§113.41. Calf safety test. — Inbound Citations

(b) Samples of each lot of Master Seed Virus and final container samples of completed product from each serial or first subserial of live virus vaccine recommended for animals other than poultry shall be tested for safety in at least one species for which the vaccine is intended using methods prescribed in §§ 113.39, 113.40, 113.41, 113.44, and 113.45 or in a filed Outline of Production. The mouse safety test prescribed in § 113.33(a) shall also be conducted unless the virus or agent in the vaccine is inherently lethal for mice.

(2) The mouse safety test prescribed in § 113.33(a) and the calf safety test prescribed in § 113.41 shall be conducted.

(2) The mouse safety test prescribed in § 113.33(a) and the calf safety test prescribed in § 113.41 shall be conducted.

(2) The mouse safety test prescribed in § 113.33(a) and the calf safety test prescribed in § 113.41 shall be conducted.

(ii) Live bacterial vaccine recommended for use in cattle shall be tested as provided in § 113.41, except that calves shall be injected with the equivalent of two doses of vaccine administered as recommended on the label.

(1) Samples of completed product from each serial or first subserial shall be tested for safety in calves as provided in §§ 113.41(a) and 113.41(b) except, that the equivalent of two doses of vaccine shall be used and administered in the manner recommended on the label.

(1) Samples of completed product from each serial or first subserial shall be tested for safety in calves as provided in §§ 113.41(a) and 113.41(b), except that the equivalent of two doses of vaccine shall be used and administered in the manner recommended on the label.

(1) Samples of completed product from each serial or first subserial shall be tested for safety in calves as provided in §§ 113.41(a) and 113.41(b) except, that the equivalent of two doses of vaccine shall be used and administered in the manner recommended on the label.

(1) Samples of completed product from each serial or first subserial shall be tested for safety in calves as provided in §§ 113.41(a) and 113.41(b), except that the equivalent of two doses of vaccine shall be used and administered in the manner recommended on the label.