Compliance Policy Guide; Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs; Notice To Extend Expiration Date, 80827 [2010-32274]
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Federal Register / Vol. 75, No. 246 / Thursday, December 23, 2010 / Notices
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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
https://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
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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 https://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.
The Food and Drug
Administration (FDA) is extending the
expiration date of compliance policy
guide (CPG) Sec. 400.210 entitled
SUMMARY:
PO 00000
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80827
‘‘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.
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.
SUPPLEMENTARY INFORMATION:
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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[Federal Register Volume 75, Number 246 (Thursday, December 23, 2010)]
[Notices]
[Page 80827]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-32274]
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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 long-term 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
