Dear Therapeutic Goods Administration,

I request access to the following documents under the Freedom of Information Act 1982:

1. The most recent 30 notices of charges issued to FOI applicants.

For each of these 30 requests, if applicable, please also provide:

2. Any subsequent decisions regarding charges following applicant contention.

3. Any subsequent decisions regarding charges following internal or external review.

Please exclude the following information:

i) Personal information of FOI applicants.

ii) Personal information of third parties.

Yours faithfully,

CR

TGA FOI, Therapeutic Goods Administration

1 Attachment

Dear CR

 

FREEDOM OF INFORMATION REQUEST – NOTIFICATION OF RECEIPT

 

I am writing to notify you that the Therapeutic Goods Administration
(Department of Health and Aged Care) has received your request for access
to documents under the Freedom of Information Act 1982 (FOI Act) as
follows:

 

‘…I request access to the following documents under the Freedom of
Information Act 1982:

 

1. The most recent 30 notices of charges issued to FOI applicants.

 

For each of these 30 requests, if applicable, please also provide:

2. Any subsequent decisions regarding charges following applicant
contention.

3. Any subsequent decisions regarding charges following internal or
external review.

 

Please exclude the following information:

i) Personal information of FOI applicants.

ii) Personal information of third parties.’

 

Under section 15(5)(b) of the FOI Act, the agency has 30 calendar days
from the date your request was received in which to provide a decision in
response to your request for access. A decision is currently due on or
before 31 October 2024. Due to the statutory processing time afforded
under the FOI Act in which to provide you with a decision in relation to
your FOI request, we would be grateful if you could please monitor your
emails periodically for updates regarding your request.

 

Where there is requirement to undertake consultation with affected third
parties, this timeframe is extended by a further 30 days. It may also be
extended in certain circumstances, including with your agreement or where
the Department applies to the Office of the Australian Information
Commissioner for an extension.

 

Unless you advise otherwise, draft and duplicate documents, Commonwealth
employee names and contact details of staff below Senior Executive Service
level, internal group email addresses and mobile telephone numbers of all
staff will be excluded from the scope of your request under section
22(1)(a)(ii) of the FOI Act.

 

Disclosure Log Publication

The TGA is required under section 11C of the FOI Act to publish on its
website, or otherwise make available, documents released to an applicant
in response to an FOI request, unless exceptional circumstances apply. The
TGA publishes these documents on the FOI Disclosure Log at [1]FOI
Disclosure Log | Therapeutic Goods Administration. You can find more
information about the Disclosure Log at [2]OAIC FOI Guidelines |
Disclosure Logs.

 

In addition, please note that if the decision maker decides that you are
liable to pay a charge in relation to your request then this timeframe is
extended pending payment of a deposit. You will be notified by the
Department if you are liable to pay a charge and/or if third party
consultation is required.

 

If you have any queries, please contact the FOI team on (02) 6289 4630, or
via email at [3][email address].

 

Kind regards

 

Freedom of Information

Therapeutic Goods Administration

Australian Government Department of Health and Aged Care

T: 02 6289 4630 | E: [4][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [5]www.tga.gov.au

 

Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.

 

The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present.

 

 

 

-----Original Message-----
From: CR [6][FOI #12108 email]
Sent: Tuesday, October 1, 2024 1:29 PM
To: FOI [7][email address]
Subject: Freedom of Information request - FOI charges letters

 

REMINDER: Think before you click! This email originated from outside our
organisation. Only click links or open attachments if you recognise the
sender and know the content is safe.

Dear Therapeutic Goods Administration,

 

I request access to the following documents under the Freedom of
Information Act 1982:

 

1. The most recent 30 notices of charges issued to FOI applicants.

 

For each of these 30 requests, if applicable, please also provide:

 

2. Any subsequent decisions regarding charges following applicant
contention.

 

3. Any subsequent decisions regarding charges following internal or
external review.

 

Please exclude the following information:

 

i) Personal information of FOI applicants.

 

ii) Personal information of third parties.

 

Yours faithfully,

 

CR

 

-------------------------------------------------------------------

 

Please use this email address for all replies to this request:

[8][FOI #12108 email]

 

Is [9][TGA request email] the wrong address for Freedom of Information
requests to Therapeutic Goods Administration? If so, please contact us
using this form:

[10]https://www.righttoknow.org.au/change_re...

 

This request has been made by an individual using Right to Know. This
message and any reply that you make will be published on the internet.
More information on how Right to Know works can be found at:

[11]https://www.righttoknow.org.au/help/offi...

