Good afternoon

On 3 September 2021, a total of 5 (five) separate FOI requests (“the PCR
FOI requests”) were received at [1][TGA request email], addressed
respectively to:

o Advisory Committee on Medical Devices
o Advisory Committee on the Safety of Medical Devices
o Department of Health
o Medical Services Advisory Committee
o Therapeutic Goods Administration

The scope of these requests was for the following documents:

“Any report/advice/doc issued to advise public that the cdc recalled pcr
tests as they are deemed unreliable to confirm sar-cov2 when cycled above
24 false positives of 50-80%”

On 20 November 2021, you requested an internal review of a Department’s
decision. As a result of that email, an audit has been undertaken of all
of your requests, and it has been identified that the Department has not
processed your PCR FOI requests.

BACKGROUND:

By way of background, on 28 August 2021, a total of 7 (seven) separate
requests (“the face masks FOI requests”) were received at
[2][TGA request email], addressed respectively to:

o Advisory Committee on Medical Devices
o Advisory Committee on the Safety of Medical Devices
o Assistant Minister for Health
o Department of Health
o Medical Services Advisory Committee
o Minister for Health
o Therapeutic Goods Committee

The scope of these requests was for the following documents:

“Instructions, notices, evidence to support, in regards to the wearing of
face masks by your internal staff and public that was sent to you from
either the State or Federal Authorities in 2021”

The Department advised you that the request addressed to the Assistant
Minister for Health was not a valid request as no such entity existed and
that the Committees to which four of the requests were addressed were a
part of the Department and that these requests would be combined. On 2
September 2021, you responded indicating that you had no concerns with the
requests being combined. In addition, the TGA, which is responsible for
the Therapeutic Goods Committee, is also a part of the Department and the
request addressed to the Minister for Health was also combined, and
processed concurrently with the other five valid requests.

On 27 September 2021, a single decision was issued to you, under the
Department’s reference FOI-2922 releasing three documents in full.

STATUS OF PCR FOI REQUESTS:

At the time that your five separate requests dated 3 September 2021 were
received, the Department was receiving an unprecedented number of new FOI
requests, and the PCR FOI requests received on 3 September 2021 were
mistakenly assumed to be further duplicates of the seven other face masks
FOI requests that it had received from you on 28 August 2021.

A decision on access in relation to the five PCR FOI requests received on
3 September 2021 is now outside the statutory timeframes provided for by
the FOI Act, and as such the Department is deemed to have refused the
requests, under section 15AC of the FOI Act.  Despite this the Department
will processes these requests as a priority and will provide a decision to
you as quickly as possible.

Because the request is “deemed refused” and it is open to you to request a
review by the Information Commissioner, the Department is unable to
undertake an Internal Review of the decision under section 54 of the FOI
Act. However, it is open to you to request a review by the Information
Commissioner. Full details of your review rights can be found here: 
[3]Reviews and complaints - Home (oaic.gov.au)

ACTION TO BE TAKEN:

The Department has now registered one PCR FOI request, being the request
sent from [4][email address] and addressed to
the Department of Health. The reference for this request is FOI-3525.

The request will be processed by the Department as quickly as possible and
as a priority.

We will provide you with an update on when we anticipate being able to
provide you with a decision on access in this request as soon as possible.

In the meantime, if you have any queries, or require any further
information, please do not hesitate to contact us at [5][TGA request email].

The Department will finalise one decision in relation to this request, and
to simplify the administration of the process, will only correspond with
the email address [6][email address] for this
particular request going forward. No further emails will be sent to the
other four email addresses. If you have any concerns with this, please do
not hesitate to let us know.

With kind regards

Alison

Freedom of Information Unit

Legal and Assurance Division | Corporate Operations Group

Legal Advice & Legislation Branch
Australian Government Department of Health

P: 02 6289 1666  E: [7][TGA request email]

GPO Box 9848, Canberra ACT 2601, Australia

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 note that this email and attachments may contain confidential or
legally privileged information. Please consult with Legal Division before
disclosing any part of this email, or attachment, outside the Department.
If you receive this email in error, please delete it and contact the
sender immediately

"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:[TGA request email]
2. mailto:[TGA request email]
3. https://www.oaic.gov.au/freedom-of-infor...
4. mailto:[email address]
5. mailto:[TGA request email]
6. mailto:[email address]
7. mailto:[TGA request email]

