that he
believed conflicted with the provisions
in an interrelated proposed rule
concerning in vitro testing, and
requested an indefinite extension of the
comment period pending resolution of
the conflicting provisions. The
remaining commenters requested
clarification of the various technical
provisions of the rule and suggested
alternative wording for our
consideration.
After considering all of the comments
that we received, we have concluded
that we will withdraw the proposed
rule. Therefore, we are withdrawing the
October 11, 1994, proposed rule
referenced above. The concerns and
recommendations of all of the
commenters will be considered if any
new proposed regulations concerning a
Standard Requirement for E. coli
bacterins are developed.
SUPPLEMENTARY INFORMATION:
Authority: 21 U.S.C. 151–159; 7 CFR 2.22,
2.80, and 371.4.
VerDate jul<14>2003
15:05 Mar 15, 2005
Jkt 205001
Done in Washington, DC, this 10th day of
March 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 05–5155 Filed 3–15–05; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
9 CFR Part 113
[Docket No. 03–054–2]
Viruses, Serums, Toxins, and
Analogous Products; Standard
Requirements for Bovine Virus
Diarrhea and Bovine Rhinotracheitis
Vaccines
Animal and Plant Health
Inspection Service, USDA.
ACTION: Proposed rule; withdrawal.
AGENCY:
SUMMARY: We are withdrawing a
proposed rule to amend the VirusSerum-Toxin Act regulations
concerning Standard Requirements for
Bovine Virus Diarrhea Vaccine, Killed
Virus, and Bovine Rhinotracheitis
Vaccine, Killed Virus. The proposed
rule would have required vaccines to
elicit specific antibody titer that is at
least 80 percent of the geometric mean
antibody titer obtained in the vaccinates
in the host animal protection study to
pass the potency test. We are taking this
action after considering the comments
we received following the publication of
the proposed rule.
FOR FURTHER INFORMATION CONTACT: Dr.
Albert P. Morgan, Section Leader,
Operational Support Section, Center for
Veterinary Biologics, Policy, Evaluation,
and Licensing, APHIS, 4700 River Road,
Unit 148, Riverdale, MD 20737–1231;
(301) 734–8245.
SUPPLEMENTARY INFORMATION:
Background
The Virus-Serum-Toxin Act
regulations in 9 CFR part 113 (referred
to below as the regulations) prescribe
standard requirements for the
preparation and testing of veterinary
biological products. On October 6, 2003,
we published in the Federal Register
(68 FR 57638–57639, Docket No. 03–
054–1) a proposed rule to amend the
regulations concerning Standard
Requirements for Bovine Virus Diarrhea
Vaccine, Killed Virus, and Bovine
Rhinotracheitis Vaccine, Killed Virus, to
require that those vaccines elicit
specific antibody titer that is at least 80
percent of the geometric mean antibody
PO 00000
Frm 00003
Fmt 4702
Sfmt 4702
titer obtained in the vaccinates in the
host animal protection study to pass the
potency test. The proposed action
would have established potency test
requirements for these vaccines that
were based on the host animal
protection study performed by the
licensee.
We solicited comments concerning
our proposal for 60 days ending on
December 5, 2003. We received nine
comments by that date. The comments
were from veterinary biologics
manufacturers, trade associations
representing veterinary biologics
manufacturers, a microbiologist, and a
veterinary association. One commenter
supported the proposed rule. Another
commenter expressed support for the
proposal in principle, but urged delay in
its implementation pending the
completion of additional studies. The
remaining commenters were opposed to
the proposed rule. Some of those
commenters stated that the proposed
rule was scientifically flawed, and
suggested that it be withdrawn lest it
have a negative impact on the industry
and future availability of vaccine. Other
commenters stated that the proposed
rule was inconsistent with the
requirements for vaccine evaluated by
other test methods and suggested that
the Agency address the disparity in
requirements.
