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

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]

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