Draft Guidance for Industry: Testing for Salmonella, 16425 [2011-6793]
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Federal Register / Vol. 76, No. 56 / Wednesday, March 23, 2011 / Notices
section for electronic
access to the draft guidance.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
INFORMATION
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration
Michael E. Kashtock, Center for Food
Safety and Applied Nutrition (HFS–
317), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740,301–436–2022.
SUPPLEMENTARY INFORMATION:
[Docket No. FDA–2011–D–0091]
Draft Guidance for Industry: Testing
for Salmonella Species in Human
Foods and Direct-Human-Contact
Animal Foods; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Testing for
Salmonella Species in Human Foods
and Direct-Human-Contact Animal
Foods.’’ The draft guidance, when
finalized, is intended for firms that
manufacture, process, pack, or hold
human foods or direct-human-contact
animal foods intended for distribution
to consumers, institutions, or food
processors. The draft guidance does not
apply to egg producers and other
persons who are covered by FDA’s final
rule ‘‘Prevention of Salmonella
Enteritidis in Shell Eggs During
Production, Storage, and
Transportation.’’ The draft guidance
addresses testing procedures for
Salmonella species (spp.) in human
foods (except shell eggs) and directhuman-contact animal foods, and the
interpretation of test results, when the
presence of Salmonella spp. in the food
may render the food injurious to human
health.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115 (g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
concerning the draft guidance by June
21, 2011.
ADDRESSES: Submit electronic
comments on the draft guidance to
https://www.regulations.gov. Submit
written comments on the draft guidance
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
written requests for single copies of the
draft guidance to the Office of Food
Safety, Center for Food Safety and
Applied Nutrition (HFS–317), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740. Send
two self-addressed adhesive labels to
assist that office in processing your
request. See the SUPPLEMENTARY
jlentini on DSKJ8SOYB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:46 Mar 22, 2011
Jkt 223001
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Testing for Salmonella Species in
Human Foods and Direct-HumanContact Animal Foods.’’ The draft
guidance, when finalized, is intended
for firms that manufacture, process,
pack, or hold human foods or directhuman-contact animal foods intended
for distribution to consumers,
institutions, or food processors. The
draft guidance does not apply to egg
producers and other persons who are
covered by FDA’s final rule ‘‘Prevention
of Salmonella Enteritidis in Shell Eggs
During Production, Storage, and
Transportation’’ (21 CFR part 118; the
shell egg final rule). The draft guidance
addresses testing procedures for
Salmonella spp. in human foods (except
shell eggs) and direct-human-contact
animal foods, and the interpretation of
test results, when the presence of
Salmonella spp. in the food may render
the food injurious to human health.
FDA intends to issue a separate
guidance document responding to
questions FDA has received on the shell
egg final rule since its publication and
include in that document guidance on
environmental and egg testing for
Salmonella Enteritidis.
Salmonella spp. can cause serious
and sometimes fatal infections in young
children, frail or elderly people, and
others with weakened immune systems.
Healthy persons infected with
Salmonella spp. often experience fever,
diarrhea (which may be bloody), nausea,
vomiting, and abdominal pain. In rare
circumstances, infection with
Salmonella spp. can result in the
organism getting into the blood stream
and producing more severe illnesses
such as arterial infections (i.e., infected
aneurysms), endocarditis, and arthritis.
In addition, direct-human-contact
animal foods contaminated with
Salmonella spp. pose a significant
health risk to humans who have direct
contact with the foods at homes, petting
zoos, agricultural fairs, or similar
venues.
The draft guidance represents the
Agency’s current thinking on testing for
Salmonella spp. in human foods and
direct-human-contact animal foods. It
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
16425
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 this document. 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 guidance at either
https://www.fda.gov/FoodGuidances or
https://www.regulations.gov. Always
access an FDA guidance document by
using the Web sites listed previously to
find the most current version of the
guidance.
