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Scheduling delegate's interim decisions and invitation for further comment: ACCS/ACMS, October 2015
Interim decisions and invitation for further comment. Closing date: 15 October 2015
This consultation closes on 15 October 2015
Notice under subsections 42ZCZP of the Therapeutic Goods Regulations 1990 (the Regulations)
A delegate of the Secretary to the Department of Health hereby gives notice of delegate's interim decisions for amending the Poisons Standard (commonly referred to as the Standard for the Uniform Scheduling of Medicines and Poisons - SUSMP) under subsections 42ZCZP the (the Regulations). This notice also provides the reasons for each decision and the date of effect (implementation date) of the decision.
The delegate's interim decisions and reasons relate to:
- scheduling proposals initially referred to the August 2015 meeting of the Advisory Committee on Chemicals Scheduling (ACCS#14);
- scheduling proposals initially referred to the August 2015 Joint meeting of the Advisory Committee on Chemicals Scheduling and the Advisory Committee of Medicines Scheduling (ACCS/ACMS #11)
Pre-meeting public notice
A 'pre-meeting' public notice inviting submissions on the scheduling proposals referred to the expert advisory committees was published on 28 May 2015 at Consultation: Invitation for public comment - ACCS meeting, August 2015.
Redacted versions of these public submissions received in response to this invitation were published in October 2015 at Public submissions on scheduling matters.
This notice provides the interim decisions of the delegate, the reasons for those decisions and invites further submissions from the applicant and parties who made valid submissions in response to the original invitations for submissions. Further 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 15 October 2015.
Further submissions from parties other than those who made a valid submission in response to the original invitation or the applicant, or those received after the closing date, need not be considered by the delegate.
Please note that all valid submissions received on or before the closing date will be published following removal of confidential information. It is up to the person making the submissions 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 for Medicines and Chemicals (SPF, 2015), issued by the Australian Health Ministers' Advisory Council (AHMAC).
Persons making submissions are strongly encouraged to lodge submissions in electronic format (word or unsecured PDF preferred) via the email address Chemicals.Scheduling@health.gov.au.
The closing date for further submissions is 15 October 2015.
Privacy and your personal information
Your personal information is protected by law, including the Privacy Act 1988. It is collected by the Australian Government Department of Health for the purpose of identifying the person making a submission as part of the public invitation process, and contacting that person about their submission, for example to seek clarification of issues raised in submissions.
The consequence of not providing your personal information may result in the Department being unable to communicate with you about your submission.
The Department is unlikely to disclose your personal information it has collected as part of the public comment process to any other Department, body or person or to overseas recipients.
- Part A - Scheduling proposals referred to the August 2015 meeting of the Advisory Committee on Chemicals Scheduling (ACCS#14)
- 1.1 Cyclopropylmethyl, 3-hexenoate
- 1.2 Bicyclopyrone
- 1.3 Clitoria ternatea extract
- 1.4 Cyclopentane, alpha,alpha-dimethylpropanol
- 1.5 Hydramethylnon
- 1.6 Momfluorothin
- 1.7 Carcinogenic amines (Azodyes)
- 1.8 Quinoline, 5,6,7,8-tetrahydro-8-(1-methylpropyl)
- 1.9 Phenol 4-amino-3-methyl (4-amino-m-cresol)
- 1.10 Phenol 5-amino-2-methyl (4-amino-2-hydroxytoluene)
- 1.11 Phenol 2-amino-6-chloro-4-nitro (2-amino-6-chloro-4-nitrophenol)
- Part B. Scheduling proposals referred to the August 2015 Joint meeting of the Advisory Committee on Chemicals Scheduling and the Advisory Committee on Medicines Scheduling (ACCS/ACMS #11)