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 

mstockstill on DSK4VPTVN1PROD with NOTICES