Good afternoon

On 3 September 2021, a total of 5 (five) separate FOI requests (“the PCR
FOI requests”) were received at [1][TGA request email], addressed
respectively to:

o Advisory Committee on Medical Devices
o Advisory Committee on the Safety of Medical Devices
o Department of Health
o Medical Services Advisory Committee
o Therapeutic Goods Administration

The scope of these requests was for the following documents:

“Any report/advice/doc issued to advise public that the cdc recalled pcr
tests as they are deemed unreliable to confirm sar-cov2 when cycled above
24 false positives of 50-80%”

On 20 November 2021, you requested an internal review of a Department’s
decision. As a result of that email, an audit has been undertaken of all
of your requests, and it has been identified that the Department has not
processed your PCR FOI requests.

BACKGROUND:

By way of background, on 28 August 2021, a total of 7 (seven) separate
requests (“the face masks FOI requests”) were received at
[2][TGA request email], addressed respectively to:

o Advisory Committee on Medical Devices
o Advisory Committee on the Safety of Medical Devices
o Assistant Minister for Health
o Department of Health
o Medical Services Advisory Committee
o Minister for Health
o Therapeutic Goods Committee

The scope of these requests was for the following documents:

“Instructions, notices, evidence to support, in regards to the wearing of
face masks by your internal staff and public that was sent to you from
either the State or Federal Authorities in 2021”

The Department advised you that the request addressed to the Assistant
Minister for Health was not a valid request as no such entity existed and
that the Committees to which four of the requests were addressed were a
part of the Department and that these requests would be combined. On 2
September 2021, you responded indicating that you had no concerns with the
requests being combined. In addition, the TGA, which is responsible for
the Therapeutic Goods Committee, is also a part of the Department and the
request addressed to the Minister for Health was also combined, and
processed concurrently with the other five valid requests.

On 27 September 2021, a single decision was issued to you, under the
Department’s reference FOI-2922 releasing three documents in full.

STATUS OF PCR FOI REQUESTS:

At the time that your five separate requests dated 3 September 2021 were
received, the Department was receiving an unprecedented number of new FOI
requests, and the PCR FOI requests received on 3 September 2021 were
mistakenly assumed to be further duplicates of the seven other face masks
FOI requests that it had received from you on 28 August 2021.

A decision on access in relation to the five PCR FOI requests received on
3 September 2021 is now outside the statutory timeframes provided for by
the FOI Act, and as such the Department is deemed to have refused the
requests, under section 15AC of the FOI Act.  Despite this the Department
will processes these requests as a priority and will provide a decision to
you as quickly as possible.

Because the request is “deemed refused” and it is open to you to request a
review by the Information Commissioner, the Department is unable to
undertake an Internal Review of the decision under section 54 of the FOI
Act. However, it is open to you to request a review by the Information
Commissioner. Full details of your review rights can be found here: 
[3]Reviews and complaints - Home (oaic.gov.au)

ACTION TO BE TAKEN:

The Department has now registered one PCR FOI request, being the request
sent from [4][email address] and addressed to
the Department of Health. The reference for this request is FOI-3525.

The request will be processed by the Department as quickly as possible and
as a priority.

We will provide you with an update on when we anticipate being able to
provide you with a decision on access in this request as soon as possible.

In the meantime, if you have any queries, or require any further
information, please do not hesitate to contact us at [5][TGA request email].

The Department will finalise one decision in relation to this request, and
to simplify the administration of the process, will only correspond with
the email address [6][email address] for this
particular request going forward. No further emails will be sent to the
other four email addresses. If you have any concerns with this, please do
not hesitate to let us know.

With kind regards

Alison

Freedom of Information Unit

Legal and Assurance Division | Corporate Operations Group

Legal Advice & Legislation Branch
Australian Government Department of Health

P: 02 6289 1666  E: [7][TGA request email]

GPO Box 9848, Canberra ACT 2601, Australia

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 note that this email and attachments may contain confidential or
legally privileged information. Please consult with Legal Division before
disclosing any part of this email, or attachment, outside the Department.
If you receive this email in error, please delete it and contact the
sender immediately

"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:[TGA request email]
2. mailto:[TGA request email]
3. https://www.oaic.gov.au/freedom-of-infor...
4. mailto:[email address]
5. mailto:[TGA request email]
6. mailto:[email address]
7. mailto:[TGA request email]

