Dear Faustus

 

I refer to your FOI request of 1 July 2017 to the Therapeutic Goods
Administration (TGA) seeking access to certain information relating to the
Special Access Scheme.

 

Section 15 of the FOI Act requires that a request for documents meets
certain requirements.  Your request, in its current form, does not
constitute a valid request. Please note that the Act provides for access
to documents and not to 'information'.  In order for your request to be
processed under the provisions of the FOI Act you must provide us with
further information to enable us to identify the document or documents you
are seeking. 

 

Furthermore, in relation to your request for the data to be in a
particular order, the documents you are seeking must already be in
existence and there is no requirement for the TGA to create a document for
the purposes of an FOI request. Therefore any information contained in
documents in the TGA’s possession may or may not be in the order/grouping
you requested.

 

You should also be aware that in relation to Category A of the Special
Access Scheme the TGA does not authorise supply. The TGA just receives
notification of the supply. The Special Access Scheme, which is a scheme
to authorise supply of unapproved products, is also separate from the
process required to authorise the importation of the product that is
authorised to be supplied under the Special Access Scheme.

 

In order to make your request valid, you may wish to consider submitting
the following scope:

 

“With respect to applications to supply unapproved therapeutic goods under
TGA's Special Access Scheme between 1 January 2015 to 30 June 2017, I
kindly request the following documents:

1. List of drugs for which supply was notified (Category A) or authority
to supply was sought (Category B);

2. Total number of applications approved/rejected in relation to Category
B;

3. Total number of applications by Category A/B.”

 

Please note that this scope is an example only.  At this early stage, a
search and retrieval has not been conducted and the TGA is unable to
advise on whether it may be too voluminous to process or if any documents
will be returned.  

 

Alternatively, I would greatly appreciate if you could provide us with
more information on the specific documents that you require.

 

Please don't hesitate to contact me should you have any further questions.

 

Kind regards

Jacki

 

Freedom of Information
(02) 6232 8612

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

[2]cid:image001.png@01D2F408.3F1C7130

 

 

 

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

From: faustus [[3]mailto:[FOI #3697 email]]

Sent: Saturday, 1 July 2017 2:23 AM

To: FOI

Subject: Freedom of Information request - applications to import
unapproved therapeutic goods under TGA's Special Access Scheme, 2015 to
mid-2017 [SEC=No Protective Marking]

 

Dear Madam/Sir,

 

With respect to applications to import unapproved therapeutic goods under
TGA's Special Access Scheme between 2015 to mid-2017, I kindly request the
following information:

 

List of drugs for which authority to import was sought (grouped by generic
name)

                - Total number of applications, grouped by outcome
(approved/rejected)

                - For applications grouped by outcome, total number of
applications by patient category (Category A/B)

 

For clarity, supposing there have been 20 applications in total to import
somecompound hydrochloride under the Special Access Scheme. Structure of
data sought might be as follows:

 

-----

 

somecompound hydrochloride (total applications = 20)

 

Approved (total = 19)

- Category A (total = 15)

- Category B (total = 4)

 

Rejected (total = 1)

- Category A (total = 0)

- Category B (total = 1)

 

-----

 

I trust that this request is not an onerous one and that it will not incur
any processing fees. If this is not the case, please advise on possible
ways that I might narrow the scope of the request.

 

I thank you for your assistance.

 

faustus

 

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

 

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

[4][FOI #3697 email]

 

Is [5][TGA request email] the wrong address for Freedom of Information
requests to Therapeutic Goods Administration? If so, please contact us
using this form:

[6]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:

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

 

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]
3. mailto:[FOI #3697 email]
4. mailto:[FOI #3697 email]
5. mailto:[TGA request email]
6. https://www.righttoknow.org.au/change_re...
7. https://www.righttoknow.org.au/help/offi...

hide quoted sections

Dear Faustus,

 

Your request has been discussed with the relevant area and they have
indicated that information in the following fields could be provided to
you in table format for date range 01/01/2015-30/06/2017:

·         Therapeutic good

·         Date of application

·         Category (A, B or C)

·         Indication

·         Status (that is approved or rejected)

 

Please note that medical condition, diagnosis and indication are different
things. For example an individual may be diagnosed with cancer but the
Special Access Scheme (SAS) application may be for a medication to treat
nausea associated with the cancer. In this example the diagnosis is cancer
but the indication is nausea. Only the indication for an SAS application
is recorded in searchable form. Additional work would be required to
provide information in relation to medical condition or diagnosis.

 

The area has also indicated that it would take four weeks to compile the
information.

 

Can you please respond by 1 August 2017 indicating whether the proposed
information to be provided and the timeframe are acceptable.

 

Regards,

Jacki

 

Freedom of Information
(02) 6232 8612

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

[2]cid:image001.png@01D1D5D9.7DDEADA0

 

-----Original Message-----
From: faustus [[3]mailto:[FOI #3697 email]]
Sent: Thursday, 20 July 2017 11:03 AM
To: TGA FOI
Subject: Re: FOI 002-1718 - Invalid FOI Request [SEC=UNCLASSIFIED]

 

Dear Jacki,

 

I thank you for your response dated 3 July, 2017. I note that you are
unable to fulfil my FOI request in its present form. In light of your
recommendations, I will clarify the nature of my request, and modify the
specificity of the data being sought.

 

AIM

Broadly, I would like an idea of what therapeutic agents are being
processed under the Special Access Scheme, and the relative demand for
each agent as reflected by the number of submissions for each agent.

 

SCOPE

Records. Although the documents that the TGA holds is unclear, I imagine
that the granularity of the records proceeds in the following stepwise
manner:

 

1. List of therapeutic agents submitted under the SAS;

2. As above, with information regarding number of submissions per agent;

3. As above, with information regarding number of submissions by Category
(A/B/C);

4. As above, with information regarding medical condition, diagnosis, or
indication;

5. As above, with information regarding number of applications rejected
(Category B)

 

Realistically, I would anticipate that you might be able to identify a
single recording containing the information in #3 -- some sort of document
grouped by Category A, B, and C, and a list of agents in each group.

 

Date. The previous date range 01/01/2015-30/06/2017 was arbitrary. I am
amenable to any relatively recent records of what agents have been
approved. Ideally, I would like information spanning a period of two or
more years.

