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