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Register
here to Submit the Prior Notice
GTHUB
PN Service Costs
This
analysis is based on information gathered from the Federal
Register of February 3rd, 2003. Part IV, Department
of Health and Human Services, Food and Drug Administration.
It
is obvious that the Bioterrorism Act is going to increase
the operating expenses of each company that exports to the
USA. The FDA did a Cost Analysis of the economic impact of
complying with the Bioterrorism Act, which totaled into the
hundreds of millions of dollars per year. Your Company has
two options to cover those new costs:
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1. Assume the costs and reduce your annual profits, or
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2. Pass on the costs to the Buyer by increasing your product
costs. |
In
order to provide a realistic cost analysis, you will need
to add all the costs involved to fill out, submit and track
each Prior Notice (PN). You will need to estimate the human
resource costs, social benefits, administration, time, supervision,
office expenses, internet, information research, time to group
the information, fill out the Form, review and submit it to
the FDA, track the PN and maintain all records filed for one
to two years.
The
person in charge of the PN needs to dedicate full time to
the process of Prior Notice submission. One serious mistake
can cost your company thousands of dollars and possibly loss
of a shipment. We presume that the person in charge of the
PN is educated and qualified to handle an important task as
this. Each PN should be reviewed by a supervisor, if you want
to be certain that it is properly filled out with all the
information required by the FDA.
In
order to provide a simple calculation, we calculate a medium
salary as the basis of our analysis. Depending on the country,
this salary can be more or less than our medium salary. For
our analysis, we will base the salary on $1,600.00
per month, plus the social benefits. Per year, the employer
will pay $19,200.00, plus the social benefits
and all the other costs mentioned above should be added to
arrive at a realistic cost analysis.
We
need to remind you that the PN is not by shipment; it is by
product, size and/or brand. It is conceivable that in one
shipment you will need to submit various PN. It is estimated
that more than 100 PN submissions per month, you will need
more employee(s), dedicated exclusively to PN submissions.
This
analysis does not contemplate the costs for Administrative
Detention or refusal of the product for not properly submitting
the PN.
GTHUB service costs for PN submissions
GTHUB
developed the Prior Notice process to be simple, easy and
intelligent to save you time and money. Maintaining our Corporate
policy to offer a professional and quality service at reasonable
costs, the following table reflects our commitment.
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PN
Service Plans
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Amount
of Plan
|
Costs
per Plan |
_Payment
(50%)*
|
| Basic Plan |
100
|
$500.00
|
$250.00
|
| Sm Business Plan
|
250
|
$750.00
|
$375.00
|
| Executive Plan |
500
|
$1,000.00
|
$500.00
|
|
Entrepreneurial
Plan
|
1,000
|
$1,500.00
|
$750.00
|
|
Corporative
Plan
|
1,500
|
$2,000.00
|
$1,000.00
|
|
Export
Plan
|
2,000
|
$2,500.00
|
$1,250.00
|
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Prestige
Plan
|
4,000
|
$3,000.00
|
$1,500.00
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Depending
on the amount of PN you need to submit each year, the cost
per PN submission can be as low as $0.25 cents of a dollar.
The average cost for PN submissions through GTHUB will be
around $0.50 cents of a dollar.
NOTE:
The
“Amount of PN” in each Plan is for each individual
shipment, and it includes up to two (2) additional FREE PN
per shipment. (Example; if you have one (1) shipment, but
you have three (3) “articles of food”, you have
to submit three (3) PN; you will only use one (1) PN of your
Plan. If you have one (1) shipment, but you have five (5)
“articles of food”, you have to submit five (5)
PN; you will only use two (2) PN of your Plan).
The
Plans do not have a time limit of use and you can renew the
same Plan or change to a different Plan as required.
Register
here to Submit the Prior Notice
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