National Health and Medical Research Council Regulations 1993

National Health and Medical Research Council Regulations 1993

Statutory Rules 1993 No. 198 as amended

made under the

National Health and Medical Research Council Act 1992

This compilation was prepared on 10 October 2005
taking into account amendments up to SLI 2005 No. 218

Prepared by the Office of Legislative Drafting and Publishing,
Attorney-General’s Department, Canberra

Contents

 1 Name of Regulations [see Note 1]

 2 Interpretation 

 2A Publication of timetable (Act s 11A) 

 3 Notices under sections 12, 13, 14 and 14B of Act 

 4 Appointment of members of Council from prescribed bodies 

 5 Appointment of members of the Australian Health Ethics Committee from prescribed bodies             

Schedule 1  Forms 

Form 1 Timetable and procedures 

Form 2 Notice under s 12 (2) (b) Act 

Form 3 Notice under s 12 (3) (a) Act 

Form 4 Notice under s 12 (3) (b) Act 

Form 5 Notice under s 13 (1) (b) Act 

Form 6 Notice under s 14 (2) Act 

Form 7 Notice under s 14B (2) Act 

Schedule 2  Prescribed bodies who may nominate persons to be appointed as Members of Council             

Schedule 3  Prescribed bodies who may nominate persons to be appointed as members of the Australian Health Ethics Committee             

Notes   

1 Name of Regulations [see Note 1]

  These Regulations are the National Health and Medical Research Council Regulations 1993.

2 Interpretation

 (1) In these regulations, unless the contrary intention appears:

Act means the National Health and Medical Research Council Act 1992.

 (2) A reference in these regulations to a Form by number is a reference to the Form so numbered in Schedule 1.

2A Publication of timetable (Act s 11A)

  For section 11A of the Act, a notice of timetable and procedures must be:

 (a) in accordance with Form 1; and

 (b) published, at least 60 days before the closing date for applications for the relevant grant, in the Gazette and on an Internet website established and maintained by the Council.

3 Notices under sections 12, 13, 14 and 14B of Act

 (1) A notice under subsection 12 (2) of the Act:

 (a) must be in accordance with Form 2; and

 (b) must be published in the Gazette, and on an Internet website established and maintained by the Council, at least 30 days before the last day on which the Council will accept submissions on the matter set out in the notice.

 (2) A notice under paragraph 12 (3) (a) of the Act:

 (a) must be in accordance with Form 3; and

 (b) must be published in the Gazette, and on an Internet website established and maintained by the Council, at least 30 days before the last day on which the Council will accept submissions on the matter set out in the notice.

 (3) A notice under paragraph 12 (3) (b) of the Act:

 (a) must be in accordance with Form 4; and

 (b) must be published in the Gazette and on an Internet website established and maintained by the Council.

 (4) A notice under paragraph 13 (1) (b) of the Act must be:

 (a) in accordance with Form 5; and

 (b) published in the Gazette, and on an Internet website established and maintained by the Council, at least 30 days before the last day on which the Council will accept submissions relating to the draft guidelines mentioned in the notice.

 (5) A notice under subsection 14 (2) of the Act must be:

 (a) in accordance with Form 6; and

 (b) published in the Gazette, and on an Internet website established and maintained by the Council, at least 30 days before the last day on which the Council will accept submissions relating to the interim recommendation or guidelines mentioned in the notice.

 (6) A notice under subsection 14B (2) of the Act must be:

 (a) in accordance with Form 7; and

 (b) published in the Gazette, and on an Internet website established and maintained by the Council, no later than 30 days after the day on which the decision to which the notice relates was made.

4 Appointment of members of Council from prescribed bodies

  For the purposes of subsection 21 (3) of the Act, the bodies mentioned in Column 3 of an item in Schedule 2 are prescribed as bodies of the kind mentioned in Column 2 of that item and referred to in the paragraph of the Act mentioned in Column 2 of that item.

5 Appointment of members of the Australian Health Ethics Committee from prescribed bodies

  For the purposes of subsection 36 (6) of the Act, the bodies mentioned in Column 3 of an item in Schedule 3 are prescribed as bodies of the kind mentioned in Column 2 of that item and referred to in the paragraph of the Act mentioned in Column 2 of that item.

Schedules

Schedule 1 Forms

(regulations 2A and 3)

Form 1 Timetable and procedures

National Health and Medical Research Council Act 1992

NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL

TIMETABLE AND PROCEDURES RELATING TO RESEARCH AND TRAINING GRANTS FOR [grant period]

For section 11A of the Act, the National Health and Medical Research Council has made the timetable and procedures, set out below, to assist it in making recommendations to the Commonwealth on the application of the Medical Research Endowment Account on:

(a) public health research and training; and

(b) medical research and training.

[Category of grant]

Form 2 Notice under s 12 (2) (b) Act

National Health and Medical Research Council Act 1992

[Subject-matter of notice]

AN INVITATION TO MAKE SUBMISSIONS ABOUT:

* A PROPOSED REGULATORY RECOMMENDATION

* A PROPOSED PRESCRIBED ACTIVITY

The National Health and Medical Research Council intends to:

* make a regulatory recommendation about [subject].

* engage in the following prescribed activity:

[summary]

You are invited, under paragraph 12 (2) (b) of the Act, to make a submission to the Council about the proposed *recommendation/*prescribed activity.

How to make your submission

Please make your submission in writing or on audio tape, and include your name and address or phone number at which we can contact you.

Please send your submission to: [address].