 

Record type. Perhaps a spreadsheet comprising raw data of date,
therapeutic agent, SAS Category and indication; a report summarising SAS
submissions over the previous calendar year.

 

I trust that the above clarifies my request for you. However, should you
encounter any problems please advise and I will adjust accordingly.

 

Many Thanks,

 

faustus

 

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

 

Dear Faustus

 

 

 

I refer to your FOI request of 1 July 2017 to the Therapeutic Goods
Administration (TGA) seeking access to certain information relating to the
Special Access Scheme.

 

 

 

Section 15 of the FOI Act requires that a request for documents meets
certain requirements. Your request, in its current form, does not
constitute a valid request. Please note that the Act provides for access
to documents and not to 'information'. In order for your request to be
processed under the provisions of the FOI Act you must provide us with
further information to enable us to identify the document or documents you
are seeking.

 

 

 

Furthermore, in relation to your request for the data to be in a
particular order, the documents you are seeking must already be in
existence and there is no requirement for the TGA to create a document for
the purposes of an FOI request. Therefore any information contained in
documents in the TGA’s possession may or may not be in the order/grouping
you requested.

 

 

 

You should also be aware that in relation to Category A of the Special
Access Scheme the TGA does not authorise supply. The TGA just receives
notification of the supply. The Special Access Scheme, which is a scheme
to authorise supply of unapproved products, is also separate from the
process required to authorise the importation of the product that is
authorised to be supplied under the Special Access Scheme.

 

 

 

In order to make your request valid, you may wish to consider submitting
the following scope:

 

 

 

“With respect to applications to supply unapproved therapeutic goods under
TGA's Special Access Scheme between 1 January 2015 to 30 June 2017, I
kindly request the following documents:

 

1. List of drugs for which supply was notified (Category A) or authority
to supply was sought (Category B);

 

2. Total number of applications approved/rejected in relation to Category
B;

 

3. Total number of applications by Category A/B.”

 

 

 

Please note that this scope is an example only. At this early stage, a
search and retrieval has not been conducted and the TGA is unable to
advise on whether it may be too voluminous to process or if any documents
will be returned.

 

 

 

Alternatively, I would greatly appreciate if you could provide us with
more information on the specific documents that you require.

 

 

 

Please don't hesitate to contact me should you have any further questions.

 

 

 

Kind regards

 

Jacki

 

 

 

Freedom of Information

(02) 6232 8612

 

Reporting and Collaboration Services Section

 

Regulatory Engagement and Planning Branch

 

Therapeutic Goods Administration

Address: PO Box 100, Woden ACT, 2606

Email: [1][email address]

 

 

 

[2][4]cid:image001.png@01D2F408.3F1C7130

 

 

 

 

 

 

 

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

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

[5][FOI #3697 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:

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

 

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]
3. mailto:[FOI #3697 email]
4. file:///tmp/cid:image001.png@01D2F408.3F1C7130
5. mailto:[FOI #3697 email]
6. https://www.righttoknow.org.au/help/offi...

hide quoted sections

Dear Faustus

 

I am writing to follow up a response to email in relation to the scope of
your request which was sent to you on 27 July 2017.

 

As the due date for your response has now passed, I would be very grateful
if you could please provide a response by COB Monday 7 August 2017.

 

Kind regards

Heather

 

Freedom of Information
(02) 6232 8612

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

[2]cid:image001.png@01D1D5D9.7DDEADA0

 

 

From: TGA FOI
Sent: Thursday, 27 July 2017 12:45 PM
To: 'faustus'
Cc: TGA FOI
Subject: RE: FOI 002-1718 - Invalid FOI Request [SEC=UNCLASSIFIED]

 

Dear Faustus,

 

Your request has been discussed with the relevant area and they have
indicated that information in the following fields could be provided to
you in table format for date range 01/01/2015-30/06/2017:

·         Therapeutic good

·         Date of application

·         Category (A, B or C)

·         Indication

·         Status (that is approved or rejected)

 

Please note that medical condition, diagnosis and indication are different
things. For example an individual may be diagnosed with cancer but the
Special Access Scheme (SAS) application may be for a medication to treat
nausea associated with the cancer. In this example the diagnosis is cancer
but the indication is nausea. Only the indication for an SAS application
is recorded in searchable form. Additional work would be required to
provide information in relation to medical condition or diagnosis.

 

The area has also indicated that it would take four weeks to compile the
information.

 

Can you please respond by 1 August 2017 indicating whether the proposed
information to be provided and the timeframe are acceptable.

 

Regards,

Jacki

 

Freedom of Information
(02) 6232 8612

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [3][email address]

 

[4]cid:image001.png@01D1D5D9.7DDEADA0

 

-----Original Message-----
From: faustus [[5]mailto:[FOI #3697 email]]
Sent: Thursday, 20 July 2017 11:03 AM
To: TGA FOI
Subject: Re: FOI 002-1718 - Invalid FOI Request [SEC=UNCLASSIFIED]

 

Dear Jacki,

 

I thank you for your response dated 3 July, 2017. I note that you are
unable to fulfil my FOI request in its present form. In light of your
recommendations, I will clarify the nature of my request, and modify the
specificity of the data being sought.

 

AIM

Broadly, I would like an idea of what therapeutic agents are being
processed under the Special Access Scheme, and the relative demand for
each agent as reflected by the number of submissions for each agent.

 

SCOPE

Records. Although the documents that the TGA holds is unclear, I imagine
that the granularity of the records proceeds in the following stepwise
manner:

 

1. List of therapeutic agents submitted under the SAS;

2. As above, with information regarding number of submissions per agent;

3. As above, with information regarding number of submissions by Category
(A/B/C);

4. As above, with information regarding medical condition, diagnosis, or
indication;

5. As above, with information regarding number of applications rejected
(Category B)

 

Realistically, I would anticipate that you might be able to identify a
single recording containing the information in #3 -- some sort of document
grouped by Category A, B, and C, and a list of agents in each group.

 

Date. The previous date range 01/01/2015-30/06/2017 was arbitrary. I am
amenable to any relatively recent records of what agents have been
approved. Ideally, I would like information spanning a period of two or
more years.

 

Record type. Perhaps a spreadsheet comprising raw data of date,
therapeutic agent, SAS Category and indication; a report summarising SAS
submissions over the previous calendar year.

 

I trust that the above clarifies my request for you. However, should you
encounter any problems please advise and I will adjust accordingly.

