s22
Email: s22
Dear s22
FREEDOM OF INFORMATION REQUEST FOI 5360
Estimate of Charges
1. I refer to your request dated 13 August 2024 under the
Freedom of Information Act
1982 (the FOI Act) and subsequent correspondence between you and the TGA in which
the scope of your request was clarified as being for access to the following documents:
'(1) The case number and age (years) of all adverse event reports (AERs) in the Adverse
Event Management System (AEMS) where one or more non-COVID-19 vaccines have been
listed as a suspected medicine WHERE DEATH WAS A REPORTED OUTCOME. This
includes AERs where both one or more non-COVID-19 vaccines have been listed as a
suspected medicine AND one or more one or more COVID-19 vaccines have been listed as
a suspected medicine. This request relates to the period from 1/1/1971 to 14/8/2024 or
the date of extraction, whichever is later. The date range boxes did not allow 1971 to be
selected.
(2) The raw data for the time between the most recent non-covid vaccination and death.
This does not have to be linked directly to the above data and can be a single column of
data however it is requested that the data for all deaths is provided (ie the overall
number of deaths should match) and that there is an entry for cases where the time
between the most recent non-covid vaccination and death is unknown. This request
relates to the period from 1/1/1971 to 14/8/2024 or the date of extraction, whichever is
later. The date range boxes did not allow 1971 to be selected.
(3) The raw data for the time between the most recent covid-19 vaccination and death
for all adverse event reports in the Adverse Event Management System (AEMS) where
one or more COVID-19 vaccines have been listed as a suspected medicine and WHERE
DEATH WAS A REPORTED OUTCOME.
It is requested that the data for al deaths is provided and that there is an entry for cases
where the time between the most recent covid-19 vaccination and death is unknown.
This request relates to the period from 1/12/2020 to 14/8/2024 or the date of
extraction, whichever is later.'
Scope clarified 26/8.
‘…By “raw data”, I mean the calculated time between: (1) the most recent non-covid-19
vaccination and death; and (1) most recent covid-19 vaccination and death. For
example: 1 day, 32 days, unknown. I am not requesting any dates. .’
PO Box 100 Woden ACT 2606 ABN 40 939 406 804
Phone: 1800 020 653 or 02 6289 4124 Fax: 02 6203 1605
Emai
l: xxxx@xxx.xxx.xx
https://www.tga.gov.au
‘…I only want cases where non-covid 19 vaccines were listed as a suspected medicine. I do
not want cases where other medicines were listed as suspected medicines, where no non-
covid vaccines was listed as suspected medicines. .’
Scope clarified 29/8.
‘I am specifical y wanting all adverse event reports in the AEMS where one or more non-
covid vaccines have been listed as a suspected medicine as I am wanting the AEMS ages
which can differ to the DAEN for some cases. I am also interested in the number of cases
in the AEMS not listed in the DAEN. This is something I can work out for myself. If I have
any questions about these, I wil submit a fol ow up FOI. .'
2. Under the
Freedom of Information (Charges) Regulations 2019 (the Regulations) a
charge can be imposed in respect of a request for access to documents under the FOI
Act. The charge is for the search and retrieval of documents, decision making and
provision of access.
3. I am an authorised decision maker under section 23 of the FOI Act and I have decided
that you are liable to pay a charge in respect of the processing of your request for
access.
4. A search and retrieval of documents relevant to your request has been undertaken and
a preliminary estimate of charges has been calculated. It is set out in the table below.
Search and retrieval time (including 4.00 hours @ $15.00 per hour
$60.00
time spent locating relevant files and
collating relevant documents
contained on those files)
Decision making time (including
5.81 hours @ $20.00 per hour
$16.25
time spent examining the
L ess first 5 hours which are free
documents, considering exemptions,
undertaking consultation, writing
the decision and preparing any
documents for release)
TOTAL
$76.25
Deposit required
$20.00
5. Under the Regulations where a charge is imposed and exceeds $25.00 but is less than
$100.00, a deposit of $20.00 may be sought. Based on the preliminary estimate of
charges for your request which is $76.25, I have decided you are required to pay a
deposit of $20.00. Details of how to make a payment are outlined below.
6. Under subsection 29(1) of the FOI Act, I am required to notify you that you have 30
calendar days from receipt of this notice to do one of the following:
• pay the charge, being the deposit outlined above, and notify the FOI Team via the
email below; or
• notify the TGA that you wish to contend that:
- the charge has been wrongly assessed, giving reasons; or
- the charge should be reduced or not imposed (for instance, where payment of
the charge would cause you financial hardship or where you believe access to
documents is in the general public interest), with reasons; or
•
notify the TGA that you w ithdraw your request.
