Federal Register / Vol. 79, No. 244 / Friday, December 19, 2014 / Notices 75821 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–1092] 

Minimizing Risk for Children’s Toy 

Laser Products; 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 guidance entitled 

‘‘Minimizing Risk for Children’s Toy 

Laser Products.’’ This guidance is 

intended to inform manufacturers of 

laser products, FDA headquarters and 

field personnel, and the public of the 

Center for Devices and Radiological 

Health’s (CDRH) current thinking on the 

safety of children’s toy laser products 

and to provide specific safety 

recommendations for the manufacture 

and labeling of children’s toy laser 

products. 

DATES: Submit either electronic or 

written comments on this guidance at 

any time. General comments on Agency 

guidance documents are welcome at any 

time. 

ADDRESSES: An electronic copy of the 

guidance document is available for 

download from the Internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the guidance 

document entitled ‘‘Minimizing Risk for 

Children’s Toy Laser Products’’ to the 

Office of the Center Director, Guidance 

and Policy Development, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 5431, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request. 

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. Identify comments with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Hewett, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4250, Silver Spring, 

MD 20993–0002, 301–796–5864. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This guidance is intended to inform 

manufacturers of laser products, FDA 

headquarters and field personnel, and 

the public of CDRH’s current thinking 

on the safety of children’s toy laser 

products. Lasers with outputs above 

certain levels that are operated in 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. 

Federal law requires that, other than 

for certain exceptions, laser products 

manufactured or assembled after August 

1, 1976, must 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 identify what constitutes 

children’s toy laser products. In the 

Federal Register of June 24, 2013, FDA 

issued a proposed rule that proposed to 

define children’s toy laser products and 

require them to be within the 

International Electrotechnical 

Commission (IEC) Class 1 emission limit 

(see proposed 21 CFR 1040.10(b)(1), (2) 

and 1040.11(d) at 78 FR 37723 (June 24, 

2013)). While this rulemaking process is 

ongoing, CDRH recommends that 

manufacturers keep children’s toy laser 

products within the FDA Class I or IEC 

Class 1 emission limits in order to 

minimize the risk they pose to users 

and/or others in range of the laser beam, 

including the vulnerable population for 

whom they are intended. For those 

children’s toy laser products that meet 

the definition of a ‘‘demonstration laser 

product’’ or ‘‘surveying, leveling, or 

alignment laser product,’’ CDRH will 

not object to compliance with the 

International Electrotechnical 

Commission Class I emission limit (set 

forth in IEC 60825–1:2007). To that end, 

this guidance supersedes in part the 

policy set forth in the Guidance on 

Laser Products—Conformance with IEC 

60825–1 and IEC 60601–2–22 (Laser 

Notice No. 50), which will cease to be 

effective by its own terms upon the 

effective date of amendments to the 

regulations applicable to laser products. 

(Ref. #1). However, because IEC Classes 

1M and 2M do not have comparable 

analogs in FDA’s classification system, 

manufacturers should not conform to 

the parameters for IEC Classes 1M or 2M 

unless they also comply with FDA’s 

performance standards for laser 

products. 

In the Federal Register of August 7, 

2013 (78 FR 48172), the Agency issued 

the draft guidance entitled ‘‘Minimizing 

Risk for Children’s Toy Laser 

Products—Draft Guidance for Industry 

and Food and Drug Administration 

Staff.’’ The Agency received two 

comments on the 2013 draft guidance 

and has incorporated most of the 

recommendations in this final guidance. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking on children’s toy 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 guidance may do so by 

downloading an electronic copy from 

the Internet. 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. Persons 

unable to download an electronic copy 

of ‘‘Minimizing Risk for Children’s Toy 

Laser Products’’ may send an email 

request to CDRH-Guidance@fda.hhs.gov 

to receive an electronic copy of the 

document. Please use the document 

number 1810 to identify the guidance 

you are requesting. 

IV. Paperwork Reduction Act of 1995 

This guidance refers to a previously 

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 

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 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 

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75822 Federal Register / Vol. 79, No. 244 / Friday, December 19, 2014 / Notices 

will be posted to the docket at http://

www.regulations.gov. 

VI. References 

The following reference has been 

placed on display in the Division of 

Dockets Management (see ADDRESSES), 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday, and is available 

electronically at http://

www.regulations.gov. (FDA has verified 

the Web site address in this reference 

section, but we are not responsible for 

any subsequent changes to the Web site 

after this document publishes in the 

Federal Register.) 

1. FDA Guidance on Laser Products— 

Conformance with IEC 60825–1 and 

IEC 60601–2–22 (Laser Notice No. 

50) (June 2007), available at http:// 

www.fda.gov/downloads/Medical

Devices/.../ucm094366.pdf. 