 

Please note that in some cases publication of requests and responses will
be delayed.

 

If you find this service useful as an FOI officer, please ask your web
manager to link to us from your organisation's FOI page.

 

-------------------------------------------------------------------

"Important: This transmission is intended only for the use of the
addressee and may contain confidential or legally privileged information. 
If you are not the intended recipient, you are notified that any use or
dissemination of this communication is strictly prohibited.  If you
receive this transmission in error please notify the author immediately
and delete all copies of this transmission."

References

Visible links
1. https://www.tga.gov.au/foi-disclosure-log
2. https://www.oaic.gov.au/freedom-of-infor...
3. mailto:[email address]
4. mailto:[email address]
5. http://www.tga.gov.au/
6. mailto:[FOI #12108 email]
7. mailto:[email address]
8. mailto:[FOI #12108 email]
9. mailto:[TGA request email]
10. https://www.righttoknow.org.au/change_re...
11. https://www.righttoknow.org.au/help/offi...

hide quoted sections

Dear FOI Officer,

I am writing to amend the scope of my FOI request to assist with its processing.

As I wish to access only recent charge decisions, I have introduced a time frame and clarified the exclusions. I confirm the revised scope of my request as follows:

1. The most recent 30 notices of charges issued to FOI applicants.

For each of these 30 requests, if applicable, please also provide:

2. Any subsequent decisions regarding charges following applicant contention.

3. Any subsequent decisions regarding charges following internal or external review.

The time period for my request is from 1 July 2022 to 1 October 2024.

Please exclude the following information:

i) Personal information of FOI applicants, including supporting evidence or details of personal circumstances in a financial hardship contention.

ii) Emails that attached the charges notices/decision letters.

Please feel free to contact me if you require any clarification or have further questions regarding this request.

Yours sincerely,

CR

TGA FOI, Therapeutic Goods Administration

1 Attachment

Dear CR

 

Thank you for your email to the TGA regarding your request, FOI 25-0037.

 

The TGA acknowledges the amendments (below) to the scope of your request.
I write to confirm that you are still amenable to omit personal
information of third parties from the scope of your request (and not just
FOI applicants) where applicable?

 

Personal information of third parties can include (but not limited to),
names and contact details of individuals, or any information that could
reasonably identify an individual. Seeking this information may require
the Department to consult with the identified individuals. This will
increase the time taken to process your request and the costs involved. As
such, we would be grateful if you would consider removing the personal
information of third parties from the scope of your request. 

 

We would be grateful for your confirmation by 12pm tomorrow, Thursday 10
October 2024.

 

If you have any questions or concerns, please don’t hesitate to contact
the TGA FOI team.

 

Kind regards

 

Freedom of Information

Therapeutic Goods Administration

Australian Government Department of Health and Aged Care

T: 02 6289 4630 | E: [1][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [2]www.tga.gov.au

 

Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.

 

The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present.

 

-----Original Message-----
From: CR <[FOI #12108 email]>
Sent: Tuesday, October 8, 2024 9:31 PM
To: TGA FOI <[email address]>
Subject: Re: FOI 25-0037 - Notification of receipt [SEC=OFFICIAL]

 

REMINDER: Think before you click! This email originated from outside our
organisation. Only click links or open attachments if you recognise the
sender and know the content is safe.

Dear FOI Officer,

 

I am writing to amend the scope of my FOI request to assist with its
processing.

 

As I wish to access only recent charge decisions, I have introduced a time
frame and clarified the exclusions. I confirm the revised scope of my
request as follows:

 

1. The most recent 30 notices of charges issued to FOI applicants.

 

For each of these 30 requests, if applicable, please also provide:

 

2. Any subsequent decisions regarding charges following applicant
contention.

 

3. Any subsequent decisions regarding charges following internal or
external review.

 

The time period for my request is from 1 July 2022 to 1 October 2024.

 

Please exclude the following information:

 

i) Personal information of FOI applicants, including supporting evidence
or details of personal circumstances in a financial hardship contention.

ii) Emails that attached the charges notices/decision letters.

 

Please feel free to contact me if you require any clarification or have
further questions regarding this request.