 

Many Thanks,

 

faustus

 

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

 

Dear Faustus

 

 

 

I refer to your FOI request of 1 July 2017 to the Therapeutic Goods
Administration (TGA) seeking access to certain information relating to the
Special Access Scheme.

 

 

 

Section 15 of the FOI Act requires that a request for documents meets
certain requirements. Your request, in its current form, does not
constitute a valid request. Please note that the Act provides for access
to documents and not to 'information'. In order for your request to be
processed under the provisions of the FOI Act you must provide us with
further information to enable us to identify the document or documents you
are seeking.

 

 

 

Furthermore, in relation to your request for the data to be in a
particular order, the documents you are seeking must already be in
existence and there is no requirement for the TGA to create a document for
the purposes of an FOI request. Therefore any information contained in
documents in the TGA’s possession may or may not be in the order/grouping
you requested.

 

 

 

You should also be aware that in relation to Category A of the Special
Access Scheme the TGA does not authorise supply. The TGA just receives
notification of the supply. The Special Access Scheme, which is a scheme
to authorise supply of unapproved products, is also separate from the
process required to authorise the importation of the product that is
authorised to be supplied under the Special Access Scheme.

 

 

 

In order to make your request valid, you may wish to consider submitting
the following scope:

 

 

 

“With respect to applications to supply unapproved therapeutic goods under
TGA's Special Access Scheme between 1 January 2015 to 30 June 2017, I
kindly request the following documents:

 

1. List of drugs for which supply was notified (Category A) or authority
to supply was sought (Category B);

 

2. Total number of applications approved/rejected in relation to Category
B;

 

3. Total number of applications by Category A/B.”

 

 

 

Please note that this scope is an example only. At this early stage, a
search and retrieval has not been conducted and the TGA is unable to
advise on whether it may be too voluminous to process or if any documents
will be returned.

 

 

 

Alternatively, I would greatly appreciate if you could provide us with
more information on the specific documents that you require.

 

 

 

Please don't hesitate to contact me should you have any further questions.

 

 

 

Kind regards

 

Jacki

 

 

 

Freedom of Information

(02) 6232 8612

 

Reporting and Collaboration Services Section

 

Regulatory Engagement and Planning Branch

 

Therapeutic Goods Administration

Address: PO Box 100, Woden ACT, 2606

Email: [1][email address]

 

 

 

[2][6]cid:image001.png@01D2F408.3F1C7130

 

 

 

 

 

 

 

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

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

[7][FOI #3697 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...

 

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]
3. mailto:[email address]
5. mailto:[FOI #3697 email]
6. file:///tmp/cid:image001.png@01D2F408.3F1C7130
7. mailto:[FOI #3697 email]
8. https://www.righttoknow.org.au/help/offi...

hide quoted sections

Dear Faustus,

 

The relevant area has provided further detail on what information they can
provide:

 

Category A

For Category A, this is a notification only, therefore, ‘Status’ and
‘application date’ are irrelevant, and we don’t collect an ‘Indication’.
Therefore, we can provide:

·         Category

·         Therapeutic good

 

Category B

For Category B, we can’t provide an ‘Indication’ but we could provide
‘Diagnosis Clinical Justification’ if that is acceptable? We propose to
provide the following:

·         Category

·         Date of Application

·         Therapeutic good

·         Diagnosis Clinical Justification

·         Status

 

Category C

This pathway only became available from 3 July 2017 and therefore will be
no information available for this.

 

The area propose that they can provide you with two excel spreadsheets
with the above information for categories A and B.

 

Can you confirm that the above proposed information is acceptable.

 

Regards,

Jacki

 

Freedom of Information
(02) 6232 8612

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

[2]cid:image001.png@01D1D5D9.7DDEADA0

 

-----Original Message-----
From: faustus [mailto:[FOI #3697 email]]
Sent: Thursday, 3 August 2017 5:58 PM
To: TGA FOI
Subject: Re: FOI 002-1718 - Clarify scope [SEC=UNCLASSIFIED]

 

Dear Heather,

 

Thank you for your response and please accept my apologies in the lateness
of my reply.

 

In my previous correspondence with Jacki, it has been noted that the
following information is available with regards to my FOI request:

 

Table format for date range 01/01/2015-30/06/2017:

 

- Therapeutic

- Date of application

- Category (A, B or C)

- Indication

- Status (that is approved or rejected)

 

This is perfectly adequate for my needs and I am happy for you to proceed
with this request.

 

Many Thanks,

 

faustus

 

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

 

Dear Faustus

 

 

 

I am writing to follow up a response to email in relation to the scope of 
your request which was sent to you on 27 July 2017.

 

 

 

As the due date for your response has now passed, I would be very
grateful  if you could please provide a response by COB Monday 7 August
2017.

 

 

 

Kind regards

 

Heather

 

 

 

Freedom of Information

(02) 6232 8612

 

Reporting and Collaboration Services Section

 

Regulatory Engagement and Planning Branch

 

Therapeutic Goods Administration

Address: PO Box 100, Woden ACT, 2606

Email: [1][email address]

 

 

 

[2][3]cid:image001.png@01D1D5D9.7DDEADA0

 

 

 

 

 

From: TGA FOI

Sent: Thursday, 27 July 2017 12:45 PM

To: 'faustus'

Cc: TGA FOI

Subject: RE: FOI 002-1718 - Invalid FOI Request [SEC=UNCLASSIFIED]

 

 

 

Dear Faustus,

 

 

 

Your request has been discussed with the relevant area and they have 
indicated that information in the following fields could be provided to 
you in table format for date range 01/01/2015-30/06/2017:

 

·         Therapeutic good

 

·         Date of application

 

·         Category (A, B or C)

 

·         Indication

 

·         Status (that is approved or rejected)

 

 

 

Please note that medical condition, diagnosis and indication are
different  things. For example an individual may be diagnosed with cancer
but the  Special Access Scheme (SAS) application may be for a medication
to treat  nausea associated with the cancer. In this example the diagnosis
is cancer  but the indication is nausea. Only the indication for an SAS
application  is recorded in searchable form. Additional work would be
required to  provide information in relation to medical condition or
diagnosis.

 

 

 

The area has also indicated that it would take four weeks to compile the 
information.

