Consultation: Invitation for public comment - ACCS and joint ACCS/ACMS meetings, July 2013

This consultation closed on 11 July 2013.

Notice inviting public submissions under Regulation 42ZCZK of the Therapeutic Goods Regulations 1990

The delegate of the Secretary of the Department of Health and Ageing hereby gives notice that the proposed amendments to the current Poisons Standard contained in this notice will be referred for scheduling advice to relevant expert advisory committees.¹

Accordingly, the following scheduling proposals are open for public submissions. Submissions must be relevant to the proposed amendment, must address a matter mentioned in section 52E of the Therapeutic Goods Act 1989 and be received by the closing date.

Persons wishing to make a submission are strongly encouraged to submit them in electronic format (word or unsecured PDF) to the email address provided below by 11 July 2013.

Public submissions received after the closing date may or may not be considered by the advisory committee(s).

Public submissions must include the name of the person making the submission and preferably an email or postal address.

Please note that the submissions received on or before the closing date will be published following removal of confidential information. It is up to the person making the submission to highlight any information which they wish to be considered as confidential. Material claimed to be commercial-in-confidence will be considered against the guidelines for the use and release of confidential information set out in Chapter 6 of the Scheduling Policy Framework (SPF), issued by the National Coordinating Committee on Therapeutic Goods.

The relevant expert advisory committee(s) will then consider all valid submissions and provide advice to the delegate in relation to the proposed amendment. After considering this advice, the delegate will make an interim scheduling decision. This interim decision is expected to be published on 26 September 2013. The applicant and persons who made a submission in response to the original invitation received on or before the closing date will be invited to comment on the delegates' interim decision.

The current Poisons Standard is available at The Poisons Standard (the SUSMP). Queries can be directed to the Scheduling Secretariat at SMP@health.gov.au.

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1. Notice inviting public submissions for the general scheduling applications was published on 24 April 2013 with the public comments due on 23 May 2013.

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Proposed amendments to the Poisons Standard referred by the delegate for scheduling advice

1. Proposed amendments referred by the delegate for scheduling advice for consideration by the Advisory Committee on Chemicals Scheduling (ACCS)

Substance	Scheduling proposal
1,2-benzenediol (Catechol)	Proposal to include preparations containing 1,2-benzenediol for domestic use in Schedule 6 or Schedule 7 and preparations containing 1,2-benzenediol for cosmetic use in Appendix C. This proposal also includes consideration of appropriate cut-offs for exemption from scheduling.
3-iodo-2-propynyl butyl carbamate (Iodocarb)	Proposal to amend the current Schedules 5 and 6 iodocarb entries to include cosmetic preparations containing iodocarb in Appendix C. This consideration also includes whether an Appendix C exemption cut-off for cosmetic preparations containing 0.05 per cent or 0.1 per cent iodocarb is appropriate.
Cocoyl glycinate	Proposal to include cocoyl glycinate in Schedule 6 with lower concentration cut-offs for leave-on and rinse-off preparations. This proposal also includes consideration whether an Appendix E listing is required for cocoyl glycinate.
Deltamethrin	Proposal to amend the Schedule 5 deltamethrin entry to include ready-to-use mosquito net containing 1 per cent or less deltamethrin in Schedule 5 or to create a specific exemption for this product from current deltamethrin schedule entries.
Hexyloxyethanol	Proposal to create a separate Schedule 6 entry for hexyloxyethanol to complement the generic entry for ethylene glycol monoalkyl ethers. This consideration includes whether Appendices E, F and I entries are required for hexyloxyethanol.

2. Proposed amendments referred by the delegate for scheduling advice for consideration by the joint meeting of the Advisory Committee on Chemicals Scheduling (ACCS) & the Advisory Committee on Medicines Scheduling (ACMS)

Substance	Scheduling proposal
Hydroquinone	Proposal to exempt from scheduling for cosmetic gel nail preparations (in LED/UV light activated nail gel/polish) and dental bonding materials (in LED/UV light activated dental bonding materials) containing 0.02 per cent or less hydroquinone. This consideration also includes whether amendments to the hydroquinone's Appendices E and/or F entries are required.
Monobenzone	Proposal to exempt from scheduling for cosmetic gel nail preparations (in LED/UV light activated nail gel/polish) and dental bonding materials (in LED/UV light activated dental bonding materials) containing 0.02 per cent or less monobenzone.
Pradofloxacin	Proposal to include pradofloxacin in Schedule 4 or Schedule 7. This proposal also includes if a Schedule 4 listing is appropriate for pradofloxacin, whether this entry should specify 'for the treatment of animals'.

3. Proposed amendment referred by the delegate for scheduling advice for consideration by the Advisory Committee on Medicines Scheduling (ACMS)

Substance	Scheduling proposal
Lurasidone	Proposal for a new Appendix K entry for Lurasidone

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