HALLELUJAH!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

RT @micheletjay (UC Davis)

PetFoodEarlyWarning Recall wo allow consumers report adverse w #petfood FDAseeking comments: http://bit.ly/6b5uK4

http://edocket.access.gpo.gov/2009/E9-30872.htm

[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.

God, I'm crying ...

I agree! This is great news!  I also think we should all send our comments in telling them to please do this and thank them.  I do worry that the pet food industry might try to block this but maybe they cant because its part of the FDA Amendment Act? 

http://www.petconnection.com/blog/2009/12/30/fda-wants-to-hear-from-you-on-pet-food-early-warning-recall-questionnaire/

this has some good info for those of us who are going to comment...

http://www.gpo.gov/fdsys/pkg/FR-2009-12-30/pdf/FR-2009-12-30.pdf
Federal Register, Dec. 30, 2009, 270 page pdf file. Pet Food Early Warning notice on pages 131 to 136 in my Adobe 9 Reader:

69106-69111

II. Pet Food Early Warning Recall
Rational Questionnaire as Part of the
MedWatchPlus 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 MedWatchPlus 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 MedWatchPlus 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
MedWatchPlusPortal 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
MedWatchPlus Portal and Rational
Questionnaire initiatives. Following is a
VerDate Nov<24>2008 19:01 Dec 29, 2009 Jkt 220001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\30DEN1.SGM 30DEN1 mstockstill on DSKH9S0YB1PROD with NOTICES
Federal Register /Vol. 74, No. 249 /Wednesday, December 30, 2009 /Notices 69107
table describing the data elements to be
included in the instrument.
{more to come ... }

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.
VerDate Nov<24>2008 19:01 Dec 29, 2009 Jkt 220001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\30DEN1.SGM 30DEN1 mstockstill on DSKH9S0YB1PROD with NOTICES
69108 Federal Register / Vol. 74, No. 249 / Wednesday, December 30, 2009 / Notices
TABLE 1.—DATA ELEMENTS FOR VOLUNTARY PET FOOD REPORTS OF PRODUCT PROBLEMS AND/OR ADVERSE EVENTS
SUBMITTED THROUGH THE MEDWATCHPLUS RATIONAL QUESTIONNAIRE SAFETY REPORTING PORTAL—Continued
Data Element Description
*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 event?
This asks the reporter to identify whether the animal was taking
medication or had a health 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).
{more to come...}

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.
VerDate Nov<24>2008 19:01 Dec 29, 2009 Jkt 220001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\30DEN1.SGM 30DEN1 mstockstill on DSKH9S0YB1PROD with NOTICES
Federal Register /Vol. 74, No. 249 /Wednesday, December 30, 2009 /Notices 69109
TABLE 1.—DATA ELEMENTS FOR VOLUNTARY PET FOOD REPORTS OF PRODUCT PROBLEMS AND/OR ADVERSE EVENTS
SUBMITTED THROUGH THE MEDWATCHPLUS RATIONAL QUESTIONNAIRE SAFETY REPORTING PORTAL—Continued
Data Element Description
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.
{more to come ...}

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).
VerDate Nov<24>2008 19:01 Dec 29, 2009 Jkt 220001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\30DEN1.SGM 30DEN1 mstockstill on DSKH9S0YB1PROD with NOTICES
69110 Federal Register / Vol. 74, No. 249 / Wednesday, December 30, 2009 / Notices
TABLE 1.—DATA ELEMENTS FOR VOLUNTARY PET FOOD REPORTS OF PRODUCT PROBLEMS AND/OR ADVERSE EVENTS
SUBMITTED THROUGH THE MEDWATCHPLUS RATIONAL QUESTIONNAIRE SAFETY REPORTING PORTAL—Continued
Data Element Description
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.
{more to come ... }

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

{End of Federal Register Notice}

SOMEONE ELSE IS GOING TO HAVE TO NAIL DOWN ELECTRONIC PORTAL SUBMISSION ...