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 applications have been made to reassess the following trade name products under section 29 of the Act:

Trade Name: TeatSeal

Reference: A007294

Active Ingredient and Concentration:

Bismuth subnitrate 2.6g per 4.0g syringe

Formulation Type: Intramammary suspension

General Use Claim:

For the prevention of mastitis during the non-lactating (dry) period.

Use Claims Impacted by the Reassessment:

• For the prevention of mastitis during the non-lactating (dry) period in lactating heifers (first calvers) and cows with somatic cell counts (SCC) of less than 120,000 and 150,000 respectively.
• For the prevention of mastitis during the non-lactating (dry) period in cows and heifers with a higher SCC immediately following treatment with Orbenin Enduro (A6036) or Orbenin Dry Cow (A0888).
• For the prevention of peri-calving mastitis in maiden heifers.

The applicant’s address for service is:

Zoetis New Zealand Limited, Level 5, 8 Mahuhu Crescent, Auckland Central, Auckland 1010. Postal Address: PO Box 2094, Auckland 1140.

Trade Name: DC Duo

Reference: A011025

Active Ingredients and Concentrations:

Cloxacillin 500mg as the benzathine salt per 8.5g syringe

Ampicillin 250mg as the Trihydrate per 8.5g syringe

Bismuth subnitrate 2.6g per 8.5g syringe

Chlorhexidine 20mg per 8.5g syringe

Formulation Type: Intramammary suspension

General Use Claim:

For the treatment and prevention of mastitis in cows at drying off.

Use Claim Impacted by the Reassessment:

Formulated for use in the dairy cow at the point of drying off, that is, as soon as possible after the last milking of lactation in order to treat existing mastitis and to provide protection against further infections during the dry period.

The applicant’s address for service is:

Bayer New Zealand Limited, 3 Argus Place, Hillcrest, Auckland 0627. Postal Address: PO Box 2825, Shortland Street, Auckland 1140.

Trade Name: Intercept

Reference: A010540

Active Ingredients and Concentrations:

Bismuth subnitrate 2.6g per 4.0g syringe

Chlorhexidine 20mg per 4.0g syringe

Formulation Type: Intramammary suspension

General Use Claim:

For the prevention of mastitis in cows after drying off and peri-calving mastitis in maiden heifers.

Use Claims Impacted by the Reassessment:

• For the prevention of mastitis during the non-lactating (dry period) dairy cows and heifers (first calvers) with low individual somatic cell counts (first lactation <120,000 cells/mL; subsequent lactation <150,000 cells/mL) at drying off.
• For pre-calving administration in maiden heifers for the prevention of mastitis.

The applicant’s address for service is:

Bayer New Zealand Limited, 3 Argus Place, Hillcrest, Auckland 0627. Postal Address: PO Box 2825, Shortland Street, Auckland 1140.

Trade Name: drySeal

Reference: A011157

Active Ingredients and Concentrations:

Bismuth subnitrate 650mg/g and PVP-iodine as a preservative 1mg/g per 4.0g syringe

Formulation Type: Intramammary suspension

General Use Claim:

For the prevention of mastitis during the non-lactating (dry) period in cows, and also heifers at the end of their first lactation.

Use Claims Impacted by the Reassessment:

• For the prevention of mastitis during the non-lactating (dry) period in cows and heifers at the end of the first lactation with somatic cell counts (SCC) of less than 150,000 and 120,000 respectively.
• For the prevention of mastitis during the non-lactating (dry) period in cows and heifers with higher somatic cell counts (SCC) immediately following treatment with an appropriate antibiotic dry cow therapy.

The applicant’s address for service is:

Norbrook NZ Limited, KPMG Centre, 18 Viaduct Harbour Avenue, Auckland 1010. Postal Address: Norbrook Laboratories Australia Pty Limited, PO Box 189, Tullamarine, Australia.

Trade Name: Sureseal

Reference: A010866

Active Ingredient and Concentration:

Bismuth subnitrate 650mg/g per 4.0g syringe

Formulation Type: Intramammary suspension

General Use Claim:

For the prevention of mastitis during the non-lactating (dry) period.

Use Claims Impacted by the Reassessment:

• For the prevention of mastitis during the non-lactating (dry) period in lactating heifers (first calvers) and cows with somatic cell counts (SCC) of less than 120,000 and 150,000 respectively.
• For the prevention of mastitis during the non-lactating (dry) period in cows and heifers with higher somatic cell counts (SCC), or immediately following treatment with Noroclox DC 600 (A9281), Cloxamp DC 500 (A8038), Cloxamp DC 600 (A8039), or Durodry (A7862).
• For the prevention of peri-calving mastitis in maiden heifers.

The applicant’s address for service is:

Norbrook NZ Limited, KPMG Centre, 18 Viaduct Harbour Avenue, Auckland 1010. Postal Address: Norbrook Laboratories Australia Pty Limited, PO Box 189, Tullamarine, Australia.

Trade Name: Bio-Bloc

Reference: A010586

Active Ingredients and Concentrations:

Bismuth subnitrate 2.4g per 4.0g syringe

3% thyme oil per 4.0g syringe

Formulation Type: Intramammary suspension

General Use Claim:

Use in dairy cows as an integral/routine part of mastitis control.

Use Claims Impacted by the Reassessment:

• For the prevention of mastitis during the dry period in heifer and cows with individual somatic cell counts of less than 120,000 and 150,000 respectively.
• For the prevention of peri-calving mastitis in maiden heifers.

The applicant’s address for service is:

Merial New Zealand Limited, Level 3, Merial Building, 2 Osterley Way, Auckland 2104. Postal Address: PO Box 76211, Auckland.

The purpose of the reassessment is to re-evaluate the dose volume per teat of product when used in small cows and heifers.

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; and
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; and
2. where requests for copies of the public information relating to the application can be sent; and
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.

Dated at Wellington this 16th day of August 2016.

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