[Federal Register: March 16, 2005 (Volume 70, Number 50)]
[Proposed Rules]
[Page 12814]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16mr05-16]
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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.
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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]
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