 

Yours sincerely,

 

CR

 

-----Original Message-----

 

Dear CR

 

 

 

FREEDOM OF INFORMATION REQUEST – NOTIFICATION OF RECEIPT

 

 

 

I am writing to notify you that the Therapeutic Goods Administration 
(Department of Health and Aged Care) has received your request for access 
to documents under the Freedom of Information Act 1982 (FOI Act) as

follows:

 

 

 

‘…I request access to the following documents under the Freedom of 
Information Act 1982:

 

 

 

1. The most recent 30 notices of charges issued to FOI applicants.

 

 

 

For each of these 30 requests, if applicable, please also provide:

 

2. Any subsequent decisions regarding charges following applicant 
contention.

 

3. Any subsequent decisions regarding charges following internal or 
external review.

 

 

 

Please exclude the following information:

 

i) Personal information of FOI applicants.

 

ii) Personal information of third parties.’

 

 

 

Under section 15(5)(b) of the FOI Act, the agency has 30 calendar days 
from the date your request was received in which to provide a decision in 
response to your request for access. A decision is currently due on or 
before 31 October 2024. Due to the statutory processing time afforded 
under the FOI Act in which to provide you with a decision in relation to 
your FOI request, we would be grateful if you could please monitor your
emails periodically for updates regarding your request.

 

 

 

Where there is requirement to undertake consultation with affected third 
parties, this timeframe is extended by a further 30 days. It may also be 
extended in certain circumstances, including with your agreement or where 
the Department applies to the Office of the Australian Information 
Commissioner for an extension.

 

 

 

Unless you advise otherwise, draft and duplicate documents, Commonwealth 
employee names and contact details of staff below Senior Executive
Service  level, internal group email addresses and mobile telephone
numbers of all  staff will be excluded from the scope of your request
under section

22(1)(a)(ii) of the FOI Act.

 

 

 

Disclosure Log Publication

 

The TGA is required under section 11C of the FOI Act to publish on its 
website, or otherwise make available, documents released to an applicant 
in response to an FOI request, unless exceptional circumstances apply.
The  TGA publishes these documents on the FOI Disclosure Log at [1]FOI 
Disclosure Log | Therapeutic Goods Administration. You can find more 
information about the Disclosure Log at [2]OAIC FOI Guidelines | 
Disclosure Logs.

 

 

 

In addition, please note that if the decision maker decides that you are 
liable to pay a charge in relation to your request then this timeframe is 
extended pending payment of a deposit. You will be notified by the 
Department if you are liable to pay a charge and/or if third party 
consultation is required.

 

 

 

If you have any queries, please contact the FOI team on (02) 6289 4630,
or  via email at [3][email address].

 

 

 

Kind regards

 

 

 

Freedom of Information

 

Therapeutic Goods Administration

 

Australian Government Department of Health and Aged Care

 

T: 02 6289 4630 | E: [4][email address]

 

PO Box 100, Woden ACT 2606, Australia

 

Web: [5][3]www.tga.gov.au

 

 

 

Important: This transmission is intended only for the use of the
addressee  and may contain confidential or legally privileged information.
If you are  not the intended recipient, you are notified that any use or
dissemination  of this communication is strictly prohibited. If you
receive this  transmission in error please notify the author immediately
and delete all  copies of this transmission.

 

 

 

The Department of Health acknowledges the Traditional Custodians of 
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present.

 

 

 

 

 

 

 

-------------------------------------------------------------------

Please use this email address for all replies to this request:

[4][FOI #12108 email]

 

This request has been made by an individual using Right to Know. This
message and any reply that you make will be published on the internet.
More information on how Right to Know works can be found at:

[5]https://www.righttoknow.org.au/help/offi...

 

Please note that in some cases publication of requests and responses will
be delayed.

 

If you find this service useful as an FOI officer, please ask your web
manager to link to us from your organisation's FOI page.

 

-------------------------------------------------------------------

 

 

"Important: This transmission is intended only for the use of the
addressee and may contain confidential or legally privileged information. 
If you are not the intended recipient, you are notified that any use or
dissemination of this communication is strictly prohibited.  If you
receive this transmission in error please notify the author immediately
and delete all copies of this transmission."

References

Visible links
1. mailto:[email address]
2. http://www.tga.gov.au/
3. http://www.tga.gov.au/
4. mailto:[FOI #12108 email]
5. https://www.righttoknow.org.au/help/offi...

hide quoted sections

Dear FOI Officer,

I can confirm the exclusion of personal information of third parties.

Yours sincerely,

CR

TGA FOI, Therapeutic Goods Administration

1 Attachment

Dear CR

 

I refer to previous correspondence regarding the scope of your request FOI
25-0037.

