Applicationfor DeclarationFile/CCIformJan2014v3.docx · Web viewor trading: name) Accreditation Number ... The header and footer of all pages must contain the word ‘Sensitive’

Applicationfor Declarationthat specified information is confidential commercial information (CCI)

Applicant Organisation name:(legal entity or trading name)

Click here to enter text.

Accreditation Number:(if organisation is accredited by the Gene Technology Regulator)


Time taken to complete this form

Hours Minutes



Version 3 – January 2014

General Instructions Application for declarationThe completion of this form indicates you are applying for a declaration that specified information is Confidential Commercial Information (CCI) under the Gene Technology Act 2000 (the Act). The Gene Technology Regulator (the Regulator) needs the information you provide in this form to assist in determining whether or not to make such a declaration. If the information you provide is incorrect or incomplete the Regulator’s decision about this application may be delayed. It may also delay consideration of an application for a licence, certification or accreditation.

The Regulator may require you to provide additional information. If this is necessary you will be notified in writing of the additional information required.

Please note that a declaration that specified information is CCI (CCI declaration) relates to information, not to specified text in a particular document. It is therefore important to clearly characterise the information over which a declaration is sought, as well as indicating where this information occurs in particular documents.

Once declared, information will remain CCI unless and until the declaration is revoked by the Regulator. Therefore it is not necessary to re-apply each time the same information is provided to the Regulator.

The completed CCI application form must be forwarded with the relevant application identified in Section 1, Part B.

Accuracy of informationThe 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.

All sections, parts and questions must be completed unless otherwise directed on the form. If the spaces provided are not sufficient to set out the requested information, you should attach additional information and clearly mark on the attachment which section, part and question the information relates to. You should also indicate against the item that there is additional information attached, noting the attachment title/number and the page number(s).

EthicsThe 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, consistent with the national regulatory system administered by the Regulator. It replaces the 2006 National Framework for the Development of Ethical Principles in Gene Technology.

The Ethics Framework provides guidance for organisations and individuals and sets out key principles and values to inform and support the consideration of ethical issues relevant to all aspects of gene technology. The Ethics Framework is also intended to provide assurance to the Australian community that not only are any risks involved in gene technology properly managed but that ethical issues are also properly considered.

The Office of the Gene Technology Regulator (the OGTR) encourages organisations and individuals to refer to the Ethics Framework and to make it available to those involved in the conduct or oversight of gene technology work. The Ethics Framework is available from the OGTR website.

AuthorisationThe application must be signed by a person authorised to sign on behalf of the organisation.

2 Version 3 – January 2014

Application of security markingsAs a result of the Government’s implementation of the Protective Security Policy Framework (PSPF) all CCI material is to be marked with the Dissemination Limiting Marker (DLM) of ‘Sensitive’. Under the guidelines for Protectively marking and handling sensitive and security classified information, material with a DLM of ‘Sensitive’ must be conspicuously marked as such.

The following must be applied to any document provided to the OGTR containing information that has been declared as CCI or for which a declaration of CCI is being sought.

The header and footer of all pages must contain the word ‘Sensitive’.

Where the word ‘Sensitive’ appears it must be formatted to be at least 5 mm in height (most common fonts of 24 point or greater will achieve this), bolded, centred and preferably in red.

For example: SensitiveA statement describing the reason for the ‘Sensitive’ marking and the handling requirements for the document must also be included in one of the following two ways:

The first page footer must also contain the following text located above the ‘Sensitive’ marking:

CONFIDENTIAL COMMERCIAL INFORMATION (CCI)Information in this document has been assigned a Dissemination Limiting Marker (DLM) of

‘Sensitive’ and is information subject to Section 185 of the Gene Technology Act 2000 (the Act) and may only be used and accessed subject to the provisions of the Act.

SensitiveThere are no specific font parameters mandated for this additional reason and handling statement but it is suggested that it be centred and prominent to alert a person to the reason for the marker.

Alternatively, a cover page containing the following text can be included at the beginning of the document instead of including the statement in the first page footer.

The attached document contains Sensitive informationCONFIDENTIAL COMMERCIAL INFORMATION (CCI)

Information in this document has been assigned a Dissemination Limiting Marker (DLM) of ‘Sensitive’ and is information subject to Section 185 of the Gene Technology Act 2000 (the Act)

and may only be used and accessed subject to the provisions of the Act.

