Federal Register / Vol. 75, No. 246 / Thursday, December 23, 2010 / Notices 80825 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0368] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Pet Event Tracking 

Network—State, Federal Cooperation 

To Prevent Spread of Pet Food Related 

Diseases 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by January 24, 

2011. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910-new and title 

Pet Event Tracking Network—State, 

Federal Cooperation to Prevent Spread 

of Pet Food Related Diseases. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Johnny Vilela, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

7651, Juanmanuel.vilela@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Pet Event Tracking Network (PETNet)— 

State, Federal Cooperation To Prevent 

Spread of Pet Food Related Diseases— 

(OMB Control Number 0910-New) 

In August 2008, FDA sponsored the 

‘‘Gateway to Food Protection’’ meeting, 

also known as the ‘‘50–State’’ meeting. 

The meeting included representatives 

from other Federal Agencies, the States, 

localities, territories, and tribal partners, 

and was held to address the challenges 

necessary to ensure the safety of the 

U.S. food supply. Work groups were 

formed during the meeting which met 

and produced recommendations in 

specific topic areas. One of the 

workgroups, the Outbreaks/Food-Borne 

and Feed-Borne Investigations 

Workgroup, created a subgroup 

consisting of veterinarians, animal feed 

regulators, and others involved with 

animal health issues. This subgroup 

developed an ambitious proposal for an 

early warning system to identify, track, 

and report disease outbreaks in 

companion animals or contamination 

incidents concerning pet food or 

animals feed, which they named ‘‘The 

Pet Event Tracking Network’’ (PETNet). 

The PETNet proposal was developed in 

response to the 2007 outbreak that 

occurred in companion animals that 

was associated with the deliberate 

adulteration of pet food components, 

such as wheat gluten, with melamine. 

As envisioned by the subgroup at that 

time, PETNet would include a system 

for reporting outbreaks and would be 

supported by adequate diagnostic 

laboratory facilities and an established 

mechanism for conducting national 

epidemiological investigations. 

The PETNet subgroup subsequently 

met twice in face-to-face meetings, in 

May and November 2009, during which 

time the proposed scope of PETNet was 

streamlined to focus the program on 

information sharing, rather than 

epidemiology or other aspects. One of 

the main concerns of FDA’s State 

regulatory partners regarding FDA’s 

handling of the melamine incident was 

that many States provided information 

to FDA, but the information reported by 

the States to FDA and other information 

in the possession of FDA was not shared 

by FDA with the States. States believed 

that if they had received more 

information about what was going on in 

a timely manner, they could perhaps 

have taken appropriate action to 

safeguard animal and the public health 

by using their own regulatory 

authorities and resources. The Agency 

agreed with the States, and thus decided 

to focus PETNet on being a system for 

sharing information between FDA, other 

Federal Agencies, and the States about 

food-borne illness outbreaks in 

companion animals. By the end of the 

November 2009, meeting, this revised 

vision of PETNet was firmly established 

with many of the details about the 

system in place. 

FDA is planning to implement an 

initiative called PETNet that will allow 

FDA and its State partners to quickly 

and effectively exchange information 

about outbreaks of illness in companion 

animals associated with pet food. FDA 

has worked closely with its Federal and 

State partners to develop the PETNet, 

and believes that it will serve an 

important function in protecting the 

public and animal health. 

PETNet will be a secure, Internetbased network comprised of FDA, other 

Federal Agencies, and State regulatory 

Agencies/officials that have authority 

over pet food. The Network will provide 

timely and relevant information about 

pet food-related incidents to FDA, the 

States, and other Federal Government 

Agencies charged with protecting 

animal and public health. FDA intends 

to identify and invite State participants 

from all 50 States to participate in 

PETNet. Members of the network will be 

able to both receive alerts about pet food 

incidents, as well as create alerts when 

they are aware of a pet food incident 

within their jurisdiction. The 

information will be used to help State 

and Federal regulators determine how 

best to use inspectional and other 

resources to either prevent or quickly 

limit the adverse events caused by 

adulterated pet food. Many States have 

regulatory authority beyond that of FDA 

and often can be in a position to act 

independently of FDA with the 

information they will receive from the 

PetNet. 

Use of the system, including the 

reporting of incidents by States to FDA, 

will be entirely voluntary. The PETNet 

system will be housed in Food Shield, 

a proprietary software system, and will 

be accessible only to members via 

password. The system will make use of 

a standardized electronic form housed 

on FoodShield to collect and distribute 

basic information about pet food-related 

incidents. The form contains the 

following data elements, almost all of 

which are drop down menu choices: 

The species involved, clinical signs, 

number of animals exposed, number of 

animals affected, animal ages, date of 

onset, name and type of pet food 

involved, the manufacturer and 

distributor of the pet food (if known), 

the State where the incident occurred, 

the origin of the information, whether 

there are supporting laboratory results, 

and contact information for the 

reporting PETNet member (i.e., name, 

telephone number). The form would be 

filled out and submitted by a PETNet 

member on FoodShield, at which time 

it will be available to other PETNet 

members. Thus, the information will be 

entered and received by PETNet 

members in as close to real time as 

possible. FDA has designed the form 

itself to contain only the essential 

information necessary to alert PETNet 

members about pet food-related 

incidents. For further information, such 

as laboratory results, PETNet members 

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80826 Federal Register / Vol. 75, No. 246 / Thursday, December 23, 2010 / Notices 

can contact the reporting PETNet 

member. 