 

As an update, I can advise that the TGA is continuing to process your
request. In addition to omitting personal information of third parties
from your scope, we ask that you also consider omitting the details of
third party organisations. There may be instances where an applicant is
requesting documents relating to a specific organisation, sponsor, or
other industry party.

 

In these instances, it would be necessary to conduct a third party
consultation with the affected third party to provide them with an
opportunity to comment on the release of documents to the FOI applicant.
Omitting these details will remove the necessity to conduct a consultation
with any affected third party.  

 

We would be grateful for your consideration and confirmation of the above
by 10am tomorrow, Wednesday 16 October 2024.

 

If you have any questions or concerns, please don’t hesitate to contact
the FOI team.

 

Kind regards

 

Freedom of Information

Therapeutic Goods Administration

Australian Government Department of Health and Aged Care

T: 02 6289 4630 | E: [1][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [2]www.tga.gov.au

 

Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.

 

The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present.

 

-----Original Message-----
From: CR <[FOI #12108 email]>
Sent: Wednesday, October 9, 2024 2:18 PM
To: TGA FOI <[email address]>
Subject: RE: FOI 25-0037 - Notification of receipt [SEC=OFFICIAL]

 

REMINDER: Think before you click! This email originated from outside our
organisation. Only click links or open attachments if you recognise the
sender and know the content is safe.

Dear FOI Officer,

 

I can confirm the exclusion of personal information of third parties.

 

Yours sincerely,

 

CR

 

-----Original Message-----

 

Dear CR

 

 

 

Thank you for your email to the TGA regarding your request, FOI 25-0037.

 

 

 

The TGA acknowledges the amendments (below) to the scope of your request.

I write to confirm that you are still amenable to omit personal 
information of third parties from the scope of your request (and not just 
FOI applicants) where applicable?

 

 

 

Personal information of third parties can include (but not limited to),
names and contact details of individuals, or any information that could
reasonably identify an individual. Seeking this information may require
the Department to consult with the identified individuals. This will 
increase the time taken to process your request and the costs involved.
As  such, we would be grateful if you would consider removing the
personal  information of third parties from the scope of your request. 

 

 

 

We would be grateful for your confirmation by 12pm tomorrow, Thursday 10 
October 2024.

 

 

 

If you have any questions or concerns, please don’t hesitate to contact 
the TGA FOI team.

 

 

 

Kind regards

 

 

 

Freedom of Information

 

Therapeutic Goods Administration

 

Australian Government Department of Health and Aged Care

 

T: 02 6289 4630 | E: [1][email address]

 

PO Box 100, Woden ACT 2606, Australia

 

Web: [2][3]www.tga.gov.au

 

 

 

Important: This transmission is intended only for the use of the
addressee  and may contain confidential or legally privileged information.
If you are  not the intended recipient, you are notified that any use or
dissemination  of this communication is strictly prohibited. If you
receive this  transmission in error please notify the author immediately
and delete all  copies of this transmission.

 

 

 

The Department of Health acknowledges the Traditional Custodians of 
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present.

 

 

 

-------------------------------------------------------------------

Please use this email address for all replies to this request:

[4][FOI #12108 email]

 

This request has been made by an individual using Right to Know. This
message and any reply that you make will be published on the internet.
More information on how Right to Know works can be found at:

[5]https://www.righttoknow.org.au/help/offi...

 

Please note that in some cases publication of requests and responses will
be delayed.

 

If you find this service useful as an FOI officer, please ask your web
manager to link to us from your organisation's FOI page.

 

-------------------------------------------------------------------

 

 

"Important: This transmission is intended only for the use of the
addressee and may contain confidential or legally privileged information. 
If you are not the intended recipient, you are notified that any use or
dissemination of this communication is strictly prohibited.  If you
receive this transmission in error please notify the author immediately
and delete all copies of this transmission."

References

Visible links
1. mailto:[email address]
2. http://www.tga.gov.au/
3. http://www.tga.gov.au/
4. mailto:[FOI #12108 email]
5. https://www.righttoknow.org.au/help/offi...

hide quoted sections

Dear FOI Officer,

Please exclude details of third party organisations.

Yours sincerely,

CR

TGA FOI, Therapeutic Goods Administration

1 Attachment

Dear CR

 

I refer to previous correspondence regarding your FOI request, and I can
advise that the TGA is continuing to process your request.

 

As an update, we wish to advise that the decision maker for this matter
has decided to not impose charges for the processing of your request and
accordingly, a decision is currently being prepared.

 

The current due date for a decision in relation to your request is 31
October 2024.