 

 

 

Can you please respond by 1 August 2017 indicating whether the proposed 
information to be provided and the timeframe are acceptable.

 

 

 

Regards,

 

Jacki

 

 

 

Freedom of Information

(02) 6232 8612

 

Reporting and Collaboration Services Section

 

Regulatory Engagement and Planning Branch

 

Therapeutic Goods Administration

Address: PO Box 100, Woden ACT, 2606

Email: [3][email address]

 

 

 

[4][4]cid:image001.png@01D1D5D9.7DDEADA0

 

 

 

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

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

[5][FOI #3697 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:

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

 

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]
3. file:///tmp/cid:image001.png@01D1D5D9.7DDEADA0
4. file:///tmp/cid:image001.png@01D1D5D9.7DDEADA0
5. mailto:[FOI #3697 email]
6. https://www.righttoknow.org.au/help/offi...

hide quoted sections

Dear Faustus,

 

I am following up on the below email to ask if you could respond by 11
August 2017.

 

In addition as previously advised the relevant area has indicated that it
will take four weeks to compile the requested information. Due to this, I
would be grateful if you could please consider agreeing to an extension
(under section 15AA) of fourteen (14) days for the processing of your
request. The decision on your request would become due by 2 September
2017. Could you respond advising whether you agree to this extension by 11
August 2017.

 

Regards,

Jacki

 

Freedom of Information
(02) 6232 8612

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

[2]cid:image001.png@01D1D5D9.7DDEADA0

 

From: TGA FOI
Sent: Friday, 4 August 2017 9:11 AM
To: 'faustus'
Cc: TGA FOI
Subject: RE: FOI 002-1718 - Clarify scope [SEC=UNCLASSIFIED]

 

Dear Faustus,

 

The relevant area has provided further detail on what information they can
provide:

 

Category A

For Category A, this is a notification only, therefore, ‘Status’ and
‘application date’ are irrelevant, and we don’t collect an ‘Indication’.
Therefore, we can provide:

·         Category

·         Therapeutic good

 

Category B

For Category B, we can’t provide an ‘Indication’ but we could provide
‘Diagnosis Clinical Justification’ if that is acceptable? We propose to
provide the following:

·         Category

·         Date of Application

·         Therapeutic good

·         Diagnosis Clinical Justification

·         Status

 

Category C

This pathway only became available from 3 July 2017 and therefore will be
no information available for this.

 

The area propose that they can provide you with two excel spreadsheets
with the above information for categories A and B.

 

Can you confirm that the above proposed information is acceptable.

 

Regards,

Jacki

 

Freedom of Information
(02) 6232 8612

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [3][email address]

 

[4]cid:image001.png@01D1D5D9.7DDEADA0

 

-----Original Message-----
From: faustus [[5]mailto:[FOI #3697 email]]
Sent: Thursday, 3 August 2017 5:58 PM
To: TGA FOI
Subject: Re: FOI 002-1718 - Clarify scope [SEC=UNCLASSIFIED]

 

Dear Heather,

 

Thank you for your response and please accept my apologies in the lateness
of my reply.

 

In my previous correspondence with Jacki, it has been noted that the
following information is available with regards to my FOI request:

 

Table format for date range 01/01/2015-30/06/2017:

 

- Therapeutic

- Date of application

- Category (A, B or C)

- Indication

- Status (that is approved or rejected)

 

This is perfectly adequate for my needs and I am happy for you to proceed
with this request.

 

Many Thanks,

 

faustus

 

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

 

Dear Faustus

 

 

 

I am writing to follow up a response to email in relation to the scope of 
your request which was sent to you on 27 July 2017.

 

 

 

As the due date for your response has now passed, I would be very
grateful  if you could please provide a response by COB Monday 7 August
2017.

 

 

 

Kind regards

 

Heather

 

 

 

Freedom of Information

(02) 6232 8612

 

Reporting and Collaboration Services Section

 

Regulatory Engagement and Planning Branch

 

Therapeutic Goods Administration

Address: PO Box 100, Woden ACT, 2606

Email: [1][email address]

 

 

 

[2][6]cid:image001.png@01D1D5D9.7DDEADA0

 

 

 

 

 

From: TGA FOI

Sent: Thursday, 27 July 2017 12:45 PM

To: 'faustus'

Cc: TGA FOI

Subject: RE: FOI 002-1718 - Invalid FOI Request [SEC=UNCLASSIFIED]

 

 

 

Dear Faustus,

 

 

 

Your request has been discussed with the relevant area and they have 
indicated that information in the following fields could be provided to 
you in table format for date range 01/01/2015-30/06/2017:

 

·         Therapeutic good

 

·         Date of application

 

·         Category (A, B or C)

 

·         Indication

 

·         Status (that is approved or rejected)

 

 

 

Please note that medical condition, diagnosis and indication are
different  things. For example an individual may be diagnosed with cancer
but the  Special Access Scheme (SAS) application may be for a medication
to treat  nausea associated with the cancer. In this example the diagnosis
is cancer  but the indication is nausea. Only the indication for an SAS
application  is recorded in searchable form. Additional work would be
required to  provide information in relation to medical condition or
diagnosis.

 

 

 

The area has also indicated that it would take four weeks to compile the 
information.

 

 

 

Can you please respond by 1 August 2017 indicating whether the proposed 
information to be provided and the timeframe are acceptable.

 

 

 

Regards,

 

Jacki

 

 

 

Freedom of Information

(02) 6232 8612

 

Reporting and Collaboration Services Section

 

Regulatory Engagement and Planning Branch

 

Therapeutic Goods Administration

Address: PO Box 100, Woden ACT, 2606

Email: [3][email address]

 

 

 

[4][7]cid:image001.png@01D1D5D9.7DDEADA0

 

 

 

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

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

[8][FOI #3697 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...

 

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]
3. mailto:[email address]
5. mailto:[FOI #3697 email]
6. file:///tmp/cid:image001.png@01D1D5D9.7DDEADA0
7. file:///tmp/cid:image001.png@01D1D5D9.7DDEADA0
8. mailto:[FOI #3697 email]
9. https://www.righttoknow.org.au/help/offi...

hide quoted sections

Dear Faustus

 

The TGA is currently processing your FOI request. As we have not had a
response to our previous email, I am writing to advise that we will be
proceeding with the following scope:

 

“With respect to applications to import unapproved therapeutic goods under
TGA's Special Access Scheme between 1 January 2015 to 30 June 2017, I
kindly request the following information:

 

Category A

·         Category

·         Therapeutic good

 

Category B

·         Category

·         Date of Application

·         Therapeutic good

·         Diagnosis Clinical Justification

·         Status”

 

Category C

Please note, there no documents in existence for this point as the
Category C pathway only became available from 3 July 2017.

