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Code · REGISTER · 2016-03-14 · Food and Drug Administration, HHS · Notices

Notices. Notice of meeting

477 words·~2 min read·/register/2016/03/14/2016-05627·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 4164-01-P 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]
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