
[Federal Register Volume 80, Number 170 (Wednesday, September 2, 2015)]
[Notices]
[Pages 53162-53163]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21639]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Food and Drug Administration/Drug Information Association 
Oligonucleotide-Based Therapeutics Conference 2015

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting.

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SUMMARY: The Food and Drug Administration's (FDA's) Center for Drug 
Evaluation and Research, in cosponsorship with the Drug Information 
Association (DIA), is announcing a meeting entitled ``FDA/DIA 
Oligonucleotide-Based Therapeutics Conference 2015'' (FDA/DIA 2015 
conference). The purpose of the meeting is to discuss advances, safety, 
and challenges in the field of oligonucleotide-based therapeutics.

DATES: The meeting will be held on September 9 to September 10, 2015, 
from 7 a.m. to 5 p.m. and September 11, 2015, from 7 a.m. to 12 noon.

ADDRESSES: The meeting will be held at the Grand Hyatt Washington, 1000 
H St. NW., Washington, DC 20001.

FOR FURTHER INFORMATION CONTACT: Meredith Kaganovskiy, Drug Information 
Association (DIA), 800 Enterprise Rd., Horsham, PA 19044, 215-442-6117, 
FAX: 215-293-5923, email: Meredith.kaganovskiy@diaglobal.org; or Robert 
T. Dorsam, Food and Drug Administration, Center for Drug Evaluation and 
Research (CDER), 10903 New Hampshire Ave., Silver Spring, MD 20993-
0002; 301-796-1623, email: robert.dorsam@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    Oligonucleotide therapeutics constitute a diverse and evolving 
class of drug products that are being developed for a wide variety of 
indications. The FDA/DIA 2015 conference is a forum where regulators, 
academics, and members of industry will discuss the advances, 
challenges, and opportunities in the field of oligonucleotide 
therapeutics. This is the sixth meeting in approximately eight years 
where attendees will discuss oligonucleotide therapeutics in clinical, 
nonclinical, and chemistry tracks. The meeting will provide updates on 
advancements in this field, and will also present time for stakeholders 
to discuss challenges in the development and regulation of 
oligonucleotide therapeutics. Topics will be addressed using 
presentations, panel discussions, case studies, and a poster session to 
facilitate discipline-specific and multidisciplinary discussions. The 
goal of the meeting is to provide a current view of oligonucleotide 
therapeutics and foster advancement in the field through discussions 
among regulators, academics, and industry members.

II. Registration and Accommodations

A. Registration

    There is a registration fee to attend this meeting. The 
registration fee is charged to help defray the costs of facilities, 
meeting materials, and food. Seats are limited, and registration will 
be on a first-come, first-served basis.
    To register, please complete registration online at http://www.diaglobal.org/. (FDA has verified the Web address, but FDA is not 
responsible for subsequent changes to the Web site after this document 
publishes in the Federal Register.) The costs of registration for the 
different categories of attendees are as follows:

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                          Category                               Cost
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Industry Representatives...................................       $1,350
Charitable Nonprofit/Academic..............................          675
Government.................................................          405
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B. Accommodations

    Attendees are responsible for their own hotel accommodations. 
Attendees making reservations at the Grand Hyatt Washington are 
eligible for a reduced rate of $209, not including applicable taxes. 
This rate is available for a limited number of rooms. To receive the 
reduced rate, hotel reservations must be made with onPeak and not 
directly with the hotel. Contact information for onPeak is as follows: 
Toll free in the United States 1-855-355-0302 or 1-212-532-1660. When 
calling, please select option 1 for ``Hotel Reservations,'' and inform 
the phone agent that you are making a reservation for Event #15011.
    If you need special accommodations due to a disability, please 
contact Meredith Kaganovskiy (DIA) or Robert.

[[Page 53163]]

T. Dorsam (FDA) (see FOR FURTHER INFORMATION CONTACT).

    Dated: August 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-21639 Filed 9-1-15; 8:45 am]
BILLING CODE 4164-01-P


