[Federal Register Volume 76, Number 18 (Thursday, January 27, 2011)]
[Notices]
[Pages 4918-4919]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-1759]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0143; (formerly Docket No. FDA-2008-D-0128)]


Drug-Induced Liver Injury: Are We Ready to Look?; 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 ``Drug-Induced Liver Injury: Are We Ready to 
Look?'' The public conference will be cosponsored with the American 
Association for the Study of Liver Diseases (AASLD) and the 
Pharmaceutical and Research Manufacturers of America to discuss and 
debate issues regarding drug-induced liver injury (DILI). The purpose 
of this conference is to consider the effect of the recommendations in 
the guidance for industry entitled ``Drug-Induced Liver Injury: 
Premarketing Clinical Evaluation'' since its publication in July 2009 
and to seek suggestions for future revision.

DATES: The public conference will be held on March 23, 2011, from 8 
a.m. to 6 p.m. and March 24, 2011, from 8 a.m. until 3:30 p.m. Submit 
either electronic or written comments on Agency guidance at any time.

ADDRESSES: The conference will take place at the National Labor 
College, 10000 New Hampshire Ave., Silver Spring, MD 20993.
    Submit written requests for single copies of the 2009 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. Send one self-addressed 
adhesive label to assist that office in processing your requests. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 2009 
guidance document.
    Submit electronic comments on the 2009 guidance and the issues and 
questions presented at the conference 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.

FOR FURTHER INFORMATION CONTACT: Lana L. Pauls, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 4307, Silver Spring, MD 20993-0002, 301-
796-0518, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In July 2009, FDA made available a guidance for industry entitled 
``Drug-Induced Liver Injury: Premarketing Clinical Evaluation'' (see 74 
FR 38035, July 30, 2009). The 2009 guidance explains that DILI has been 
the most frequent cause of safety-related drug marketing withdrawals 
for the past 50 years, and that hepatoxicity has limited the 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 elevations, and how 
those laboratory tests might change over time, along with symptoms and 
physical findings, to allow estimation of severity of the injury. It 
suggests some rules for stopping or interrupting drug treatment, and 
the need to obtain additional clinical information to estimate the 
likelihood of the true cause. Public comments on the draft guidance 
were sought in 2007 and 2008, and those comments were taken into 
consideration when issuing the final guidance in July 2009.

II. The Public Conference

A. Why are we holding this conference?

    The purpose of the 2011 conference is to discuss the most current 
information and thinking about how drugs cause liver injury and why 
certain individuals are more susceptible than others, combining views 
of both basic science and clinical experts, and selecting for specific 
debate and discussion issues such as:
     Liver injury and dysfunction in patients,
     Liver reaction to injury,
     Biomarkers and predictors of liver injury and dysfunction, 
and
     Postmarketing DILI.

[[Page 4919]]

B. Is there a fee and how do I register for the conference?

    A registration fee will be charged to attendees other than invited 
speakers to help defray the costs of rental of the meeting spaces, 
meals and snacks provided, and if possible, to cover travel costs 
incurred by invited academic (but not Government or industry) speakers, 
and other costs. The fee for the 2-day meeting is $500 for industry 
registrants and $250 for Federal Government and academic registrants. 
Registration fees will be waived for invited speakers and moderators.
    The registration process will be handled by AASLD, a not-for-profit 
organization with extensive experience in planning, organizing, and 
executing educational meetings.
    Additional information on the conference, program, and registration 
procedures is available on the Internet at http://www.aasld.org (go to 
Conferences and Education, Meetings and Conferences), and also at 
http://www.fda.gov by typing into the search box ``liver toxicity.'' 
(FDA has verified the AASLD Web site address, but FDA is not 
responsible for any subsequent changes to the Web site after this 
document publishes in the Federal Register.)
    Transcripts: The presentations and discussions will be transcribed 
and published on the Internet at http://www.aasld.org for public 
availability after minor editing by the organizers of the meeting (Lana 
Pauls and John Senior). Please be advised that as soon as a transcript 
is available, it will also be accessible at http://www.regulations.gov. 
It may be viewed at the Division of Dockets Management (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A 
transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. Written requests 
are to be sent to Division of Freedom of Information (HFI-35), Office 
of Management Programs, Food and Drug Administration, 5600 Fishers 
Lane, rm. 6-30, Rockville, MD 20857.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding the 
guidance and the issues and questions presented at the conference. It 
is only necessary to send one set of comments. It is no longer 
necessary to send two copies of mailed comments. Identify comments with 
the docket number found in brackets in the heading of this notice. 
Received comments may be seen in the Division of Dockets Management 
between 9 a.m. Monday through 4 p.m. Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: January 19, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-1759 Filed 1-26-11; 8:45 am]
BILLING CODE 4160-01-P