[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Data Element Description
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Introduction Page
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Report Identifying Information
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
*Which of the following best describes you? This describes whether the reporter is a consumer/private citizen, or a veterinary
professional.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
*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.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
*What type of report are you submitting? This describes the type of report being submitted (e.g., adverse event, product problem, or
both).
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
*Are you the animal owner? This indicates whether the reporter is the owner of an animal involved in the report.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Contact Information Page
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Your Contact Information
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
First Name This is the reporter's first name.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Last Name This is the reporter's last name.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
*May the FDA contact you to follow-up, if necessary? This indicates whether FDA may contact the reporter if follow-up information is needed.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
E-mail This is the reporter's e-mail address.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Confirm e-mail This requests that e-mail information be confirmed by the reporter.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Primary Phone This is the reporter's primary phone number.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Other Phone This is the reporter's alternate phone number.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Country This is the reporter's country of residence.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Street Address Line 1 This is the street address of the reporters primary residence.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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).
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
City/Town This is the reporter's city or town of residence.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
State This is the reporter's State of residence.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
ZIP/Postal Code This is the zip code for the reporter's residence.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Other Parties Reported To
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Problem Summary Page
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Affected Animal Information
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Number of animals given the product This asks about the number of animals that received the product.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
*Number of animals reacted This asks about the number of animals that became ill or had a reaction after receiving the
product.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Animal Name/Identifier This asks the reporter to provide a name or other means to identify the animal(s) involved in
the report.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
*Species This is a list of values describing the species of the animal(s) involved in the report.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 69108]]
*Breed This is a list of values describing the breed(s) of the animal(s) involved in the report.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Age This is the animal's age.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Weight This is the animal's weight.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Gender This asks the reporter to identify the gender (sex) of the animal involved in the report.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
*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).
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
*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.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
*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.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Medical History
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Problem Description
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
*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.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
*Date problem started This asks the reporter what date the problem started.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Date of recovery This is the date the animal recovered from the illness associated with, or the reaction to, the
product.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
*Outcome to date This requests that the reporter identify the current condition of the animal.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
*Date of death This is the date the animal died (if applicable).
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Products Page
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Product Details
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
*Product Brand Name This is the name of the product.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
UPC from Label This is the 12-digit bar code that can be found on the product label.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
*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.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Package Type This is a list of values for the type of package or container for the product.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Package Size This asks the reporter to provide information on the quantity of the product contained in the
package.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Date last purchased product This is the date the product was last purchased.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
[[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.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Product Use Details
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Describe how the product was used or administered. This asks the reporter to describe how the product was given to the animal.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
How Product Was Used
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Was product use started again? This asks the reporter to indicate whether the product was used again after its use was
stopped.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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).
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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).
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Product Purchase Location
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Store/place of purchase. This is the name of the store or the Web address from which the product was purchased.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Country This is the country associated with the store or the Web address from which the product was
purchased.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Street Address Line 1 This is the street address associated with the store or the Web address from which the product
was purchased.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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).
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 69110]]
City/Town This is the city or town associated with the store or the Web address from which the product
was purchased.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
State This is the State associated with the store or the Web address from which the product was
purchased.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
State/Province This is the State/Province associated with the store or the Web address from which the product
was purchased.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
ZIP/Postal Code This is the zip code associated with the store or the Web address from which the product was
purchased.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Firm/Organization on Label
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Firm/Organization Name This is name of the firm that appears on the label.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Firm/Organization Type This is the type of firm whose name appears on the label.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Country This is the country associated with the firm that appears on the label.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Primary Phone This is the primary phone number associated with the firm that appears on the label.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Street Address Line 1 This is the street address associated with the firm that appears on the label.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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).
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
City/Town This is the city or town associated with the firm that appears on the label.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
State This is the State associated with the firm that appears on the label.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
State/Province This is the State/Province associated with the firm that appears on the label.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
ZIP/Postal Code This is the zip code associated with the firm that appears on the label.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Web address This is the Web address for the firm whose name appears on the label.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Product Lots
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Lot Number This requests the reporter to provide the lot number or production code that can be found on
the label.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Veterinarian Visits Page
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Veterinary Visit Details
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Veterinarian Information
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
*First Name This is the first name of the veterinarian who was consulted.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
*Last Name This is the last name of the veterinarian who was consulted.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Veterinary Practice Name This is the name of the veterinary practice in which the veterinarian that was consulted works.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 69111]]
Country This is the country of the veterinary practice where the animal was examined.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Street Address Line 1 This is the street address of the veterinary practice where the animal was examined.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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).
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
City/Town This is the city or town of the veterinary practice where the animal was examined.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
State This is the State of the veterinary practice where the animal was examined.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
ZIP/Postal Code This is the zip code of the veterinary practice where the animal was examined.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
E-mail This is the e-mail address of the veterinary practice where the animal was examined.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
*Primary Phone This is the primary phone number of the veterinary practice where the animal was examined.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Attachments Page
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Attach File
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
*Description of Attachment This requests the reporter provide a brief description of the file being attached, e.g.,
scanned label or medical records.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
*Type of Attachment This requests the reporter indicate the specific contents of the attachment.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
* Indicates the information or a response is necessary for FDA to fully process a report.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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