Good afternoon

On 3 September 2021, a total of 5 (five) separate FOI requests (“the PCR
FOI requests”) were received at [1][TGA request email], addressed
respectively to:

o Advisory Committee on Medical Devices
o Advisory Committee on the Safety of Medical Devices
o Department of Health
o Medical Services Advisory Committee
o Therapeutic Goods Administration

The scope of these requests was for the following documents:

“Any report/advice/doc issued to advise public that the cdc recalled pcr
tests as they are deemed unreliable to confirm sar-cov2 when cycled above
24 false positives of 50-80%”

On 20 November 2021, you requested an internal review of a Department’s
decision. As a result of that email, an audit has been undertaken of all
of your requests, and it has been identified that the Department has not
processed your PCR FOI requests.

BACKGROUND:

By way of background, on 28 August 2021, a total of 7 (seven) separate
requests (“the face masks FOI requests”) were received at
[2][TGA request email], addressed respectively to:

o Advisory Committee on Medical Devices
o Advisory Committee on the Safety of Medical Devices
o Assistant Minister for Health
o Department of Health
o Medical Services Advisory Committee
o Minister for Health
o Therapeutic Goods Committee

The scope of these requests was for the following documents:

“Instructions, notices, evidence to support, in regards to the wearing of
face masks by your internal staff and public that was sent to you from
either the State or Federal Authorities in 2021”

The Department advised you that the request addressed to the Assistant
Minister for Health was not a valid request as no such entity existed and
that the Committees to which four of the requests were addressed were a
part of the Department and that these requests would be combined. On 2
September 2021, you responded indicating that you had no concerns with the
requests being combined. In addition, the TGA, which is responsible for
the Therapeutic Goods Committee, is also a part of the Department and the
request addressed to the Minister for Health was also combined, and
processed concurrently with the other five valid requests.

On 27 September 2021, a single decision was issued to you, under the
Department’s reference FOI-2922 releasing three documents in full.

STATUS OF PCR FOI REQUESTS:

At the time that your five separate requests dated 3 September 2021 were
received, the Department was receiving an unprecedented number of new FOI
requests, and the PCR FOI requests received on 3 September 2021 were
mistakenly assumed to be further duplicates of the seven other face masks
FOI requests that it had received from you on 28 August 2021.

A decision on access in relation to the five PCR FOI requests received on
3 September 2021 is now outside the statutory timeframes provided for by
the FOI Act, and as such the Department is deemed to have refused the
requests, under section 15AC of the FOI Act.  Despite this the Department
will processes these requests as a priority and will provide a decision to
you as quickly as possible.

Because the request is “deemed refused” and it is open to you to request a
review by the Information Commissioner, the Department is unable to
undertake an Internal Review of the decision under section 54 of the FOI
Act. However, it is open to you to request a review by the Information
Commissioner. Full details of your review rights can be found here: 
[3]Reviews and complaints - Home (oaic.gov.au)

ACTION TO BE TAKEN:

The Department has now registered one PCR FOI request, being the request
sent from [4][email address] and addressed to
the Department of Health. The reference for this request is FOI-3525.

The request will be processed by the Department as quickly as possible and
as a priority.

We will provide you with an update on when we anticipate being able to
provide you with a decision on access in this request as soon as possible.

In the meantime, if you have any queries, or require any further
information, please do not hesitate to contact us at [5][TGA request email].

The Department will finalise one decision in relation to this request, and
to simplify the administration of the process, will only correspond with
the email address [6][email address] for this
particular request going forward. No further emails will be sent to the
other four email addresses. If you have any concerns with this, please do
not hesitate to let us know.

With kind regards

Alison

Freedom of Information Unit

Legal and Assurance Division | Corporate Operations Group

Legal Advice & Legislation Branch
Australian Government Department of Health

P: 02 6289 1666  E: [7][TGA request email]

GPO Box 9848, Canberra ACT 2601, Australia

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 note that this email and attachments may contain confidential or
legally privileged information. Please consult with Legal Division before
disclosing any part of this email, or attachment, outside the Department.
If you receive this email in error, please delete it and contact the
sender immediately

"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:[TGA request email]
2. mailto:[TGA request email]
3. https://www.oaic.gov.au/freedom-of-infor...
4. mailto:[email address]
5. mailto:[TGA request email]
6. mailto:[email address]
7. mailto:[TGA request email]

