Commonwealth Numbered Regulations - Explanatory Statements

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NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL REGULATIONS 1993 NO. 198

STATUTORY RULES 1993 No. 198

Issued by authority of the Minister for Health

National Health and Medical Research Council Act 1992

National Health and Medical Research Council Regulations

The National Health and Medical Research Council Act 1992 (the Act) provides, in part, for the manner in which the National Health and medical Research Council (the Council) shall conduct public consultations when it intends to make a regulatory recommendation, issue guidelines or engage in any other prescribed activity.

Section 85 of the Act provides that the Governor-General may make regulations for the purposes of the Act.

Subsection 12(1) of the Act provides that the Council must consult persons or bodies in accordance with the Act before the Council makes a regulatory recommendation, or issues guidelines, or engages in any other prescribed activity.

The regulations prescribe the manner and form of the notices required issued by sections 12, 13 and 14 of the Act. The regulations also require that the notices be published in the Commonwealth Gazette, that notices inviting submissions must be published at least 30 days before the closing date for submissions and that notices under subsection 13(2) must be published no more than 30 days after the relevant decision is made.

The prescribed forms in the Schedule only address the activities of the Council in relation to making regulatory recommendations and issuing guidelines. At this time no additional prescribed activities are proposed. Accordingly, the regulations make no reference to prescribed activities. Proposals to amend the forms will be made at the time any additional activity is proposed to be prescribed.

Subsection 12(2) of the Act provides that the Council must publish a notice in the prescribed form, informing of its intention to make a recommendation, issue guidelines, or engage in any other prescribed activity, and inviting interested persons or bodies to make submissions relating to the matters within the time specified in the notice.

Subsection 12(3) of the Act provides that after it has considered the submissions the Council must either: a) prepare a draft of the recommendation or guideline, or an outline of the activity, and publish it in a notice in the prescribed form, inviting submissions relating to the draft or outline; or b) publish a notice in the prescribed form informing that it no longer intends to make the recommendation, issue the guidelines or engage in the prescribed activity.

Subsection 13(1) of the Act provides that the Council may dispense with all or any of the steps in section 12 of the Act where it is satisfied that the proposed regulatory recommendation, proposed guidelines or proposed prescribed activity, raises issues that are of minor importance only. Subsection 13(2) of the Act provides that the Council must publish a notice, in the manner and form, and within the period, specified in the regulations of its reasons for proposing to omit the steps.

Subsection 14(1) of the Act provides that where a matter that would ordinarily involve public consultation in accordance with section 12 must be dealt with urgently, the Council may make an interim regulatory recommendation or issue guidelines without first taking one or more of the steps set out in section 12. Subsection 14(2) provides that where the Council does not invite submissions on the draft in accordance with paragraph 12(3)(a), it must publish within 30 days, a notice in the manner and form specified in the regulations, setting out its reasons for making the interim recommendation or issuing the interim guidelines, setting out the interim recommendation or guidelines and inviting interested persons or bodies to make submissions on it.

The regulations commence on the date of their gazettal.