Post Market Review - Spinal Cord Stimulation
Dear Department of Health,
I am seeking access to all correspondence, including briefs, emails, meeting records and other documents between the Therapeutic Goods Administration and Saluda Medical Pty Ltd as part of the TGA's Post-market review of spinal cord stimulation (SCS) devices between 1 December 2023 and 23 June 2024.
Yours faithfully,
Will B
Dear Will
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 am seeking access to all correspondence, including
briefs, emails, meeting records and other documents between the
Therapeutic Goods Administration and Saluda Medical Pty Ltd
as part of the TGA's Post-market review of spinal cord stimulation (SCS)
devices between 1 December 2023 and 23 June 2024.’
The timeframe for your request is from 01 December 2023 to 23 June 2024.
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 01 August 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:
I note from your request that you have not indicated that you wish to seek
access 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). 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.
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.
I would be grateful if you could respond to this email by COB Thursday 04
July 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
Emilee
Freedom of Information
Karen | Emily | Tara | Christina | Lily| Emilee| Russel
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 and Aged Care 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: Will B [6][FOI #11599 email]
Sent: Tuesday, July 2, 2024 10:14 AM
To: FOI [7][email address]
Subject: Freedom of Information request - Post Market Review - Spinal Cord
Stimulation
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Dear Department of Health,
I am seeking access to all correspondence, including briefs, emails,
meeting records and other documents between the Therapeutic Goods
Administration and Saluda Medical Pty Ltd as part of the TGA's Post-market
review of spinal cord stimulation (SCS) devices between 1 December 2023
and 23 June 2024.
Yours faithfully,
Will B
-------------------------------------------------------------------
Please use this email address for all replies to this request:
[8][FOI #11599 email]
Is [9][Health request email] the wrong address for Freedom of Information
requests to Department of Health? 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.
Dear Will
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 23 July 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
Emilee
Freedom of Information
Karen | Emily | Tara | Christina | Lily| Emilee| Russel
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 and Aged Care 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 Will
We are writing to remind you that a response to the request consultation
notice issued to you (below and attached) is due by 23 July 2024.
As noted in the letter sent to you on 9 July 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
Emilee
Freedom of Information
Karen Bedford | Emily May | Tara Condon | Christina Bush
Lily Espinosa | Emilee Walker | Russel Rahman | Reirden Marks
Regulatory Legal Services Branch | Health Products Regulation Group
Australian Government Department of Health and Aged Care
FOI Hotline: 02 6289 4630
Email: [1][email address]
Location: Scherger Drive - Fairbairn – Level 2 | PO Box 100, Woden ACT
2606, Australia
The Department of Health and Aged Care 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 [2][email address]
Sent: Tuesday, July 9, 2024 5:06 PM
To: '[FOI #11599 email]'
[3][FOI #11599 email]
Cc: TGA FOI [4][email address]
Subject: Request consultation - FOI 5242 [SEC=OFFICIAL]
Dear Will
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 23 July 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
Emilee
Freedom of Information
Karen | Emily | Tara | Christina | Lily| Emilee| Russel
Therapeutic Goods Administration
Australian Government Department of Health and Aged Care
T: 02 6289 4630 | E: [5][email address]
PO Box 100, Woden ACT 2606, Australia
Web: [6]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 and Aged Care 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. mailto:[email address]
3. mailto:[FOI #11599 email]
4. mailto:[email address]
5. mailto:[email address]
6. http://www.tga.gov.au/