 

Could you also please advise whether or not you agree to an extension
(under section 15AA) of fourteen (14) days to the processing time for your
request by Thursday 17 August 2017.

 

Kind regards

Karen

 

Freedom of Information
(02) 6232 8720

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

[2]cid:image001.png@01D1D5D9.7DDEADA0

 

From: TGA FOI
Sent: Tuesday, 8 August 2017 12:15 PM
To: 'faustus'
Cc: TGA FOI
Subject: RE: FOI 002-1718 - Clarify scope [SEC=UNCLASSIFIED]

 

Dear Faustus,

 

I am following up on the below email to ask if you could respond by 11
August 2017.

 

In addition as previously advised the relevant area has indicated that it
will take four weeks to compile the requested information. Due to this, I
would be grateful if you could please consider agreeing to an extension
(under section 15AA) of fourteen (14) days for the processing of your
request. The decision on your request would become due by 2 September
2017. Could you respond advising whether you agree to this extension by 11
August 2017.

 

Regards,

Jacki

 

Freedom of Information
(02) 6232 8612

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [3][email address]

 

[4]cid:image001.png@01D1D5D9.7DDEADA0

 

From: TGA FOI
Sent: Friday, 4 August 2017 9:11 AM
To: 'faustus'
Cc: TGA FOI
Subject: RE: FOI 002-1718 - Clarify scope [SEC=UNCLASSIFIED]

 

Dear Faustus,

 

The relevant area has provided further detail on what information they can
provide:

 

Category A

For Category A, this is a notification only, therefore, ‘Status’ and
‘application date’ are irrelevant, and we don’t collect an ‘Indication’.
Therefore, we can provide:

·         Category

·         Therapeutic good

 

Category B

For Category B, we can’t provide an ‘Indication’ but we could provide
‘Diagnosis Clinical Justification’ if that is acceptable? We propose to
provide the following:

·         Category

·         Date of Application

·         Therapeutic good

·         Diagnosis Clinical Justification

·         Status

 

Category C

This pathway only became available from 3 July 2017 and therefore will be
no information available for this.

 

The area propose that they can provide you with two excel spreadsheets
with the above information for categories A and B.

 

Can you confirm that the above proposed information is acceptable.

 

Regards,

Jacki

 

Freedom of Information
(02) 6232 8612

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [5][email address]

 

[6]cid:image001.png@01D1D5D9.7DDEADA0

 

-----Original Message-----
From: faustus [[7]mailto:[FOI #3697 email]]
Sent: Thursday, 3 August 2017 5:58 PM
To: TGA FOI
Subject: Re: FOI 002-1718 - Clarify scope [SEC=UNCLASSIFIED]

 

Dear Heather,

 

Thank you for your response and please accept my apologies in the lateness
of my reply.

 

In my previous correspondence with Jacki, it has been noted that the
following information is available with regards to my FOI request:

 

Table format for date range 01/01/2015-30/06/2017:

 

- Therapeutic

- Date of application

- Category (A, B or C)

- Indication

- Status (that is approved or rejected)

 

This is perfectly adequate for my needs and I am happy for you to proceed
with this request.

 

Many Thanks,

 

faustus

 

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

 

Dear Faustus

 

 

 

I am writing to follow up a response to email in relation to the scope of
your request which was sent to you on 27 July 2017.

 

 

 

As the due date for your response has now passed, I would be very grateful
if you could please provide a response by COB Monday 7 August 2017.

 

 

 

Kind regards

 

Heather

 

 

 

Freedom of Information

(02) 6232 8612

 

Reporting and Collaboration Services Section

 

Regulatory Engagement and Planning Branch

 

Therapeutic Goods Administration

Address: PO Box 100, Woden ACT, 2606

Email: [1][email address]

 

 

 

[2][8]cid:image001.png@01D1D5D9.7DDEADA0

 

 

 

 

 

From: TGA FOI

Sent: Thursday, 27 July 2017 12:45 PM

To: 'faustus'

Cc: TGA FOI

Subject: RE: FOI 002-1718 - Invalid FOI Request [SEC=UNCLASSIFIED]

 

 

 

Dear Faustus,

 

 

 

Your request has been discussed with the relevant area and they have
indicated that information in the following fields could be provided to
you in table format for date range 01/01/2015-30/06/2017:

 

· Therapeutic good

 

· Date of application

 

· Category (A, B or C)

 

· Indication

 

· Status (that is approved or rejected)

 

 

 

Please note that medical condition, diagnosis and indication are different
things. For example an individual may be diagnosed with cancer but the
Special Access Scheme (SAS) application may be for a medication to treat
nausea associated with the cancer. In this example the diagnosis is cancer
but the indication is nausea. Only the indication for an SAS application
is recorded in searchable form. Additional work would be required to
provide information in relation to medical condition or diagnosis.

 

 

 

The area has also indicated that it would take four weeks to compile the
information.

 

 

 

Can you please respond by 1 August 2017 indicating whether the proposed
information to be provided and the timeframe are acceptable.

 

 

 

Regards,

 

Jacki

 

 

 

Freedom of Information

(02) 6232 8612

 

Reporting and Collaboration Services Section

 

Regulatory Engagement and Planning Branch

 

Therapeutic Goods Administration

Address: PO Box 100, Woden ACT, 2606

Email: [3][email address]

 

 

 

[4][9]cid:image001.png@01D1D5D9.7DDEADA0

 

 

 

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

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

[10][FOI #3697 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:

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

 

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]
3. mailto:[email address]
5. mailto:[email address]
7. mailto:[FOI #3697 email]
8. file:///tmp/cid:image001.png@01D1D5D9.7DDEADA0
9. file:///tmp/cid:image001.png@01D1D5D9.7DDEADA0
10. mailto:[FOI #3697 email]
11. https://www.righttoknow.org.au/help/offi...

hide quoted sections

Dear Faustus

 

Thank you for your email and accepting the proposed scope for your
request.

