
[Federal Register: December 30, 2009 (Volume 74, Number 249)]
[Notices]               
[Page 69106-69111]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30de09-70]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0546]

 
Agency Information Collection Activities; Proposed Collection; 
Comment Request; Pet Food Early Warning Recall Rational Questionnaire 
as Part of the MedWatch\Plus\ Portal and Rational Questionnaire 
Initiative

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information and 
to allow for public comment in response to the notice. This notice 
solicits comments on the data elements for the Rational Questionnaire 
which is being rolled out as part of the ongoing MedWatch\Plus\ Portal 
and Rational Questionnaire initiative.

DATES:  Submit written or electronic comments on the collection of 
information by January 29, 2010.

ADDRESSES:  Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Denver Presley Jr., Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793.

SUPPLEMENTARY INFORMATION:

I. Background

    Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain 
approval from the Office of Management and Budget (OMB) for each 
collection of information they conduct or sponsor. ``Collection of 
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and 
includes agency requests or requirements that members of the public 
submit reports, keep records, or provide information to a third party. 
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires 
Federal agencies to provide a notice in the Federal Register concerning 
each proposed collection of information before submitting the 
collection to OMB for approval. To comply with this requirement, FDA is 
publishing notice of the proposed collection of information set forth 
in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

II. Pet Food Early Warning Recall Rational Questionnaire as Part of the 
MedWatch\Plus\ Portal and Rational Questionnaire Initiative (OMB 
Control No. 0910-0645)--Revision

    Section 1002(b) of the FDA Amendments Act of 2007 (FDAAA) (Public 
Law 110-85), directs the Secretary of Health and Human Services (the 
Secretary), to establish an early warning and surveillance system to 
identify adulteration of the pet food supply and outbreaks of illness 
associated with pet food. As part of the effort to fulfill that 
directive, the Secretary tasked FDA with developing the instrument that 
would allow consumers to report voluntarily adverse events associated 
with pet food. In a 60-day Federal Register notice, which published on 
October 23, 2008 (73 FR 63153 at 63155), and a 30-day notice, which 
published on May 20, 2009 (74 FR 23721 at 23726), FDA announced the 
agency-wide information collection initiatives MedWatch\Plus\ Portal 
and Rational Questionnaire. These initiatives are components of a 
larger electronic system being developed to collect, submit, and 
process adverse event reports and other safety information for all FDA-
regulated products. The MedWatch\Plus\ Portal, a Web-based portal, and 
the Rational Questionnaire, a user-friendly data collection tool, 
together make it easy for the public to report a safety problem.
    In this 30-day notice, FDA is requesting public comment on data 
elements associated with the roll out of the Pet Food Early Warning 
System component of the overall MedWatch\Plus\Portal and Rational 
Questionnaire initiative, whose framework and burden hours were 
approved under OMB Control Number 0910-0645. This notice refers to the 
instrument described in that information collection. FDA previously 
estimated the total burden hours associated with the Pet Food Early 
Warning System to be 324 hours (73 FR 63153 at 63155; 74 FR 23721 at 
23726). The estimated burden hours associated with this information 
collection remain 324 total hours.

III. Data Elements for Pet Food Early Warning System Rational 
Questionnaire

    In this 30-day notice, FDA is requesting public comment on data 
elements associated with the Pet Food Early Warning System component of 
the MedWatch\Plus\ Portal and Rational Questionnaire initiatives. 
Following is a

[[Page 69107]]

table describing the data elements to be included in the instrument.