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7. Please note, should you seek a reduction or waiver of charges on the grounds of
financial hardship it would assist the decision maker considering your request if you
provide suitable evidence of financial hardship (for example, by providing evidence of
receipt of a pension or income support payment; or provide evidence of income, debts
or assets). This is consistent with the FOI Guideline
s www.oaic.gov.au/freedom-of-
information/foi-guidelines/part-4-charges-for-providing-access. Evidence should be
provided at the time of seeking waiver or reduction.
8. If you fail to notify the TGA within 30 days about what you propose to do, the FOI Act
provides under subsection 29(2) that you are taken to have withdrawn your request.
Timeframes
9. The time limit for processing your request is suspended, in accordance with section 31
of the FOI Act, from the date you receive this notice and resumes on the day you pay
the charge or deposit (including any reduced charge or deposit), or the day on which
the TGA makes a decision not to impose a charge.
10. Once your FOI request has been processed, the TGA will determine the actual charge
you must pay before the documents can be provided to you. The final charge for
processing your request may be different from the estimate quoted in this letter. If I
decide to grant full access to all the documents within the scope of your request, you
must pay the actual charges for the time and disbursements involved in processing
your request ascertained in accordance with the table set out above (which may be
greater or less than the estimate). However, if you are only granted partial access to
the documents, you will only be required to pay whichever amount is the lesser of the
estimate quoted in this letter and the actual charges.
11. Please note that the decision maker can make a decision to charge for search and
retrieval that the TGA has already undertaken for the purposes of your request in its
current form, but it may be possible to reduce the decision making charges that might
be incurred by the TGA in the future if you refine the scope of your request, for
example, by limiting the date range of documents sought or excluding a particular
category of documents.
12. If you agree to pay the charge, you are accepting liability for settlement of the debt
upon completion of processing the FOI request. Once your FOI request has been
processed, the outstanding amount of the charge becomes a debt to the
Commonwealth. The TGA is obliged to pursue recovery of the debt in accordance with
the
Public Governance, Performance and Accountability Act 2013.
Payment
13. Payments for FOI requests must be made online via the TGA’s
Online Payment
Portal (www.tga.gov.au/how-we-regulate/fees-and-payments/payment-
options/online-payment-portal).
14. To make an FOI payment, you will be required to enter specific information as outlined
below. From the Online Payment Portal site, click on the option titled ‘
Online
payment portal’ to display the payment portal page. From the payment portal page,
enter the following information:
• ‘
Biller Code’, click on the drop-down arrow to select option ’
11 – Freedom of
Information (FOI)’.
• ‘
Client Identification Number’, enter ‘
CO-9001’.
• ‘
Reference Number’, enter your unique FOI identification number fol owed by
your first and last name (e.g. ‘
FOI-XXXX John Smith’).
• ‘
Email Address for Tax Receipt’, enter the email address you wish to receive a tax
receipt for your payment transaction. This email will contain a unique 11 digit
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payment transaction number to quote if you have any queries. Please retain this
email for your records. A tax invoice will not be issued for this transaction.
• ‘
Amount (AUD)’, enter the amount of the payment being made.
• ‘
Select your payment option’, click on the relevant icon to proceed to the next
screen.
Please include reference to FOI 5360 in your payment.
15. If you require assistance with making a payment please contact the TGA Accounts
team on 1800 020 653 (option 5) or by email at
xxxxxxxxxxx@xxxxxx.xxx.xx. Users
who are deaf or have a hearing or speech impairment can call through the National
Relay Service: TTY or computer with modem users: phone 1800 555 677 then ask for
1800 020 653. Speak and listen (speech to speech relay) users: phone 1800 555 727
then ask for 1800 020 653.
16.
IMPORTANT: Once payment has been made, please notify the FOI Team via the
following email address:
xxxxxx@xxxxxx.xxx.xx. Failure to notify the FOI Team of
payment may result in delays to the processing of your FOI request.
Third Party Consultation
17. In the event your request relates to documents that include information about a
person or their business or professional affairs or about the business, commercial or
financial affairs of an organisation or undertaking, pursuant to section 27 and 27A of
the FOI Act the TGA will be required to provide that person or organisation the
opportunity to make submissions if it appears that they may wish to argue any
document is exempt from release.
18. The statutory time limit for processing an FOI request will be extended by 30 days
under subsection 15(6) of the FOI Act where a third party is to be consulted.
19. If you require clarification of any of the matters discussed in this letter, please contact
the FOI Team on (02) 6289 4630.
Yours sincerely
Authorised and electronically signed by
Dr Claire Larter
A/g Assistant Secretary
Pharmacovigilance Branch
Therapeutic Goods Administration
9 September 2024
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