Post-market review and incident reporting by Saluda Medical
Dear Advisory Committee on Medical Devices,
I am writing regarding your Post-market review of spinal cord stimulation (SCS) devices.
May you please provide the following information that was submitted by Saluda Medical, relating to their Evoke Closed Loop Spinal Cord Stimulator:
- All domestic and international incidents, adverse events, complaints, and any investigations undertaken, and corrective actions made as a result of these investigations
Thank you kindly for your assistance.
Yours faithfully,
Sarah
Dear Sarah
FREEDOM OF INFORMATION REQUEST – NOTIFICATION OF RECEIPT
I am writing to notify you that the Therapeutic Goods Administration (a
part of the Department of Health and Aged Care) has accepted carriage of
your request to 23 August 2024 for access to documents under the Freedom
of Information Act 1982 (FOI Act) as follows:
‘I am writing regarding your Post-market review of spinal
cord stimulation (SCS) devices.
May you please provide the following information that was submitted by
Saluda Medical, relating to their Evoke Closed Loop Spinal Cord
Stimulator:
- All domestic and international incidents, adverse events, complaints,
and any investigations undertaken, and corrective actions made as a result
of these investigations.’
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 22 September 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.
Personal information:
With regard to the personal information of third parties (e.g. the names
and contact details of individuals, or any information that could
reasonably identify an individual outside of the Department), seeking this
information may require the Department to consult with the identified
individuals. This may increase the time taken to process your request. As
such, we would be grateful if you would consider removing the personal
information of third parties outside of the Department from the scope of
your request.
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.
We would be grateful if you could respond to this email by Thursday 5
September 2024 so that we may continue processing your request.
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
[6][IMG][7][IMG][8][IMG]
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: Sarah [9][FOI #11941 email]
Sent: Friday, August 23, 2024 9:00 AM
To: FOI [10][email address]
Subject: Freedom of Information request - Post-market review and incident
reporting by Saluda Medical
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 Advisory Committee on Medical Devices,
I am writing regarding your Post-market review of spinal cord stimulation
(SCS) devices.
May you please provide the following information that was submitted by
Saluda Medical, relating to their Evoke Closed Loop Spinal Cord
Stimulator:
- All domestic and international incidents, adverse events, complaints,
and any investigations undertaken, and corrective actions made as a result
of these investigations
Thank you kindly for your assistance.
Yours faithfully,
Sarah
-------------------------------------------------------------------
Please use this email address for all replies to this request:
[11][FOI #11941 email]
Is [12][Advisory Committee on Medical Devices request email] the wrong address for Freedom of Information
requests to Advisory Committee on Medical Devices? If so, please contact
us using this form:
[13]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:
[14]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
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2. https://www.oaic.gov.au/freedom-of-infor...
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4. mailto:[email address]
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8. https://www.youtube.com/channel/UCem9INJ...
9. mailto:[FOI #11941 email]
10. mailto:[email address]
11. mailto:[FOI #11941 email]
12. mailto:[Advisory Committee on Medical Devices request email]
13. https://www.righttoknow.org.au/change_re...
14. https://www.righttoknow.org.au/help/offi...
Dear TGA FOI,
Thank you kindly for your prompt reply!
I’m a tad confused about the steps required from your message. However, I believe I need to confirm acceptance of your response and request that we proceed? In which case, I accept.
Please let me know if I have misinterpreted your email or if you require anything else from me.
Yours sincerely,
Sarah
Dear Sarah
Thank you for your email. We kindly seek your views on the personal
information of third parties as part of your request, as follows:
Personal information:
With regard to the personal information of third parties (e.g. the names
and contact details of individuals, or any information within documents
that could reasonably identify an individual outside of the Department),
seeking this information may require the Department to consult with the
identified individuals. This may increase the time taken to process your
request. As such, we would be grateful if you would consider removing the
personal information of third parties outside of the Department from the
scope of your request.
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
[3][IMG][4][IMG][5][IMG]
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: Sarah <[FOI #11941 email]>
Sent: Tuesday, September 3, 2024 8:18 AM
To: TGA FOI <[email address]>
Subject: Re: FOI 5361 - Notification of receipt and third party personal
information (for response) [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,
Thank you kindly for your prompt reply!
I’m a tad confused about the steps required from your message. However, I
believe I need to confirm acceptance of your response and request that we
proceed? In which case, I accept.
Please let me know if I have misinterpreted your email or if you require
anything else from me.