Good afternoon

On 3 September 2021, a total of 5 (five) separate FOI requests (“the PCR
FOI requests”) were received at [1][TGA request email], addressed
respectively to:

o Advisory Committee on Medical Devices
o Advisory Committee on the Safety of Medical Devices
o Department of Health
o Medical Services Advisory Committee
o Therapeutic Goods Administration

The scope of these requests was for the following documents:

“Any report/advice/doc issued to advise public that the cdc recalled pcr
tests as they are deemed unreliable to confirm sar-cov2 when cycled above
24 false positives of 50-80%”

On 20 November 2021, you requested an internal review of a Department’s
decision. As a result of that email, an audit has been undertaken of all
of your requests, and it has been identified that the Department has not
processed your PCR FOI requests.

BACKGROUND:

By way of background, on 28 August 2021, a total of 7 (seven) separate
requests (“the face masks FOI requests”) were received at
[2][TGA request email], addressed respectively to:

o Advisory Committee on Medical Devices
o Advisory Committee on the Safety of Medical Devices
o Assistant Minister for Health
o Department of Health
o Medical Services Advisory Committee
o Minister for Health
o Therapeutic Goods Committee

The scope of these requests was for the following documents:

“Instructions, notices, evidence to support, in regards to the wearing of
face masks by your internal staff and public that was sent to you from
either the State or Federal Authorities in 2021”

The Department advised you that the request addressed to the Assistant
Minister for Health was not a valid request as no such entity existed and
that the Committees to which four of the requests were addressed were a
part of the Department and that these requests would be combined. On 2
September 2021, you responded indicating that you had no concerns with the
requests being combined. In addition, the TGA, which is responsible for
the Therapeutic Goods Committee, is also a part of the Department and the
request addressed to the Minister for Health was also combined, and
processed concurrently with the other five valid requests.

On 27 September 2021, a single decision was issued to you, under the
Department’s reference FOI-2922 releasing three documents in full.

STATUS OF PCR FOI REQUESTS:

At the time that your five separate requests dated 3 September 2021 were
received, the Department was receiving an unprecedented number of new FOI
requests, and the PCR FOI requests received on 3 September 2021 were
mistakenly assumed to be further duplicates of the seven other face masks
FOI requests that it had received from you on 28 August 2021.

A decision on access in relation to the five PCR FOI requests received on
3 September 2021 is now outside the statutory timeframes provided for by
the FOI Act, and as such the Department is deemed to have refused the
requests, under section 15AC of the FOI Act.  Despite this the Department
will processes these requests as a priority and will provide a decision to
you as quickly as possible.

Because the request is “deemed refused” and it is open to you to request a
review by the Information Commissioner, the Department is unable to
undertake an Internal Review of the decision under section 54 of the FOI
Act. However, it is open to you to request a review by the Information
Commissioner. Full details of your review rights can be found here: 
[3]Reviews and complaints - Home (oaic.gov.au)

ACTION TO BE TAKEN:

The Department has now registered one PCR FOI request, being the request
sent from [4][email address] and addressed to
the Department of Health. The reference for this request is FOI-3525.

The request will be processed by the Department as quickly as possible and
as a priority.

We will provide you with an update on when we anticipate being able to
provide you with a decision on access in this request as soon as possible.

In the meantime, if you have any queries, or require any further
information, please do not hesitate to contact us at [5][TGA request email].

The Department will finalise one decision in relation to this request, and
to simplify the administration of the process, will only correspond with
the email address [6][email address] for this
particular request going forward. No further emails will be sent to the
other four email addresses. If you have any concerns with this, please do
not hesitate to let us know.

With kind regards

Alison

Freedom of Information Unit

Legal and Assurance Division | Corporate Operations Group

Legal Advice & Legislation Branch
Australian Government Department of Health

P: 02 6289 1666  E: [7][TGA request email]

GPO Box 9848, Canberra ACT 2601, Australia

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 note that this email and attachments may contain confidential or
legally privileged information. Please consult with Legal Division before
disclosing any part of this email, or attachment, outside the Department.
If you receive this email in error, please delete it and contact the
sender immediately

"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:[TGA request email]
2. mailto:[TGA request email]
3. https://www.oaic.gov.au/freedom-of-infor...
4. mailto:[email address]
5. mailto:[TGA request email]
6. mailto:[email address]
7. mailto:[TGA request email]