Dated: March 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–6793 Filed 3–22–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0028]
Guidance for Industry and Food and
Drug Administration Staff; Class II
Special Controls Guidance Document:
Ovarian Adnexal Mass Assessment
Score Test System; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the special controls
guidance entitled ‘‘Class II Special
Controls Guidance Document: Ovarian
Adnexal Mass Assessment Score Test
System.’’ This guidance document
describes a means by which the ovarian
adnexal mass assessment score test
system may comply with the
requirement of special controls for class
II devices. Elsewhere in this issue of the
Federal Register, FDA is publishing a
final rule to classify these device types
into class II (special controls). This
SUMMARY:
E:\FR\FM\23MRN1.SGM
23MRN1
]]>Agencies
[Federal Register Volume 76, Number 56 (Wednesday, March 23, 2011)]
[Notices]
[Page 16425]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-6793]
[[Page 16425]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0091]
Draft Guidance for Industry: Testing for Salmonella Species in
Human Foods and Direct-Human-Contact Animal Foods; 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 industry entitled ``Testing for
Salmonella Species in Human Foods and Direct-Human-Contact Animal
Foods.'' The draft guidance, when finalized, is intended for firms that
manufacture, process, pack, or hold human foods or direct-human-contact
animal foods intended for distribution to consumers, institutions, or
food processors. The draft guidance does not apply to egg producers and
other persons who are covered by FDA's final rule ``Prevention of
Salmonella Enteritidis in Shell Eggs During Production, Storage, and
Transportation.'' The draft guidance addresses testing procedures for
Salmonella species (spp.) in human foods (except shell eggs) and
direct-human-contact animal foods, and the interpretation of test
results, when the presence of Salmonella spp. in the food may render
the food injurious to human health.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115 (g)(5)), to ensure that the Agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments concerning the
draft guidance by June 21, 2011.
ADDRESSES: Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments on the draft guidance to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of the draft guidance to the
Office of Food Safety, Center for Food Safety and Applied Nutrition
(HFS-317), Food and Drug Administration, 5100 Paint Branch Pkwy.,
College Park, MD 20740. 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 guidance.
FOR FURTHER INFORMATION CONTACT: Michael E. Kashtock, Center for Food
Safety and Applied Nutrition (HFS-317), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740,301-436-2022.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Testing for Salmonella Species in Human Foods and Direct-
Human-Contact Animal Foods.'' The draft guidance, when finalized, is
intended for firms that manufacture, process, pack, or hold human foods
or direct-human-contact animal foods intended for distribution to
consumers, institutions, or food processors. The draft guidance does
not apply to egg producers and other persons who are covered by FDA's
final rule ``Prevention of Salmonella Enteritidis in Shell Eggs During
Production, Storage, and Transportation'' (21 CFR part 118; the shell
egg final rule). The draft guidance addresses testing procedures for
Salmonella spp. in human foods (except shell eggs) and direct-human-
contact animal foods, and the interpretation of test results, when the
presence of Salmonella spp. in the food may render the food injurious
to human health. FDA intends to issue a separate guidance document
responding to questions FDA has received on the shell egg final rule
since its publication and include in that document guidance on
environmental and egg testing for Salmonella Enteritidis.
Salmonella spp. can cause serious and sometimes fatal infections in
young children, frail or elderly people, and others with weakened
immune systems. Healthy persons infected with Salmonella spp. often
experience fever, diarrhea (which may be bloody), nausea, vomiting, and
abdominal pain. In rare circumstances, infection with Salmonella spp.
can result in the organism getting into the blood stream and producing
more severe illnesses such as arterial infections (i.e., infected
aneurysms), endocarditis, and arthritis. In addition, direct-human-
contact animal foods contaminated with Salmonella spp. pose a
significant health risk to humans who have direct contact with the
foods at homes, petting zoos, agricultural fairs, or similar venues.
The draft guidance represents the Agency's current thinking on
testing for Salmonella spp. in human foods and direct-human-contact
animal foods. 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 this
document. 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 guidance
at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Always access an FDA guidance document by using
the Web sites listed previously to find the most current version of the
guidance.
Dated: March 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-6793 Filed 3-22-11; 8:45 am]
BILLING CODE 4160-01-P