 

If you have any questions or concerns, please don’t hesitate to contact
the FOI team.

 

Kind regards

 

Freedom of Information

Therapeutic Goods Administration

Australian Government Department of Health and Aged Care

T: 02 6289 4630 | E: [1][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [2]www.tga.gov.au

 

Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.

 

The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present.

 

 

-----Original Message-----
From: CR [3][FOI #12108 email]
Sent: Tuesday, October 15, 2024 1:40 PM
To: TGA FOI [4][email address]
Subject: RE: FOI 25-0037 - Notification of receipt [SEC=OFFICIAL]

 

REMINDER: Think before you click! This email originated from outside our
organisation. Only click links or open attachments if you recognise the
sender and know the content is safe.

Dear FOI Officer,

 

Please exclude details of third party organisations.

 

Yours sincerely,

 

CR

 

-----Original Message-----

 

Dear CR

 

I refer to previous correspondence regarding the scope of your request
FOI  25-0037.

 

As an update, I can advise that the TGA is continuing to process your 
request. In addition to omitting personal information of third parties 
from your scope, we ask that you also consider omitting the details of 
third party organisations. There may be instances where an applicant is
requesting documents relating to a specific organisation, sponsor, or 
other industry party.

 

In these instances, it would be necessary to conduct a third party 
consultation with the affected third party to provide them with an 
opportunity to comment on the release of documents to the FOI applicant.

Omitting these details will remove the necessity to conduct a
consultation  with any affected third party.  

 

We would be grateful for your consideration and confirmation of the above 
by 10am tomorrow, Wednesday 16 October 2024.

 

If you have any questions or concerns, please don’t hesitate to contact 
the FOI team.

 

Kind regards

 

Freedom of Information

 

Therapeutic Goods Administration

 

Australian Government Department of Health and Aged Care

 

T: 02 6289 4630 | E: [1][email address]

 

PO Box 100, Woden ACT 2606, Australia

 

Web: [2][5]www.tga.gov.au

 

Important: This transmission is intended only for the use of the
addressee  and may contain confidential or legally privileged information.
If you are  not the intended recipient, you are notified that any use or
dissemination  of this communication is strictly prohibited. If you
receive this  transmission in error please notify the author immediately
and delete all  copies of this transmission.

 

The Department of Health acknowledges the Traditional Custodians of 
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present.

 

-------------------------------------------------------------------

Please use this email address for all replies to this request:

[6][FOI #12108 email]

 

This request has been made by an individual using Right to Know. This
message and any reply that you make will be published on the internet.
More information on how Right to Know works can be found at:

[7]https://www.righttoknow.org.au/help/offi...

 

Please note that in some cases publication of requests and responses will
be delayed.

 

If you find this service useful as an FOI officer, please ask your web
manager to link to us from your organisation's FOI page.

 

-------------------------------------------------------------------

"Important: This transmission is intended only for the use of the
addressee and may contain confidential or legally privileged information. 
If you are not the intended recipient, you are notified that any use or
dissemination of this communication is strictly prohibited.  If you
receive this transmission in error please notify the author immediately
and delete all copies of this transmission."

References

Visible links
1. mailto:[email address]
2. http://www.tga.gov.au/
3. mailto:[FOI #12108 email]
4. mailto:[email address]
5. http://www.tga.gov.au/
6. mailto:[FOI #12108 email]
7. https://www.righttoknow.org.au/help/offi...

hide quoted sections

Dear FOI Team,

I wish to provide clarification as to the scope of my request.

If a preliminary charge notice or decision of a charge is sent via the body of an email (as opposed to an email attachment) I wish to access a copy of that email, as well as the applicant's contention reasons.

Yours sincerely,

CR

TGA FOI, Therapeutic Goods Administration

1 Attachment

Dear CR

 

Thank you for your email regarding your request, FOI 25-0037.

 

I can confirm that all documents relevant to the scope of your request
have been captured. This includes any documents regarding a request for a
waiver or reduction in fees and any subsequent decision, whether this be
in the format of an email or official letter to the applicant.

 

I trust this information is of assistance.

 

If you have any further questions or concerns, please don’t hesitate to
contact the TGA FOI team.

 

Kind regards

 

Freedom of Information

Therapeutic Goods Administration

Australian Government Department of Health and Aged Care

T: 02 6289 4630 | E: [1][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [2]www.tga.gov.au

 

Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.

 

The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present.