After considering all of the comments
that we received, we have concluded
that we will withdraw the proposed
rule. Therefore, we are withdrawing the
October 6, 2003, proposed rule
referenced above. The concerns and
recommendations of all of the
commenters will be considered if any
new proposed regulations concerning
Standard Requirements for Bovine Virus
Diarrhea Vaccine, Killed Virus, and
Bovine Rhinotracheitis Vaccine, Killed
Virus, are developed.
Authority: 21 U.S.C. 151–159; 7 CFR 2.22,
2.80, and 371.4.
Done in Washington, DC, this 10th day of
March 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 05–5156 Filed 3–15–05; 8:45 am]
BILLING CODE 3410–34–P
E:\FR\FM\16MRP1.SGM
16MRP1
Agencies
[Federal Register Volume 70, Number 50 (Wednesday, March 16, 2005)]
[Proposed Rules]
[Page 12814]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-5156]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 113
[Docket No. 03-054-2]
Viruses, Serums, Toxins, and Analogous Products; Standard
Requirements for Bovine Virus Diarrhea and Bovine Rhinotracheitis
Vaccines
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule; withdrawal.
-----------------------------------------------------------------------
SUMMARY: We are withdrawing a proposed rule to amend the Virus-Serum-
Toxin Act regulations concerning Standard Requirements for Bovine Virus
Diarrhea Vaccine, Killed Virus, and Bovine Rhinotracheitis Vaccine,
Killed Virus. The proposed rule would have required vaccines to elicit
specific antibody titer that is at least 80 percent of the geometric
mean antibody titer obtained in the vaccinates in the host animal
protection study to pass the potency test. We are taking this action
after considering the comments we received following the publication of
the proposed rule.
FOR FURTHER INFORMATION CONTACT: Dr. Albert P. Morgan, Section Leader,
Operational Support Section, Center for Veterinary Biologics, Policy,
Evaluation, and Licensing, APHIS, 4700 River Road, Unit 148, Riverdale,
MD 20737-1231; (301) 734-8245.
SUPPLEMENTARY INFORMATION:
Background
The Virus-Serum-Toxin Act regulations in 9 CFR part 113 (referred
to below as the regulations) prescribe standard requirements for the
preparation and testing of veterinary biological products. On October
6, 2003, we published in the Federal Register (68 FR 57638-57639,
Docket No. 03-054-1) a proposed rule to amend the regulations
concerning Standard Requirements for Bovine Virus Diarrhea Vaccine,
Killed Virus, and Bovine Rhinotracheitis Vaccine, Killed Virus, to
require that those vaccines elicit specific antibody titer that is at
least 80 percent of the geometric mean antibody titer obtained in the
vaccinates in the host animal protection study to pass the potency
test. The proposed action would have established potency test
requirements for these vaccines that were based on the host animal
protection study performed by the licensee.
We solicited comments concerning our proposal for 60 days ending on
December 5, 2003. We received nine comments by that date. The comments
were from veterinary biologics manufacturers, trade associations
representing veterinary biologics manufacturers, a microbiologist, and
a veterinary association. One commenter supported the proposed rule.
Another commenter expressed support for the proposal in principle, but
urged delay in its implementation pending the completion of additional
studies. The remaining commenters were opposed to the proposed rule.
Some of those commenters stated that the proposed rule was
scientifically flawed, and suggested that it be withdrawn lest it have
a negative impact on the industry and future availability of vaccine.
Other commenters stated that the proposed rule was inconsistent with
the requirements for vaccine evaluated by other test methods and
suggested that the Agency address the disparity in requirements.
After considering all of the comments that we received, we have
concluded that we will withdraw the proposed rule. Therefore, we are
withdrawing the October 6, 2003, proposed rule referenced above. The
concerns and recommendations of all of the commenters will be
considered if any new proposed regulations concerning Standard
Requirements for Bovine Virus Diarrhea Vaccine, Killed Virus, and
Bovine Rhinotracheitis Vaccine, Killed Virus, are developed.
Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.
Done in Washington, DC, this 10th day of March 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 05-5156 Filed 3-15-05; 8:45 am]
BILLING CODE 3410-34-P