
[Federal Register Volume 81, Number 49 (Monday, March 14, 2016)]
[Notices]
[Page 13376]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05627]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


The Fifth Annual Food and Drug Administration-International 
Society for Pharmaceutical Engineering Quality Conference

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting.

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

SUMMARY: The Food and Drug Administration's (FDA) Center for Drug 
Evaluation and Research, in co-sponsorship with the International 
Society for Pharmaceutical Engineering (ISPE), is announcing a meeting 
entitled ``Fifth Annual FDA-ISPE Quality Conference.'' The purpose of 
the meeting is to discuss manufacturing, compliance, and management 
practices that create, implement, and sustain a culture of high quality 
and result in reliable pharmaceutical and biologic products that 
support patient health.

DATES: The meeting will be held on June 6, 7, and 8, 2016, from 8:30 
a.m. to 4 p.m.

ADDRESSES: The meeting will be held at the Bethesda North Marriott 
Hotel & Conference Center, 5701 Marinelli Rd., Bethesda, MD 20852.

FOR FURTHER INFORMATION CONTACT: Susan Krys, ISPE, 7200 Wisconsin Ave., 
Suite 305, Bethesda, MD 20814, 301-364-9202, FAX: 240-204-6024, email: 
skrys@ispe.org, or Sau (Larry) Lee, 301-796-2905, email: 
Sau.Lee@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: ISPE is an association of engineers, 
scientists, manufacturing, quality, and industrial professionals 
involved in the development, manufacture, quality control, and 
regulation of pharmaceuticals and related products. This co-sponsored 
meeting facilitates discussion and problem solving around technical, 
quality, compliance, and other manufacturing issues.
    Registration: There is a registration fee to attend this meeting. 
The registration fee is charged to help defray the costs of programming 
and facilities. Seats are limited, and registration will be on a first-
come, first-served basis.
    To register, please complete registration online at http://www.ispe.org/events. 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:

----------------------------------------------------------------------------------------------------------------
                    Category                                                   Cost
----------------------------------------------------------------------------------------------------------------
Industry Representatives:
    ISPE Members...............................  $1,895 (early-bird); $2,095 (onsite).
    Non-members................................  $2,275 (early-bird); $2,475 (onsite).
Academic.......................................  $1,425 (early-bird); $1,575 (onsite).
Government.....................................  $700 (early-bird); $700 (onsite).
----------------------------------------------------------------------------------------------------------------

    Accommodations: Attendees are responsible for their own hotel 
accommodations. Attendees making reservations at the Bethesda North 
Marriott Hotel & Conference Center in Bethesda, MD are eligible for a 
reduced rate of $209 USD, not including applicable taxes. To receive 
the reduced rate, contact the Bethesda North Marriott Hotel (1-301-822-
9200 or 1-800-859-8003) and identify yourself as an attendee of the 
meeting. If you need special accommodations due to a disability, please 
contact Susan Krys at least 7 days in advance.
    Transcripts: We expect that transcripts will be available 
approximately 30 days after the meeting. A transcript will be available 
in either hard copy or on CD-ROM, after submission of a Freedom of 
Information request. The Freedom of Information office address is 
available on the Agency's Web site at http://www.fda.gov. Send faxed 
requests to 301-827-9267.

    Dated: March 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05627 Filed 3-11-16; 8:45 am]
 BILLING CODE 4164-01-P