      Table 1.--Data Elements for Voluntary Pet Food Reports of Product Problems and/or Adverse Events Submitted Through the MedWatch\Plus\ Rational Questionnaire Safety Reporting Portal
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                                          Data Element                                                                                     Description
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                                                                                        Introduction Page
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                                                                                 Report Identifying Information
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*Which of the following best describes you?                                                      This describes whether the reporter is a consumer/private citizen, or a veterinary
                                                                                                  professional.
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*Enter a name to help you identify the report.                                                   This requests that the reporter enter a short name, description, or title that the reporter
                                                                                                  associates with the event reported.
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*What type of report are you submitting?                                                         This describes the type of report being submitted (e.g., adverse event, product problem, or
                                                                                                  both).
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*Are you the animal owner?                                                                       This indicates whether the reporter is the owner of an animal involved in the report.
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                                                                                    Contact Information Page
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                                                                                    Your Contact Information
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First Name                                                                                       This is the reporter's first name.
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Last Name                                                                                        This is the reporter's last name.
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*May the FDA contact you to follow-up, if necessary?                                             This indicates whether FDA may contact the reporter if follow-up information is needed.
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E-mail                                                                                           This is the reporter's e-mail address.
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Confirm e-mail                                                                                   This requests that e-mail information be confirmed by the reporter.
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Primary Phone                                                                                    This is the reporter's primary phone number.
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Other Phone                                                                                      This is the reporter's alternate phone number.
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Country                                                                                          This is the reporter's country of residence.
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Street Address Line 1                                                                            This is the street address of the reporters primary residence.
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Street Address Line 2                                                                            This is additional street address information for the reporter's primary residence (if
                                                                                                  additional lines are necessary to report that information).
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City/Town                                                                                        This is the reporter's city or town of residence.
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State                                                                                            This is the reporter's State of residence.
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ZIP/Postal Code                                                                                  This is the zip code for the reporter's residence.
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                                                                                    Other Parties Reported To
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Indicate any other parties that you notified about this issue                                    This asks the reporter to identify (in general) other parties told about the problem being
                                                                                                  reported to FDA.
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                                                                                      Problem Summary Page
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                                                                                   Affected Animal Information
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Number of animals given the product                                                              This asks about the number of animals that received the product.
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*Number of animals reacted                                                                       This asks about the number of animals that became ill or had a reaction after receiving the
                                                                                                  product.
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Animal Name/Identifier                                                                           This asks the reporter to provide a name or other means to identify the animal(s) involved in
                                                                                                  the report.
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*Species                                                                                         This is a list of values describing the species of the animal(s) involved in the report.
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[[Page 69108]]


*Breed                                                                                           This is a list of values describing the breed(s) of the animal(s) involved in the report.
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Age                                                                                              This is the animal's age.
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Weight                                                                                           This is the animal's weight.
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Gender                                                                                           This asks the reporter to identify the gender (sex) of the animal involved in the report.
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*Reproductive status                                                                             This asks the reporter to identify whether the animal's reproductive organs are intact or
                                                                                                  whether the animal had been neutered (e.g., sterilized, castrated or spayed).
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*Was animal pregnant at time of event?                                                           This asks the reporter to identify whether the animal was pregnant at the time of the adverse
                                                                                                  event.
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*Was the animal lactating at time of event?                                                      This asks the reporter to identify whether the animal was producing milk at the time of the
                                                                                                  adverse event.
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Prior to the event what was the animal's overall state of health?                                This asks the reporter to identify the overall or general state of the animal's health before
                                                                                                  the adverse event.
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                                                                                         Medical History
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Did the animal have any health problems and/or was the animal taking medication prior to the     This asks the reporter to identify whether the animal was taking medication or had a health
 event?                                                                                           problem before the adverse event.
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                                                                                       Problem Description
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*Describe what happened                                                                          This asks the reporter to describe in a narrative what was observed with the product, and/or
                                                                                                  how the animal reacted to the product.
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*Date problem started                                                                            This asks the reporter what date the problem started.
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Date of recovery                                                                                 This is the date the animal recovered from the illness associated with, or the reaction to, the
                                                                                                  product.
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*Outcome to date                                                                                 This requests that the reporter identify the current condition of the animal.
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*Date of death                                                                                   This is the date the animal died (if applicable).
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                                                                                          Products Page
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                                                                                         Product Details
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*Product Brand Name                                                                              This is the name of the product.
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UPC from Label                                                                                   This is the 12-digit bar code that can be found on the product label.
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*Product Type                                                                                    This asks the reporter to identify whether the product is food for people, food for pet
                                                                                                  animals, or food for other animals, such as livestock, zoo, or research animals.
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Was product recalled?                                                                            This asks the reporter to identify whether the reporter knows if the manufacturer has removed
                                                                                                  from sale and destroyed the product being reported, regardless of whether the manufacturer did
                                                                                                  so voluntarily or at the request of a government agency.
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Package Type                                                                                     This is a list of values for the type of package or container for the product.
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Package Size                                                                                     This asks the reporter to provide information on the quantity of the product contained in the
                                                                                                  package.
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Date last purchased product                                                                      This is the date the product was last purchased.
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Number purchased on this date                                                                    This asks the reporter to enter the number of packages, containers, or other units of the
                                                                                                  product purchased on the date the product was last purchased.
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[[Page 69109]]


