A carve-out is a standing agreement between the Office of Impact Analysis (OIA) and a department, removing the need for a preliminary assessment to be sent to OIA for certain types of regulatory change.
Introduction
The Australian Government Guide to Policy Impact Analysis (the Guide) outlines the role and requirements of Impact Analysis in the policy development process.
The Guide describes some special cases in the Impact Analysis process, one of which relates to carve-outs. A carve-out is a standing agreement between the Office of Impact Analysis (OIA) and a department, removing the need for a Preliminary Assessment to be sent to OIA for certain types of policy changes.
A carve-out can be used when anticipated policy changes are minor or machinery in nature and likely to occur on a regular basis. A change is minor if it does not substantially alter existing arrangements for people, businesses, or community organisations. Machinery changes are changes that are consequential to, and required as a result of, a substantive policy decision, and for which there is limited discretion available to the decision maker.
Carve-outs cannot be applied to proposals where Cabinet is the decision maker.
This guidance note gives further information about carve-outs, explains how to obtain one, and lists the carve-outs currently in place.
Objectives
Carve-outs aim to improve the efficiency of the Preliminary Assessment process by reducing the workload for both parties (the department and OIA) while ensuring consistent advice from OIA.
Risks
Key risks include inappropriate carving out of policy proposals and misinterpretation of the standing agreement (for example, using the carve-out to cover policy proposals that have a greater impact than the proposal was originally intended for). To manage this risk, the agreement must:
- be phrased succinctly and avoid ambiguity in the proposals to be carved out
- state that carve-outs are not an opportunity for broader departmental self-assessment
- be clear that you need to continue to consult OIA on matters not covered by the carve-out, or where there is uncertainty about where the carve-out applies be subject to a periodic review.
Completed carve-outs are listed in Table 1 at the end of this guidance note.
Criteria
A carve-out can be used for regulatory changes that occur on a regular basis and are minor or machinery in nature, but not for proposals where Cabinet is the decision maker. Potential carve-outs should take into account future expectations about relevant Preliminary Assessments sent to OIA. If there is a low likelihood of receiving further Preliminary Assessments on a given topic, it may not be worth issuing a carve-out.
Possible categories of carve-outs include indexation, regular, routine administrative and machinery changes. The following examples are from Table 1 at the end of this guidance note.
Indexation Changes
Routine indexation changes use a well-established formula, such as:
- routine indexation of aged care subsidies in line with increases in the Consumer Price Index.
Regular Changes
Regular changes are those about which OIA is consulted regularly and which are consistently assessed as minor or machinery in nature. OIA is often consulted on instruments that regularly update information that is considered machinery. For example:
- the Australian Communications and Media Authority regularly contacts OIA about variations in established licence area plans, factsheets for consumers and other issues.
Routine administration changes
Routine administrative changes follow a regular process that has been identified as minor or machinery. They are generally done in accordance with existing legislation and can often be approved by a departmental delegate. They do not require Impact Analysis for further changes. These changes tend to involve legislative instruments, but where an Act is amended it would tend to affect only a schedule or a clause of the legislation. For example:
- the Department of Health regularly updates the listing and price of medicines available under the Pharmaceutical Benefits Scheme.
Machinery changes
Machinery changes to legislation that do not constitute a new regulatory burden are appropriate for carving out. For example:
- the Attorney-General's Department is required to alter Substituted References Orders because they need to reflect changes contained in Administrative Arrangements Orders or changes in the titles of ministers or departments.
Carve-out process
OIA officers assess newly received Preliminary Assessments to identify suitable proposals to be carved out. They will inform you when they consider that a series of proposals should be carved out. However, an agency may also recommend potential carve-outs.
The steps in the carve-out process are as follows:
- You should review Preliminary Assessments previously sent to OIA. Identify policy areas that meet the criteria for minor or machinery changes made by non-Cabinet decision makers. Consider the likelihood of future Preliminary Assessments arising in those areas.
- Obtain Executive Level 2 (EL2) clearance for the proposal to carve-out. Email OIA with a suggestion to consider the carving-out proposal.
- OIA will check the appropriateness of the proposed carve-outs.
- If OIA concurs, the office will send you a letter confirming that a carve-out has been granted and the proposals that it applies to.
Approval
The carve-out can be approved between OIA and the department at the EL2 level and will be periodically published in updates of this note.
