Maree Zinzley, Manager Approvals Operations of the Ministry for Primary Industries (MPI), acting under delegated authority from the Director-General of MPI, gives notice, under section 14(1) of the Agricultural Compounds and Veterinary Medicines Act 1997 (“Act”), that the following application has been made to register a trade name product under section 9(1) of the Act:

Trade Name: Settle

Reference: A011453

Active Ingredient and Concentration:

Mycobacterium cell wall fraction 1mg/mL

Formulation Type: Aqueous suspension

General Use Claim:

An immunotherapeutic agent for use by or under the direction of a registered Veterinarian as an aid in the treatment of Equine Endomertitis caused by Streptococcus zooepidemicus.

Any person may make a written submission to the director-general concerning this application.

Under sections 16 and 17 of the Act, a written submission:

1. must state in full the reasons for making the submission;
2. may state any decision sought on that application; and
3. must be received by the director-general no later than 30 working days after the date of notification in the New Zealand Gazette.

Under section 18 of the Act, a copy of every submission will be forwarded to the applicant for the applicant’s information.

The following address is:

1. where submissions on this application are to be sent;
2. where requests for copies of the public information relating to the application can be sent;
3. where public information relating to the application can be viewed; and
4. the director-general’s address for service:

ACVM Group, Ministry for Primary Industries, Pastoral House, 25 The Terrace, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140.

The applicant’s address for service is:

NovaVive Inc, 79 Howard Crescent, Belleville, Ontario K8N 4Z7, Canada. Postal Address: PO Box 3005, RR#7, Belleville, Ontario K8N 4Z7, Canada.

Dated at Wellington this 30th day of May 2017.

MAREE ZINZLEY, Manager Approvals Operations, Ministry for Primary Industries (acting under delegated authority).