Yours sincerely,
Sarah
-----Original Message-----
Dear Sarah
FREEDOM OF INFORMATION REQUEST – NOTIFICATION OF RECEIPT
I am writing to notify you that the Therapeutic Goods Administration (a
part of the Department of Health and Aged Care) has accepted carriage of
your request to 23 August 2024 for access to documents under the Freedom
of Information Act 1982 (FOI Act) as follows:
‘I am writing regarding your Post-market review of spinal
cord stimulation (SCS) devices.
May you please provide the following information that was submitted by
Saluda Medical, relating to their Evoke Closed Loop Spinal Cord
Stimulator:
- All domestic and international incidents, adverse events, complaints,
and any investigations undertaken, and corrective actions made as a
result of these investigations.’
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 22 September 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.
Personal information:
With regard to the personal information of third parties (e.g. the names
and contact details of individuals, or any information that could
reasonably identify an individual outside of the Department), seeking
this information may require the Department to consult with the
identified individuals. This may increase the time taken to process your
request. As such, we would be grateful if you would consider removing the
personal information of third parties outside of the Department from the
scope of your request.
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.
We would be grateful if you could respond to this email by Thursday 5
September 2024 so that we may continue processing your request.
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][6]www.tga.gov.au
[6][IMG][7][IMG][8][IMG]
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:
[7][FOI #11941 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:
[8]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. https://www.facebook.com/TGAgovau/
4. https://twitter.com/TGAgovau
5. https://www.youtube.com/channel/UCem9INJ...
6. http://www.tga.gov.au/
7. mailto:[FOI #11941 email]
8. https://www.righttoknow.org.au/help/offi...
Dear TGA FOI,
Thank you for clarifying.
Confirming that I consent to removing all third party information from my request. I don’t require any personal details of any people involved in the reports.
Please let me know if there’s anything else that you may need!
All the best. Yours sincerely,
Sarah
Dear Sarah
Please find attached correspondence in relation to your Freedom of
Information request.
As outlined in the attached letter, pursuant to section 24AB(8) of the
Freedom of Information Act 1982, the processing time for your request has
been set aside to allow for the commencement of the request consultation
period.
During the consultation period, the FOI team (in collaboration with the
relevant line area) are available to assist you in revising the scope of
your request so that the practical refusal reason no longer exists, as is
required under the FOI Act. Our aim during the consultation period is to
assist you to define a revised scope which can then be formally submitted
so that processing of your request may continue, and a practical refusal
decision may be avoided.
To assist you further, you may also consider submitting a draft revised
scope to us for consideration during the request consultation period. We
will then liaise with the relevant TGA line area on your behalf and
provide you with advice as to whether your amended scope is now considered
reasonable to process.
The request consultation period currently expires on 25 September 2024.
Therefore, we seek your response prior to this date. We would be happy to
extend the consultation process under section 24AB(5) of the FOI Act
should the initial 14 day period not be sufficient to reach agreement.
Please note, once you formally submit a revised scope to us, the
processing clock will recommence and processing of your request will
continue. If the revised scope remains unreasonable to process, the
decision maker may decide to refuse your request under section 24 of the
FOI Act.
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
[3][IMG][4][IMG][5][IMG]
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/
3. https://www.facebook.com/TGAgovau/
4. https://twitter.com/TGAgovau
5. https://www.youtube.com/channel/UCem9INJ...
Dear Sarah
We are writing to remind you that a response to the request consultation
notice issued to you (below and attached) is due by 25 September 2024.
As noted in the letter sent to you on 11 September 2024, before the end of
the 14-day consultation period, you may do one of the following:
• withdraw your request;
• make a revised request; or
• indicate that you do not wish to revise your request.
As mentioned below, you may wish to consider submitting a draft revised
scope to us for consideration during the request consultation period. We
will then liaise with the relevant TGA line area on your behalf and
provide you with advice as to whether your amended scope is now considered
reasonable to process.
Further, as outlined in the letter, if you have not contacted the TGA
within 14 days of receiving this letter to do one of the above or
consulted the TGA to discuss revising your scope, your request is taken to
have been withdrawn.
If you require further time to consider a response, please let us know and
we would be happy to extend the request consultation process timeframe.
If you would like to discuss or have any questions, please feel free to
contact the FOI team, either by responding to this email or calling on
(02) 6289 4630.
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
[3][IMG][4][IMG][5][IMG]
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: Wednesday, September 11, 2024 4:33 PM
To: 'Sarah' <[FOI #11941 email]>
Cc: TGA FOI <[email address]>
Subject: Request consultation - FOI 5361 [SEC=OFFICIAL]
Dear Sarah
Please find attached correspondence in relation to your Freedom of
Information request.
