Minimizing Risk for Children's Toy Laser Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 48172-48173 [2013-19018]

Download as PDF 48172 Federal Register / Vol. 78, No. 152 / Wednesday, August 7, 2013 / Notices ANNUAL BURDEN ESTIMATES Instrument Number of respondents Number of responses per respondent Average burden hours per response Total burden hours None ................................................................................................................ 1,113,719 1 0.17 189,332.23 Estimated Total Annual Burden Hours: 189,332.23. In compliance with the requirements of Section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L’Enfant Promenade SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. Email address: infocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. SUMMARY: Robert Sargis, Reports Clearance Officer. BILLING CODE 4160–01–P [FR Doc. 2013–19058 Filed 8–6–13; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4184–01–P mstockstill on DSK4VPTVN1PROD with NOTICES [Docket No. FDA–2012–N–0937] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Clinical Laboratory Improvement Amendments Waiver Applications ACTION: Food and Drug Administration, Notice. VerDate Mar<15>2010 17:03 Aug 06, 2013 Jkt 229001 [FR Doc. 2013–19053 Filed 8–6–13; 8:45 am] [Docket No. FDA–2012–D–1092] Food and Drug Administration HHS. Dated: August 1, 2013. Leslie Kux, Assistant Commissioner for Policy. Food and Drug Administration DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Clinical Laboratory Improvement Amendments Waiver Applications’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 5156, Daniel.Gittleson@fda.hhs.gov. SUPPLEMENTARY INFORMATION: On April 23, 2013, the Agency submitted a proposed collection of information entitled ‘‘Clinical Laboratory Improvement Amendments Waiver Applications’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0598. The approval expires on July 31, 2016. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. 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. The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Minimizing Risk for Children’s SUMMARY: PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 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. 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 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. 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. ADDRESSES: 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 E:\FR\FM\07AUN1.SGM 07AUN1 Federal Register / Vol. 78, No. 152 / Wednesday, August 7, 2013 / Notices 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. mstockstill on DSK4VPTVN1PROD with NOTICES 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 https://www.fda.gov/ MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://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 VerDate Mar<15>2010 17:03 Aug 06, 2013 Jkt 229001 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 https://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 https:// 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–D–0597] Guidance for Industry on Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring.’’ This guidance assists sponsors in developing risk-based monitoring strategies and plans for clinical investigations of human drugs, biologics, medical devices, and combinations thereof. The overarching goal of this guidance is to enhance human subject protection and the quality of clinical trial data by focusing sponsor oversight on the most important aspects of study conduct and reporting. The guidance makes clear that sponsors can use a variety of approaches to meet their responsibilities for monitoring investigational new drug or investigational device exemption studies. SUMMARY: Submit either electronic or written comments on Agency guidances at any time. DATES: PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 48173 Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993–0002; the Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448; or the Office of Communication and Education, 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 requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. 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. FOR FURTHER INFORMATION CONTACT: Ann Meeker-O’Connell, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 5356, Silver Spring, MD 20993–0002, 301– 796–7615; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210; or Linda Godfrey, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3446, Silver Spring, MD 20993–0002, 301–796–5490. SUPPLEMENTARY INFORMATION: ADDRESSES: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring.’’ FDA is publishing this guidance to assist sponsors of clinical investigations in developing risk-based monitoring strategies and plans for clinical investigations of human drug and biological products, medical devices, and combinations thereof. This guidance is intended to make clear that sponsors can use a variety of approaches to meet their responsibilities for monitoring clinical investigations under 21 CFR parts 312 and 812. E:\FR\FM\07AUN1.SGM 07AUN1

Agencies

[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.

-----------------------------------------------------------------------

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 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. 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 
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at 
https://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 https://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 https://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