If the product is reconstituted, what is the percentage of the product that is water?            This asks the reporter to provide information for the proportion (expressed as a percentage) of
                                                                                                  the final product fed that is water, if water is added to the product before feeding it.
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Were there any other foods or products given to the animal during this period of time?           This asks the reporter to identify whether the animal was fed any other foods or supplements
                                                                                                  during the time the animal was fed the product.
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Do you have a package/container of unopened product from this purchase?                          This asks the reporter to identify whether the reporter has any remaining unopened packages or
                                                                                                  containers of the product.
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Describe how the product was stored before and after opening.                                    This asks the reporter to describe how the product was stored in the user's home before it was
                                                                                                  opened and after it was opened.
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                                                                                       Product Use Details
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Describe how the product was used or administered.                                               This asks the reporter to describe how the product was given to the animal.
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Date first fed the animal product from this purchase                                             This is the first date the animal received product from the most recent purchase of that
                                                                                                  product.
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Date last fed the animal product from this purchase                                              This is the last date the animal received product from the most recent purchase of that
                                                                                                  product.
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Percentage of daily ration of product that animal consumed.                                      This asks the reporter to provide an estimate of the percentage of the animal's total diet that
                                                                                                  is represented by the product being reported.
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                                                                                      How Product Was Used
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Amount of time from use of product to onset of the event?                                        This asks the reporter to provide information on the amount of time the product was used before
                                                                                                  the animal became ill or reacted to the product.
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Was the product use stopped after the onset of the adverse event?                                This asks the reporter to identify whether the use of the product was stopped after the animal
                                                                                                  became ill or reacted to the product.
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Did the adverse event diminish or stop after the product use was stopped?                        This asks the reporter to identify whether the signs of illness or reaction stopped or lessened
                                                                                                  after use of the product was stopped.
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Was product use started again?                                                                   This asks the reporter to indicate whether the product was used again after its use was
                                                                                                  stopped.
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Length of waiting period between stopping and restarting product use                             This is the amount of time between stopping use of the product and restarting the use of the
                                                                                                  product (if applicable).
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Did the adverse event reappear after reintroducing this product?                                 This requests the reporter identify whether the illness or reaction to the product occurred
                                                                                                  again after the use of the product was restarted (if applicable).
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In your opinion, how likely is it that the use of this product is related to the adverse event?  This requests the reporter to indicate how strongly the reporter believes the use of the
                                                                                                  product caused the illness or adverse reaction.
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                                                                                    Product Purchase Location
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Store/place of purchase.                                                                         This is the name of the store or the Web address from which the product was purchased.
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Country                                                                                          This is the country associated with the store or the Web address from which the product was
                                                                                                  purchased.
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Street Address Line 1                                                                            This is the street address associated with the store or the Web address from which the product
                                                                                                  was purchased.
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Street Address Line 2                                                                            This is additional street address information associated with the store or the Web address from
                                                                                                  which the product was purchased (if additional lines are necessary to report that
                                                                                                  information).
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[[Page 69110]]