Further information
For further information on carve-outs, OIA can be contacted on:
- Email: helpdesk-OIA@pmc.gov.au
- Phone: 02 6271 6270
Department | Proposal | Why is the proposed change an indexation, routine administrative or minor or machinery change? | OIA reference number | Comments / limits on carve-out |
---|---|---|---|---|
Attorney-General's Department | Amendments to Federal Court Rules of Court | Minor or machinery: Changes to Rules of Court are unlikely to have significant impacts on businesses, community organisations or individuals. | 11644 | |
Attorney-General's Department | Substituted References Orders made under sections 19B and 19BA of the Acts Interpretation Act 1901 | Machinery: The orders are altered to reflect changes in Administrative Arrangements Orders or changes in the titles of ministers or departments. | 13423 | |
Attorney-General's Department | Statute Update Bills (SUBs) prepared by OPC and sponsored by the Attorney-General | Minor or machinery: SUBs contain technical amendments that are within existing policy, where it is considered appropriate for a Minister to provide policy authority for the amendment in accordance with PM&C's Legislation Handbook. The amendments made by SUBs will always be minor or machinery in nature, and will never substantially alter existing arrangements or have regulatory impacts on businesses, individuals or community organisations. |
25784 | The carve out is approved for SUBs containing technical amendments (e.g. correcting errors, updating language, referencing responsible Ministers) that do not alter policy or have regulatory impacts on businesses, individuals or community organisations. SUBs that do not meet this criteria are subject to normal Preliminary Assessment and Impact Analysis requirements. |
Attorney-General's Department | Standing exemption for certain amendments to the Specified Laws instruments under the Safety, Rehabilitation and Compensation (Specified Laws) Declaration 2017 (F2019C00329) and the Seafarers Rehabilitation and Compensation (Specified Laws) Declaration 2019 (F2019L00294) | Machinery: Listed instruments must be revised to reflect changes to, or newly introduced, State and Territory compensation legislation. | 23941, 24218 and 42774 | The carve out is limited to changes to the Specified Laws Instruments that: Add laws that replace existing specified laws; Add new laws that provide a new type of compensation that needs to be specified (in accordance with the above criteria); and Remove laws that no longer need to be specified (because, for example, they have been repealed and there is no longer any scope for double dipping of compensation payments). The carve out is not applicable where the Minister exercises discretion outside the above criteria. |
Attorney-General's Department | Self-insuring licence eligibility declarations made under section 100 of the Safety, Rehabilitation and Compensation Act 1988 (SRC Act) for workers' compensation purposes | Minor or machinery: These instruments allow eligible entities to join the Comcare scheme where they have applied to do so. The decision to issue the instrument is the routine application of Ministerial discretion as enabled by the Act. | 23425 | |
Australian Communications and Media Authority | Variations to established licence area plans, field trials of mobile jammers, factsheets for consumers and enforceable undertakings. | Minor: Variations to individual licence area plans are unlikely to have a more than minor regulatory impact. | 13301 | While variations to individual licence area plans are minor changes, variations to the way licence area plans work and the creation of new licence area plans could have a significant regulatory impact, and OIA should be contacted about the need for further analysis. |
Australian Communications and Media Authority | Standing exemption for amendments made to the Radiocommunications (Australian Space Objects) Determination 2014 (ASOD) and the Radiocommunications (Foreign Space Objects) Determination 2014 (FSOD) to include new satellite operators. | Minor or machinery. Listing a new satellite operator does not confer a right on that entity to have a licence nor operate in frequency bands identified in the Radiocommunications (Communications with Space Object) Class Licence 2015 (the CSO Class Licence). | 43253 | The carve-out applies to amendments that add the name of a controlling business entity to the list at Section 4 of the ASOD or Schedule 1 of the FSOD. |
Australian Fisheries Management Authority (AFMA) | Setting total allowable catch (TAC), or total allowable effort (TAE) for a fishery; setting opening and closing dates for fishing season; setting fishing boundaries; directing that fishing not be engaged in sub-areas of a fishery; starting arrangements for a fishing season, such as Vessel Monitoring System start times and assembly areas; prescribing designated areas where operators can undertake gear trials in a fishery prior to the start of the fishing season; annually setting cost recovery levies; the continuation of a requirement to use a turtle or seal excluder device in a fishery; and setting undercatch and overcatch provisions in a fishery. | Machinery: AFMA is required to make decisions under current regulatory settings and follow certain procedures when making those decisions. | 14421 | |
Australian Maritime Safety Authority (AMSA) | Amendments to regulatory instruments that arise from changes to International Maritime Organization (IMO) conventions and codes that have previously been subject to OIA assessment as part of the Joint Standing Committee on Treaties (JSCOT) process. | Minor. Carve out only applies to regulatory changes resulting from changes to IMO conventions and codes that the OIA has previously assessed through the JSCOT process as having only minor and/or machinery regulatory impacts. In such cases, it is not necessary for AMSA to seek further OIA assessment for these same changes when they are subsequently implemented in AMSA's regulatory instruments. | 16724 | This carve-out category includes only changes that have already been assessed by the OIA as not imposing more than minor impacts or changes to compliance costs. |
Australian Maritime Safety Authority (AMSA) | Amendments to regulatory instruments that make minor editorial changes to an instrument, or external material referenced in that instrument, and do not change current regulatory requirements. | Minor. Carve out only applies to regulatory changes that: Make minor editorial amendments; Amend text, formatting and punctuation; Recast existing text in a modern drafting style or in a different form; Clarify existing text; Update cross-references; Incorporate or consolidate existing information or requirements from other related instruments (which may include instruments to be repealed); Correct drafting errors; Align text with primary legislation, related regulatory instruments or other parts of the instrument; and do not change current regulatory requirements. |
43657 | This carve-out category includes only editorial changes that will not impose more than minor impacts or changes to compliance costs. |
Australian Maritime Safety Authority (AMSA) | Amendments to instruments that make minor administrative changes to an instrument, or external material referenced in that instrument, and do not change current requirements. | Minor. Carve out only applies to changes that: amend the format or information contained in existing documents, forms, certificates and electronic systems; keep already required documents and records up to date or in a specified format; amend the format of reporting already required to a authority for certain events; amend the forms, electronic systems or processes to obtain or maintain already required permissions; amend the format or list of recipients for documents already required to be produced for third parties; and do not change current requirements. |
