[Federal Register Volume 59, Number 79 (Monday, April 25, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-9904]


[[Page Unknown]]

[Federal Register: April 25, 1994]


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DEPARTMENT OF AGRICULTURE
9 CFR Part 113

[Docket No. 92-153-2]

 

Viruses, Serums, Toxins, and Analogous Products; Pasteurella 
Multocida Vaccine, Avian Isolate

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending the regulations for the Standard Requirement 
for Pasteurella Multocida Vaccine, Avian Isolate, by increasing from 14 
to 16 the minimum number of vaccinated birds out of 20 that must 
survive infection with virulent Pasteurella multocida for an adequate 
demonstration of vaccine efficacy. This amendment is necessary to 
provide greater assurance that a licensed Pasteurella Multocida 
Vaccine, Avian Isolate, meets the efficacy standard consumers have come 
to expect for this type of product.

EFFECTIVE DATE: May 25, 1994.

FOR FURTHER INFORMATION CONTACT: Dr. David A. Espeseth, Deputy 
Director, Veterinary Biologics, BBEP, APHIS, USDA, room 838, Federal 
Building, 6505 Belcrest Road, Hyattsville, MD 20782, (301) 436-8245.

SUPPLEMENTARY INFORMATION:

Background

    In accordance with the regulations contained in 9 CFR part 113, 
Standard Requirements are prescribed for the preparation of veterinary 
biological products. The Standard Requirement for Pasteurella Multocida 
Vaccine, Avian Isolate, in Sec. 113.70 states that a minimum of 14 of 
20 vaccinates must survive exposure to live bacteria for a successful 
demonstration of efficacy.
    On July 13, 1993, we published in the Federal Register (58 FR 
37670-37671, Docket No. 92-153-1) a proposal to amend the regulations 
by revising Sec. 113.70 to indicate that the minimum number of 
vaccinated birds out of 20 that must survive exposure to live bacteria 
for a successful demonstration of vaccine efficacy is 16. This action 
was taken to provide greater assurance that a licensed Pasteurella 
Multocida Vaccine meets the efficacy standard consumers have come to 
expect for this type of product.
    We solicited comments on our proposal for a 60-day period ending 
September 13, 1993. We received one comment by that date. The comment 
fully supported the proposed action. Therefore, based on the rationale 
set forth in the proposed rule, we are adopting the provisions of the 
proposal as a final rule without change.

Executive Order 12866 and Regulatory Flexibility Act

    The Department is issuing this final rule in conformance with 
Executive Order 12886.
    This amendment should not have a significant economic impact on 
manufacturers since the revised efficacy standard is one that has been 
readily achieved by all such vaccine licensed in recent years. The 
change from 14 of 20 to 16 of 20 vaccinated birds surviving exposure to 
live organisms in order to demonstrate satisfactory protection against 
disease will help ensure that consumers receive a highly efficacious 
vaccine without adding undue cost to the manufacturer. The revised 
efficacy standard assures that fewer birds will experience disease when 
vaccinated with a product that can still be manufactured at a 
reasonable cost to the producer.
    Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service has determined that this action will 
not have a significant economic impact on a substantial number of small 
entities.

Executive Order 12778

    This final rule has been reviewed under Executive Order 12778, 
Civil Justice Reform. It is not intended to have retroactive effect. 
This rule will not preempt any State or local laws, regulations, or 
policies, unless they present an irreconcilable conflict with this 
rule. There are no administrative proceedings which must be exhausted 
prior to any judicial challenge to the regulations under the rule.

Paperwork Reduction Act

    This rule contains no new information collection or recordkeeping 
requirements under the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 
et seq.).

Executive Order 12372

    This program/activity is listed in the category of Federal Domestic 
Assistance under No. 10.025 and is subject to Executive Order 12372, 
which requires intergovernmental consultation with State and local 
officials. (See 7 CFR part 3015, subpart V.)

List of Subjects in 9 CFR Part 113

    Animal biologics, Exports, Imports, and Reporting and recordkeeping 
requirements.

    Accordingly, we are amending 9 CFR part 113 as follows:

PART 113--STANDARD REQUIREMENTS

    1. The authority citation for part 113 continues to read as 
follows:

    Authority: 21 U.S.C. 151-159; 7 CFR 2.17, 2.51, and 371.2(d).

    2. In Sec. 113.70, paragraph (b)(4) is revised to read as follows:


Sec. 113.70  Pasteurella Multocida Vaccine, Avian Isolate.

* * * * *
    (b) * * *
    (4) Eight or more of the unvaccinated controls must die for the 
test to be valid. If at least 16 of 20 of the vaccinates do not survive 
the 14-day postchallenge period, the Master Seed is unsatisfactory at 
the selected bacterial count.
* * * * *
    Done in Washington, DC, this 19th day of April 1994.
Patricia Jensen,
Assistant Secretary, Marketing and Inspection Services.
[FR Doc. 94-9904 Filed 4-22-94; 8:45 am]
BILLING CODE 3410-34-P