Further informationContact the Office of The Gene Technology Regulator by telephone on1800 181 030 or e-mail at [email protected]

Lodging the applicationThe completed application form can be lodged with the OGTR:

By mail to the Office of The Gene Technology Regulator, MDP 54, GPO Box 9848, CANBERRA, ACT, 2601; or

By e-mail to [email protected]; or By fax to the Office of The Gene Technology Regulator on (02) 6271 4202; or In person at Level 1, Pharmacy Guild House, 15 National Circuit, BARTON ACT 2600.

You are encouraged to retain a copy of your completed application.


Acknowledgement of receiptIf you have not received any communication acknowledging the receipt of your application within two weeks, please e-mail [email protected] or telephone 1800 181 030.


Section 1, Part A: Contact information for applicationPlease provide contact details for the person who an OGTR evaluator can contact with any queries about this application.

Application contact

Personal title:(eg Ms/Mr/Dr) Enter here Surname: Click here to enter text.

First name: Click here to enter text. Preferred first name: Click here to enter text.

Phone number: Enter here Mobile: Enter here Fax: Enter here

E-mail Address: Click here to enter text.

Position title: Click here to enter text.Organisation (for postal delivery): Click here to enter text.

Postal address: Click here to enter text.

Postal Locality:(City/Suburb/Location) Click here to enter text. State: Enter here

Postcode: Enter here Country: Click here to enter text.


Section 1, Part B: Document informationUsually applications for CCI are for information that is included in another application or place. In this context please indicate the other application(s) in which the information for which a declaration of CCI is being sought also occurs.

Select the application type below.

☐ DIR

☐ DNIR

☐ Certification

☐ Accreditation

☐ NLRD

☐ Transfer/Variation/Surrender/Suspension Of Enter DIR/DNIR/Cert/Accr identifier here.

Enter the details of the application below which contains the information for which a declaration for CCI is sought.

OGTR Reference Number: Click here to enter text.Title: Click here to enter text.Date submitted to OGTR: Click here to enter a date.Name of Applicant: Click here to enter text.

☐ OTHER – use the box below to identify the person/organisation which has provided the information to the Regulator, and the circumstances, e.g. information required to be provided to the Therapeutic Goods Administration which in turn has been provided to the Regulator.


NOTE: If you do not have a file number or reference number please ensure that the information you provide is sufficient to enable the Regulator to clearly identify the information for which the CCI declaration is sought.


Section 2Information in support of application- explanatory notesIn order to assess the application, the Regulator must be able to readily identify the information for which the declaration is sought.

Note that a CCI declaration relates to information, not to specified text in a particular document. Once declared, information will remain CCI in other forms, parts of text, documents or contexts. Therefore it is very important that the application precisely identifies and characterises the information for which the CCI declaration is sought, as well as specifying blocks of text in which the information is embedded in an attached document.

Section 2, Part A, below, requires that you identify that information. Section 2, Part B, below, requires that you provide a justification for your request.

Section 2, Part C, below, requires you to provide additional information if your application relates to field trials.

The Regulator may refuse to declare that information is CCI if satisfied that the public interest in disclosure outweighs the prejudice that the disclosure would cause to any person. Section 2, Part D, below, allows you to provide details of any prejudice that would be caused to a person by disclosure of the information.

Please note the following instructions before completing Section 2, Part A and Section 2, Part B.

Precisely identify the specified information and where it occurs.

For information to be declared CCI you must satisfy the Regulator that the information you specify below, in Section 2, Part A, is:

a trade secret; or

any other information that has a commercial or other value that would be, or could be reasonably expected to be destroyed or diminished if the information were disclosed; or

other information that concerns the lawful commercial or financial affairs of a person, organisation or undertaking and if it were disclosed, could unreasonably affect the person, organisation or undertaking.

It is necessary to precisely identify the information in Section 2, Part A, so that the Regulator can consider whether it qualifies for a declaration as CCI. You will be required to tell us:

precisely what the information is;

identify exactly where it is located; and

identify each occasion on which it is mentioned.

For example, a document may contain a description of a gene construct which is arguably a trade secret, but no other information which would qualify for a declaration of CCI. In such a case, only the description of the gene construct should be identified as information over which a declaration is sought. Identifying the entire document, or indeed an entire table or block of text in a document, as information in relation to which a declaration is sought will mean that you have identified information in respect of which no declaration may be made and will require the Regulator to ask for clarification. This will delay processing of your application.


It is also necessary for us to know where, in the documents held by the OGTR, the information is located, and also, each occasion on which it is mentioned. For example, details of a gene construct may be mentioned on numerous occasions and in different parts of documents provided with a licence application. Each mention of the gene construct needs to be identified by you as part of your application.