43657 | This carve-out category includes only administrative changes that will not impose more than minor impacts or changes to compliance costs. |
Australian Maritime Safety Authority (AMSA) | Amendments to regulatory instruments that make minor changes to an instrument, or external material referenced in that instrument, that will not affect Australian businesses, individuals or community organisations. | Minor. Carve out only applies to changes that align instruments with international treaty obligations or other external requirements where these changes are not relevant to, or will not affect, any existing or expected future Australian businesses, individuals or community organisations. Any affected foreign operators must also already face the same international treaty obligations or external requirements, or would not be expected to pass-on any costs to Australian businesses, individuals or community organisations. | 43657 | This carve-out category includes only changes that will not impose more than minor impacts or changes to compliance costs. |
Australian Maritime Safety Authority (AMSA) | Establishment or reissue of a Heritage Management Plan that does not deviate from the status quo. | Minor. | 42955 | This carve-out category includes only changes that will not impose more than minor impacts or changes to compliance costs. It only applies to new or reissued Heritage Management Plans that do not change existing requirements (the status quo). |
Australian Pesticides and Veterinary Medicines Authority | The making of an existing maximum residue limit standard as a legislative instrument. | Machinery. | 14469 | |
Australian Public Service Commission | Instruments that deal primarily with intra-governmental public sector employment matters. | Minor or machinery. | 13837 | The standing exemption applies to the following instruments: regulations made under the Public Service Act 1999 (PS Act), directions issued by the Public Service Commissioner under the PS Act, directions issued by the Prime Minister under section 21 of the PS Act, rules about the classification of APS employees made under section 23 of the PS Act, determinations about remuneration and terms and conditions of employment issued under subsection 24(1) of the PS Act, determinations about remuneration and terms and conditions of employment issued under subsection 24 (3) of the PS Act, regulations made under the Maternity Leave (Commonwealth Employees) Act 1973, determinations made by the Remuneration Tribunal under the Remuneration Tribunal Act 1973, regulations made under the Remuneration Tribunal Act 1973, regulations made under the Long Service Leave (Commonwealth Employees) Act 1976, regulations made under the Judicial and Statutory Officers (Remuneration and Allowance) Act 1984, and regulations made under the Remuneration and Allowance Act 1990. |
Civil Aviation Safety Authority (CASA) | Foreign and Australian Airworthiness Directives | Machinery: CASA issues airworthiness directives to address unsafe conditions on aircraft and aeronautical equipment. The review of these directives does not require Impact Analysis because it is an obligation of Australia under the Chicago Convention. | 14507 | |
CASA | Amendments to CASR Part 61 to add additional aircraft for the purpose of pilot type ratings | Minor: These amendments do not substantially alter existing arrangements. | 14507 | |
CASA | Amendments to Manuals of Standards (MOSs) | Minor or machinery: MOSs are referenced standards that are not regulatory in nature. | 14507 | |
CASA | Advisory publications (e.g. CAAPs, ACs, information brochures) with no mandatory legislative effect | Minor: These documents are advisory and have no direct or significant indirect impact on businesses, community organisations or individuals. | 14507 | |
CASA | Directions, approvals, permissions and exemptions | Minor or machinery: These instruments do not substantially alter existing arrangements, and their issue is required by the Act and regulations in the course of their administration by CASA. | 14507 | |
Clean Energy Regulator (CER) | Setting the Renewable Power Percentage and the Small-scale Technology Percentage under the Renewable Energy (Electricity) Act 2000 in circumstances where the CER uses data derived from modelling of the electricity market by independent third parties | The making of regulations to set the RPP and STP under the Actis a regular occurrence that takes into account the same considerations each time. | 20056 | When the default calculation or any other method of calculating the percentages is used, the CER should confirm with the OIA that an Impact Analysis is not required to be prepared. |
Comcare | Legislative Instrument to specify the rate of weekly interest deemed to accrue on the superannuation lump sum pursuant to section 21(5) of the Safety, Rehabilitation and Compensation Act 1988 (SRC Act) | Machinery. Section 21(5) of the SRC Act requires the instrument to be issued annually. The instrument prescribes a routine update to an annually indexed statutory rate and is machinery in nature. | 20920 | |
Department of Agriculture and Water Resources | Amendments to the Fisheries Research and Development Corporation Regulations 1991 to enable the annual transfer of research and development funds to the Fisheries Research and Development Corporation (FRDC) | Minor or machinery: These amendments are made annually to specify the proportion of the annual fishing levy that is equivalent to the research and development component to enable it to be paid to the FRDC each financial year. | 20522 | |
Department of Agriculture and Water Resources | Increases or decreases in agricultural levies where they relate to a levy's existing purpose | Minor or machinery. Increases or decreases in agricultural levies within the scope of their existing purposes are a regular occurrence in response to changes in the level of industry needs. | 22416 | |
Department of Agriculture and Water Resources | Routine minor amendments to biosecurity goods determinations | Minor or machinery: The determinations are typically amended two to three times a year. Changes generally amend existing alternative conditions, add new alternative conditions for certain goods requiring an import permit, and make minor technical amendments. |
23368 | Carve out applies to amendments to: Biosecurity (Prohibited and Conditionally Non-prohibited Goods) Determination 2016 Biosecurity (Prohibited and Conditionally Non-prohibited Goods—Christmas Island) Determination 2016 Biosecurity (Prohibited and Conditionally Non-prohibited Goods—Cocos (Keeling) Islands) Determination 2016 Biosecurity (Prohibited and Conditionally Non-prohibited Goods—Norfolk Island) Determination 2016 Biosecurity (Prohibited and Conditionally Non-prohibited Goods—Torres Strait) Determination 2016. Biosecurity (Conditionally Non-prohibited Goods) Determination 2021 (2021 Determination). Amendments must: be minor or technical amendments of the kind that have been previously made; not have more than a minor impact on industry; and be in line with the current biosecurity policy settings. |