City/Town                                                                                        This is the city or town associated with the store or the Web address from which the product
                                                                                                  was purchased.
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State                                                                                            This is the State associated with the store or the Web address from which the product was
                                                                                                  purchased.
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State/Province                                                                                   This is the State/Province associated with the store or the Web address from which the product
                                                                                                  was purchased.
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ZIP/Postal Code                                                                                  This is the zip code associated with the store or the Web address from which the product was
                                                                                                  purchased.
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                                                                                   Firm/Organization on Label
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Do you have one or more labels from this product?                                                This requests the reporter to indicate whether the reporter has one or more labels from the
                                                                                                  product being reported.
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Firm/Organization Name                                                                           This is name of the firm that appears on the label.
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Firm/Organization Type                                                                           This is the type of firm whose name appears on the label.
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Country                                                                                          This is the country associated with the firm that appears on the label.
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Primary Phone                                                                                    This is the primary phone number associated with the firm that appears on the label.
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Street Address Line 1                                                                            This is the street address associated with the firm that appears on the label.
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Street Address Line 2                                                                            This is additional street address information associated with the firm that appears on the
                                                                                                  label (if additional lines are needed to report that information).
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City/Town                                                                                        This is the city or town associated with the firm that appears on the label.
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State                                                                                            This is the State associated with the firm that appears on the label.
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State/Province                                                                                   This is the State/Province associated with the firm that appears on the label.
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ZIP/Postal Code                                                                                  This is the zip code associated with the firm that appears on the label.
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Web address                                                                                      This is the Web address for the firm whose name appears on the label.
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                                                                                          Product Lots
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Lot Number                                                                                       This requests the reporter to provide the lot number or production code that can be found on
                                                                                                  the label.
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Expiration/use-by date                                                                           This is the month and year of an expiration date or use-by (best-by, best-before) date that
                                                                                                  appears on the label.
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                                                                                    Veterinarian Visits Page
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                                                                                    Veterinary Visit Details
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Was a veterinarian consulted?                                                                    This requests the reporter to indicate whether a veterinarian was consulted about the illness
                                                                                                  or reaction the animal had to the product.
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                                                                                    Veterinarian Information
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*First Name                                                                                      This is the first name of the veterinarian who was consulted.
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*Last Name                                                                                       This is the last name of the veterinarian who was consulted.
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Veterinary Practice Name                                                                         This is the name of the veterinary practice in which the veterinarian that was consulted works.
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[[Page 69111]]


Country                                                                                          This is the country of the veterinary practice where the animal was examined.
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Street Address Line 1                                                                            This is the street address of the veterinary practice where the animal was examined.
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Street Address Line 2                                                                            This is additional street address information for the veterinary practice where the animal was
                                                                                                  examined (if additional lines are needed to report that information).
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City/Town                                                                                        This is the city or town of the veterinary practice where the animal was examined.
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State                                                                                            This is the State of the veterinary practice where the animal was examined.
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ZIP/Postal Code                                                                                  This is the zip code of the veterinary practice where the animal was examined.
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E-mail                                                                                           This is the e-mail address of the veterinary practice where the animal was examined.
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*Primary Phone                                                                                   This is the primary phone number of the veterinary practice where the animal was examined.
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                                                                                        Attachments Page
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                                                                                           Attach File
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*Description of Attachment                                                                       This requests the reporter provide a brief description of the file being attached, e.g.,
                                                                                                  scanned label or medical records.
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*Type of Attachment                                                                              This requests the reporter indicate the specific contents of the attachment.
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* Indicates the information or a response is necessary for FDA to fully process a report.
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IV. Request for Comments

    FDA invites comments on all aspects of the collection of the data 
elements for this Pet Food Early Warning System Rational Questionnaire. 
Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding the proposed 
changes. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified with the docket number found 
in brackets in the heading of this document. Received comments may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: December 22, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-30872 Filed 12-29-09; 8:45 am]

BILLING CODE 4160-01-S
