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Application for the Certification of a Physical Containment Facility
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Application for the Certification of a Physical Containment Facility
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Information

Application for the Certification of a Physical Containment Facility
Fields marked with  * are required

Before starting your application

This form is for the certification of a facility to a specified containment level in accordance with Guidelines for the Certification of Physical Containment Facilities issued under the Gene Technology Act 2000 (Commonwealth) (the Act). The Gene Technology Regulator (the Regulator) needs the information you provide in this form to assist in determining whether to certify the facility. Before beginning an application for certification, potential applicants should ensure they have the required information for completing this form. Details of required information can be obtained by printing the checklist below and/or consulting the Guide to Physical Containment Levels and Facility Types. If the required information is not provided, the Regulator may request further information, and a decision on the certification application may be delayed (see Timeframe for decision below).

Saving your application

You may save your application at any time, however if an incomplete application remains unchanged for 10 days it will be automatically deleted. The checklist above can be useful for determining the required information, prior to beginning an application.

Attachments

There is a total attachment size limit of 20 MB if you reach or exceed the limit you will be unable to attach further files to this form. Please contact us on 1800 181 030 or ogtr.applications@health.gov.au if your total attachment size is greater than 20 MB.

After you submit your application

When you lodge your application, you will receive an email receipt containing a PDF of your application. Once this application is received, you will be notified of the assigned OGTR identifier. Please use this identifier in any correspondence regarding the certification application. Please contact us on 1800 181 030 or ogtr.applications@health.gov.au if we have not confirmed receipt within two weeks of submission.

Accuracy of information

The information you provide in this application must be true and accurate. The Act (and corresponding state law) provides for imprisonment and fines where a person gives information to the Regulator that the person knows to be false or misleading.

Timeframes

Under Regulation 14(1)(a) of the Gene Technology Regulations 2001 the Regulator must consider and decide on an application for certification within 90 working days after the day the application is received by the Regulator. However, days on which the decision making process cannot proceed because the Regulator is waiting for information that the applicant has been asked to provide do not count as part of this timeframe.

Personal information

Personal information is collected by the OGTR to enable the Gene Technology Regulator to perform the functions set out under the Act. Personal information specified in this form is collected for the purpose of assessing applications under the Act, and is handled in accordance with the Australian Privacy Principles (APP) set out in the Privacy Act 1988. More information can be accessed at the OGTRs Privacy and personal information web page. The OGTRs privacy policy explains how the OGTR collects, stores, uses and discloses personal information, including how a person may seek access to, or correct their personal information, and how a complaint about a breach of the APPs can be made.

Ethics

The National Framework of Ethical Principles in Gene Technology 2012 (Ethics Framework) has been developed by the Gene Technology Ethics and Community Consultative Committee (GTECCC) to provide a national reference point for promoting ethical conduct in gene technology.

Authorisation

The application must be submitted by a person authorised to sign on behalf of the organisation.

Further information

The OGTR can be contacted by telephone on 1800 181 030 or e-mail at ogtr@health.gov.au. Further information is available on the OGTR website www.ogtr.gov.au.

Privacy

The Address search fields in this form use Google Places to help fill in the address details. By using this feature you agree to be bound by Google’s Terms of Service and are subject to Google’s Privacy Policy.

Maintenance

Scheduled maintenance for this form will occur on a weekly basis every Friday, between 8pm and 10pm. All users must refrain from accessing the form during this time.

CCI

Application for the Certification of a Physical Containment Facility
Fields marked with  * are required

CCI

Does this application contain any Confidential Commercial Information (CCI)
To lodge an Application for the Certification of a Physical Containment Facility with confidential commercial information please use the Data Portal (if you have already established access) or contact the OGTR on 1800 181 030 or ogtr.applications@health.gov.au.

Contact information

Application for the Certification of a Physical Containment Facility
Fields marked with  * are required

Name of applicant organisation

Postal address

Is this an Australian or international address?

Application contact

Please provide contact details for the person whom an OGTR evaluator can contact with any queries about this application. The certification instrument and facility door signs will be sent to this person if the application is approved.

Postal address

Is this an Australian or international address?

Facility contact

This is a person, such as a facility manager, that the OGTR can contact for further information about the facility, both during the evaluation of this application and during the period of certification.

Postal address

Is this an Australian or international address?

Facility details

Application for the Certification of a Physical Containment Facility
Fields marked with  * are required

Level and type of containment facility

Please indicate the physical containment (PC) level and facility type on the list below. Guidance on the OGTR’s PC levels and facility types is provided in the Guide to Physical Containment Levels and Facility Types.

Existing certification

Is any part of this facility currently certified by the Regulator under an existing certification? *
(e.g. is the certification held by another organisation; is it certified as both PC3 and PC2; is the area covered by another certification?)

Facility details

Please provide the facility details below. This information is required to assist the OGTR to identify and locate the facility.
The standard format for the OGTR name will usually follow the following format, which generally starts from the smallest identifiable component and ends with the largest: Room number(s); Floor/Level; Building name/number; then any additional description of the facility which assists in the identification of location e.g. University Campus, Research Institute etc.
Example:
Rooms 102 to 110, Level 1, George Hamblin Building (#25), University of Manangatang.

