Pet Event Tracking Network (PETNet)— State, Federal Cooperation to Prevent Spread of Pet Food Related Diseases

0680 83C Change Request Justification Memorandum 1-6-2017.doc

Pet Event Tracking Network (PETNet)--State, Federal Cooperation to Prevent Spread of Pet Food Related Diseases

Pet Event Tracking Network (PETNet)— State, Federal Cooperation to Prevent Spread of Pet Food Related Diseases

OMB: 0910-0680

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Pet Event Tracking Network (PETNet)—

State, Federal Cooperation to Prevent Spread of Pet Food Related Diseases


0910-0680


JUSTIFICATION MEMORANDUM FOR 83-C CHANGE REQUEST



The Food and Drug Administration (FDA or we) is submitting this nonmaterial/non-substantive change request (83-C) to obtain Office of Management and Budget (OMB) approval of a rational questionnaire to be used on the Pet Event Tracking Network (PETNet) for voluntary animal food/feed adverse event reporting. We currently have OMB approval to receive two types of reports via the tracking network: reports of pet food related illness and product defects associated with dog food, cat food, and food for other pets, which are submitted via the Pet Event Tracking Network (PETNet); and, reports of animal food-related illness and product defects associated with animal food for livestock animals, aquaculture species, and horses, which are submitted via LivestockNet. The third rational questionnaire is written with descriptive language specific to reports of animal food-related illness and product defects associated with specific laboratory food samples (SampleNet). For the purposes of this 83-C request, there is no change to the type of information currently being requested; we are seeking to make the tracking network available to submitters who choose to make voluntary adverse event reports about specific samples of animal food/feed.


Currently, reporters (Federal, State, and Territorial regulatory and public health agency employees with membership access to the tracking network) may voluntarily choose to electronically submit adverse event reports about animal food/feed. With the new questionnaire, respondents will be permitted to select whether to characterize their adverse event report as relating to a specific laboratory sample of animal food/feed. Information submitted is similar to the type of information currently submitted and will include descriptive information about the product, the laboratory/reporter, and the related complaint/product defect. FDA expects that this characterization will not cause any change to the average burden per response, which will remain at 15 minutes.


We request OMB approval of the new rational questionnaire for the Pet Event Tracking Network (PETNet) as a "non-substantive, non-material" change.



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File Typeapplication/msword
AuthorTaylor, Anne
Last Modified ByMizrachi, Ila
File Modified2017-01-09
File Created2017-01-09

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