Department of Communications | Exemptions under clause 9A and clause 21A of Schedule 4 to the Broadcasting Services Act 1992. | Machinery. | 15001 | |
Department of Defence | Determine which allowances paid under the Defence Act 1903 are pay-related allowances for the purposes of subsection 11(1) of the Military Rehabilitation and Compensation Act 2004 | Minor or machinery: These instruments ensure continuity in compensation payments by ensuring that references to amounts that can be included in compensation payments remain current. They do not alter the existing formulae used for calculating the compensation payments. The determinations simply ensure that there is a current list of allowances that those formulae can draw from. | 17489 | The allowances that are mentioned in the determinations are part of the ordinary Australian Defence Force benefits. They are either tabled and subject to Parliamentary scrutiny (if made under section 58B Defence Act 1903) or tabled after determination by the Defence Force Remuneration Tribunal (if made under section 58H Defence Act 1903). |
Department of Education | Annual legislative instrument to specify the risk rated premium and special tuition protection components of the Tuition Protection Service (TPS) Levy. Education Services for Overseas Students (TPS Levies – Risk Rated Premium and Special Tuition Protection Components) Instrument |
Minor or machinery: This is an annual process and the changes are administrative in nature. | 25749 | |
Department of Education | Annual legislative instrument to set the Administrative Fee and Base Fee components of the Tuition Protection Service (TPS) Levy. Education Services for Overseas Students (TPS Levies – Administrative Fee and Base Fee Components) Instrument |
Minor or machinery: This is an annual process and the changes are administrative in nature. | OBPR22-03444 | |
Department of Education | Approval, suspension and revocation of the approval of a new higher education FEE-HELP provider under the Higher Education Support Act 2003. | No more than minor impact as these processes are completed routinely through legislative instruments under the Higher Education Support Act 2003 and can be approved by a department delegate. | 02827 | |
Department of the Environment and Energy | Minor changes or bug fixes to software tools accredited under the Nationwide House Energy Rating Scheme (NatHERS) | Minor: Minor changes or bug fixes to NatHERS-accredited software programs are unlikely to have significant impacts on businesses, community organisations or individuals. | 21938 | Carve-out applies to: Software bug fixes: defined as a coding error fix to existing software to generate an energy rating that does not affect ratings. Minor changes to software: defined as a coding error fix that may have a minor impact on NatHERS rating outcomes; or an enhancement/improvement to the existing software to generate or accurately calculate a NatHERS energy rating that may have a minor impact on rating outcomes. |
Department of Finance | Certification of Parliamentary Precincts under the Parliamentary Precincts Act 1988 | Minor: Regulations provide for the making of a certification by the minister that Commonwealth leased or owned land is a parliamentary precinct under the Act, and therefore the Speaker has certain powers and the Australian Federal Police has jurisdiction. This is intended to cover emergency situations in which Parliament House is unavailable for use. | 13038 | Minor impacts; land will be subject to Commonwealth lease arrangements. |
Department of Foreign Affairs and Trade | Update the Diplomatic Privileges and Immunities (Indirect Tax Concession Scheme) Determination 2000, and the Consular Privileges and Immunities (Indirect Tax Concessions Scheme) Determination 2000 to reflect the countries currently registered to have access to immunities. | Non-regulatory: Updates to the determination occur 5-6 times annually and do not have regulatory impacts. | 22459 |
Carve-out applies to countries that currently have access to diplomatic and or consular indirect tax concessions.
|
Department of Foreign Affairs and Trade | Standing exemption for minor or machinery amendments made to sanctions regulations as a result of United Nations Security Council Resolutions. | Minor or machinery. DFAT has advised that amendments to existing regulations will not materially change burdens. |
44148 | Entirely new sanctions regulations, and amendments with more than a minor impact on businesses, individuals or community organisations are not captured by this exemption. |
Department of Foreign Affairs and Trade | Standing exemption for minor or machinery decisions of the Minister for Foreign Affairs to list, relist or delist persons or entities under the Charter of the United Nations Act 1945 (Cth), pursuant to Australia's international legal obligations under United Nations Security Council Resolution 1373 (2001). | Minor or machinery. United Nations Security Council Resolution 1373 (2001) decides that states shall freeze without delay, assets of persons who commit, or attempt to commit, terrorist acts or participate in or facilitate the commission of terrorist acts; of entities owned or controlled directly or indirectly by such persons; and of persons and entities acting on behalf of, or at the direction of such persons and entities. The Minister for Foreign Affairs' listing of persons or entities which meet the above criteria is therefore required in order for Australia to meet its international legal obligations under United Nations Security Council Resolution 1373 (2001). |
OBR22-01748 |
This carve-out applies to the listing of people or entities that do not have significant economic ties to Australian people and markets. Decisions to list individuals or entities that do not meet that criteria may have a more than minor impact on individuals, businesses or community organisations, and as such are not captured by this exemption. Decisions not captured by this exemption will require a Preliminary Assessment form to be submitted to OIA for advice. |
Department of Foreign Affairs and Trade | Standing exemption for minor or machinery decisions of the Minister for Foreign Affairs to list, relist and revoke persons, entities, assets or vessels under the Autonomous Sanctions Regulations 2011. This exemption applies to Regulations 6, 6A, 7, 8, 9 and 10. | Minor or machinery. Financial sanctions/travel bans and the issuing of directions to listed vessels occur as needed to respond to situations of international concern. Sanctions captured by this exemption will mainly impact overseas individuals/entities. |
OBPR22-02078 | This carve-out applies to the listing of people, entities, assets or vessels that do not have significant economic ties to Australian people and markets. Listing decisions that do not meet that criteria may have a more than minor impact on individuals, businesses or community organisations, and as such are not captured by this exemption. Decisions not captured by this exemption will require a Preliminary Assessment form to be submitted to OIA for advice. |
Department of Health | Dental Benefits Rules 2009 | Indexation: Indexing the dental benefit in line with Medicare indexation (which is calculated using the WCI5). Indexation will occur annually. | 11949 | |
Department of Health | Amendments to the Private Health Insurance (Complying Product) Rules. The purpose of this proposal is to reflect increases in the Nursing Home Type Patient contribution at public hospitals for privately insured patients in all states and territories and privately insured patients in private hospitals | Indexation: The change is in line with the biannual indexation of Adult Age Pension Rates and Rent Assistance that occurs on 20 March and 20 September each year. | 12116 | |
