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menusux
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« on: May 24, 2010, 12:25:10 PM »

http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm212845.htm

Safety Reporting Portal: A New Online Tool

On May 24, 2010, the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) launched a new Web site for industry to report food safety problems or adverse events involving FDA-regulated foods (except for dietary supplements and infant formula), animal feeds, and animal drugs. Consumers can also use the site to report problems with pet foods and pet treats.

http://www.safetyreporting.hhs.gov/

Safety Reporting Portal

https://www.safetyreporting.hhs.gov/fpsr/FAQ.aspx

Safety Reporting Portal FAQs
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3catkidneyfailure
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« Reply #1 on: May 24, 2010, 01:55:14 PM »

Seriously shout this one from the rooftops I think. Not that FDA does anything about it, but
at least they're in theory taking consumer reports. Hallelujah!!! ...
now, if consumers could search this report base and see what's being reported? That would help a lot.


http://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm212664.htm

Animal & VeterinaryHome> Animal & Veterinary> Safety & Health> Report a ProblemSection Contents Menu
Safety & Health
 Report a Problem
 
How to Report a Pet Food Complaint Veterinary Adverse Event Reporting for Manufacturers Veterinary Adverse Event Voluntary Reporting -Resources for YouSafety Reporting Portal  

-- Pet Food Safety Reporting Frequently Asked Questions
How do I report a problem related to pet food?
Does “pet food” include pet treats?
How long will it take me to complete a report?
Do I need to provide my name and other personal information in order to submit a report?
Do I need an account in order to report a pet food problem?
Can I begin a report and, if I do not finish it, save it for completion at a later time?
What information do I need to set up an account?
Can anyone submit a report about a problem with a pet food?
If I suspect a problem with pet food, does an animal have to be affected in order for me to submit a report?
If an animal is affected, but I am not the owner of that animal, can I still report the pet food problem?
What information am I required to provide about the animals involved?
What information will I need to know about the pet food products suspected to have a problem before I am ready to submit a report?
If I already reported the suspected pet food problem to the store where I purchased it or to the product’s manufacturer or distributor, should I still report the problem to FDA?
If I am not able to complete every question on the report because I do not have all the information requested, will the report still be accepted?
I am not sure what information is being asked in the section titled “How Product Was Used.” Can you tell me what type of information should be reported in that section?
One of the questions asks me to provide the “Universal Product Code” for the product in question. Can you tell me what the term Universal Product Code means?
There is a box on the form labeled “Product Lot.” What does that term refer to and what happens if I click the “Add” button in that box?
If several products were fed to the animal, can I enter information on the form for each product?
I am not sure if I need to report information related to veterinarian visits. Is this required information?
If I have documents related to this report that I think are important for FDA to see, can I include these documents with my report?
How do I know if my report was successfully entered into the system?

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

How do I report a problem related to pet food?
Go to “How to Report a Pet Food Complaint1,” and click on the Safety Reporting Portal2 link to fill out the electronic questionnaire.

1.  http://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm182403.htm
2.  https://www.safetyreporting.hhs.gov/fpsr/WorkflowLoginIO.aspx?metinstance=54F53A73C742E908F56076A829F0C049B137DDFE

Does “pet food” include pet treats?
Yes. You can report problems potentially associated with treats, chews, and nutritional supplements, as well as complete diets. Anything that is intended to be ingested by the pet that is not a drug is considered a pet food for purposes of the Pet Food Reporting electronic portal.

How long will it take me to complete a report?
We estimate that it will take between 20 minutes to 2 hours to complete and submit a report – 20 minutes if you already have an account and you have gathered the information you’ll need to complete the report, up to 2 hours if you have to complete those steps.

Do I need to provide my name and other personal information in order to submit a report?
You do not need to provide your name or other personal information in order to submit a report. If you do not wish to provide your name when submitting a report, simply register as a “guest” user on the website. As a guest user, one of the main limitations is that you will be required to complete your report during a single session. In other words, you cannot save a partially completed report and finish it later, as you can do if you are a registered user. As a guest user, you can elect to remain anonymous, or you can provide information that will allow FDA to contact you, if necessary. The method you choose to submit your report and the amount of personal information you provide is up to you.

Do I need an account in order to report a pet food problem?
Although you are not required to create an account, you are encouraged to do so. Having an account will allow you to save a partially completed report and finish it later, provide additional information more easily for a report you have already submitted (i.e., submit a follow-up report), pre-populate information such as your name and contact information in new and follow-up reports, and see a list of reports that you have submitted.