 

In relation to the additional information requested in your email of 16
August 2017, I will need to seek the views of the relevant line area in
order to provide a response. As such, I would be grateful if you could
please consider agreeing to an additional extension (under section 15AA)
of fourteen (14) days for the processing of your request. If you agree to
this extension the decision on your request would then be due on or before
16 September 2017.

 

Could you please respond advising whether you agree to this extension by
COB Thursday 24 August 2017.

 

Thank you for your consideration of this matter.

 

Please do not hesitate to contact me if you have any questions.

 

Kind regards

Heather

 

Freedom of Information
(02) 6232 8720

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

[2]cid:image001.png@01D1D5D9.7DDEADA0

 

 

 

 

-----Original Message-----
From: faustus [[3]mailto:[FOI #3697 email]]
Sent: Wednesday, 16 August 2017 3:16 PM
To: TGA FOI
Subject: Re: FOI 002-1718 - Scope confirmation and request for extension
[SEC=UNCLASSIFIED]

 

Dear Karen,

 

Thank you for your e-mail.

 

I must apologise again for the lateness of my reply -- I am utilising the
public FOI service Right To Know ([4]www.righttoknow.org.au) and have not
been receiving notifications. However, I have made the appropriate
modifications and will now be able receive and therefore respond to any
additional correspondence of yours in a timely manner.

 

With respect to the proposed scope of my FOI request, what you are
proposing is entirely acceptable. However, if I may, I was wondering if I
could also request the following:

 

For Category A and B, would the name of the clinician submitting the
request/notification be available? If so, is it possible for you to
anonymise the clinician's name using a crypotographic hash function and
include that as an additional column in the spreadsheet? In short, I have
no interest in knowing the actual clinician's name, but do have an
interest in knowing how the prescribing practices of any particular
clinician might be contributing to the absolute number of SAS requests
and/or notifications for a specific therapeutic agent. However, if you are
unable to do this then it is entirely fine -- please proceed as you
otherwise would.

 

Also, regarding your request for a deadline extension: yes, by all means
please take your time processing this request.

 

I look forward to hearing from you.

 

Best Regards,

 

faustus

 

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

 

Dear Faustus

 

 

 

The TGA is currently processing your FOI request. As we have not had a
response to our previous email, I am writing to advise that we will be
proceeding with the following scope:

 

 

 

“With respect to applications to import unapproved therapeutic goods under
TGA's Special Access Scheme between 1 January 2015 to 30 June 2017, I
kindly request the following information:

 

 

 

Category A

 

· Category

 

· Therapeutic good

 

 

 

Category B

 

· Category

 

· Date of Application

 

· Therapeutic good

 

· Diagnosis Clinical Justification

 

· Status”

 

 

 

Category C

 

Please note, there no documents in existence for this point as the
Category C pathway only became available from 3 July 2017.

 

 

 

Could you also please advise whether or not you agree to an extension
(under section 15AA) of fourteen (14) days to the processing time for your
request by Thursday 17 August 2017.

 

 

 

Kind regards

 

Karen

 

 

 

Freedom of Information

(02) 6232 8720

 

Reporting and Collaboration Services Section

 

Regulatory Engagement and Planning Branch

 

Therapeutic Goods Administration

Address: PO Box 100, Woden ACT, 2606

Email: [1][email address]

 

 

 

[2][5]cid:image001.png@01D1D5D9.7DDEADA0

 

 

 

From: TGA FOI

Sent: Tuesday, 8 August 2017 12:15 PM

To: 'faustus'

Cc: TGA FOI

Subject: RE: FOI 002-1718 - Clarify scope [SEC=UNCLASSIFIED]

 

 

 

Dear Faustus,

 

 

 

I am following up on the below email to ask if you could respond by 11
August 2017.

 

 

 

In addition as previously advised the relevant area has indicated that it
will take four weeks to compile the requested information. Due to this, I
would be grateful if you could please consider agreeing to an extension
(under section 15AA) of fourteen (14) days for the processing of your
request. The decision on your request would become due by 2 September
2017. Could you respond advising whether you agree to this extension by 11
August 2017.

 

 

 

Regards,

 

Jacki

 

 

 

Freedom of Information

(02) 6232 8612

 

Reporting and Collaboration Services Section

 

Regulatory Engagement and Planning Branch

 

Therapeutic Goods Administration

Address: PO Box 100, Woden ACT, 2606

Email: [3][email address]

 

 

 

[4][6]cid:image001.png@01D1D5D9.7DDEADA0

 

 

 

From: TGA FOI

Sent: Friday, 4 August 2017 9:11 AM

To: 'faustus'

Cc: TGA FOI

Subject: RE: FOI 002-1718 - Clarify scope [SEC=UNCLASSIFIED]

 

 

 

Dear Faustus,

 

 

 

The relevant area has provided further detail on what information they can

provide:

 

 

 

Category A

 

For Category A, this is a notification only, therefore, ‘Status’ and
‘application date’ are irrelevant, and we don’t collect an ‘Indication’.

Therefore, we can provide:

 

· Category

 

· Therapeutic good

 

 

 

Category B

 

For Category B, we can’t provide an ‘Indication’ but we could provide
‘Diagnosis Clinical Justification’ if that is acceptable? We propose to
provide the following:

 

· Category

 

· Date of Application

 

· Therapeutic good

 

· Diagnosis Clinical Justification

 

· Status

 

 

 

Category C

 

This pathway only became available from 3 July 2017 and therefore will be
no information available for this.

 

 

 

The area propose that they can provide you with two excel spreadsheets
with the above information for categories A and B.

 

 

 

Can you confirm that the above proposed information is acceptable.

 

 

 

Regards,

 

Jacki

 

 

 

Freedom of Information

(02) 6232 8612

 

Reporting and Collaboration Services Section

 

Regulatory Engagement and Planning Branch

 

Therapeutic Goods Administration

Address: PO Box 100, Woden ACT, 2606

Email: [5][email address]

 

 

 

[6][7]cid:image001.png@01D1D5D9.7DDEADA0

 

 

 

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

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

[8][FOI #3697 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...

