[Federal Register Volume 79, Number 27 (Monday, February 10, 2014)]
[Notices]
[Pages 7680-7681]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-02755]


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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: Who Gets It? Who Doesn't? 
Why?; Public Conference; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
conference entitled ``Serious Drug-Induced Liver Injury (DILI): Who 
Gets It? Who Doesn't? Why?'' This conference will be cosponsored with 
the Critical Path Institute (C-Path) and the Pharmaceutical Research 
and Manufacturers of America. Its purpose 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 19, 2014, from 8 
a.m. to 6 p.m., and March 20, 2014, from 8 a.m. to 4 p.m.

ADDRESSES: The conference will take place 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. 4482, Silver Spring, MD 20993-0002, 301-
796-0518, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    In July 2009, FDA announced the availability of guidance for 
industry entitled ``Drug-Induced Liver Injury: Premarketing Clinical 
Evaluation'' (74 FR 38035; July 30, 2009). This guidance explained that 
DILI was the most frequent cause of safety-related drug marketing 
withdrawals for the past 50 years and that hepatotoxicity has limited 
use of many drugs that have been approved and 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. 
It 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.

[[Page 7681]]

II. Conference Information

    The purpose of the 2014 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 costs of renting meeting spaces and the meals and snacks 
provided. The fee will also be used to cover travel costs 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 and 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, it can 
be obtained in either hardcopy or on CD-ROM, after submission of a 
Freedom of Information request. Written 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 2013) may be 
accessed at www.aasld.org. Click on ``Education/Training'' and then 
scroll down to ``Drug Induced Liver Injury 2013 Program.''

    Dated: February 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02755 Filed 2-7-14; 8:45 am]
BILLING CODE 4160-01-P