[Federal Register Volume 79, Number 244 (Friday, December 19, 2014)]
[Notices]
[Page 75822]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-29720]


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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: 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.

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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: <a href="/cdn-cgi/l/email-protection#bdd1dcd3dc93cddcc8d1cefddbd9dc93d5d5ce93dad2cb"><span class="__cf_email__" data-cfemail="c8a4a9a6a9e6b8a9bda4bb88aeaca9e6a0a0bbe6afa7be">[email protected]</span></a>.

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


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