Guidance for Industry: Testing for Salmonella Species in Human Foods and Direct-Human-Contact Animal Foods; Availability, 14022-14023 [2012-5628]
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14022
Federal Register / Vol. 77, No. 46 / Thursday, March 8, 2012 / Notices
OMB has now approved the information
collection and has assigned OMB
control number 0910–0626. The
approval expires on February 28, 2015.
A copy of the supporting statement for
this information collection is available
on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
Dated: March 2, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
SUPPLEMENTARY INFORMATION:
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0112]
Guidance for Industry on Chemistry,
Manufacturing, and Controls
Information—Fermentation-Derived
Intermediates, Drug Substances, and
Related Drug Products for Veterinary
Medicinal Use; Availability
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
#216 entitled ‘‘Chemistry,
Manufacturing, and Controls (CMC)
Information—Fermentation-Derived
Intermediates, Drug Substances, and
Related Drug Products for Veterinary
Medicinal Use.’’
The purpose of this document is to
provide recommendations on what
documentation to submit to support the
CMC information for fermentationderived intermediates, drug substances,
and related drug products for veterinary
medicinal use.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Communications Staff (HFV–12), Center
for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
wreier-aviles on DSK5TPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
15:20 Mar 07, 2012
Jkt 226001
Michael J. Popek, Center for Veterinary
Medicine (HFV–144), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8269,
email: michael.popek@fda.hhs.gov.
I. Background
[FR Doc. 2012–5632 Filed 3–7–12; 8:45 am]
AGENCY:
FOR FURTHER INFORMATION CONTACT:
This level 1 guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance will represent the
Agency’s current thinking on this topic.
It does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
III. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
this guidance have been approved under
OMB control number 0910–0032.
IV. 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. 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.
Fmt 4703
Sfmt 4703
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0091]
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 or the Agency) is
announcing the availability of a
guidance entitled ‘‘Guidance for
Industry: Testing for Salmonella Species
in Human Foods and Direct-HumanContact Animal Foods.’’ The document
provides guidance to firms that
manufacture, process, pack, or hold
human foods or direct-human-contact
animal foods intended for distribution
to consumers, institutions, or food
processors. This 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 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: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of the 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
SUMMARY:
II. Significance of Guidance
Frm 00024
Dated: March 5, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–5629 Filed 3–7–12; 8:45 am]
In the Federal Register of March 14,
2011 (76 FR 13629), FDA published the
notice of availability for a draft guidance
entitled ‘‘Chemistry, Manufacturing,
and Controls (CMC) Information—
Fermentation-Derived Intermediates,
Drug Substances, and Related Drug
Products for Veterinary Medicinal Use’’
giving interested persons until May 30,
2011, to comment on the draft guidance.
FDA received one comment on the draft
guidance. No substantive changes were
made in finalizing this guidance
document.
The guidance announced in this
notice finalizes the draft guidance dated
March 14, 2012.
PO 00000
V. Electronic Access
Persons with access to the Internet
may obtain the guidance at either
https://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm or
https://www.regulations.gov.
E:\FR\FM\08MRN1.SGM
08MRN1
Federal Register / Vol. 77, No. 46 / Thursday, March 8, 2012 / Notices
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments on the
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
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, 240–402–2022.
SUPPLEMENTARY INFORMATION:
wreier-aviles on DSK5TPTVN1PROD with NOTICES
I. Background
In the Federal Register of March 23,
2011 (76 FR 16425), FDA made
available a draft guidance entitled
‘‘Testing for Salmonella Species in
Human Foods and Direct-HumanContact Animal Foods’’ and gave
interested parties an opportunity to
submit comments by June 21, 2011. The
Agency reviewed and evaluated these
comments and has modified the
guidance where appropriate.
This guidance 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 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 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 issued separate guidances in
December 2011 and July 2011,
respectively, entitled ‘‘Guidance for
Industry: Prevention of Salmonella
Enteritidis in Shell Eggs During
Production, Storage and
Transportation,’’ which provides
guidance to egg producers on how to
comply with certain provisions
contained in the shell egg final rule,
including provisions for environmental
and egg testing for Salmonella
Enteritidis; and ‘‘Draft Guidance for
Industry: Questions and Answers
Regarding the Final Rule, Prevention of
Salmonella Enteritidis in Shell Eggs
During Production, Storage, and
Transportation,’’ which responds to
questions FDA has received on the shell
VerDate Mar<15>2010
15:20 Mar 07, 2012
Jkt 226001
14023
egg final rule since its publication and
includes guidance on environmental
and egg testing for Salmonella
Enteritidis.