Provide the OGTR with expurgated copies of the documents (with the information you seek to have declared as CCI removed) and a signed consent form.The OGTR is required to disclose information in many different circumstances. For example, the OGTR is required to provide copies of applications for licences if requested, and in response to requests under Freedom of Information legislation. However, the OGTR does protect from disclosure information that has been declared to be CCI.

To assist the Regulator to protect this information, you are required to provide a copy of the relevant document to which the CCI application relates, with all the information specified as CCI removed. Consideration should be given to alternate text that can replace the removed CCI text to ensure that the expurgated document makes sense when read in isolation.

For example, if you are seeking to have the name of a gene declared as CCI, you should provide the OGTR with a copy of the relevant document with all occurrences of the gene name deleted. In place of the gene name, generic words such as ‘the insecticidal gene’ might be used to ensure the readability of the expurgated document.

You may wish to apply for a declaration in respect of several pieces of information, each of which requires a different and discrete justification. In such a case you will be required to provide a separate application for each piece of information (including a separate justification).

For example:

You wish to apply for a declaration that details of Gene Construct Y (including DNA sequence and origin of sequence elements) are CCI on the basis that it is a trade secret.

Accordingly you would:

1. Complete an application form identifying details of Gene Construct Y (including DNA sequence and origin of sequence elements) in Section 2, Part A, as specified information for which you are seeking a declaration, and answer all questions under Section 2, Part A which apply to Gene Construct Y.

2. On the same application form, complete Section 2, Part B stating that details of Gene Construct Y are a trade secret and then answer all questions under Section 2, Part B, which apply to Gene Construct Y.

However, you also wish to apply for a declaration that Process X, which uses Gene Construct Y, but which is not a trade secret, is nevertheless CCI because it is information that has a commercial or other value that would be, or could be reasonably expected to be destroyed or diminished if the information were disclosed.

Accordingly you would also:

3. Complete a separate second application form for Process X, identifying the description of Process X in Section 2, Part A, as specified information for which you are seeking a declaration, and answer all questions under Section 2, Part A which apply to Process X.

4. On the second application form, complete Section 2, Part B stating the description of Process X is information that has a commercial or other value that would be, or could be reasonably expected to be, destroyed or diminished if the information were disclosed and then answer all questions under Section 2, Part B, which apply to Process X.


You are not confined to addressing one criterion only in your justification.

In Section 2, Part B, you are not confined to justifying the specified information for which a declaration is sought on the basis of one criterion only.

For example, for details of Gene Construct Y, you may:

5. Provide a justification for a claim that it is a trade secret by answering all questions under Part B that apply to trade secrets; and

6. On the same application form, you may provide a justification that details of Gene Construct Y are also information that has a commercial or other value that would be, or could be reasonably expected to be destroyed or diminished if the information were disclosed by answering all questions under Part B that apply to that criterion.


Section 2, Part AInformation in relation to which a declaration is soughtPlease provide responses to the following questions. If there is insufficient space you should attach the additional information, clearly marking on the attachment the Section, Part and Question to which the information relates, and include any additional information and copies of relevant documents.

Please note that a CCI declaration relates to information, as well as specific blocks of text in which the information is embedded, in a particular document. It is therefore important to clearly characterise the information over which a declaration is sought, as well as indicating where this information occurs in particular documents.

Once declared, information will remain CCI unless and until the declaration is revoked by the Regulator. Therefore it is not necessary to re-apply each time the same information is provided to the Regulator.

A1 Describe all the documents within which there is information over which a declaration is sought, including where relevant, the title, date, and author of the document. If the information appears in more than one document, identify each document in which it appears.


A2 Attach a copy of the full document(s) or of the relevant sections.

A3 Precisely describe the information in the document over which a declaration is sought and identify each occurrence of the information in each document described in Question A1 above.

Examples:

the identity/name of the gene gene1 in connection with licence application A, including associated citations of publications which reveal this information, which appear at pages x, y and z of licence application A and pages a, b, and c of document T;

the details of the gene construct construct1, including DNA sequence, origin and order of sequence elements, contained in paragraph m on page xx and in figure n on page y of document A;

the phenotype produced in the GMOs by introduction of the gene construct construct2, as described in paragraph p on page z and in table q on page w, of licence application B;

the experimental results presented in table r on page v of document C;

the statement of fact xyz, which is made on page abc of document D.

It is also helpful to include copies of the relevant documents with each occurrence of the specified information highlighted (any previously declared CCI should also be highlighted). However, note that simply specifying sections of text in a document is not sufficient to precisely describe the information over which a declaration is sought, as it may not be clear what elements of the specified text encapsulate that information.