As outlined in the attached letter, pursuant to section 24AB(8) of the
Freedom of Information Act 1982, the processing time for your request has
been set aside to allow for the commencement of the request consultation
period.
During the consultation period, the FOI team (in collaboration with the
relevant line area) are available to assist you in revising the scope of
your request so that the practical refusal reason no longer exists, as is
required under the FOI Act. Our aim during the consultation period is to
assist you to define a revised scope which can then be formally submitted
so that processing of your request may continue, and a practical refusal
decision may be avoided.
To assist you further, you may also consider submitting a draft revised
scope to us for consideration during the request consultation period. We
will then liaise with the relevant TGA line area on your behalf and
provide you with advice as to whether your amended scope is now considered
reasonable to process.
The request consultation period currently expires on 25 September 2024.
Therefore, we seek your response prior to this date. We would be happy to
extend the consultation process under section 24AB(5) of the FOI Act
should the initial 14 day period not be sufficient to reach agreement.
Please note, once you formally submit a revised scope to us, the
processing clock will recommence and processing of your request will
continue. If the revised scope remains unreasonable to process, the
decision maker may decide to refuse your request under section 24 of the
FOI Act.
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: [6][email address]
PO Box 100, Woden ACT 2606, Australia
Web: [7]www.tga.gov.au
[8][IMG][9][IMG][10][IMG]
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/
3. https://www.facebook.com/TGAgovau/
4. https://twitter.com/TGAgovau
5. https://www.youtube.com/channel/UCem9INJ...
6. mailto:[email address]
7. http://www.tga.gov.au/
8. https://www.facebook.com/TGAgovau/
9. https://twitter.com/TGAgovau
10. https://www.youtube.com/channel/UCem9INJ...
Dear TGA FOI,
Thank you for the reminder and the generous offer to allow me to submit a revised request. May I please request further time for my reply? I would really like to make sure that I get it done properly.
Thank you again and all the best. I hope you’re having a lovely week.
Yours sincerely,
Sarah
Dear Sarah
Thank you for your email.
Of course, that is no problem at all.
To allow you further time to consider a revised scope and similarly, for
the relevant line area to consider your revised scope, in which they will
undertake an assessment as to the proposed work involved in meeting your
revised request, I would be grateful for your consideration of agreeing to
an extension to the request consultation period, (under section 24AB(5))
of the Freedom of Information Act 1982, of 7 days. If granted, the request
consultation period will expire on 2 October 2024.
S24AB(5) - Extension of consultation period
(5) The contact person may, with the applicant’s
agreement, extend the consultation period by written notice to the
applicant.
We would be grateful if you can respond, advising whether you agree to the
extension, by 23 September 2024 if you can.
Thank you for your time and consideration of this matter.
Please do not hesitate to contact the FOI team if you have any questions
and wishing you a lovely weekend.
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
[3][IMG][4][IMG][5][IMG]
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: Sarah <[FOI #11941 email]>
Sent: Friday, September 20, 2024 6:54 AM
To: TGA FOI <[email address]>
Subject: RE: Request consultation - FOI 5361 [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,
Thank you for the reminder and the generous offer to allow me to submit a
revised request. May I please request further time for my reply? I would
really like to make sure that I get it done properly.
Thank you again and all the best. I hope you’re having a lovely week.
Yours sincerely,
Sarah
-----Original Message-----
Dear Sarah
We are writing to remind you that a response to the request consultation
notice issued to you (below and attached) is due by 25 September 2024.
As noted in the letter sent to you on 11 September 2024, before the end
of the 14-day consultation period, you may do one of the following:
• withdraw your request;
• make a revised request; or
• indicate that you do not wish to revise your request.
As mentioned below, you may wish to consider submitting a draft revised
scope to us for consideration during the request consultation period. We
will then liaise with the relevant TGA line area on your behalf and
provide you with advice as to whether your amended scope is now
considered reasonable to process.
Further, as outlined in the letter, if you have not contacted the TGA
within 14 days of receiving this letter to do one of the above or
consulted the TGA to discuss revising your scope, your request is taken
to have been withdrawn.
If you require further time to consider a response, please let us know
and we would be happy to extend the request consultation process
timeframe.
If you would like to discuss or have any questions, please feel free to
contact the FOI team, either by responding to this email or calling on
(02) 6289 4630.
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][6]www.tga.gov.au
[3][IMG][4][IMG][5][IMG]
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: Wednesday, September 11, 2024 4:33 PM
To: 'Sarah' <[FOI #11941 email]>
Cc: TGA FOI <[email address]>
Subject: Request consultation - FOI 5361 [SEC=OFFICIAL]
Dear Sarah
Please find attached correspondence in relation to your Freedom of
Information request.