Can I begin a report and, if I do not finish it, save it for completion at a later time?
Yes, as long as you have an account, you can log on multiple times to work on a single report. If you do not have an account, this feature is not available to you.

What information do I need to set up an account?
If you choose to create an account, you must provide the following information (if you wish to report as a guest, you may, but are not required to, provide this information): your first and last name, your primary or preferred telephone number, the name of the country in which you live, your mailing address, and your e-mail address.

Can anyone submit a report about a problem with a pet food?
Yes, anyone can submit a report about a problem with a pet food. If you are submitting such a report, however, you are most likely either a veterinarian, veterinary staff member, consumer (pet owner), or concerned citizen who is submitting a product problem and/or adverse event report involving pet food. If you are a manufacturer, distributor, or retailer of food, including pet food, or a federal, state, or local public health official, you are most likely submitting a Reportable Food Report and should use the Reportable Food section of the Safety Reporting Portal.

If I suspect a problem with pet food, does an animal have to be affected in order for me to submit a report?
No, if you suspect that there is a problem with pet food, an animal does not need to be affected in order for you to file a report. Some examples of problems with pet food that would warrant a report are foul odor, off color, swollen can or pouch, leaking container, foreign object found in the product. You will be asked to provide details about the problem you observed when you file your report.

If an animal is affected, but I am not the owner of that animal, can I still report the pet food problem?
Yes, you can report a pet food problem regardless of whether or not you own the affected animal. If you are not the animal owner, you can (but are not required to) provide the following contact information for the owner: pet owner’s first and last name, pet owner’s telephone number(s), name of the country in which the pet owner lives, pet owner’s mailing address, and pet owner’s e-mail address.

What information am I required to provide about the animals involved?
The following information is required: the number of animals that reacted, the species of animal, the breed of animal, the reproductive status of one of the animals. The following information is not required, but requested: number of animals given the product, name or identifier for one of the animals, age, weight, and gender of the named animal, overall state of the animal’s health prior to the adverse event, any health problems and/or any medication the animal was being given prior to the adverse event.

What information will I need to know about the pet food products suspected to have a problem before I am ready to submit a report?
The Brand name of the product in question must be provided. The following product information is requested, if known: product type, package type, package size, Universal Product Code (UPC), lot number, and use-by (expiration) date on the product label, name and address of the manufacturer or distributor of the product, date the product was last purchased, number purchased on this date, if you have a package/container of unopened product from this purchase, if you have a package/container of opened product from this purchase, and the name and address of store or place where the product was purchased.

If I already reported the suspected pet food problem to the store where I purchased it or to the product’s manufacturer or distributor, should I still report the problem to FDA?
Yes, you should still report the problem to the FDA even if you already reported the suspected pet food problem to the store where you purchased it, to the product manufacturer or distributor, or to another responsible party. We recommend that, in addition to informing FDA of the problem, you also inform the manufacturer or distributor that is on the product label.

If I am not able to complete every question on the report because I do not have all the information requested, will the report still be accepted?
In order for the report to be accepted, certain fields on the form are required to be completed. Required fields on the form are noted with an asterisk (*). If you are unable to complete the required fields on the form, i.e., the fields identified by asterisks, your report will not be accepted.

I am not sure what information is being asked in the section titled “How Product Was Used.” Can you tell me what type of information should be reported in that section?
In the section titled “How Product Was Used,” you can describe how the product was used or administered (that is, how the product was fed or given to the animal), describe how the product was stored before and after opening, provide the date the animal was first fed product from this purchase (the most recent purchase), provide the date the animal was last fed product from this purchase, report any other foods or products given to the animal during this time period, describe the amount of time from use of product to onset of the event, state whether use of the product was stopped after the onset of the adverse event, state whether product use was started again, and state whether the event occurred again. In fact, you can provide any other information you think relevant to the use of the product, including whether, in your opinion, it is likely that the use of the product is related to an adverse event experienced by the animal.

One of the questions asks me to provide the “Universal Product Code” for the product in question. Can you tell me what the term Universal Product Code means?
Universal Product Code (UPC) refers to the bar coded portion of the product’s label. Generally, this bar code is read by automated readers at stores during the checkout process. The label shows a series of printed black bars against a white background. Numbers appear beneath the black bars. Here is an example of a UPC:

 



There is a box on the form labeled “Product Lot.” What does that term refer to and what happens if I click the “Add” button in that box?
Product Lot is product manufacturing information that allows FDA to identify the product in question. If you click the “Add” button in the “Product Lot” box, a new window will open on your computer screen. The window contains two fields, allowing you to enter the lot number and the product expiration, use-by, best-by, or best before date (the date can either be typed in manually or selected from a pull-up calendar). Here is an example of a label showing the lot number and use by date:

 



If several products were fed to the animal, can I enter information on the form for each product?
The form allows you to enter information for several products in cases where more than one product is being fed to the animal.

