
[Federal Register Volume 78, Number 152 (Wednesday, August 7, 2013)]
[Notices]
[Pages 48172-48173]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-19018]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-1092]


Minimizing Risk for Children's Toy Laser Products; Draft Guidance 
for Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Minimizing Risk for 
Children's Toy Laser Products.'' This draft guidance is to inform 
manufacturers of laser products, FDA headquarters and field personnel, 
and the public of the Center for Devices and Radiological Health's 
(CDRH) proposed approach on the safety of toy laser products. This 
draft guidance is not final nor is it in effect at this time.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by November 5, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Minimizing Risk for Children's Toy Laser 
Products'' to the Division of Small Manufacturers, International and 
Consumer Assistance, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, 
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to 
assist that office in processing your request, or fax your request to 
301-847-8149. See the SUPPLEMENTARY INFORMATION section for information 
on electronic access to the guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Robert J. Doyle, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 4672, Silver Spring, MD 20993-0002, 301-
796-5863.

I. Background

    This draft guidance is to inform manufacturers of laser products, 
FDA headquarters and field personnel, and the public of CDRH's proposed 
approach on the safety of children's toy laser products. Lasers with 
outputs above certain levels that are operated in

[[Page 48173]]

an unsafe and uncontrolled manner may cause injury to the user and/or 
others within range of the laser beam. This is a particular concern for 
lasers intended for entertainment purposes, especially when intended to 
be used as toys by children. Although Federal law requires all laser 
products sold in the United States to be in compliance with the Federal 
Performance Standards for Laser Products (21 CFR 1040.10 and 1040.11), 
at present FDA regulations do not specifically address children's toy 
laser products. FDA recently issued a proposed rule (78 FR 37723) that 
proposes to define children's toy laser products and require them to be 
within International Electrotechnical Commission (IEC) Class 1 emission 
limits. While this rulemaking process is ongoing, CDRH encourages 
manufacturers to keep children's toy laser products within IEC Class 1 
emission limits in order to minimize the risk they pose to this 
vulnerable population.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance 
represents the Agency's proposed approach on children's toys that are 
or that contain laser products. 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 statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by using the Internet. To receive ``Minimizing Risk for Children's 
Toy Laser Products,'' you may either send an email request to 
dsmica@fda.hhs.gov to receive an electronic copy of the document or 
send a fax request to 301-847-8149 to receive a hard copy. Please use 
the document number 1810 to identify the guidance you are requesting. A 
search capability for all CDRH guidance documents is available at 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at 
http://www.regulations.gov.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to a currently approved collection of 
information found in FDA regulations. This collection of information is 
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 
collection of information in 21 CFR part 1040 is approved under OMB 
control number 0910-0025.

V. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments 
regarding this document to the Division of Dockets Management (see 
ADDRESSES). 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, and will 
be posted to the docket at http://www.regulations.gov.

    Dated: August 1, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-19018 Filed 8-6-13; 8:45 am]
BILLING CODE 4160-01-P