Good afternoon

On 3 September 2021, a total of 5 (five) separate FOI requests (“the PCR
FOI requests”) were received at [1][TGA request email], addressed
respectively to:

o Advisory Committee on Medical Devices
o Advisory Committee on the Safety of Medical Devices
o Department of Health
o Medical Services Advisory Committee
o Therapeutic Goods Administration

The scope of these requests was for the following documents:

“Any report/advice/doc issued to advise public that the cdc recalled pcr
tests as they are deemed unreliable to confirm sar-cov2 when cycled above
24 false positives of 50-80%”

On 20 November 2021, you requested an internal review of a Department’s
decision. As a result of that email, an audit has been undertaken of all
of your requests, and it has been identified that the Department has not
processed your PCR FOI requests.

BACKGROUND:

By way of background, on 28 August 2021, a total of 7 (seven) separate
requests (“the face masks FOI requests”) were received at
[2][TGA request email], addressed respectively to:

o Advisory Committee on Medical Devices
o Advisory Committee on the Safety of Medical Devices
o Assistant Minister for Health
o Department of Health
o Medical Services Advisory Committee
o Minister for Health
o Therapeutic Goods Committee

The scope of these requests was for the following documents:

“Instructions, notices, evidence to support, in regards to the wearing of
face masks by your internal staff and public that was sent to you from
either the State or Federal Authorities in 2021”

The Department advised you that the request addressed to the Assistant
Minister for Health was not a valid request as no such entity existed and
that the Committees to which four of the requests were addressed were a
part of the Department and that these requests would be combined. On 2
September 2021, you responded indicating that you had no concerns with the
requests being combined. In addition, the TGA, which is responsible for
the Therapeutic Goods Committee, is also a part of the Department and the
request addressed to the Minister for Health was also combined, and
processed concurrently with the other five valid requests.

On 27 September 2021, a single decision was issued to you, under the
Department’s reference FOI-2922 releasing three documents in full.

STATUS OF PCR FOI REQUESTS:

At the time that your five separate requests dated 3 September 2021 were
received, the Department was receiving an unprecedented number of new FOI
requests, and the PCR FOI requests received on 3 September 2021 were
mistakenly assumed to be further duplicates of the seven other face masks
FOI requests that it had received from you on 28 August 2021.

A decision on access in relation to the five PCR FOI requests received on
3 September 2021 is now outside the statutory timeframes provided for by
the FOI Act, and as such the Department is deemed to have refused the
requests, under section 15AC of the FOI Act.  Despite this the Department
will processes these requests as a priority and will provide a decision to
you as quickly as possible.

Because the request is “deemed refused” and it is open to you to request a
review by the Information Commissioner, the Department is unable to
undertake an Internal Review of the decision under section 54 of the FOI
Act. However, it is open to you to request a review by the Information
Commissioner. Full details of your review rights can be found here: 
[3]Reviews and complaints - Home (oaic.gov.au)

ACTION TO BE TAKEN:

The Department has now registered one PCR FOI request, being the request
sent from [4][email address] and addressed to
the Department of Health. The reference for this request is FOI-3525.

The request will be processed by the Department as quickly as possible and
as a priority.

We will provide you with an update on when we anticipate being able to
provide you with a decision on access in this request as soon as possible.

In the meantime, if you have any queries, or require any further
information, please do not hesitate to contact us at [5][TGA request email].

The Department will finalise one decision in relation to this request, and
to simplify the administration of the process, will only correspond with
the email address [6][email address] for this
particular request going forward. No further emails will be sent to the
other four email addresses. If you have any concerns with this, please do
not hesitate to let us know.

With kind regards

Alison

Freedom of Information Unit

Legal and Assurance Division | Corporate Operations Group

Legal Advice & Legislation Branch
Australian Government Department of Health

P: 02 6289 1666  E: [7][TGA request email]

GPO Box 9848, Canberra ACT 2601, Australia

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 note that this email and attachments may contain confidential or
legally privileged information. Please consult with Legal Division before
disclosing any part of this email, or attachment, outside the Department.
If you receive this email in error, please delete it and contact the
sender immediately

"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:[TGA request email]
2. mailto:[TGA request email]
3. https://www.oaic.gov.au/freedom-of-infor...
4. mailto:[email address]
5. mailto:[TGA request email]
6. mailto:[email address]
7. mailto:[TGA request email]