Dated: March 1, 2012.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy
II. Significance of Guidance
The final guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The 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.
[FR Doc. 2012–5683 Filed 3–7–12; 8:45 am]
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding the guidance. It is
only necessary to send one set of
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.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/FoodGuidances or
https://www.regulations.gov. Always
access an FDA document using the FDA
Web site listed previously to find the
most current version of the guidance.
Dated: March 5, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–5628 Filed 3–7–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse
and Alcoholism; Amended Notice of
Meeting
Notice is hereby given of a change in
the meeting of the National Institute on
Alcohol Abuse and Alcoholism Special
Emphasis Panel, March 28, 2012, 4 p.m.
to March 29, 2012, 8 p.m., Legacy Hotel
and Meeting Center, 1775 Rockville
Pike, Rockville, MD, 20852 which was
published in the Federal Register on
January 17, 2012, 77 FR 2304.
This meeting will now be held at 5635
Fishers Lane, Rockville MD 20852. The
meeting is closed to the public.
PO 00000
Frm 00025
Fmt 4703
Sfmt 9990
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse
and Alcoholism; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Alcohol Abuse and Alcoholism Special
Emphasis Panel; NIAAA Member Conflict
application reviews—Biosciences.
Date: March 26, 2012.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: NIAAA/NIH, 5635 Fishers Lane,
Rockville, MD 20852, (Telephone Conference
Call).
Contact Person: Ranga Srinivas, Ph.D.,
Chief, Extramural Project Review Branch
EPRB, NIAAA, National Institutes of Health,
5365 Fishers Lane, Room 2085, Rockville,
MD 20852, (301) 451–2067,
srinivar@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.271, Alcohol Research
Career Development Awards for Scientists
and Clinicians; 93.272, Alcohol National
Research Service Awards for Research
Training; 93.273, Alcohol Research Programs;
93.891, Alcohol Research Center Grants;
93.701, ARRA Related Biomedical Research
and Research Support Awards, National
Institutes of Health, HHS)
Dated: March 1, 2012.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–5680 Filed 3–7–12; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\08MRN1.SGM
08MRN1
Agencies
[Federal Register Volume 77, Number 46 (Thursday, March 8, 2012)]
[Notices]
[Pages 14022-14023]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-5628]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0091]
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 or the Agency) is
announcing the availability of a guidance entitled ``Guidance for
Industry: Testing for Salmonella Species in Human Foods and Direct-
Human-Contact Animal Foods.'' The document provides guidance to firms
that manufacture, process, pack, or hold human foods or direct-human-
contact animal foods intended for distribution to consumers,
institutions, or food processors. This 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 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: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of the 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
[[Page 14023]]
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance.
Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments on the guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
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, 240-402-2022.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of March 23, 2011 (76 FR 16425), FDA made
available a draft guidance entitled ``Testing for Salmonella Species in
Human Foods and Direct-Human-Contact Animal Foods'' and gave interested
parties an opportunity to submit comments by June 21, 2011. The Agency
reviewed and evaluated these comments and has modified the guidance
where appropriate.
This guidance 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
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 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 issued separate guidances in
December 2011 and July 2011, respectively, entitled ``Guidance for
Industry: Prevention of Salmonella Enteritidis in Shell Eggs During
Production, Storage and Transportation,'' which provides guidance to
egg producers on how to comply with certain provisions contained in the
shell egg final rule, including provisions for environmental and egg
testing for Salmonella Enteritidis; and ``Draft Guidance for Industry:
Questions and Answers Regarding the Final Rule, Prevention of
Salmonella Enteritidis in Shell Eggs During Production, Storage, and
Transportation,'' which responds to questions FDA has received on the
shell egg final rule since its publication and includes guidance on
environmental and egg testing for Salmonella Enteritidis.
II. Significance of Guidance
The final guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The 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.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding the
guidance. It is only necessary to send one set of 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.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/FoodGuidances or https://www.regulations.gov.
Always access an FDA document using the FDA Web site listed previously
to find the most current version of the guidance.
Dated: March 5, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-5628 Filed 3-7-12; 8:45 am]
BILLING CODE 4160-01-P