In the Federal Register of July 27, 

2010 (75 FR 43990), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. FDA received 12 comments 

on the 60-day notice, 11 from private 

citizens and one from a veterinary 

association. None of the comments 

addressed paperwork issues. Ten of the 

comments generally supported the 

PETNet concept, while two comments 

generally did not support it. 

Several comments suggested that it be 

mandatory, rather than voluntary, for all 

50 States to participate in PETNet. FDA 

declines to follow the comments’ 

suggestion, but we note that invitations 

have been sent to all 50 States 

requesting their participation in 

PETNet, and at this time 35 States have 

responded that they will participate in 

the program. 

Several comments stated that the 

information in PETNet should be 

publicly available and not just available 

to Federal and State pet food regulators. 

FDA disagrees with this comment. 

Much of the information shared through 

PETNet will be preliminary reports of 

potential pet food problems that turn 

out to be false or to otherwise have no 

public health significance. FDA and 

State Agencies routinely receive these 

types of reports and followup on them 

without notifying the public. FDA 

believes that State and Federal 

regulators can decide how to best use 

the information in PETNet, including 

how to use their resources to determine 

if a pet food incident warranting public 

notification exists. 

One comment recommended that 

FDA ‘‘closely assess reported incidents 

as soon as possible to ensure no 

confounding factors bias any 

determination of a need for a pet food 

recall.’’ To assist in this effort, the 

comment recommended that FDA 

incorporate drop down menus in the 

PETNet reporting form to collect 

information about whether the adverse 

event was confirmed (versus suspected) 

to have been caused by pet food, if the 

exposure was acute or chronic, and the 

clinical outcome of the case. 

PETNet will be an additional 

information resource used by FDA, but 

will not change FDA’s current process 

for determining the need for pet food 

recalls. The information the American 

Veterinary Medical Association 

recommends FDA collect will be 

considered by pet food regulatory 

professional in deciding whether to 

enter a report into PETNet. Some of the 

recommended information may also be 

derived from the current PETNet form. 

For example, question 11 asks if the 

reporter has laboratory results available 

to share. Laboratory results are key 

factors in confirming whether an 

adverse event is caused by a pet food. 

Answers to question 8 will provide an 

indication about duration of exposure, 

and some clinical outcomes can be 

derived form question 6. 

One comment stated that the focus of 

PETNet is wrong and that the U.S. 

Department of Agriculture (USDA) 

should be involved because it is their 

responsibility to inspect pet food plants. 

FDA notes that it is FDA, not USDA that 

is responsible for ensuring the safety of 

pet food, and that FDA conducts 

inspections of pet food manufacturing 

establishments. However, USDA is a 

Federal Agency that can contribute to 

PETNet and USDA has been invited/ 

will participate in PETNet. Another 

comment stated that PETNet ‘‘lacks data 

security’’ and is a ‘‘needlessly invasive 

project’’ whose object to ‘‘identify 

tainted doggie food’’ is of questionable 

value. With respect to data security, the 

data shared through PETNet is 

contained on a database limited to State 

and Federal Government officials, and 

the data collection form has been 

designed such that it is highly unlikely 

to contain confidential or trade secret 

information that requires additional 

data protection measures. Additionally, 

the Agency disagrees that the project is 

invasive since it is just a method of 

sharing existing information among 

State and Federal regulators. Finally, the 

objective of the project is to protect 

animal health is valid and consistent 

with FDA’s mission. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 U.S.C. 342 & 343/Section 1002(b) of the 2007 FDA 

amendments act/form FDA 

Number of 

respondents 

Annual 

frequency per 

response 

Total annual 

responses 

Hours per 

response Total hours 

Form FDA 3756 ................................................................... 50 10 500 20/60 167 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

FDA estimates that each State will 

report (i.e., fill out the PETNet form to 

alert other PETNet members about a pet 

food-related incident) approximately 10 

times per year. This estimate represents 

the maximum number of reports that 

FDA expects a State to submit in a year, 

and in many cases the number of reports 

submitted by a State will probably be far 

less. FDA believes that, given the form 

only has 11 items and most are drop 

down fields, 20 minutes is a sufficient 

amount of time to complete the form. 

State regulatory officials responsible for 

pet food already possess computer 

systems and have the Internet access 

necessary to participate in PETNet, and 

thus there are no capital expenditures 

associated with the reporting. 

Regarding recordkeeping, State 

regulatory officials who report on 

PETNet receive the reportable 

information from consumers in their 

States in the course of their customary 

and regular duties. Further, these 

individuals already maintain records of 

such consumer complaints in the course 

of their duties which are sufficient for 

the purposes of reporting on PETNet. 

Therefore, FDA believes that the 

proposed collection of information does 

not have additional recordkeeping 

requirements. 

Dated: December 16, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–32275 Filed 12–22–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0466] 

Compliance Policy Guide Sec. 527.300 

Dairy Products—Microbial 

Contaminants and Alkaline 

Phosphatase Activity; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of Compliance Policy Guide 

Sec. 527.300 Dairy Products—Microbial 

Contaminants and Alkaline Phosphatase 

mstockstill on DSKH9S0YB1PROD with NOTICES