 

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]
3. mailto:[FOI #3697 email]
4. http://www.righttoknow.org.au/
5. file:///tmp/cid:image001.png@01D1D5D9.7DDEADA0
6. file:///tmp/cid:image001.png@01D1D5D9.7DDEADA0
7. file:///tmp/cid:image001.png@01D1D5D9.7DDEADA0
8. mailto:[FOI #3697 email]
9. https://www.righttoknow.org.au/help/offi...

hide quoted sections

Dear Faustus,

We refer to your FOI request FOI002-1718 currently being processed by the TGA and to your query dated 16 August 2017 (copy below).

Following discussions with our line area, we advise that to undertake the additional task of anonymising the clinician's name using a crypotographic hash function would be a substantially onerous task and potentially not possible to carry out.

As you previously indicated your agreement to proceed without this information, the TGA intends to continue processing your FOI request on that basis.

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

Kind regards,

Freedom of Information

Reporting and Collaboration Services Section
Regulatory Engagement and Planning Branch
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [email address]

-----Original Message-----
From: faustus [mailto:[FOI #3697 email]]
Sent: Wednesday, 16 August 2017 3:16 PM
To: TGA FOI
Subject: Re: FOI 002-1718 - Scope confirmation and request for extension [SEC=UNCLASSIFIED]

Dear Karen,

Thank you for your e-mail.

I must apologise again for the lateness of my reply -- I am utilising the public FOI service Right To Know (www.righttoknow.org.au) and have not been receiving notifications. However, I have made the appropriate modifications and will now be able receive and therefore respond to any additional correspondence of yours in a timely manner.

With respect to the proposed scope of my FOI request, what you are proposing is entirely acceptable. However, if I may, I was wondering if I could also request the following:

For Category A and B, would the name of the clinician submitting the request/notification be available? If so, is it possible for you to anonymise the clinician's name using a crypotographic hash function and include that as an additional column in the spreadsheet? In short, I have no interest in knowing the actual clinician's name, but do have an interest in knowing how the prescribing practices of any particular clinician might be contributing to the absolute number of SAS requests and/or notifications for a specific therapeutic agent. However, if you are unable to do this then it is entirely fine -- please proceed as you otherwise would.

Also, regarding your request for a deadline extension: yes, by all means please take your time processing this request.

I look forward to hearing from you.

Best Regards,

faustus

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

Dear Faustus

The TGA is currently processing your FOI request. As we have not had a response to our previous email, I am writing to advise that we will be proceeding with the following scope:

“With respect to applications to import unapproved therapeutic goods under TGA's Special Access Scheme between 1 January 2015 to 30 June 2017, I kindly request the following information:

Category A

· Category

· Therapeutic good

Category B

· Category

· Date of Application

· Therapeutic good

· Diagnosis Clinical Justification

· Status”

Category C

Please note, there no documents in existence for this point as the Category C pathway only became available from 3 July 2017.

Could you also please advise whether or not you agree to an extension (under section 15AA) of fourteen (14) days to the processing time for your request by Thursday 17 August 2017.

Kind regards

Karen

Freedom of Information
(02) 6232 8720

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

[2]cid:image001.png@01D1D5D9.7DDEADA0

From: TGA FOI
Sent: Tuesday, 8 August 2017 12:15 PM
To: 'faustus'
Cc: TGA FOI
Subject: RE: FOI 002-1718 - Clarify scope [SEC=UNCLASSIFIED]

Dear Faustus,

I am following up on the below email to ask if you could respond by 11 August 2017.

In addition as previously advised the relevant area has indicated that it will take four weeks to compile the requested information. Due to this, I would be grateful if you could please consider agreeing to an extension (under section 15AA) of fourteen (14) days for the processing of your request. The decision on your request would become due by 2 September 2017. Could you respond advising whether you agree to this extension by 11 August 2017.

Regards,

Jacki

Freedom of Information
(02) 6232 8612

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [3][email address]

[4]cid:image001.png@01D1D5D9.7DDEADA0

From: TGA FOI
Sent: Friday, 4 August 2017 9:11 AM
To: 'faustus'
Cc: TGA FOI
Subject: RE: FOI 002-1718 - Clarify scope [SEC=UNCLASSIFIED]

Dear Faustus,

The relevant area has provided further detail on what information they can
provide:

Category A

For Category A, this is a notification only, therefore, ‘Status’ and ‘application date’ are irrelevant, and we don’t collect an ‘Indication’.
Therefore, we can provide:

· Category

· Therapeutic good

Category B

For Category B, we can’t provide an ‘Indication’ but we could provide ‘Diagnosis Clinical Justification’ if that is acceptable? We propose to provide the following:

· Category

· Date of Application

· Therapeutic good

· Diagnosis Clinical Justification

· Status

Category C

This pathway only became available from 3 July 2017 and therefore will be no information available for this.

The area propose that they can provide you with two excel spreadsheets with the above information for categories A and B.

Can you confirm that the above proposed information is acceptable.

Regards,

Jacki

Freedom of Information
(02) 6232 8612

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [5][email address]

[6]cid:image001.png@01D1D5D9.7DDEADA0

-------------------------------------------------------------------
Please use this email address for all replies to this request:
[FOI #3697 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:
https://www.righttoknow.org.au/help/offi...

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."

hide quoted sections

Dear Faustus,

 

Thank you for your FOI request which was received by the Therapeutic Goods
Administration on 20 July 2017.  

 

I am writing to inform you that, whilst undertaking the search and
retrieval process the line area have advised that it appears the scope of
your request may be too voluminous.  

 

Currently, the search and retrieval process has revealed over 11,000 SAS
Category B medical devices and biological applications relevant to the
scope of your request.

 

The line area have advised that to provide the diagnosis/clinical
justification for these SAS Category B applications would require someone
sorting through over 11,000 hard copy forms to extract the information
manually. This information can however be provided for medicines
applications.

 

In order to reduce your scope to a size that is more manageable, you may
wish to consider revising the scope of your request to exclude
diagnosis/clinical justification for medical device and biological SAS
Category B applications.

 

For example, you may wish to consider submitting the following the revised
scope:

 

                “With respect to applications to import unapproved
therapeutic goods under TGA’s Special Access Scheme between 1 January 2015
and 30 June 2017, I kindly request the following information:

                Category A:

                -Category

                -Therapeutic Good

                Category B:

                -Category

                -Date of Application

                -Therapeutic Good

                -Status

                -Diagnosis Clinical Justification (for medicines only).”

 

We would be grateful for your response by COB Monday 28 August 2017.