Anteroom / Airlock

Does the facility have a dedicated anteroom/airlock *
If an adjoining corridor or another certified or non-certified room is proposed to perform the function of an anteroom, this is not considered a dedicated anteroom. Supporting information must be supplied to indicate any risks that might arise from using the adjoining corridor or other room as the anteroom. If there is any doubt about this, it is recommended you contact the OGTR on 1800 181 030 or Ogtr.CDES@health.gov.au to discuss your proposal prior to submitting the application.

Facility ownership

Application for the Certification of a Physical Containment Facility
Fields marked with  * are required

Facility ownership

Does the applicant organisation own the facility?
Can the applicant organisation comply with certification conditions which require: * upkeep of the physical containment attributes of the facility; maintenance and testing of fittings required by the conditions of certification; and the capacity to exclude persons from the facility?
For this to be considered a complete application, the answer to this question must be “Yes”. Incomplete applications cannot be submitted. If you wish to discuss submission of an incomplete application, you must contact the OGTR on 1800 181 030 or Ogtr.CDES@health.gov.au.

Facility equipment

Does the applicant organisation own the equipment in the facility?
Can the applicant organisation comply with any conditions which require testing, maintenance and operation of the containment equipment?
For this to be considered a complete application, the answer to this question must be “Yes”. Incomplete applications cannot be submitted. If you wish to discuss submission of an incomplete application, you must contact the OGTR on 1800 181 030 or Ogtr.CDES@health.gov.au.

Inspection and attachments

Application for the Certification of a Physical Containment Facility
Fields marked with  * are required

Inspection and Attachments

Has the facility been inspected by an appropriate person as outlined (details contained in the information button)? *
The facility must be inspected by a person who has acquired through training, qualifications or experience, or a combination of these, the knowledge and skill enabling that person to assess compliance with the requirements for certification of a physical containment facility. The applicant is responsible for choosing an appropriate person to do the inspection. The inspection could be conducted by, for example, an IBC member, a contractor, an independent expert, an employee, or anyone else considered by the organisation to be appropriate. The OGTR does not provide any endorsement of any individuals or organisations to conduct inspections, and keeps no details of appropriate persons or organisations.
For this to be considered a complete application, the answer to this question must be “Yes”. Incomplete applications cannot be submitted. If you wish to discuss submission of an incomplete application, you must contact the OGTR on 1800 181 030 or Ogtr.CDES@health.gov.au.
Does the facility meet all requirements contained in the relevant certification guidelines?
A report of the inspection must be provided to support the application for this facility type. The report must address the extent of compliance with the requirements for certification for the specific facility type/PC level being applied for. The inspection could be conducted by, for example, an IBC member, a contractor, an independent expert, an employee, a third party assessor or anyone else considered by the organisation to be appropriate. The OGTR will arrange an independent inspection of the facility in addition to the applicant organisation’s inspection. The OGTR is willing to undertake joint inspections with the applicant organisation’s inspectors and/or third party inspectors for DAFF Biosecurity. Please contact the OGTR well in advance of anticipated/proposed inspection dates to make arrangements for this to occur. Inspection checklists are available on the OGTR website. Only a single checklist should be submitted even if the facility is inspected by more than one person.
Inspection Report/Checklist *
File:
Other AttachmentsThe following attachments are required for this facility type. Please indicate below that you have uloaded the required attachments using the "other attachments" upload box below.
Evidence that BSCs (or other containment equipment) have been installed and commisioned will need to be provided prior to certification. If this documentation is not yet available please contact the ogtr on ogtr.cdes@health.gov.au to discuss your timeframe for completion
If a complete facility manual is not yet available, at a minimum a draft facility manual must be provided.
Other attachments
(Please refer to the relevant guidelines for the specific requirements for attachments)
Other attachments
File:

Floor Plan and Other Attachments

Floor Plan
Please attach a formal floor plan of the facility that shows sufficient details to enable the OGTR to evaluate whether the facility has the required specifications. At a minimum, ensure the following is shown:
allocated room numbers (if applicable); all doorways and doors; emergency exits; any lifts, stairs or ramps between levels inside the building; if certification is sought for one or more rooms within a larger area, the boundary of the facility (doors and walls) as well as any adjoining areas and their doors; if certification of a whole building, or the majority of a building, the entire floor plan.
When applying for certification of facilities that require anterooms or airlocks the anteroom(s)/airlocks(s) must be clearly indicated. If an adjoining corridor or another certified or non-certified room is proposed to perform the function of an anteroom, the floor plan must show all doors, lifts, stairs or ramps, and any other relevant details that may compromise the functioning of the corridor or room as an anteroom.
Facility floor plan
File:
Other attachments
Other attachments
File:

Other information

Declaration

Application for the Certification of a Physical Containment Facility
Fields marked with  * are required

Declaration

Do you need to have this application signed in hard copy?
Is the person submitting this application the same as the application contact?
Please state the name and position of the authorised person submitting this form
all information provided on this form is correct and true to the best of your knowledge; and you are a person authorised to submit this form.
all information provided on this form is correct and true to the best of your knowledge; and you are a person authorised to submit this form.
Click the print button below to produce a hard copy. Ensure that popups are allowed to be able to print the hard copy.
Upload signed hard copy
File:
Office of the Gene Technology Regulator