National Institute of Mental Health; Notice of Closed Meeting, 71133 [2010-29356]
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Federal Register / Vol. 75, No. 224 / Monday, November 22, 2010 / Notices
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0571]
Guidance for Industry: The Safety of
Imported Traditional Pottery Intended
for Use With Food and the Use of the
Term ‘‘Lead Free’’ in the Labeling of
Pottery; and Proper Identification of
Ornamental and Decorative
Ceramicware; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance entitled
‘‘Guidance for Industry: The Safety of
Imported Traditional Pottery Intended
for Use With Food and the Use of the
Term ‘Lead Free’ in the Labeling of
Pottery; and Proper Identification of
Ornamental and Decorative
Ceramicware.’’ FDA is issuing the
guidance in response to recent findings
of lead contamination of imported
traditional pottery labeled as ‘‘Lead
Free.’’ The guidance identifies several
key practices that manufacturers of
pottery may implement to help ensure
that lead contamination of non-lead
glazed (NLG) pottery will not occur and
also reminds manufacturers of existing
requirements for properly labeling
certain ornamental and decorative
ceramicware as not for use for foodhandling purposes.
DATES: Submit either electronic or
written comments on the guidance at
any time.
ADDRESSES: 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, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. 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 SUPPLEMENTARY
INFORMATION section for electronic
access to the 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.
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SUMMARY:
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I. Background
FDA is announcing the availability of
a guidance entitled ‘‘The Safety of
Imported Traditional Pottery Intended
for Use With Food and the Use of the
Term ‘Lead Free’ in the Labeling of
Pottery; and Proper Identification of
Ornamental and Decorative
Ceramicware.’’ FDA is issuing the
guidance in response to recent findings
of lead contamination of imported
traditional pottery labeled as ‘‘Lead
Free.’’ This contamination is occurring
even with the use of newer production
practices that do not utilize
intentionally added lead (e.g., the use of
non-lead glazes). The guidance
identifies several key practices that
manufacturers of pottery may
implement to help ensure that lead
contamination of NLG pottery will not
occur and also reminds manufacturers
of existing requirements for properly
labeling certain ornamental and
decorative ceramicware items as not for
use for food-handling purposes.
FDA is issuing this guidance as level
1 guidance. Consistent with FDA’s good
guidance practices regulation (21 CFR
10.115), the Agency will accept
comments, but is implementing the
guidance document immediately, in
accordance with 21 CFR 10.115(g)(2),
because the Agency has determined that
prior public participation is not feasible
or appropriate in light of the need to
respond expeditiously to numerous
recent reports of lead contamination of
imported traditional pottery. The
guidance represents the Agency’s
current thinking on food safety
considerations relevant to lead
contamination of NLG traditional
pottery, and labeling considerations for
food use and non food use pottery that
may contain lead. 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 guidance. 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.
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III. Electronic Access
Persons with access to the Internet
may obtain the guidance at https://
www.fda.gov/FoodGuidances or https://
www.regulations.gov.
Dated: November 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–29292 Filed 11–19–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
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 of
Mental Health Special Emphasis Panel;
Competitive Revision for Stem Cell
Repository Relevant to Mental Disorders.
Date: December 1, 2010.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Vinod Charles, PhD,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Blvd., Room 6151, MSC 9606,
Bethesda, MD 20892–9606, 301–443–1606,
charlesvi@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.242, Mental Health Research
Grants; 93.281, Scientist Development
Award, Scientist Development Award for
Clinicians, and Research Scientist Award;
93.282, Mental Health National Research
Service Awards for Research Training,
National Institutes of Health, HHS).
Dated: November 16, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–29356 Filed 11–19–10; 8:45 am]
BILLING CODE 4140–01–P
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[Federal Register Volume 75, Number 224 (Monday, November 22, 2010)]
[Notices]
[Page 71133]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-29356]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health; 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 of Mental Health Special
Emphasis Panel; Competitive Revision for Stem Cell Repository
Relevant to Mental Disorders.
Date: December 1, 2010.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Neuroscience Center, 6001
Executive Boulevard, Rockville, MD 20852, (Telephone Conference
Call).
Contact Person: Vinod Charles, PhD, Scientific Review Officer,
Division of Extramural Activities, National Institute of Mental
Health, NIH, Neuroscience Center, 6001 Executive Blvd., Room 6151,
MSC 9606, Bethesda, MD 20892-9606, 301-443-1606,
charlesvi@mail.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.242,
Mental Health Research Grants; 93.281, Scientist Development Award,
Scientist Development Award for Clinicians, and Research Scientist
Award; 93.282, Mental Health National Research Service Awards for
Research Training, National Institutes of Health, HHS).
Dated: November 16, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2010-29356 Filed 11-19-10; 8:45 am]
BILLING CODE 4140-01-P
