s22
Email: s22
Dear s22
FREEDOM OF INFORMATION REQUEST FOI 5358
Estimate of Charges
1. I refer to your request dated 13 August 2024 under the
Freedom of Information Act 1982 (the
FOI Act) 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. 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 case number and age (years) of al adverse event reports (AERs) in the Adverse Event
Management System (AEMS) where one or more COVID-19 vaccines have been listed as a
suspected medicine. This request relates to the period from 1/12/2020 to 14/8/2024 or the date of
extraction, whichever is later.'
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 2.00 hours @ $15.00 per hour
$30.00
time spent locating relevant files and
collating relevant documents
contained on those files)
Decision making time (including
5.68 hours @ $20.00 per hour
$13.50
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
$43.50
Deposit required
$20.00
PO Box 100 Woden ACT 2606 ABN 40 939 406 804
Phone: 1800 020 653 or 02 6289 4124 Fax: 02 6203 1605
Email: xxxx@xxx.xxx.xx
https://www.tga.gov.au
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 $43.50, 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 withdraw your request.
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 Guidelines 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 wil 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).
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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 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 5358 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
10 September 2024
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