Source: https://www.ecfr.gov/cgi-bin/text-idx?mc=true&node=se9.1.113_1302&rgn=div8
Timestamp: 2020-08-14 02:27:06
Document Index: 497879356

Matched Legal Cases: ['art 113', '§113', '§113', '§113', '§113', '§113']

Title 9 → Chapter I → Subchapter E → Part 113 → §113.302
§113.302 Distemper Vaccine—Mink.
Distemper Vaccine—Mink shall be prepared from virus-bearing cell culture fluids. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed Virus.
(a) The Master Seed Virus shall meet the applicable requirements prescribed in §113.300 and the requirements prescribed in this section.
(b) The lot of Master Seed Virus shall be tested for extraneous viruses as follows:
(1) To detect virulent canine distemper virus, each of two distemper susceptible mink or ferrets shall be inoculated with 1 ml of the Master Seed Virus and observed each day for 21 days. If undesirable reactions occur in either test animal, the lot of Master Seed Virus is unsatisfactory.
(2) Master Seed Virus propagated in chicken embryos shall be tested for pathogens by the chicken embryo test prescribed in §113.37 except lesions typical of distemper virus may be disregarded. If found unsatisfactory, the Master Seed Virus shall not be used.
(1) At least 25 distemper susceptible mink shall be used as test animals. Blood samples shall be drawn from these animals and individual serum samples tested. The mink shall be considered susceptible if the results are negative at a 1:2 final serum dilution in a varying serum-constant virus neutralization test with less than 500 ID50 of canine distemper virus. Other means of insuring susceptibility may be used if prior approval from Animal and Plant Health Inspection Service is received.
(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. At least 20 mink shall be vaccinated with a predetermined quantity of vaccine virus and at least 5 additional mink shall be held as unvaccinated controls. To confirm the dosage calculations, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.
(3) At least twenty-one days post-injection, the immunity of each of the vaccinates and the controls shall be challenged with the same size dose of virulent distemper virus and observed each day for 21 days.
(i) If at least 80 percent of the controls do not die or show severe signs of distemper, the test is a No Test and may be repeated.
(ii) If at least 19 of 20, 27 of 30, or 36 of 40 of the vaccinates do not survive without showing clinical signs of distemper during the observation period, the Master Seed Virus is unsatisfactory.
(4) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be authorized by Animal and Plant Health Inspection Service.
(d) Test requirements for release: Each serial and subserial shall meet the general requirements prescribed in §113.300 and the requirements 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) Mink safety test. Each of 2 mink shall be vaccinated with the equivalent of 10 doses of vaccine rehydrated with sterile diluent and administered in the manner recommended on the label. The mink shall be observed each day for 21 days. If unfavorable reactions attributable to the product occur in either of the mink during the observation period, the serial or subserial is unsatisfactory. If unfavorable reactions which are not attributable to the product occur, the test shall be declared a No Test and may be repeated: Provided, That if the test is not repeated, the serial or subserial shall be declared unsatisfactory.
(2) Potency Test. An in vitro potency test shall be conducted. To be eligible for release, each serial and subserial shall have a virus titer sufficiently greater than the titer of vaccine virus used in the immunogenicity test prescribed in paragraph (c) of this section to assure that, when tested at any time within the expiration period, each serial and subserial shall have a virus titer 100.7 greater than that used in such immunogenicity test when tested by the method used in paragraph (c)(2) of this section.
[40 FR 53000, Nov. 14, 1975, as amended at 48 FR 33471, July 22, 1983. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66784, 66786, Dec. 26, 1991; 72 FR 72564, Dec. 21, 2007]