I am not sure if I need to report information related to veterinarian visits. Is this required information?
Information on veterinarian visits is not collected for a report of a product problem, but this information may be voluntarily provided when reporting adverse events or both an adverse event and a product problem. If you report either an adverse event or both an adverse event and a product problem, the Veterinarian Visits page will open with the question, “Was a veterinarian consulted? If you answer “yes” to this question, a new box opens titled “Veterinarian Information.” Certain fields within this box are marked with an asterisk, indicating that these are required fields. You may provide information for up to three veterinarians/veterinary practices for each report.

If I have documents related to this report that I think are important for FDA to see, can I include these documents with my report?
The Attachments page allows you to attach up to 5 document files to the report. The maximum file size for each attachment is 10 MB (megabytes). The maximum size of your report, including attachments and other information, is 100 MB (megabytes). No attachments are required to submit any type of report. Click the “Add” button at the bottom right of the box on the attachments page and follow the instructions on the screen if you want to load any attachments to the report.

How do I know if my report was successfully entered into the system?
After you’ve entered all required information on each of the six pages of the report and you’ve clicked the “Submit Report” button at the end of the reporting form, you should see a message that says, “Congratulations! Your Initial FPSR.FDA.PETF.V.V1 report was successfully submitted on <date and time> to the downstream agency, and it was issued an Individual Case Safety Report Number (ICSR) of ########. Thank you for using the Safety Reporting Portal.” Print this page or copy the ICSR number and retain this information for your records. You may view or print a PDF file of the report by clicking on the “View/Print PDF” link, or you may click on the button labeled “Return to My Report History” if you are logged into an account. This will bring you back to the My Reports page. You can also close or exit your web browser after the report has been successfully submitted.

     - - Links on this page:http://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm182403.htmhttp://www.safetyreporting.hhs.gov
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« Last Edit: May 24, 2010, 02:07:26 PM by 3catkidneyfailure » Logged
3catkidneyfailure
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« Reply #2 on: May 25, 2010, 06:32:45 AM »

http://www.foodsafetynews.com/2010/05/feds-expand-reportable-registry-to-include-animal-drugs-pet-food/

Registry to Include Animal Drugs, Pet Food
by Helena Bottemiller | May 25, 2010

... "According to the release yesterday, the new Web portal includes a number of different features:

-Reportable Food Registry:  Industry will have a more user-friendly electronic portal for submitting reportable food reports that are required by law. This electronic portal collects reports from the food industry and public health officials regarding problems with articles of food, including animal feed, that present a reasonable probability of causing serious adverse health consequences or death to humans or animals.

-Pets: Pet owners and veterinarians will be able to use the portal to report product problems with pet foods and pet treats.

-Animal drugs: Animal drug manufacturers can report adverse drug events associated with animal drugs.

-Clinical Trials: Biomedical researchers involved in human gene transfer clinical trials can report an adverse event, indicating whether it might be an unanticipated consequence of the product being tested. Trial sponsors can use the portal to prepare a report, print it, and send it to the agency to satisfy reporting requirements for investigational new drugs.

"In the future, the system will encompass other types of clinical trials and, eventually, safety problems arising from products regulated by a broad array of federal agencies," according to the FDA. "This is a first step toward a common electronic reporting system that will offer one-stop shopping, allowing an individual to file a single report to multiple agencies that may have an interest in the event."

The agencies did not release a timeline for when the site will be fully functioning, but did note that, in the meantime, the new portal will redirect individuals seeking to submit reports to the right contact at the appropriate federal agency, including the U.S. Department of Agriculture, the Environmental Protection Agency, or the Consumer Product Safety Commission."

