Document ID: FDA-2008-D-0128-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry on Drug-Induced Liver Injury: Premarketing Clinical Evaluation; Reopening of Comment Period; Public Conference
Posted Date: 2008-03-06T05:00Z

[Federal Register: March 6, 2008 (Volume 73, Number 45)]
[Notices]               
[Page 12181-12182]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06mr08-75]                         

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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)

 
Draft Guidance for Industry on Drug-Induced Liver Injury: 
Premarketing Clinical Evaluation; Reopening of Comment Period; Public 
Conference

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of reopening of comment period; notice of public 
conference.

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SUMMARY: The Food and Drug Administration (FDA) is reopening until June 
30, 2008, the comment period for the draft guidance for industry 
entitled ``Drug-Induced Liver Injury: Premarketing Clinical 
Evaluation,'' published in the Federal Register of October 25, 2007 (72 
FR 60681). FDA is also announcing a public conference entitled 
``Detecting and Investigating Drug-Induced Liver Injury During Clinical 
Trials.'' FDA is cosponsoring the conference with the American 
Association for the Study of Liver Diseases (AASLD) and the 
Pharmaceutical and Research Manufacturers of America. The purpose of 
the conference is to discuss the draft guidance and to solicit 
additional input on the issues and questions presented in this 
document.

DATES: The public conference will be held on March 26, 2008, from 8 
a.m. to 6 p.m. and March 27, 2008, from 8 a.m. to 3 p.m. Please 
register by March 14, 2008, to make an oral presentation during the 
open public session on March 27, 2008. Submit written or electronic 
comments on the draft guidance, the conference program and 
presentations, and the issues and questions presented in this document 
by June 30, 2008.

ADDRESSES: The public conference will be held at the National Labor 
College (NLC), 10000 New Hampshire Ave., Silver Spring, MD 20903.
    Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:  Lana L. Pauls, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, e-mail: 
lana.pauls@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Reopening of Comment Period for the Draft Guidance

    In the Federal Register of October 25, 2007, FDA issued the draft 
guidance ``Drug-Induced Liver Injury: Premarketing Clinical 
Evaluation'' and invited comments by December 24, 2007. This draft 
guidance describes methods for detecting drug-induced liver injury 
(DILI) that may occur during the course of conducting controlled 
clinical trials. To provide interested persons additional time to 
review the draft guidance and submit comments, the agency is reopening 
the comment period until June 30, 2008.

II. The Public Conference

A. Why Are We Holding This Public Conference?

    The purpose of the conference is to discuss the draft guidance and 
issues that it may raise and to solicit additional input on the issues 
and questions presented in this document.

B. What Are the Topics We Intend to Address at the Conference?

    We hope to discuss a large number of issues at the conference, 
including, but not limited to:
     The approach to detecting the potential for severe DILI 
described in the draft guidance;
     What stopping rules should govern the administration of an 
investigational agent during a clinical trial;
     When should rechallenge of a suspected injurious agent be 
considered;
     Should patients or study participants with stable chronic 
liver disease be included in clinical trials; and
     Other issues and questions raised by the conference 
attendees or others.

C. Is There a Fee and How Do I Register for the Conference?

    There is a modest fee to attend the conference, to defray the costs 
of meals provided, rental of the NLC meeting facility, travel expenses 
for invited

[[Page 12182]]

academic (but not government or industry) speakers, and other expenses. 
The fee for the 2-day meeting for registrants from industry is $350, 
and the fee for academic or government registrants is $175. Fees will 
be waived for invited speakers and moderators.
    The registration process will be handled by AASLD, which has 
extensive experience in planning, executing, and organizing educational 
meetings. Register online at http://www.aasld.org. Although the NLC 
facility is spacious, registration will be on a first-come, first-
served basis. If you would like to make an oral presentation during the 
open hour of the conference on March 27, 2008, you must register with 
Lana Pauls (see FOR FURTHER INFORMATION CONTACT) by close of business 
on March 14, 2008. To make a presentation, you will be asked to provide 
your name, title, business affiliation (if applicable), address, and 
type of organization you represent (e.g., industry, consumer 
organization). Persons registered to make an oral presentation should 
check in before the conference. If you need special accommodations 
because of a disability, please contact Lana Pauls at least 7 days 
before the conference.

D. Where Can I Find Out More About This Public Conference?

    Background information on the conference, registration information, 
the agenda, information about lodging, and other relevant information 
will be posted, as it becomes available, on the Internet at http://
www.fda.gov/cder/livertox and http://www.aasld.org.

E. Conference Transcripts

    We will prepare a transcript of the conference presentations and 
discussions and will post it online along with copies of slides shown. 
The transcript will be available for review on the Internet at http://
www.fda.gov/cder/livertox approximately 30 days after the conference.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding the draft 
guidance and the issues and questions presented in this document or at 
the conference. Submit a single copy of electronic comments or two 
paper copies of any mailed comments, except that individuals may submit 
one paper copy. Comments are to be identified 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.
    Please note that on January 15, 2008, the FDA Web site transitioned 
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will 
be accepted by FDA through FDMS only.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cder/guidance/index.htm or http://
www.fda.gov/ohrms/dockets/default.htm.

    Dated: February 29, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-4361 Filed 3-5-08; 8:45 am]

BILLING CODE 4160-01-S