Department of Health | Amendments to the Private Health Insurance (Complaints Levy) Rules 2007. The Complaints Levy is collected each year from private health insurers to support the work of the Private Health Insurance Ombudsman (PHIO). The amount to be levied from each insurer is calculated by applying insurers' annual membership data to a formula in the Private Health Insurance (Complaints Levy) Rules 2007. Collectively, these amounts must meet the PHIO Complaints Levy budget. | Minor: Minor amendments to the formula are sometimes necessary to address changes to the complaints levy budget to enable the budget to be met. The levy is spread across more than 30 insurers, so the impact on each insurer is minor. | 12116 | |
Department of Health | Amendments to the Private Health Insurance (National Joint Replacement Register Levy) Rules. The National Joint Replacement Register (NJRR) Levy is imposed on each sponsor for joint replacement prostheses; the Levy funds the NJRR. The Private Health Insurance (NJRR) Rules contain the formula for calculating the levy, which sets the rate of the levy imposed on a sponsor on the prescribed levy census days. | Minor: To achieve cost recovery of administered funds for the budgeted costs, minor changes to the formula are occasionally necessary. | 12116 | |
Department of Health | Amendments to the Private Health Insurance (Prostheses) Rules | Routine administrative change: The Prostheses List contains prostheses and human tissue items and the benefit to be paid by private health insurers. Under the Private Health Insurance Act 2007, private health insurers are required to pay benefits for a range of prostheses that are provided as part of an episode of hospital treatment or hospital substitute treatment for which a patient has cover and for which a Medicare benefit is payable for the associated professional service. The Private Health Insurance (Prostheses) Rules are amended twice a year. | 12116 | |
Department of Health | The declaration of a quality assurance activity under Part VC of the Health Insurance Act 1973 provides specific protection from civil proceedings (apart from those relating to the breach of the rules of procedural fairness) to health care professionals participating in the activity. The aim of providing this protection is to encourage health care professionals to fully participate in quality assurance activities. The department annually receives up to 20 applications for a declaration of a quality assurance activity each year, including new applications and renewals. Declarations expire after five years, and a new application must be submitted and assessed if cover is to continue. | Minor and machinery: The only requirement placed on organisations under the scheme that may incur a minor cost is the public interest requirement that de-identified research data is to be made publicly available. It is acceptable for such results to be published in a report or on a website. The costs involved in meeting this requirement are likely to be low. Previous advice from OIA has considered qualified privilege applications to be machinery in nature. | 12116 | |
Department of Health | Declaration under subsections 85(2) and 85(2AA) and 85(2A) of the National Health Act 1953 to declare drugs listed on (including any applicable restrictions) or deleted from the Pharmaceutical Benefits Scheme (PBS) | Minor: The Schedule of Pharmaceutical Benefits and related information are available freely on the internet and are available to purchase in other formats (for example, CD-ROM or book). Businesses will only incur costs if they choose not to use the website and purchase the schedule in an alternative format. The cost to purchase the schedule is minimal. Changes are not expected to have a more than minor impact on individuals. | 12116 | |
Department of Health | Determination made pursuant to subsections 99ADB (4) and 99ADB (5) of the National Health Act 1953 | Minor and machinery: These legislative instruments are produced three times per year to determine price disclosure related reductions of pharmaceutical items as a result of the Price Disclosure Policy. | 12116 | |
Department of Health | Determination under paragraph 98C (1) (b) of the National Health Act 1953 to determine conditions of payment for benefits supplied by approved pharmacists and medical practitioners | Minor: The Schedule of Pharmaceutical Benefits and related information are available freely on the internet and are available to purchase in other formats (for example, CD-ROM or book). Businesses will only incur costs if they choose not to use the website and purchase the schedule in an alternative format. The cost to purchase the schedule is minimal. Changes are not expected to have a more than minor impact on individuals. | 12116 | |
Department of Health | Determination under section 84AF of the National Health Act 1953 to list the responsible person and ABN for all brands of listed drugs on the PBS | Minor: The Schedule of Pharmaceutical Benefits and related information are available freely on the internet and are available to purchase in other formats (for example, CD-ROM or book). Businesses will only incur costs if they choose not to use the website and purchase the schedule in an alternative format. The cost to purchase the schedule is minimal. Changes are not expected to have a more than minor impact on individuals. | 12116 | |
Department of Health | Determination under section 85B of the National Health Act 1953 to determine prices of PBS items or brands subject to a special patient contribution, therapeutic group premium or brand premium | Minor: The Schedule of Pharmaceutical Benefits and related information are available freely on the internet and are available to purchase in other formats (for example, CD-ROM or book). Businesses will only incur costs if they choose not to use the website and purchase the schedule in an alternative format. The cost to purchase the schedule is minimal. Changes are not expected to have a more than minor impact on individuals. | 12116 | |
Department of Health | Amendments to The National Health (Concession or entitlement card fee) Determination relating to fees paid to Approved Pharmacists for the issue of a concession or Pharmaceutical Benefits Scheme entitlement card to a patient, made in accordance with Section 84HA(1) of the National Health Act 1953. | Minor. Fees are increased annually, with the written agreement of the Pharmacy Guild. | 12116 | |
Department of Health | Determination under sections 93 and 93AA of the National Health Act 1953 to determine PBS items available and maximum quantities thereof as emergency supply items for medical practitioners and nurse practitioners | Minor and machinery: The Schedule of Pharmaceutical Benefits and related information are available freely on the internet and are available to purchase in other formats (for example, CD-ROM or book). Businesses will only incur costs if they choose not to use the website and purchase the schedule in an alternative format. The cost to purchase the schedule is minimal. The determination amended as required, and the changes are machinery in nature. Changes are not expected to have a more than minor impact on individuals. | 12116 | |
