Itchmo Forums for Cats & Dogs Brought to you by Itchmo: Essential news, humor and info for cats, dogs and pet owners.
December 15, 2019, 03:22:59 AM *
Welcome, Guest. Please login or register.

Login with username, password and session length
News:
 
   Home   Help Search Login Register  

Go To Itchmo.com: Read the latest cat, dog and pet news, pet food recall info, product reviews and more — updated daily.


Pages: [1] 2 3 ... 5
  Print  
Author Topic: FDA Docket Seeks Comment: Pet Food Early Warning Recall by CONSUMERS  (Read 15422 times)
0 Members and 1 Guest are viewing this topic.
3catkidneyfailure
Guest
« on: December 30, 2009, 09:32:53 AM »

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 ...
Logged
mary blonde
Sr. Member
****
Posts: 255

Sabbath RIP 1996 - 2009


« Reply #1 on: December 30, 2009, 09:58:01 AM »

This is AWESOME!!!
We ALL need to comment on this and to spread the word.
The more responses they get, the better chance of getting it into law!!
I think this is the best thing to happen in the battle of consumers vs. PFI ever!!
Logged

Got my coffee,
Got my cigarettes,
Got my computer
and took my Prozac...
It's gonna be a great day!
Sandi K
Hero Member
*****
Posts: 7365


« Reply #2 on: December 30, 2009, 11:37:24 AM »

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? 
Logged
3catkidneyfailure
Guest
« Reply #3 on: December 30, 2009, 11:50:04 AM »

So far there's just a form to critique and comment on. But you both are right; every concerned pet owner has to do that!

Not much talk about what will be done with it, how it will be used yet. Or the veterinarian's role in all this.
Logged
Carol
Hero Member
*****
Posts: 3200


« Reply #4 on: December 30, 2009, 01:47:34 PM »

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...
Logged

“Never doubt that a small group of thoughtful, committed citizens can change the world; indeed, it’s the only thing that ever has.” — Margaret Mead

United we stand     Divided we fall....
3catkidneyfailure
Guest
« Reply #5 on: December 30, 2009, 01:57:30 PM »



http://research.scottrade.com/public/markets/news/news.asp?docKey=100-364x2422-1&section=headlines

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.

I believe I hear the patter of pet food lobby marching feet
Logged
3catkidneyfailure
Guest
« Reply #6 on: December 30, 2009, 02:36:19 PM »

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 ... }
Logged
3catkidneyfailure
Guest
« Reply #7 on: December 30, 2009, 02:37:26 PM »

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
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.
{more to come ... }
Logged
3catkidneyfailure
Guest
« Reply #8 on: December 30, 2009, 02:38:44 PM »

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...}
« Last Edit: December 30, 2009, 02:48:52 PM by 3catkidneyfailure » Logged
Sandi K
Hero Member
*****
Posts: 7365


« Reply #9 on: December 30, 2009, 02:39:16 PM »

Oh 3cat, I think you may be right but hope that doesnt happen. I suspect it may be more like the stampede of pet food lobby feet....I will be so upset if they get in the way of things.  They have had it their way for way too long, they need to button their traps and get out of the way of progress for us and our pets.

{quote author=3catkidneyfailure link=topic=10093.msg149919#msg149919 date=1262210250]


I believe I hear the patter of pet food lobby marching feet
[/quote]
« Last Edit: December 30, 2009, 02:41:19 PM by Sandi K » Logged
3catkidneyfailure
Guest
« Reply #10 on: December 30, 2009, 02:39:46 PM »

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 ...}
Logged
3catkidneyfailure
Guest
« Reply #11 on: December 30, 2009, 02:40:55 PM »

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.
{more to come ...}
Logged
3catkidneyfailure
Guest
« Reply #12 on: December 30, 2009, 02:41:48 PM »

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 ... }
Logged
3catkidneyfailure
Guest
« Reply #13 on: December 30, 2009, 02:42:44 PM »

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.
VerDate Nov<24>2008 19:01 Dec 29, 2009 Jkt 220001 PO 00000 Frm 00050 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 69111
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
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.

{more to come ... }
Logged
3catkidneyfailure
Guest
« Reply #14 on: December 30, 2009, 02:43:54 PM »

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 ...
Logged
Pages: [1] 2 3 ... 5
  Print  
 
Jump to:  

Copyright 2007 Itchmo.com: Read the latest cat, dog and pet news, pet food recall info, product reviews and more — updated daily.
Powered by SMF 1.1.21 | SMF © 2015, Simple Machines | Sitemap