 

-----Original Message-----
From: CR <[FOI #12108 email]>
Sent: Wednesday, 23 October 2024 11:11 PM
To: TGA FOI <[email address]>
Subject: Re: FOI 25-0037 - Notification of decision to not impose charges
[SEC=OFFICIAL]

 

REMINDER: Think before you click! This email originated from outside our
organisation. Only click links or open attachments if you recognise the
sender and know the content is safe.

Dear FOI Team,

 

I wish to provide clarification as to the scope of my request.

 

If a preliminary charge notice or decision of a charge is sent via the
body of an email (as opposed to an email attachment) I wish to access a
copy of that email, as well as the applicant's contention reasons.

 

Yours sincerely,

 

CR

 

-----Original Message-----

 

Dear CR

 

 

 

I refer to previous correspondence regarding your FOI request, and I can 
advise that the TGA is continuing to process your request.

 

 

 

As an update, we wish to advise that the decision maker for this matter
has decided to not impose charges for the processing of your request and 
accordingly, a decision is currently being prepared.

 

 

 

The current due date for a decision in relation to your request is 31 
October 2024.

 

 

 

If you have any questions or concerns, please don’t hesitate to contact 
the FOI team.

 

 

 

Kind regards

 

 

 

Freedom of Information

 

Therapeutic Goods Administration

 

Australian Government Department of Health and Aged Care

 

T: 02 6289 4630 | E: [1][email address]

 

PO Box 100, Woden ACT 2606, Australia

 

Web: [2][3]www.tga.gov.au

 

 

 

Important: This transmission is intended only for the use of the
addressee  and may contain confidential or legally privileged information.
If you are  not the intended recipient, you are notified that any use or
dissemination  of this communication is strictly prohibited. If you
receive this  transmission in error please notify the author immediately
and delete all  copies of this transmission.

 

 

 

The Department of Health acknowledges the Traditional Custodians of 
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present.

 

 

 

 

 

-------------------------------------------------------------------

Please use this email address for all replies to this request:

[4][FOI #12108 email]

 

This request has been made by an individual using Right to Know. This
message and any reply that you make will be published on the internet.
More information on how Right to Know works can be found at:

[5]https://www.righttoknow.org.au/help/offi...

 

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"Important: This transmission is intended only for the use of the
addressee and may contain confidential or legally privileged information. 
If you are not the intended recipient, you are notified that any use or
dissemination of this communication is strictly prohibited.  If you
receive this transmission in error please notify the author immediately
and delete all copies of this transmission."

References

Visible links
1. mailto:[email address]
2. http://www.tga.gov.au/
3. http://www.tga.gov.au/
4. mailto:[FOI #12108 email]
5. https://www.righttoknow.org.au/help/offi...

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TGA FOI, Therapeutic Goods Administration

1 Attachment

Dear CR

 

In addition to our email below, I write to request further clarification
on the scope of your request.

 

As you have requested the 30 most recent charges notices sent to FOI
applicants, there are a number of FOI requests captured by this which are
still in the process of being completed or progressing to the next stage.
In addition, some documents include background information of
correspondence between the TGA and the FOI applicant which do not relate
to the charges being imposed. There is a concern that there may be
sensitivities in releasing the scope and background information of these
requests prior to the FOI being completed and all relevant third parties
being consulted.

 

So that we can continue to process your request, we would be grateful if
you could consider omitting the ‘applicant scopes and background
information contained in the charges letters/emails’ from the scope of
your request. This will ensure that there is no need for consultation or
concerns regarding the sensitivities of information being released
prematurely.

 

I would be grateful for your consideration of omitting applicant scopes by
12pm tomorrow, Friday 25 October 2024.

 

If you have any questions or concerns, please don’t hesitate to contact
the TGA FOI team.

 

Kind regards

 

Freedom of Information

Therapeutic Goods Administration

Australian Government Department of Health and Aged Care

T: 02 6289 4630 | E: [1][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [2]www.tga.gov.au

 

Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.

 

The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present.

 

From: TGA FOI <[email address]>
Sent: Thursday, 24 October 2024 10:44 AM
To: CR <[FOI #12108 email]>
Cc: TGA FOI <[email address]>
Subject: RE: FOI 25-0037 - Clarification of scope [SEC=OFFICIAL]

 

Dear CR

 

Thank you for your email regarding your request, FOI 25-0037.

 

I can confirm that all documents relevant to the scope of your request
have been captured. This includes any documents regarding a request for a
waiver or reduction in fees and any subsequent decision, whether this be
in the format of an email or official letter to the applicant.