A4 Attach an expurgated copy of the relevant documents or the relevant sections from which all the information specified in A3 above has been removed:

Clearly title the document ‘Expurgated copy of (title of substantive application/material)’


Complete the attached Consent to the Release of Expurgated Document

Detach the Consent form, attach it to the front of your expurgated copy and submit it along with this application for CCI to the OGTR.

A5 Have there been any previous applications for declaration in relation to the information over which a declaration is now sought and which have not yet been declared or have been refused? If so, provide details of the previous application.



Consent to the release of expurgated documentI hereby give my consent to the disclosure by the Office of the Gene Technology Regulator (OGTR) of all information contained in the document(s) titled:

(1) Expurgated copy of Click here to enter text. (OGTR reference no: Click here to enter text.[if known]).

(2) Expurgated copy of Click here to enter text. (OGTR reference no: Click here to enter text.[if known]).

I understand that the Gene Technology Regulator may provide the expurgated copy referred to above to a person making a request under section 54 of the Gene Technology Act 2000. I confirm that I have taken measures to ensure that this expurgated document does not contain any information which is Confidential Commercial Information (CCI) material, being information which has been previously declared CCI or which is awaiting assessment as the subject of a declaration for CCI. In the event that the attached expurgated document contains CCI material, being information which has been previously declared CCI or which is awaiting assessment as the subject of a declaration for CCI, I agree that this consent authorises the disclosure by the OGTR of any such material and shall not hold the Commonwealth or its agents and employees in any way liable for any damage that may be incurred by any person or organisation as a consequence of its disclosure.

Printed name: Click here to enter text. Signature: Enter signature here.

Job title: Click here to enter text. Date: Click here to enter a date.

If signing on behalf of an organisation please also complete the following declaration.

I declare that I am duly authorised to sign this consent on behalf of

Name of organisation: Click here to enter text.




Section 2, Part BJustification for treatment of information as CCIFor information to be declared CCI you must satisfy the Regulator that the information you have specified in Section 2, Part A3 is:

• a trade secret; or

• any other information that has a commercial or other value that would be, or could be reasonably expected to be, destroyed or diminished if the information were disclosed; or

• other information that concerns the lawful commercial or financial affairs of a person, organisation or undertaking and, if it were disclosed, could unreasonably affect the person, organisation or undertaking.

In the appropriate spaces provided below, please give your reasons why the information identified in Section 2, Part A3, is one or more of the above. Ensure that the all reasons provided relate to the current situation at the time of lodgement of this application for declaration.

It is in your interests to ensure that you provide adequate justification to support your claim for a CCI application.

Question B1Is the information a trade secret?

☐ Yes ☐ No Move on to Question B2

If yes, use the spaces below to address the following questions as well as any other issues you consider relevant to your application.

B1.1 Is the information known outside your business?

☐ Yes ☐ No

If no, how do you know it is not known outside your business? If you have conducted literature searches, provide comprehensive details of the searches undertaken e.g. data bases searched, parameters of the search etc. If you have not conducted searches, indicate why not and explain why you are confident that the information is not known outside your business.

If yes, state by whom it is known, indicate if this entity is engaged in the same business as yourself and why you believe the information is nevertheless a trade secret. If you have conducted literature searches to support this claim, provide details.


B1.2 Does the information have value to you and/or your competitors?

☐ Yes ☐ No

If yes, provide comprehensive reasons. Note that the Regulator may request evidence to support your claims.



B1.3 Does the information provide you with an advantage over your competitors?

☐ Yes ☐ No

If yes, identify your competitors and describe how the information gives you an advantage over them.


B1.4 Have you taken any measures to guard the secrecy of the information?

☐ Yes ☐ No

If yes, describe the measures taken and evidence of them e.g. confidentiality agreements, contract clauses.


B1.5 Have you spent significant effort or money in developing the information?.

☐ Yes ☐ No

If yes, provide indicators of time and money spent on developments undertaken, and attach any available evidence.


B1.6 Would it be easy for others to acquire or duplicate the information irrespective of its disclosure by the Regulator?

☐ Yes ☐ No

If no, why not?

If yes, why is the information nevertheless a trade secret?


B1.7 Is your information used or useable in an identifiable trade?

☐ Yes ☐ No

If yes, what trade?


B1.8 Provide any further relevant statements in support of your claim that the information is a trade secret. Attach available evidence, or other material.



Question B2Is the information other information that has a commercial or other value that would be, or could be reasonably expected to be destroyed or diminished if the information were disclosed?

