National Institute on Alcohol Abuse and Alcoholism; Amended Notice of Meeting, 14023 [2012-5683]
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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available a draft guidance entitled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Enteritidis; and ‘‘Draft Guidance for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
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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.
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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]
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[Federal Register Volume 77, Number 46 (Thursday, March 8, 2012)]
[Notices]
[Page 14023]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-5683]
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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.
Dated: March 1, 2012.
Jennifer S. Spaeth,
Director, Office of Federal Advisory Committee Policy
[FR Doc. 2012-5683 Filed 3-7-12; 8:45 am]
BILLING CODE 4140-01-P
