Draft Compliance Policy Guide Sec. 690.800 Salmonella, 45130 [2010-18873]
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Federal Register / Vol. 75, No. 147 / Monday, August 2, 2010 / Notices
Abuse (LAPSA) effective May 12, 1998.
Laboratories certified through that
program were accredited to conduct
forensic urine drug testing as required
by U.S. Department of Transportation
(DOT) regulations. As of that date, the
certification of those accredited
Canadian laboratories will continue
under DOT authority. The responsibility
for conducting quarterly performance
testing plus periodic on-site inspections
of those LAPSA-accredited laboratories
was transferred to the U.S. HHS, with
the HHS’ NLCP contractor continuing to
have an active role in the performance
testing and laboratory inspection
processes. Other Canadian laboratories
wishing to be considered for the NLCP
may apply directly to the NLCP
contractor just as U.S. laboratories do.
Upon finding a Canadian laboratory to
be qualified, HHS will recommend that
DOT certify the laboratory (Federal
Register, July 16, 1996) as meeting the
minimum standards of the Mandatory
Guidelines published in the Federal
Register on April 13, 2004 (69 FR
19644). After receiving DOT
certification, the laboratory will be
included in the monthly list of HHScertified laboratories and participate in
the NLCP certification maintenance
program.
Dated: July 20, 2010.
Elaine Parry,
Director, Office of Program Services,
SAMHSA.
[FR Doc. 2010–18636 Filed 7–30–10; 8:45 am]
BILLING CODE 4160–20–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0378]
Draft Compliance Policy Guide Sec.
690.800 Salmonella in Animal Feed;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for FDA
staff entitled ‘‘Compliance Policy Guide
Sec. 690.800 Salmonella in Animal
Feed’’ (the draft CPG). The draft CPG,
when finalized, is intended to provide
guidance for FDA staff on regulatory
policy relating to animal feed or feed
ingredients that come in direct contact
with humans, such as pet food and pet
treats, contaminated with Salmonella
and also on regulatory policy relating to
animal feed or feed ingredients
erowe on DSK5CLS3C1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
15:04 Jul 30, 2010
Jkt 220001
contaminated with a Salmonella
serotype that is pathogenic to the target
animal for the animal feed.
DATES: Although you can comment on
any CPG at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on the draft
CPG before it begins work on the final
version of the CPG, submit either
electronic or written comments on the
draft CPG by November 1, 2010.
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. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft CPG.
Submit electronic comments on the
draft CPG to https://www.regulations.gov.
Submit written comments on the draft
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: Kim
Young, Center for Veterinary Medicine
(HFV–230), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 240–
276–9200.
SUPPLEMENTARY INFORMATION:
recommendations for certain
circumstances where animal feed or
feed ingredients are contaminated with
Salmonella. 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.
I. Background
FDA is announcing the availability of
a draft guidance for FDA staff entitled
‘‘Compliance Policy Guide Sec. 690.800
Salmonella in Animal Feed.’’ The draft
CPG provides guidance for FDA staff
regarding the contamination of animal
feed and feed ingredients with
Salmonella. The draft CPG proposes
criteria that should be considered in
recommending enforcement action
against animal feed or feed ingredients
that are adulterated due to the presence
of Salmonella. In particular, the draft
CPG proposes regulatory action
guidance relating to animal feed or feed
ingredients that are contaminated with
Salmonella and (1) come in direct
contact with humans, such as pet food
and pet treats, or (2) are contaminated
with a Salmonella serotype that is
pathogenic to the target animal for
which the animal feed is intended. The
draft CPG also contains information that
may be useful to regulated industry and
the public.
FDA is issuing the draft CPG as Level
1 draft guidance consistent with FDA’s
good guidance practices regulation (21
CFR 10.115). The draft CPG, when
finalized, will represent the agency’s
current thinking on enforcement
[FR Doc. 2010–18873 Filed 7–30–10; 8:45 am]
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Fmt 4703
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II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding the draft CPG. It is
only necessary to send one set of
comments. It is no longer necessary to
send two 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 draft CPG at either
https://www.fda.gov/ora/compliance_ref/
cpg/default.htm or https://www.
regulations.gov.
Dated: July 23, 2010.
Michael A. Chappell,
Acting Associate Commissioner for
Regulatory Affairs.
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0125]
Guidance for Industry and
Researchers on the Radioactive Drug
Research Committee: Human
Research Without an Investigational
New Drug Application; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
and researchers entitled ‘‘The
Radioactive Drug Research Committee:
Human Research Without an
Investigational New Drug Application.’’
This guidance provides information to
those using radioactive drugs for certain
research purposes to help determine
whether research studies may be
conducted under an FDA-approved
radioactive drug research committee, or
SUMMARY:
E:\FR\FM\02AUN1.SGM
02AUN1
]]>Agencies
[Federal Register Volume 75, Number 147 (Monday, August 2, 2010)]
[Notices]
[Page 45130]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-18873]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0378]
Draft Compliance Policy Guide Sec. 690.800 Salmonella in Animal
Feed; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for FDA staff entitled ``Compliance
Policy Guide Sec. 690.800 Salmonella in Animal Feed'' (the draft CPG).
The draft CPG, when finalized, is intended to provide guidance for FDA
staff on regulatory policy relating to animal feed or feed ingredients
that come in direct contact with humans, such as pet food and pet
treats, contaminated with Salmonella and also on regulatory policy
relating to animal feed or feed ingredients contaminated with a
Salmonella serotype that is pathogenic to the target animal for the
animal feed.
DATES: Although you can comment on any CPG at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on the
draft CPG before it begins work on the final version of the CPG, submit
either electronic or written comments on the draft CPG by November 1,
2010.
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 self-addressed adhesive labels to assist that office in processing
your request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft CPG.
Submit electronic comments on the draft CPG to https://www.regulations.gov. Submit written comments on the draft 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: Kim Young, Center for Veterinary
Medicine (HFV-230), Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 240-276-9200.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for FDA
staff entitled ``Compliance Policy Guide Sec. 690.800 Salmonella in
Animal Feed.'' The draft CPG provides guidance for FDA staff regarding
the contamination of animal feed and feed ingredients with Salmonella.
The draft CPG proposes criteria that should be considered in
recommending enforcement action against animal feed or feed ingredients
that are adulterated due to the presence of Salmonella. In particular,
the draft CPG proposes regulatory action guidance relating to animal
feed or feed ingredients that are contaminated with Salmonella and (1)
come in direct contact with humans, such as pet food and pet treats, or
(2) are contaminated with a Salmonella serotype that is pathogenic to
the target animal for which the animal feed is intended. The draft CPG
also contains information that may be useful to regulated industry and
the public.
FDA is issuing the draft CPG as Level 1 draft guidance consistent
with FDA's good guidance practices regulation (21 CFR 10.115). The
draft CPG, when finalized, will represent the agency's current thinking
on enforcement recommendations for certain circumstances where animal
feed or feed ingredients are contaminated with Salmonella. 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
draft CPG. It is only necessary to send one set of comments. It is no
longer necessary to send two 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 draft CPG at
either https://www.fda.gov/ora/compliance_ref/cpg/default.htm or https://www.regulations.gov.
Dated: July 23, 2010.
Michael A. Chappell,
Acting Associate Commissioner for Regulatory Affairs.
[FR Doc. 2010-18873 Filed 7-30-10; 8:45 am]
BILLING CODE 4160-01-S
