[Federal Register Volume 78, Number 152 (Wednesday, August 7, 2013)]
[Notices]
[Pages 48172-48173]
From the Federal Register Online via the Government Publishing 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Minimizing Risk for Children's Toy Laser Products; Draft Guidance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availability of the draft guidance entitled ``Minimizing Risk for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 This draft guidance is to inform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draft guidance is not final nor is it in effect at this time.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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by November 5, 2013.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Minimizing Risk for Children's Toy Laser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Submit electronic comments on the draft guidance to http://www.regulations.gov.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
[email protected] 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]
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