☐ Yes ☐ No Move on to Question B3


B2.1 Why is the information of value to your business? What evidence do you have to support that assessment? If you are relying in whole or in part on literature searches, provide comprehensive details of searches undertaken e.g. data bases searched, parameters of the search etc.


B2.2 Provide estimates of the value of the information to your business and a justification for that estimate.


B2.3 Would the information have a monetary value to an arms-length buyer?

☐ Yes ☐ No

If yes, why? Who would be interested in buying the information? If possible give an approximate estimate of the value and give reasons for that estimate.


B2.4 Would you expect the value of the information to be diminished or destroyed if disclosed?

☐ Yes ☐ No

If yes, provide real and substantial grounds for this conclusion. Include evidence if available.


B2.5 Is the information the subject of a confidentiality agreement with another party?

☐ Yes ☐ No

If yes, provide details and evidence.


B2.6 Is the information currently the subject of a patent application or an existing patent?

☐ Yes ☐ No

If no, is the information likely to be the subject of a patent application? State when you expect the application to be made. Explain why you have so far not made a patent application.


If yes, at what stage of the patent process is your application? Describe how the information covered in the patent or patent application relates to the information over which a declaration is sought. When did you make the application? If the material has already been released or will be released as part of that process, why would its release by the Regulator concern you? Provide evidence of your patent application. If an existing patent, provide the number(s) and countries.


B2.7 In the space below provide any further relevant statements in support of your claim that the information that has a commercial or other value that would be, or could reasonably be expected to be destroyed or diminished if the information were disclosed. Attach available evidence, or other material.


Question B3Is the information other information that concerns the lawful commercial or financial affairs of a person, organisation or undertaking and if it were disclosed, could unreasonably affect the person, organisation or undertaking?

☐ Yes ☐ No Move on to Declaration at end of Part Section 3


B3.1 How would disclosure adversely affect your organisation? Provide details. For example, if you would anticipate adverse effects on the organisation’s business, identify those effects and provide a reasoned justification. If possible attach any available evidence.


B3.2 Why would disclosure be unreasonable?


B3.3 In the space below provide any further relevant statements in support of your claim that the information concerns the lawful commercial or financial affairs of a person, organisation or undertaking which, if disclosed, could unreasonably affect the person, organisation or undertaking. Attach available evidence, or other relevant material.



Section 2, Part CAdditional information if application for declaration is related to field trial locationsYou must complete this Part only if you wish to have information about locations at which field trials involving GMOs are occurring, or are proposed to occur, declared to be CCI.

The Regulator must refuse to declare information about locations at which field trials involving GMOs are occurring, or are proposed to occur, unless satisfied that disclosure of the location would be likely to result in:

a) significant damage to the health and safety of people; or

b) significant damage to the environment; or

c) significant damage to property.

Please provide detailed answers to the questions below and attach evidence where appropriate. Inadequate answers will require the Regulator to seek clarification and could delay the processing of your CCI application or of an application to which this application for CCI applies.

Question C1If this information is disclosed, would it be likely to result in significant damage to the health and safety of people?

☐ Yes ☐ No

If yes, provide details (such as how the disclosure would be likely to result in damage and why this damage would be significant). Where possible, provide evidence to support your statements.


Question C2If this information is disclosed, would it be likely to result in significant damage to the environment?

☐ Yes ☐ No



Question C3If this information is disclosed, would it be likely to result in significant damage to property?

☐ Yes ☐ No




Question C4Is there any other information that you wish to add in respect of Part C? If yes, Provide details.

☐ Yes ☐ No

If yes, provide details.



Section 2, Part DDetails of any prejudice that would be caused to a person by disclosure of the informationThe Regulator may refuse to declare that information is CCI if the Regulator is satisfied that the public interest in disclosure outweighs the prejudice that the disclosure would cause to any person.

In the space provided, please provide additional information about the extent to which prejudice to any person would be caused as a result of disclosure of the information including any prejudice which may result to the applicant and your reason for making that claim.



Section 3SignaturesThis declaration must be completed and signed by a person with the authority to sign on behalf of the organisation.

I declare that:

• I am duly authorised to sign this declaration;

• the information supplied on this this application and attachments (if any) is true and correct at this time; and

• I am aware that the making of a false or misleading statement may be punishable by imprisonment or a fine under the Gene Technology Act 2000 and corresponding state law.




Documents

Applicationfor DeclarationFile/CCIformJan2014v3.docx · Web viewor trading: name) Accreditation Number ... The header and footer of all pages must contain the word ‘Sensitive’