[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR113.71]

[Page 621-622]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 113--STANDARD REQUIREMENTS--Table of Contents
 
Sec. 113.71  Chlamydia Psittaci Vaccine (Feline Pneumonitis), Live Chlamydia.

    Chlamydia Psittaci Vaccine (Feline Pneumonitis), Live Chlamydia, 
shall be prepared from chlamydia-bearing cell culture fluids or 
embryonated chicken eggs. Only Master Seed which has been established as 
pure, safe, and immunogenic shall be used for vaccine production. All 
serials of vaccine shall be prepared from the first through the fifth 
passage from the Master Seed.
    (a) The Master Seed shall meet the applicable requirements 
prescribed in Sec. 113.300 and the requirements in this section. Master 
Seed propagated in chicken embryos shall be tested for pathogens by the 
chicken embryo test prescribed in Sec. 113.37. If found unsatisfactory 
by any prescribed test, the Master Seed shall not be used.
    (b) Each lot of Master Seed used for vaccine production shall be 
tested for immunogenicity. The immunogenicity of a selected dose from 
the lot of Master Seed shall be established as follows:
    (1) Thirty feline pneumonitis susceptible cats shall be used as test 
animals (20 vaccinates and 10 controls). Blood samples shall be drawn 
and individual serum samples tested. The cats shall be considered 
suitable for use if all serums are negative for pneumonitis antibody in 
a complement fixation test or other test of equal sensitivity.
    (2) A geometric mean titer of the dried vaccine produced from the 
highest passage of the Master Seed shall be established before the 
immunogenicity test is conducted. The 20 cats used as vaccinates shall 
be administered a predetermined quantity of vaccine by the method to be 
recommended on the label and the remaining 10 cats shall be held as 
controls. To confirm the dosage calculations, five replicate titrations 
shall be conducted on a sample of the vaccine dilution used. If two 
doses are used, five replicate confirming titrations shall be conducted 
on each dose.
    (3) Fourteen or more days after the final dose of vaccine, the 
vaccinates and controls shall each be challenged intranasally with a 
minimum of 10,000 yolk sac LD50 of virulent feline pneumonitis furnished 
or approved by the Animal and Plant Health Inspection Service and 
observed each day for 28 days postchallenge. The rectal temperature of 
each animal shall be taken and the presence or absence of clinical signs 
noted and recorded each day.

[[Page 622]]

    (i) If less than 8 of 10 controls show clinical signs of feline 
pneumonitis infection other than fever, the test is inconclusive and may 
be repeated.
    (ii) If a significant difference in clinical signs other than fever 
or chlamydia shedding cannot be demonstrated between vaccinates and 
controls using a scoring system approved by the Animal and Plant Health 
Inspection Service, the Master Seed is unsatisfactory.
    (4) The Master Seed shall be retested for immunogenicity in 3 years 
unless use of the lot previously tested is discontinued. Either 10 
vaccinates and 6 controls or 5 vaccinates and 3 controls shall be used 
in the retest.
    (i) If less than five of six or three of three of the controls in 
the retest show clinical signs of feline pneumonitis infection other 
than fever, the test is inconclusive and may be repeated.
    (ii) A significant difference in clinical signs shall be 
demonstrated between vaccinates and controls in a valid test as 
prescribed in paragraph (c)(3)(ii) of this section.
    (5) An Outline of Production change must be made before authority 
for use of a new lot of Master Seed is granted by the Animal and Plant 
Health Inspection Service.
    (c) Test requirements for release: Except for 
Sec. 113.300(a)(3)(ii), each serial and subserial shall meet the 
requirements prescribed in Sec. 113.300 and in this paragraph. Final 
container samples of completed product shall be tested. Any serial or 
subserial found unsatisfactory by a prescribed test shall not be 
released.
    (1) The test for pathogens prescribed in Sec. 113.37 shall be 
conducted on each serial or one subserial of avian origin vaccine.
    (2) Chlamydia titer requirements. Final container samples of 
completed product shall be tested for chlamydia titer using the 
titration method used in paragraph (b)(2) of this section. To be 
eligible for release, each serial and each subserial shall have a titer 
sufficiently greater than the titer of vaccine used in the 
immunogenicity test prescribed in paragraph (b) of this section to 
assure that when tested at any time within the expiration period, each 
serial and subserial shall have a titer 0.7 greater than that used in 
such immunogenicity test but not less than 2.5 ID50 per dose.

[55 FR 35561, Aug. 31, 1990, as amended at 56 FR 66786, Dec. 26, 1991]

                     Inactivated Bacterial Products