Department of Health | Determination under subsection 84BA(2) of the National Health Act 1953 to provide for revised public hospital patient PBS co-payment amounts | Machinery: This update occurs annually. | 12116 | |
Department of Health | Determination under subsection 85A(1) and (2) and 88(1C) of the National Health Act 1953 to determine the form, manner of administration, maximum quality and maximum number of repeats of those drugs and medicinal preparations which may be prescribed by authorised optometrists | Minor: The Schedule of Pharmaceutical Benefits and related information are available freely on the internet and are available to purchase in other formats (for example, CD-ROM or book). Businesses will only incur costs if they choose not to use the website and purchase the schedule in an alternative format. The cost to purchase the schedule is minimal. Changes are not expected to have a more than minor impact on individuals. | 12116 | |
Department of Health | Determinations under section 85, 85A and 88 of the National Health Act 1953 to determine form and strength, manner of administration, maximum quality, maximum number of repeats and brands of listed drugs on the PBS | Minor: The Schedule of Pharmaceutical Benefits and related information are available freely on the internet and are available to purchase in other formats (for example, CD-ROM or book). Businesses will only incur costs if they choose not to use the website and purchase the schedule in an alternative format. The cost to purchase the schedule is minimal. Changes are not expected to have a more than minor impact on individuals. | 12116 | |
Department of Health | ETP National Health (Emergency Treatment Program) Special Arrangements Instrument 2010 (Special arrangement under Section 100 of the National Health Act 1953 for the supply of methoxyflurane) | Machinery: Changes are unlikely to occur on a regular basis. | 12116 | |
Department of Health | Private Health Insurance (Benefit Requirements) Rules under item 3A of the table in section 333-20 of the Private Health Insurance Act 2007 | Machinery: The purpose of the proposal is to reflect increases to the Nursing Home Type Patient minimum benefit and reflect changes to the table of facilities for the purpose of determining second tier default benefits. | 12116 | |
Department of Health | Private Health Insurance (Health Insurance Business) Rules and Private Health Insurance (Data Provision) Rules | Minor: Amendments reflect minor changes to insurer and hospital data reporting specifications, which commence at the beginning of each reporting year from 1 July, or on the day they are registered if registered after that date. Development of changes to the data reporting specifications occurs through consultation with industry through the Hospital Casemix Protocol Working Group and advice from insurers, service providers and software vendors. | 12116 | |
Department of Health | Regulatory amendments to update listing and price of medicines available under the PBS and National Immunisation Program (NIP) | Machinery. | 12116 | Only those elements relating to listing and pricing for the PBS and NIP are covered by this exemption. |
Department of Health | Special arrangements under section 100(1) of the National Health Act 1953 to make arrangements for the supply of pharmaceuticals in the highly specialised drugs program at public hospitals to non-admitted patients, day admitted patients or patients on discharge | Minor: The Schedule of Pharmaceutical Benefits and related information are available freely on the internet and are available for purchase in other formats (for example, CD-ROM or book). Businesses will only incur costs if they choose not to use the website and purchase the schedule in an alternative format. The cost to purchase the schedule is minimal. Changes are not expected to have a more than minor impact on individuals. | 12116 | |
Department of Health | Special arrangements under section 100(1) of the National Health Act 1953 to make arrangements to supply chemotherapy pharmaceuticals at public hospitals to non-admitted day patients, day patients or patients on discharge | Minor: The Schedule of Pharmaceutical Benefits and related information are available freely on the internet and are available to purchase in other formats (for example, CD-ROM or book). Businesses will only incur costs if they choose not to use the website and purchase the schedule in an alternative format. The cost to purchase the schedule is minimal. Changes are not expected to have a more than minor impact on individuals. | 12116 | |
Department of Health | Special arrangements under section 100(1) of the National Health Act 1953 to provide an adequate supply of special pharmaceutical products to persons receiving treatment with highly specialised drugs as non-admitted patients, day patients or patients on discharge at private hospitals | Minor: The Schedule of Pharmaceutical Benefits and related information are available freely on the internet and are available for purchase in other formats (for example, CD-ROM or book). Businesses will only incur costs if they choose not to use the website and purchase the schedule in an alternative format. The cost to purchase the schedule is minimal. Changes are not expected to have a more than minor impact on individuals. | 12116 | |
Department of Health | Changes to forms issued by the Office of the Gene Technology Regulator intended to cover the inclusion of certain information, such as additional contact details, or technical or procedural information relating to the genetic modification work being undertaken | Minor or machinery. | 12796 | Minor technical and administrative changes only; does not extend to changes to guidelines or legislation. |
Department of Health | Therapeutic Goods Administration—amendments to increase fees and charges for therapeutic goods and manufacturing licences | Minor or machinery: These amendments are calculated using a well-established formula. | 14416 | If the way the fees and charges are amended changes, that may require Impact Analysis. |
Department of Health | Therapeutic Goods Administration—discretionary standards in relation to medical devices | Minor: These amendments are not regulatory in nature, since they are made to voluntary standards that can be used by stakeholders if they choose. There is no expectation of compliance. | 14416 | |
Department of Health | Therapeutic Goods Administration—administrative amendments to forms which are referred to in the legislation | Minor or machinery: Amendments simply reflect existing underlying requirements. | 14416 | If the underlying requirements on business to provide information are amended, Impact Analysis may be required for that amendment. |
Department of Health | Therapeutic Goods Administration—adding new ingredients to the Australian Register of Therapeutic Goods | Minor: Does not appear to have an impact on businesses, community organisations or individuals. | 12796 | If ingredients are removed from the Australian Register of Therapeutic Goods, Impact Analysis may be required. |
Department of Health | Therapeutic Goods Administration—updates to Therapeutic Goods Order 70B | Machinery: Decision maker has no discretion when making the updates. | 14416 |
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Department of Health | Therapeutic Goods Administration—adding new substances to the Poisons Standard | Machinery: Decision maker has no discretion in terms of which schedule a new substance is added to. | 14416 | |