As outlined in the attached letter, pursuant to section 24AB(8) of the
Freedom of Information Act 1982, the processing time for your request has
been set aside to allow for the commencement of the request consultation
period.
During the consultation period, the FOI team (in collaboration with the
relevant line area) are available to assist you in revising the scope of
your request so that the practical refusal reason no longer exists, as is
required under the FOI Act. Our aim during the consultation period is to
assist you to define a revised scope which can then be formally submitted
so that processing of your request may continue, and a practical refusal
decision may be avoided.
To assist you further, you may also consider submitting a draft revised
scope to us for consideration during the request consultation period. We
will then liaise with the relevant TGA line area on your behalf and
provide you with advice as to whether your amended scope is now
considered reasonable to process.
The request consultation period currently expires on 25 September 2024.
Therefore, we seek your response prior to this date. We would be happy to
extend the consultation process under section 24AB(5) of the FOI Act
should the initial 14 day period not be sufficient to reach agreement.
Please note, once you formally submit a revised scope to us, the
processing clock will recommence and processing of your request will
continue. If the revised scope remains unreasonable to process, the
decision maker may decide to refuse your request under section 24 of the
FOI Act.
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: [6][email address]
PO Box 100, Woden ACT 2606, Australia
Web: [7][7]www.tga.gov.au
[8][IMG][9][IMG][10][IMG]
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
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Dear TGA FOI,
Thank you for your understanding and offer to extend the consultation period. Please take this as acceptance that I will endeavour to provide a new scope by the proposed date of 2nd of October 2024.
Yours sincerely,
Sarah
Dear TGA FOI,
Thank you for your time on the phone on Friday. I’m really glad that I could reach out directly and seek your assistance.
May I please request the following document:
- Saluda Medical “complaint summary.xlsx”
Thank you again for your understanding and assistance.
Yours sincerely,
Sarah
Dear Sarah
Please find attached correspondence in relation to your Freedom of
Information request.
IMPORTANT: Please include reference to FOI 5361 in your payment.
Consultation
As your request relates to the personal, professional, business,
commercial or financial affairs of third parties, pursuant to section 27
and 27A of the FOI Act, the TGA is required to consult with the affected
third parties and provide them an opportunity to make submissions
regarding the release of the documents.
Accordingly, under section 15(6) of the FOI Act, and upon payment of a
deposit, the timeframe for processing your request will be extended by 30
days to allow the consultation process to be conducted.
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 Sarah
I refer to the Estimate of Charges letter sent to you on 1 October 2024
(attached) relating to your request, FOI 5361.
I write to advise you that your request was deemed withdrawn, as no
response or payment was received within the legislated timeframe notified
in the Estimate of Charges letter.
Should you have any questions regarding this matter, please do not
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
[3][IMG][4][IMG][5][IMG]
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: Tuesday, 1 October 2024 12:24 PM
To: '[FOI #11941 email]'
<[FOI #11941 email]>
Cc: TGA FOI <[email address]>
Subject: FOI 5361 - Notice of Estimate of Charges [SEC=OFFICIAL]
Dear Sarah
Please find attached correspondence in relation to your Freedom of
Information request.
IMPORTANT: Please include reference to FOI 5361 in your payment.
Consultation
As your request relates to the personal, professional, business,
commercial or financial affairs of third parties, pursuant to section 27
and 27A of the FOI Act, the TGA is required to consult with the affected
third parties and provide them an opportunity to make submissions
regarding the release of the documents.
Accordingly, under section 15(6) of the FOI Act, and upon payment of a
deposit, the timeframe for processing your request will be extended by 30
days to allow the consultation process to be conducted.
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: [6][email address]
PO Box 100, Woden ACT 2606, Australia
Web: [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.
"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
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2. http://www.tga.gov.au/
3. https://www.facebook.com/TGAgovau/
4. https://twitter.com/TGAgovau
5. https://www.youtube.com/channel/UCem9INJ...
6. mailto:[email address]
7. http://www.tga.gov.au/
CR left an annotation ()
Yet another incorrect decision by the TGA to impose charges.
Sarah, feel free to use the reasons I provided to the TGA in August when I contested their charges. In that instance, they ultimately decided to waive the fees. You can find my arguments here:
https://www.righttoknow.org.au/request/p...
Just be sure to adjust the final paragraph to reflect the specific amount of charges associated with your request.
Best of luck.
CR