 

Please don't hesitate to contact me if you have any questions or if you
would like to discuss this.  

 

Kind regards

Jodie

 

Freedom of Information
(02) 6232 8720

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

[2]cid:image001.png@01D1D5D9.7DDEADA0

 

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

"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]

hide quoted sections

Dear Faustus,

 

We refer to our email of 25 August 2017 (copy below).

 

Upon further investigation, we have subsequently been advised by the
relevant line area the requested information relating to
diagnosis/clinical justification for the Medicine, Biological and Medical
Device applications for SAS Category B can be retrieved from the TGA’s
systems electronically, rather than manually from the application forms
themselves.

 

Accordingly, the TGA is able to continue processing your FOI request with
the revised scope as at 14 August 2017.

 

We apologise for any confusion caused.

 

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

 

Kind regards,

 

Freedom of Information
(02) 6232 8720

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

[2]cid:image001.png@01D1D5D9.7DDEADA0

 

From: TGA FOI
Sent: Friday, 25 August 2017 9:17 AM
To: 'faustus'
Cc: TGA FOI
Subject: FOI002-1718 - Scope revision [SEC=UNCLASSIFIED]

 

Dear Faustus,

 

Thank you for your FOI request which was received by the Therapeutic Goods
Administration on 20 July 2017.  

 

I am writing to inform you that, whilst undertaking the search and
retrieval process the line area have advised that it appears the scope of
your request may be too voluminous.  

 

Currently, the search and retrieval process has revealed over 11,000 SAS
Category B medical devices and biological applications relevant to the
scope of your request.

 

The line area have advised that to provide the diagnosis/clinical
justification for these SAS Category B applications would require someone
sorting through over 11,000 hard copy forms to extract the information
manually. This information can however be provided for medicines
applications.

 

In order to reduce your scope to a size that is more manageable, you may
wish to consider revising the scope of your request to exclude
diagnosis/clinical justification for medical device and biological SAS
Category B applications.

 

For example, you may wish to consider submitting the following the revised
scope:

 

                “With respect to applications to import unapproved
therapeutic goods under TGA’s Special Access Scheme between 1 January 2015
and 30 June 2017, I kindly request the following information:

                Category A:

                -Category

                -Therapeutic Good

                Category B:

                -Category

                -Date of Application

                -Therapeutic Good

                -Status

                -Diagnosis Clinical Justification (for medicines only).”

 

We would be grateful for your response by COB Monday 28 August 2017.

 

Please don't hesitate to contact me if you have any questions or if you
would like to discuss this.  

 

Kind regards

Jodie

 

Freedom of Information
(02) 6232 8720

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [3][email address]

 

[4]cid:image001.png@01D1D5D9.7DDEADA0

 

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

"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]
3. mailto:[email address]

hide quoted sections

Dear Mr Faustus

 

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

 

Kind regards

 

Freedom of Information
(02) 6232 8720

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

[2]cid:image001.png@01D1D5D9.7DDEADA0

 

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

"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]

hide quoted sections

Dear Faustus

Thank you for your email of 7 September 2017.

As advised in our correspondence of 1 September 2017, under subsection 29(1) of the FOI Act you are required to notify the TGA, in writing, within 30 days (by 1 October 2017) of how you wish to proceed with your request.

Please note that if you wish to contend that the charge should be reduced or not imposed because the payment would cause you financial hardship, you believe access would be in the public interest or for any other reason, you must provide sufficient persuasive reasons to provide a basis on which the decision maker could reduce, or not impose, the fee.

Your options for proceeding with your request are:
1.) Agree to pay the charge;
2.) Request a waiver of charges, stating reasons why the charge should be reduced or not imposed; or
3.) Withdraw your request.

Please note that if a response from you is not received by 1 October 2017, the FOI Act provides under subsection 29(2) that you are taken to have withdrawn your request.

Kind regards

Freedom of Information
(02) 6232 8720
Reporting and Collaboration Services Section
Regulatory Engagement and Planning Branch
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [email address]

-----Original Message-----
From: faustus [mailto:[FOI #3697 email]]
Sent: Thursday, 7 September 2017 9:33 AM
To: TGA FOI
Subject: Re: FOI 002-1718 Estimate of Charges [SEC=UNCLASSIFIED]

Dear Madam/Sir,

I refer to your last e-mail where you advised of charges relating to my FOI request. I note that you have furnished me with an estimate of charges totaling $1,613.58.

I am a little puzzled by this.

If you read my initial FOI request dated 1 July, 2017, you will note the following:

"I trust that this request is not an onerous one and that it will not incur any processing fees. If this is not the case, please advise on possible ways that I might narrow the scope of the request."

I believe a reasonable person would interpret this to mean: "I do not wish to pay a cent. If my request will incur any costs, please tell me how I might adjust it in order to avoid such costs."

After much toing-and-froing, I thought that perhaps we were on the same wavelength.

For example, in your August 25, 2017 you advised: "I am writing to inform you that, whilst undertaking the search and retrieval process the line area have advised that it appears the scope of your request may be too voluminous."

I believe a reasonable person would interpret this to mean: "Dear faustus, I am cognisant of your wishes to not pay a cent. I think we might need to adjust the scope of your request in order to avoid such costs."

However, your e-mail quoting me a fee of $1,613.58 would suggest you have conducted yourself neither in good faith, nor in earnest.

In short: rather than quoting any amount of money payable, I wonder why it is that you did not advise: "I'm sorry, it's simply not possible for your FOI request to be processed without incurring some expenses".

In light of this, I wish to make an amendment to my original FOI request:

What information might I be able to procure for $5? I am serious: I am willing to burn a crisp fiver in this endeavour. Please advise what information I can obtain for this amount of money. Ideally, I would like it to be five dollars' worth of Special-Access-Scheme-themed-TGA-documentation-goodness, but I suspect that this would be too lofty an ambition.

If this is the case, please advise how much it will cost to obtain a black piece of paper resulting from a photocopy of a fully redacted TGA document of your choosing.

Kind Regards,

faustus

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

Dear Mr Faustus

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

Kind regards

Freedom of Information
(02) 6232 8720

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

[2]cid:image001.png@01D1D5D9.7DDEADA0

-------------------------------------------------------------------
Please use this email address for all replies to this request:
[FOI #3697 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:
https://www.righttoknow.org.au/help/offi...

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."

hide quoted sections