Federal Register / Vol. 75, No. 224 / Monday, November 22, 2010 / Notices 71133 

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. 

SUMMARY: 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 http:// 

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. 

SUPPLEMENTARY INFORMATION: 

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. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at http:// 

www.fda.gov/FoodGuidances or http:// 

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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