Document ID: FDA-2013-N-0001-0088
Agency: fda
Document Type: Notice
Title: Clinical Trial Design for Intravenous Fat Emulsion Products; Public Workshop
Posted Date: 2013-09-23T04:00Z

[Federal Register Volume 78, Number 184 (Monday, September 23, 2013)]
[Notices]
[Page 58318]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-23020]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]

Clinical Trial Design for Intravenous Fat Emulsion Products; 
Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

-----------------------------------------------------------------------

    The Food and Drug Administration's (FDA) Center for Drug Evaluation 
and Research, in cosponsorship with the American Society for Parenteral 
and Enteral Nutrition, is announcing a 1-day public workshop entitled 
``Clinical Trial Design for Intravenous Fat Emulsion Products.'' This 
workshop will provide a forum to discuss trial design of clinical 
trials intended to support registration of intravenous fat emulsion 
products.
    Date and Time: The public workshop will be held on October 29, 
2013, from 8 a.m. to 5 p.m. (EST).
    Location: The public workshop will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great 
Room (Rm. 1503A), Silver Spring, MD 20993-0002.
    Contact Person: Wes Ishihara, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993-0002, 301-796-0069, FAX: 301-796-9904, email: 
richard.ishihara@fda.hhs.gov.
    Registration: There is no fee to attend the public workshop, but 
attendees must register in advance. Space is limited, and registration 
will be on a first-come, first-served basis. Persons interested in 
attending this workshop must register online at https://netforum.avectra.com/eweb/DynamicPage.aspx?Site=ASPEN&WebCode=EventDetail&evt_key=eb9c4068-8b66-4ac0-ae4f-ac266c08e33e before October 22, 2013. For those without 
Internet access, please contact Wes Ishihara (see Contact Person) to 
register. On-site registration will not be available.
    If you need special accommodations because of disability, please 
contact Wes Ishihara (see Contact Person) at least 7 days in advance.

SUPPLEMENTARY INFORMATION: This workshop will provide a forum to 
discuss the key issues in clinical trial design for intravenous fat 
emulsions. Stakeholders, including industry sponsors, academia, 
patients receiving parenteral nutrition, and FDA, will discuss 
challenging issues related to selection of endpoints and assessment 
methodologies in registration trials. Trial design strategies and 
possible candidates for endpoints will be explored.
    Transcripts: Transcripts of the workshop will be available for 
review at the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and 
on the Internet at http://www.regulations.gov approximately 30 days 
after the workshop. A transcript will also be available in either hard 
copy or on CD-ROM, after submission of a Freedom of Information 
request. Send written requests to the Division of Freedom of 
Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn 
Dr., Rockville, MD 20857. Send faxed requests to 301-827-9267.

    Dated: September 17, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-23020 Filed 9-20-13; 8:45 am]
BILLING CODE 4160-01-P