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 

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Federal Register / Vol. 75, No. 246 / Thursday, December 23, 2010 / Notices 80827 

Activity (the CPG). The CPG provides 

guidance for FDA staff on its 

enforcement policies for pathogens and 

other indicators of inadequate 

pasteurization or post-pasteurization 

contamination of dairy products. 

DATES: Submit either electronic or 

written comments on the CPG at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the CPG to the Division 

of Compliance Policy (HFC–230), Office 

of Enforcement, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. Send two selfaddressed adhesive labels to assist that 

office in processing your request, or fax 

your request to 240–632–6861. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the CPG. 

Submit electronic comments to 

http://www.regulations.gov. Submit 

written comments on the CPG to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Monica Metz, Center for Food Safety 

and Applied Nutrition (HFS–316), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

301–436–2041. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of December 1, 

2009 (74 FR 62795), FDA made 

available draft CPG Sec. 527.300 Dairy 

Products—Microbial Contaminants and 

Alkaline Phosphatase Activity and gave 

interested parties an opportunity to 

submit comments by February 1, 2010. 

The agency reviewed and evaluated 

these comments and has modified the 

CPG where appropriate. 

The CPG provides guidance for FDA 

staff regarding pathogens and indicators 

of inadequate pasteurization or postpasteurization contamination of dairy 

products. The CPG outlines regulatory 

enforcement policies for FDA staff to 

use to initiate legal action 

recommendations based on analytical 

determinations that a dairy product 

contains a pathogenic microorganism 

(i.e., Salmonella species, 

enterohemorrhagic Escherichia coli 

(EHEC) O157:H7 and other 

enterohemorrhagic Escherichia coli, 

Campylobacter jejuni, Yersinia 

enterocolitica, or Clostridium 

botulinum); toxins produced by 

Clostridium botulinum, enterotoxigenic 

Staphylococcus, or Bacillus cereus; 

Staphylococcus aureus; Bacillus cereus; 

nontoxigenic Escherichia coli; or 

alkaline phosphatase. The CPG also 

contains information that may be useful 

to the regulated industry and to the 

public. 

FDA is issuing the CPG as level 1 

guidance consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The CPG represents FDA’s 

current thinking on pathogens and 

indicators of inadequate pasteurization 

or post-pasteurization contamination of 

dairy products. It does not create or 

confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternate approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding the CPG. It is only 

necessary to submit one set of 

comments. It is no longer necessary to 

send two paper copies of mailed 

comments. Identify comments 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. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the CPG from FDA’s Office 

of Regulatory Affairs history page. It 

may be accessed at http://www.fda.gov/ 

ora/compliance_ref/cpg/default.htm. 

Dated: December 16, 2010. 

Dara Corrigan, 

Associate Commissioner for Regulatory 

Affairs. 

[FR Doc. 2010–32232 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–2004–D–0298] (Formerly 

Docket No. 2004D–0499) 

Compliance Policy Guide; 

Radiofrequency Identification 

Feasibility Studies and Pilot Programs 

for Drugs; Notice To Extend Expiration 

Date 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; extension of expiration 

date. 

SUMMARY: The Food and Drug 

Administration (FDA) is extending the 

expiration date of compliance policy 

guide (CPG) Sec. 400.210 entitled 

‘‘Radiofrequency Identification (RFID) 

Feasibility Studies and Pilot Programs 

for Drugs’’ to December 31, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Connie Jung, Office of the 

Commissioner, Office of Policy, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 32, rm. 4254, 

Silver Spring, MD 20993–0002, 301– 

796–4830. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of November 17, 2004 

(69 FR 67360), FDA announced the 

availability of CPG Sec. 400.210 entitled 

‘‘Radiofrequency Identification (RFID) 

Feasibility Studies and Pilot Programs 

for Drugs.’’ Previous extensions of the 

expiration date of the CPG were 

published in 2007 and 2008 (72 FR 

65750, November 23, 2007; 73 FR 

78371, December 22, 2008). FDA has 

identified RFID as a promising 

technology to be used in the various 

efforts to combat counterfeit drugs. The 

CPG describes how the Agency intends 

to exercise its enforcement discretion 

regarding certain regulatory 

requirements that might otherwise be 

applicable to studies involving RFID 

technology for drugs. The goal of the 

CPG is to facilitate performance of RFID 

studies and to allow industry to gain 

experience with the use of RFID 

technology and its effect on the longterm safety and integrity of the U.S. 

drug supply. 

On September 27, 2007, the Food and 

Drug Administration Amendments Act 

of 2007 (FDAAA) was signed into law. 

Section 913 of FDAAA addressed 

pharmaceutical safety and created 

section 505D of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 355e). Section 505D(b) of the 

FD&C Act requires the development of 

standards for the identification, 

validation, authentication, and tracking 

and tracing of prescription drugs. 

Section 505D(b)(3) of the FD&C Act 

states that these new standards shall 

address promising technologies, which 

may include RFID technology. 

In implementing section 505D of the 

FD&C Act, FDA is currently addressing 

issues, such as promising technologies, 

that are relevant also for the CPG. In 

addition, FDA is considering further the 

experience of stakeholders and the 

Agency under the CPG. As we consider 

all of these issues, the CPG will remain 

in effect until December 31, 2012. 

Dated: December 17, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–32274 Filed 12–22–10; 8:45 am] 

BILLING CODE 4160–01–P 

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