 

I trust this information is of assistance.

 

If you have any further questions or concerns, please don’t hesitate to
contact the TGA FOI team.

 

Kind regards

 

Freedom of Information

Therapeutic Goods Administration

Australian Government Department of Health and Aged Care

T: 02 6289 4630 | E: [3][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [4]www.tga.gov.au

 

Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.

 

The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present.

 

-----Original Message-----
From: CR <[5][FOI #12108 email]>
Sent: Wednesday, 23 October 2024 11:11 PM
To: TGA FOI <[6][email address]>
Subject: Re: FOI 25-0037 - Notification of decision to not impose charges
[SEC=OFFICIAL]

 

REMINDER: Think before you click! This email originated from outside our
organisation. Only click links or open attachments if you recognise the
sender and know the content is safe.

Dear FOI Team,

 

I wish to provide clarification as to the scope of my request.

 

If a preliminary charge notice or decision of a charge is sent via the
body of an email (as opposed to an email attachment) I wish to access a
copy of that email, as well as the applicant's contention reasons.

 

Yours sincerely,

 

CR

 

-----Original Message-----

 

Dear CR

 

 

 

I refer to previous correspondence regarding your FOI request, and I can 
advise that the TGA is continuing to process your request.

 

 

 

As an update, we wish to advise that the decision maker for this matter
has decided to not impose charges for the processing of your request and 
accordingly, a decision is currently being prepared.

 

 

 

The current due date for a decision in relation to your request is 31 
October 2024.

 

 

 

If you have any questions or concerns, please don’t hesitate to contact 
the FOI team.

 

 

 

Kind regards

 

 

 

Freedom of Information

 

Therapeutic Goods Administration

 

Australian Government Department of Health and Aged Care

 

T: 02 6289 4630 | E: [1][email address]

 

PO Box 100, Woden ACT 2606, Australia

 

Web: [2][7]www.tga.gov.au

 

 

 

Important: This transmission is intended only for the use of the
addressee  and may contain confidential or legally privileged information.
If you are  not the intended recipient, you are notified that any use or
dissemination  of this communication is strictly prohibited. If you
receive this  transmission in error please notify the author immediately
and delete all  copies of this transmission.

 

 

 

The Department of Health acknowledges the Traditional Custodians of 
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present.

 

 

 

 

 

-------------------------------------------------------------------

Please use this email address for all replies to this request:

[8][FOI #12108 email]

 

This request has been made by an individual using Right to Know. This
message and any reply that you make will be published on the internet.
More information on how Right to Know works can be found at:

[9]https://www.righttoknow.org.au/help/offi...

 

Please note that in some cases publication of requests and responses will
be delayed.

 

If you find this service useful as an FOI officer, please ask your web
manager to link to us from your organisation's FOI page.

 

-------------------------------------------------------------------

 

 

References

Visible links
1. mailto:[email address]
2. http://www.tga.gov.au/
3. mailto:[email address]
4. http://www.tga.gov.au/
5. mailto:[FOI #12108 email]
6. mailto:[email address]
7. http://www.tga.gov.au/
8. mailto:[FOI #12108 email]
9. https://www.righttoknow.org.au/help/offi...

hide quoted sections

Dear TGA FOI Team,

Thank you for your emails.

I am hesitant to impose a blanket exclusion on all applicant scopes, as this may result in the unnecessary redaction of non-sensitive information. However, I am happy to provide consent for you to exercise your discretion in excluding only those scopes or background details that are sensitive or problematic while retaining non-sensitive scopes where possible.

Would this approach allow you to proceed with processing my request? I understand that this may involve some judgment on your part, and I am comfortable with this approach in lieu of a 'black and white' written exclusion.

To satisfy the requirements of the FOI Act, I formally include the following exclusion:

- Sensitive applicant scopes and sensitive background information contained in the charges letters/emails (to be determined at your discretion).

Please let me know if this approach enables you to continue processing my request.

Thank you for your assistance.

Yours sincerely,

CR

TGA FOI, Therapeutic Goods Administration

38 Attachments

Dear CR

 

Please find attached correspondence in relation to your Freedom of
Information request.

 

If you have any questions, please do not hesitate to contact the FOI Team.

 

Kind regards

 

Freedom of Information

Therapeutic Goods Administration

Australian Government Department of Health and Aged Care

T: 02 6289 4630 | E: [1][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [2]www.tga.gov.au

 

Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.

 

The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present.

