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] 

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