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3catkidneyfailure
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« Reply #3 on: May 25, 2010, 06:36:26 AM »

May 25, 2010 Safety Reporting Portal URL:

https://www.safetyreporting.hhs.gov/fpsr/WorkflowLoginIO.aspx?metinstance=12FEAE6E19C8DBB6F3F77D8E7EE50A84E53F8C82

ETA: FDA website often changes URLs on their website. Hopefully the FDA won't change the name from Safety Reporting Portal that consumers can search.
« Last Edit: May 25, 2010, 10:37:19 AM by 3catkidneyfailure » Logged
3catkidneyfailure
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« Reply #4 on: May 25, 2010, 10:41:17 AM »

Unclear to me whether consumers can report adverse veterinary drug reactions here or not, or just manufacturers, or
manufacturers and veterinarians:

http://www.oregonlive.com/pets/index.ssf/2010/05/new_portal_to_report_pet-food.html

New portal to report pet-food issues went online today
By Jacques Von Lunen, Special to The Oregon...
May 24, 2010, 4:11PM

"The new portal includes these features:
-- Reportable Food Registry: A more user-friendly way for producers to submit the food reports required by law. It collects reports from the food industry and public health officials regarding problems with food, including animal feed, that may cause serious health issues or death to humans or animals.
-- Pet foods: Owners and veterinarians can report problems with pet foods and pet treats.
-- Animal drugs: Animal-drug manufacturers can report adverse events related to their products.

The portal is not only used for pet-related issues: it also offers a way for biomedical researchers involved in human gene transfer trials to report adverse events. In the future, the system will cover other types of clinical trials and safety problems arising from products regulated by several other federal agencies. 

The FDA says the site is a first step toward an electronic reporting system that will allow consumers and professionals to file a single report to multiple agencies."
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Spartycats
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« Reply #5 on: May 27, 2010, 06:44:16 AM »

Unclear to me whether consumers can report adverse veterinary drug reactions here or not, or just manufacturers, or
manufacturers and veterinarians:

3cat- It is only drug firms that can use this.

Animal Drugs

If you are:
A marketing authorization holder* for animal drug
And the issue you are reporting is:
A product problem*** and/or adverse drug experience**

[CLICK TO BEGIN REPORT BUTTON]

If you are:
A private individual, consumer, or veterinary health care professional
And the issue you are reporting is:
A product problem*** and/or adverse drug experience** with an animal drug

Visit FDA's Animal Drug Safety Reporting webpage http://www.fda.gov/animalveterinary/safetyhealth/reportaproblem/ucm055305.htm
for instructions on how and where to report these safety issues.

If the statements above do not describe you or the issue you are reporting, please select another type of reporter or product from the list on the left of the screen.

* The MAH is the applicant (sometimes referred to as the company or the firm) or the nonapplicant (such as the firm's distributor).
** An adverse drug experience is any adverse event associated with the use of a product, whether or not the event is considered to be product-related, and whether or not the product was used in accordance with the approved labeling (see 21 CFR 514.3).
*** A product defect/manufacturing defect is generally associated with product contamination, product deterioration, manufacturing error, defective packaging, damage from disaster, or labeling error. For example, a labeling error may include any incident that causes a distributed product to be mistaken for, or its labeling applied to, another product (see 21 CFR 514.3).


I found this by clicking on "Animal Drugs" at left of page, here:
https://www.safetyreporting.hhs.gov/fpsr/FpsrRoutingPage.aspx

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3catkidneyfailure
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« Reply #6 on: May 27, 2010, 07:26:02 AM »

Good to get that clarified. Thanks, Spartycats!

Now if consumers who suspect problems with pet foods/pet treats will only use the portal to report.
Doesn't mean you have to be 100% positive beyond all reasonable doubt. Just letting the government know there are problems. It's for sure the pet food companies don't. This is one
tool we didn't have in 2007 at all and one we've been waiting for for three years. And if the consumer record is there, who knows what it could be used for.
« Last Edit: May 27, 2010, 07:28:04 AM by 3catkidneyfailure » Logged
Sandi K
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« Reply #7 on: May 31, 2010, 07:46:58 AM »

I am very happy to see this.....but I wonder how many reports it takes for FDA to launch an investigation or at least take a look-see.  What is the criteria they use that would cause them to initiate action?  Either way its a start.....and Im kind of guessing that Pet Food Institute doesnt like this one little bit.  Didnt they try to discourage FDA from allowing consumers to submit reports?  Take that Duane-o and Hershey Bar Nancy. Tongue
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mycatpaulie
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« Reply #8 on: February 14, 2011, 07:24:56 PM »

Thank you for these websites!  I filled out a report on the Safety Reporting Portal because I have been getting a bad smell from the wellness food my cats eats, does anyone know what happens next? 
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lesliek
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Trooper,Remy & Fragile


« Reply #9 on: February 14, 2011, 09:00:08 PM »

You can still call your states FDA office, just give them the details & the report # from the portal. It might help move things along.
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