Department of Health | Therapeutic Goods Administration—down-scheduling of substances on the Poisons Standard | Minor or machinery: Amendments simply reflect existing underlying requirements. | 14416 | If the underlying requirements on business to provide information are amended, Impact Analysis may be required for that amendment. |
Department of Health | Therapeutic Goods Administration—down-scheduling of substances on the Poisons Standard | Machinery. | 14416 | |
Department of Health | Therapeutic Goods Administration—correction of minor errors on the Poisons Standard | Machinery. | 14416 | |
Department of Health | Therapeutic Goods Administration—correction of inadvertent scheduling errors on the Poisons Standard | Machinery. | 14416 | If ingredients are removed from the Australian Register of Therapeutic Goods, Impact Analysis may be required. |
Department of Health | Therapeutic Goods Administration—urgent scheduling where it relates to new substances or derivatives of existing Schedule 9 substances on the Poisons Standard | Machinery. | 14416 | Does not cover instances where urgent scheduling relates to up-scheduling of existing substances. |
Department of Health | Therapeutic Goods Administration—annual consolidation of Standard for the Uniform Scheduling of Medicines and Poisons | Machinery. | 14416 | |
Department of Health | Therapeutic Goods Administration—release of information under s. 61 of the Therapeutic Goods Act 1989 | Minor: The release of such information does not change the requirements for industry or require industry to provide additional or different information to the TGA. | 15070 | |
Department of Health | Therapeutic Goods Administration—changes to the Therapeutic Goods (Permissible Ingredients) Determination made under s 26BB of the Therapeutic Goods Act 1989 | Machinery. | 21645 | |
Department of Health and Aged Care | Therapeutic Goods Administration – standing exemption for the Minister for Health and Aged Care (or delegate) to make a Serious Scarcity Substitution Instrument (SSSI) under section 30EK of the Therapeutic Goods Act 1989 | Minor: SSSIs assist with timely patient access to medicines by allowing a pharmacist to provide a substitute medicine to a patient when the prescribed medicine is unavailable, without prior approval or a new prescription from the prescriber. | OBPR23-04289 | |
Department of Health and Aged Care | The Office of Drug Control (ODC) - standing exemption for the Minister to make amendments to section 5 of the Customs (Prohibited Imports) Regulation 1956 (PI Regulations) and section 10 and 10A of the Customs (Prohibited Exports) Regulations 1958 (PE Regulations) | Minor: Certain amendments to the PI and PE Regulations reflect Australia's international obligations to the United Nations' Commission on Narcotic Drugs and the scheduling of new substances for international control. If the relevant amendments are not made to the PI and PE Regulations, Australia may be unable to import or export the newly scheduled substances in the international drug conventions for medical or scientific purposes. | OIA23-05318 | This carve-out category includes only changes that will not impose more than minor impacts. |
Department of Home Affairs | Twice yearly amendment to the Australian Citizenship Regulation 2016 to update instrument references relating to the payment of fees and refunds in foreign countries and currencies. | Machinery. | 25331 | |
Department of Home Affairs | Bi-annual update to the Foreign Currency Exchange Rates for use at the department's overseas offices | Minor: These changes do not have a significant impact on businesses or individuals. | 25184 | |
Department of Home Affairs | Standing exemption to amend the AusCheck Act 2007, to enable AusCheck to coordinate and conduct background checks on individuals seeking accreditation to work or volunteer at an event declared by the Minister of Home Affairs (the Minister) to be a Major National Event (MNE). | Minor. The measure is in line with previous OIA advice on similar MNE proposals. The measure only applied to events that meet the MNE definition and is likely to have no more than minor impacts on business, community organisations or individuals. | 25680 | The MNE under this proposed arrangements would not require a Cabinet decision, The carve-out would only apply to MNE's that meet the established formula. Where changes to a proposed MNE's are outside the scope of the carve-out, or where there is uncertainty related to an MNE, AusCheck will consult again with the OIA. |
Department of Home Affairs | Standing exemption for legislative instruments specifying eligibility for Australian Government Endorsed Event (AGEE) Temporary Activity visa (subclass 408) and eligibility for a nil visa application charge | Minor: Both measures are in line with support and facilitation provided for participants of major events and do not have a significant impact on businesses or individuals. | 43543 | The carve out is limited to the legislative instruments affecting the eligibility and visa application charge for the Australian Government Endorsed Event (AGEE) Temporary Activity visa (subclass 408). |
Department of Home Affairs | Standing exemption for ongoing twice-yearly amendments to the Australian Citizenship Regulation 2016 (the Citizenship Regulation) to update instrument references relating to the payment of fees and refunds in foreign countries and currencies | Machinery. Instruments made under regulation 5.36 of the Migration Regulations must be revised to reflect currency fluctuations and acceptable currencies. | 42679 | The carve out is limited to changes to the Citizenship Regulation 2016 that make reference to regulation 5.36 of the Migration Regulations. |
Department of Home Affairs | Standing exemption for updates on regional processing negotiations and arrangements. | Minor or machinery. The Department of Home Affairs has advised that updates on regional processing negotiations and arrangements are unlikely to have significant impacts on businesses, community organisations or individuals. | 42523 | This carve-out category includes only updates on regional processing negotiations and arrangements that will not impose more than minor impacts or changes to compliance costs. |
Department of Immigration and Border Protection | Regular updates to educational business partners of universities participating in streamlined visa processing arrangements | Minor. | 14615 | |
Department of Immigration and Border Protection | Student visa assessment level settings | Minor: Does not have an impact on businesses or community organisations. Does not appear to have a more than minor impact on individuals. | 14622 | |
Department of Immigration and Border Protection | Legislative amendments which give effect to the United Nations Security Council Consolidated Travel Ban List | Minor: Does not have an impact on businesses, community organisations or individuals. | 14721 | |
Department of Immigration and Border Protection | Tariff Concession Orders | Machinery: Tariff concession orders help industry become more internationally competitive and reduce costs to the general community by reducing duties where there is no local industry to protect. | 14509 | |
Department of Immigration and Border Protection | Amendments to the Migration Regulations 1994 – Specification of Arrangements for Child Visa Applications to exclude specified countries | Minor. | 21693 | |
Department of Industry, Science, Energy and Resources | Standing exemption for: · Legislative exemption instruments under Section 37 of the Greenhouse and Energy Minimum Standards (GEMS Act); and · Legislative fees instruments under the GEMS (Registration Fees) Act 2012. |