Dated: December 15, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–29725 Filed 12–18–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0128] (Formerly 

Docket No. 2007D–0396) 

Serious Drug-Induced Liver Injury: The 

Importance of Getting It Right: How To 

Measure and Interpret Drug-Induced 

Liver Injury Information and Make 

Correct Diagnoses; Public Conference; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public conference; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public conference entitled ‘‘Serious 

Drug-Induced Liver Injury (DILI): The 

Importance of Getting It Right: How to 

Measure and Interpret DILI Information 

and Make Correct Diagnoses.’’ This 

conference will be cosponsored with the 

Critical Path Institute (C-Path) and the 

Pharmaceutical Research and 

Manufacturers of America. The purpose 

of the public conference is to discuss, 

debate, and share views among 

stakeholders in the pharmaceutical 

industry, academia, health care 

providers, patient groups, and 

regulatory bodies on how best to detect 

and assess the severity, extent, and 

likelihood of drug causation of liver 

injury and dysfunction in people using 

drugs for any medical purpose. 

DATES: The public conference will be 

held on March 18, 2015, from 8 a.m. to 

6 p.m. and on March 19, 2015, from 8 

a.m. to 4 p.m. 

ADDRESSES: The public conference will 

be held at the College Park Marriott 

Hotel & Conference Center, 3501 

University Blvd., Hyattsville, MD 20783. 

The hotel’s phone number is 301–985– 

7300. 

FOR FURTHER INFORMATION CONTACT: 

Lana L. Pauls, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 4478, 

Silver Spring, MD 20993–0002, 301– 

796–0518, email: lana.pauls@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In July 2009, FDA announced the 

availability of a guidance for industry 

entitled ‘‘Drug-Induced Liver Injury: 

Premarketing Clinical Evaluation’’ (74 

FR 38035, July 30, 2009). This guidance 

explains that DILI has been the most 

frequent cause of safety-related drug 

marketing withdrawals over the past 50 

years and that hepatotoxicity has 

limited the use of many drugs that have 

been approved and has prevented the 

approval of others. It discusses methods 

of detecting DILI by periodic tests of 

serum enzyme activities and bilirubin 

concentration and how changes in the 

results of those laboratory tests over 

time, along with symptoms and physical 

findings, may be used to estimate 

severity of the injury. The guidance 

suggests some ‘‘stopping rules’’ for 

interrupting drug treatment and the 

need to obtain sufficient clinical 

information to assess causation. FDA 

published a draft of this guidance in 

2006, and comments on the draft were 

taken into consideration when issuing 

the final guidance in July 2009. FDA is 

now interested in obtaining stakeholder 

input on the issues addressed in this 

guidance, including comments 

regarding potential revisions to the 

guidance. 

II. Conference Information 

The purpose of the 2015 conference is 

to invite participants to present their 

data and views, and to hold open 

discussion. 

A. Registration 

A registration fee ($600 for industry 

registrants and $300 for Federal 

government and academic registrants) 

will be charged to help defray the cost 

of renting the meeting space, providing 

meals and snacks, covering the travel 

fees incurred by invited academic (but 

not government or industry) speakers, 

and other expenses. The registration 

process will be handled by C-Path, an 

independent, nonprofit organization 

established in 2005 with public and 

private philanthropic support from the 

southern Arizona community, Science 

Foundation Arizona, and FDA. 

Additional information on the 

conference, program, and registration 

procedures may be obtained on the 

Internet at http://www.c-path.org and 

http://www.fda.gov by typing ‘‘liver 

toxicity’’ into the search box. (FDA has 

verified the C-Path Web site address but 

is not responsible for any subsequent 

changes to the Web site after this 

document publishes in the Federal 

Register.) 

B. Transcripts 

Please be advised that as soon as a 

transcript is available of the public 

conference, it can be obtained in either 

hardcopy or on CD–ROM after 

submission of a Freedom of Information 

Act (FOIA) request. Written FOIA 

requests are to be sent to the Division 

of Freedom of Information (ELEM– 

1029), Food and Drug Administration, 

12420 Parklawn Dr., Element Bldg., 

Rockville, MD 20857. 

Material presented at past programs 

(from 1999 to 2014) may be accessed at 

www.aasld.org. Click on ‘‘Events and 

Professional Development’’ and then 

scroll down to ‘‘Drug-Induced Liver 

Injury Conference.’’ 

Dated: December 15, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–29720 Filed 12–18–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–2137] 

Public Meeting on Patient-Focused 

Drug Development for Breast Cancer; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing a public meeting and an 

opportunity for public comment on 

patient-focused drug development for 

breast cancer. Patient-focused drug 

development is part of FDA’s 

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