Closing date

The closing date for submissions is [date].

Further information

For further information, please contact [name, phone number and e-mail address].

* Omit if inapplicable

Form 3 Notice under s 12 (3) (a) Act

National Health and Medical Research Council Act 1992

[Subject-matter of notice]

AN INVITATION TO MAKE SUBMISSIONS ABOUT:

* A REGULATORY RECOMMENDATION

* A PRESCRIBED ACTIVITY

The National Health and Medical Research Council:

* has made the following (summarised) draft regulatory recommendation:

[summary]

* proposes to engage in the following prescribed activity:

[outline]

You are invited, under paragraph 12 (3) (a) of the Act, to make a submission to the Council about the draft *recommendation/*proposed prescribed activity.

How to make your submission

Please make your submission in writing or on audio tape, and include your name and address or phone number at which we can contact you.

Please send your submission to: [address].

Closing date

The closing date for submissions is [date].

Further information

A copy of the draft recommendation is available from:

[website address].

* [name, phone number or e-mail address].

For further information, please contact [name, phone number and e-mail address].

* Omit if inapplicable

Form 4 Notice under s 12 (3) (b) Act

National Health and Medical Research Council Act 1992

[Subject-matter of notice]

NOTICE OF A DECISION NOT TO:

* MAKE A REGULATORY RECOMMENDATION

* ENGAGE IN A PRESCRIBED ACTIVITY

On [date], the National Health and Medical Research Council announced its intention to:

* make a regulatory recommendation about [subject].

* engage in the following prescribed activity:

[outline]

Following public consultation the Council has decided, under paragraph 12 (3) (b) of the Act, not to:

* make the recommendation

* engage in the prescribed activity

for the following reasons:

[state]

Further information

For further information, please contact [name, phone number and e-mail address].

* Omit if inapplicable

Form 5 Notice under s 13 (1) (b) Act

National Health and Medical Research Council Act 1992

[Subject-matter of notice]

NOTICE OF PROPOSED GUIDELINES

The National Health and Medical Research Council proposes to issue draft guidelines (summarised in the Schedule) about [subject].

You are invited, under paragraph 13 (1) (b) of the Act, to make a submission to the Council about the draft guidelines.

How to make your submission

Please make your submission in writing or on audio tape, and include your name and address or phone number at which we can contact you.

Please send your submission to: [address].

Closing date

The closing date for submissions is [date].

Further information

A copy of the draft guidelines is available from:

[website address].

* [name, phone number or e-mail address].

For further information, please contact [name, phone number and e-mail address].

Schedule

[summary of guidelines]

* Omit if inapplicable

Form 6 Notice under s 14 (2) Act

National Health and Medical Research Council Act 1992

[Subject-matter of notice]

 AN INVITATION TO MAKE SUBMISSIONS ABOUT

* AN INTERIM REGULATORY RECOMMENDATION

* INTERIM GUIDELINES

The National Health and Medical Research Council has:

* made the interim regulatory recommendation set out in the Schedule

* issued the interim guidelines set out in the Schedule

without inviting submissions under *paragraph 12 (3) (a)/ *13 (1) (b) of the Act.

This is because [reasons].

You are invited, under subsection 14 (2) of the Act, to make a submission to the Council about the interim *recommendation/*guidelines.

How to make your submission

Please make your submission in writing or on audio tape, and include your name and address or phone number at which we can contact you.

Please send your submission to: [address].

Closing date

The closing date for submissions is [date].

Further information

Further information is available on [website address], or by contacting [name, phone number and e-mail address].

Schedule

 * INTERIM RECOMMENDATION:

 * INTERIM GUIDELINES:

[text]

* Omit if inapplicable

Form 7 Notice under s 14B (2) Act

National Health and Medical Research Council Act 1992

[Subject-matter of notice]

NOTICE OF REASONS FOR DISPENSING WITH CONSULTATIVE STEPS

The National Health and Medical Research Council intends to:

* make a regulatory recommendation about [subject].

* engage in the following prescribed activity:

[outline]

* issue guidelines about [subject].

The Council proposes, under subsection 14B (1) of the Act, not to undertake the consultative steps set out in subsection *12 (2)/ *12 (3)/*section 13 of the Act.

This is because [reasons].

Further information

Further information is available from:

*[website address].

*[name, phone number and e-mail address].

* Omit if inapplicable

Schedule 2 Prescribed bodies who may nominate persons to be appointed as Members of Council

(regulation 4)

(The paragraphs mentioned in Column 2 are the paragraphs of the Act referring to the relevant bodies)

Schedule 3 Prescribed bodies who may nominate persons to be appointed as members of the Australian Health Ethics Committee

(regulation 5)

(The paragraphs mentioned in Column 2 are the paragraphs of the Act referring to the relevant bodies)

[* ‘Academics’:  This is the term used in paragraph 36 (6) (b) of the Act.]

Notes to the National Health and Medical Research Council Regulations 1993

Note 1

The National Health and Medical Research Council Regulations 1993 (in force under the National Health and Medical Research Council Act 1992) as shown in this compilation comprise Statutory Rules 1993 No. 198 amended as indicated in the Tables below.

Under the Legislative Instruments Act 2003, which came into force on 1 January 2005, it is a requirement for all non-exempt legislative instruments to be registered on the Federal Register of Legislative Instruments.  From 1 January 2005 the Statutory Rules series ceased to exist and was replaced with Select Legislative Instruments (SLI series). Numbering conventions remain the same, ie Year and Number.

Table of Instruments

Table of Amendments