"Important: This transmission is intended only for the use of the
addressee and may contain confidential or legally privileged information. 
If you are not the intended recipient, you are notified that any use or
dissemination of this communication is strictly prohibited.  If you
receive this transmission in error please notify the author immediately
and delete all copies of this transmission."

References

Visible links
1. mailto:[email address]
2. http://www.tga.gov.au/

Dear TGA FOI Team,

I note that request FOI 5361 was made via Right to Know to the Advisory Committee on Medical Devices. Please advise on your relation with this entity and why the TGA processed the request instead of the committee.

Yours sincerely,

CR

TGA FOI, Therapeutic Goods Administration

1 Attachment

Dear CR

 

Thank you for your email.

 

Generally, under the Freedom of Information Act 1982 (FOI Act), the Office
of the Australian Information Commissioner (OAIC) does not consider
committees to be separate ‘entities’ for FOI purposes.  The obligations
under the FOI Act apply to Australian Government agencies and a where a
committee operates within a government agency, documents held by that
committee are accessible under the FOI Act as they are considered to be
documents held by the relevant agency.

 

Where documents of a committee operating with an agency are requested, the
FOI team within that agency manages the processing of the request in
consultation with the relevant committee.

 

I hope this addresses your question.

 

Kind regards

 

Freedom of Information

Therapeutic Goods Administration

Australian Government Department of Health and Aged Care

T: 02 6289 4630 | E: [1][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [2]www.tga.gov.au

 

Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.

 

The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present.

 

-----Original Message-----
From: CR <[FOI #12108 email]>
Sent: Monday, 4 November 2024 8:10 AM
To: TGA FOI <[email address]>
Subject: Re: FOI 25-0037 - Notice of Decision [SEC=OFFICIAL]

 

REMINDER: Think before you click! This email originated from outside our
organisation. Only click links or open attachments if you recognise the
sender and know the content is safe.

Dear TGA FOI Team,

 

I note that request FOI 5361 was made via Right to Know to the Advisory
Committee on Medical Devices. Please advise on your relation with this
entity and why the TGA processed the request instead of the committee.

 

Yours sincerely,

 

CR

 

-----Original Message-----

 

Dear CR

 

 

 

Please find attached correspondence in relation to your Freedom of 
Information request.

 

 

 

If you have any questions, please do not hesitate to contact the FOI Team.

 

 

 

Kind regards

 

 

 

Freedom of Information

 

Therapeutic Goods Administration

 

Australian Government Department of Health and Aged Care

 

T: 02 6289 4630 | E: [1][email address]

 

PO Box 100, Woden ACT 2606, Australia

 

Web: [2][3]www.tga.gov.au

 

 

 

Important: This transmission is intended only for the use of the
addressee  and may contain confidential or legally privileged information.
If you are  not the intended recipient, you are notified that any use or
dissemination  of this communication is strictly prohibited. If you
receive this  transmission in error please notify the author immediately
and delete all  copies of this transmission.

 

 

 

The Department of Health acknowledges the Traditional Custodians of 
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present.

 

"Important: This transmission is intended only for the use of the 
addressee and may contain confidential or legally privileged information. 
If you are not the intended recipient, you are notified that any use or
dissemination of this communication is strictly prohibited.  If you 
receive this transmission in error please notify the author immediately
and delete all copies of this transmission."

 

References

 

Visible links

1. [4]mailto:[email address]

2. [5]http://www.tga.gov.au/

 

-------------------------------------------------------------------

Please use this email address for all replies to this request:

[6][FOI #12108 email]

 

This request has been made by an individual using Right to Know. This
message and any reply that you make will be published on the internet.
More information on how Right to Know works can be found at:

[7]https://www.righttoknow.org.au/help/offi...

 

Please note that in some cases publication of requests and responses will
be delayed.

 

If you find this service useful as an FOI officer, please ask your web
manager to link to us from your organisation's FOI page.

 

-------------------------------------------------------------------

 

 

"Important: This transmission is intended only for the use of the
addressee and may contain confidential or legally privileged information. 
If you are not the intended recipient, you are notified that any use or
dissemination of this communication is strictly prohibited.  If you
receive this transmission in error please notify the author immediately
and delete all copies of this transmission."

References

Visible links
1. mailto:[email address]
2. http://www.tga.gov.au/
3. http://www.tga.gov.au/
4. mailto:[email
5. http://www.tga.gov.au/
6. mailto:[FOI #12108 email]
7. https://www.righttoknow.org.au/help/offi...

hide quoted sections