Minor or machinery. DISER has advised that exercising the exemption and fee instruments is unlikely to have significant impacts on businesses, community organisations or individuals. | OBPR21-01246 | This carve-out category includes only use of these instruments that will not impose more than minor impacts of changes to compliance costs |
Department of Infrastructure and Regional Development | Annual determination of electricity fees applicable to the Indian Ocean Territories (IOTs) of Christmas Island and the Cocos (Keeling) Islands | Minor: The determinations set electricity fees in the Indian Ocean territories. | 21021 | |
Department of Social Services | Scheduled increases to aged residential care subsidies and charges based on the Government's pension indexation arrangements | Machinery: Relates purely to changing the amount of funds available to program recipients. | 11719 | |
Department of Social Services | Aged Care (Flexible Care Subsidy Amount—Innovative Care) Determination: Provision to allow for the payment of flexible care subsidy to an approved provider in respect of innovative care provided to a care recipient and routine indexation in line with increases in CPI as a measure of movements in the non-labour costs of providers | Indexation | 12116 | |
Department of Social Services | Aged Care (Amount of Flexible Care Subsidy—Multi-Purpose Services) Determination | Indexation: Routine indexation of subsidy in line with increases in the CPI as a measure of movements in the non-labour costs of providers. | 12116 | |
Department of Social Services | Aged Care (Amount of Flexible Care Subsidy—Transition Care) Determination | Indexation: Indexation of subsidy in line with increases in the CPI as a measure of movements in the non-labour costs of providers. | 12116 | |
Department of Social Services | Aged Care (Residential Care Subsidy—Adjusted Subsidy Reduction) Determination | Indexation: Indexation of subsidy in line with increases in the CPI as a measure of movements in the non-labour costs of providers and decisions of Fair Work Australia as a measure of non-productivity based movements of the wage costs of providers. This is in accordance with policy upon which extensive consultation was undertaken. Adjustments are likely to have low or no impact on aged care sector and consumers. | 12116 | |
Department of Social Services | Aged Care (Residential Care Subsidy—Amount of Oxygen Supplement) Determination | Indexation: Routine indexation of subsidy in line with increases in the CPI as a measure of movements in the non-labour costs of providers. | 12116 | |
Department of Social Services | Aged Care (Residential Care Subsidy—Amount of Viability Supplement) Determination | Indexation: Routine indexation of subsidy in line with increases in the CPI as a measure of movements in the non-labour costs of providers. | 12116 | |
Department of Social Services | Aged Care (Residential Care Subsidy—Amount of Basic Subsidy) Determination | Indexation: Indexation of subsidy in line with increases in the CPI as a measure of movements in the non-labour costs of providers and decisions of Fair Work Australia as a measure of non-productivity based movements of the wage costs of providers. This is in accordance with policy upon which extensive consultation was undertaken. Adjustments are likely to have low or no impact on aged care sector and consumers. | 12116 | |
Department of Social Services | Aged Care (Residential Care Subsidy—Amount of Enteral Feeding Supplement) Determination | Indexation: Indexation of subsidy in line with increases in the CPI as a measure of movements in the non-labour costs of providers and decisions of Fair Work Australia as a measure of non-productivity based movements of the wage costs of providers. This is in accordance with policy upon which extensive consultation was undertaken. Adjustments are likely to have low or no impact on aged care sector and consumers. | 12116 | |
Department of Social Services | Aged Care (Home Care Subsidy Amount) Determination | Indexation: Routine indexation of subsidy in line with increase in the CPI as a measure of movements in the non-labour costs of providers. | 15163 | |
Department of Social Services | Social Security (Special Disability Trust – Discretionary Spending) Determination | Indexation: Routine indexation of discretionary spending amount for the Special Disability Trust in line with increase in the CPI. | 25212 | |
Department of Social Services | Bi-annual amendments to the table in Schedule 3 of the Student Assistance (Education Institutions and Courses) Amendment Determination 2019. | Minor: Bi-annual amendments will comprise of the adding or removal of Masters courses and replacement of the names of existing courses listed in the table. Students enrolled in amended courses may have their student supports affected. | OIA23-05989 | |
Food Standards Australia New Zealand (FSANZ) | Applications that: permit voluntary addition of nutritive substances to foods use optional methods of analysis |
Minor: These applications do not have a significant impact on businesses or individuals. | 14943 | |
FSANZ | Applications relating to: maximum residue limits food additives processing aids genetically modified foods |
Machinery: The applications are part of implementing a regulatory framework where the use of the new processing aids, additives or genetically modified food is voluntary once the application has been approved. | 12065 | |
FSANZ | Applications that request permission to irradiate a range of fruits and vegetables as a phytosanitary treatment, primarily against fruit fly | Machinery: The applications are part of implementing a regulatory framework where the use of irradiation as a treatment is voluntary once the application has been approved. | 13845 | |
FSANZ | Applications to add new food-health relationships to the Australia New Zealand Food Standards Code - Schedule 4 - Nutrition, health and related claims | Minor: These applications do not have a significant impact on businesses or individuals. Displaying the claims associated with any of the listed food-health relationships on food packaging is voluntary | OBPR22-03450 | |
Treasury | Specific Listing of Deductable Gift Recipients | Minor: Few recipients are listed in a given year. These listings have no material impact on community organisations. | 14181 | |
Treasury |
Commonwealth prescription of professional standards schemes occurs, when the Professional Standards Council approves a new or updated professional standards scheme and requests the Commonwealth to prescribe under the applicable Commonwealth legislation(s) to limit occupational liability. Prescription of a professional standards scheme requires small regulatory amendments some or all of the following regulations, depending on the professional body: |
Machinery: the amendments involve adding a new professional standards scheme; removing an out of date scheme; extending an existing scheme; or inserting and replacing an existing scheme, to reflect the changes agreed by the Professional Standards Council. | 25848 | |
Treasury | Regulations to roll over unused exploration credits under the Junior Minerals Exploration Incentive (JMEI). | Machinery: Regulations to roll over unused JMEI credits are made on a regular basis, relate purely to changing the amount of credits available to JMEI participants in a future year of the program and are machinery in nature, and do not require consideration by the Cabinet. | OIA23-05032 |