2010-6265. Food and Drug Administration and Process Analytical Technology for Pharma Manufacturing: Food and Drug Administration-Partnering With Industry; Public Conference

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public conference.

The Food and Drug Administration (FDA) is announcing a joint conference with the University of Rhode Island (URI) College of Pharmacy entitled “FDA and PAT for Pharma Manufacturing: FDA—Partnering with Industry.” This 2-day public conference is cosponsored by FDA and the URI College of Pharmacy. This public conference is intended to disseminate current and accurate information on process analytical technology (PAT) to the pharmaceutical industry and create a venue for dialogue between PAT users and FDA. The public conference will feature FDA's perspective on where PAT will be applicable in the manufacturing process and FDA's current thinking on how PAT will be reviewed in new and abbreviated new drug applications, amendments, or supplements to an application.

Date and time: The public conference will be held on May 11 and 12, 2010, from 8 a.m. to 5 p.m.

Location: The public conference will be held at the Hyatt Regency Bethesda, One Bethesda Metro, Bethesda, MD 20814, 301-657-1234.

Contact Persons:

For information regarding the conference and registration: Christi Counts, Pharma Conference Inc., P.O. Box 291386, Kerrville, TX, 78029-1386, 830-896-0027, FAX: [phone], http://www.pharmaconference.com.

For information regarding this notice: Chris Watts, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 4142, Silver Spring, MD 20993-0002, 301-796-1625.

Registration: There is a registration fee. The registration fee includes conference materials, continental breakfast, breaks, and lunches. For payment received by April 15, 2010, the fee is $1,795. For payment received after April 15, 2010, the fee is $1,995. The fee for government employees is $750. The following forms of payment will be accepted: American Express, Visa, Mastercard, and company checks. No checks will be accepted on site. Early registration is recommended because seating is limited. There will be no onsite registration. To register for the public conference online, please visit http://www.pharmaconference.com/​upcoming2010/​beth_​10.htm. To register by mail, please send your name, title, firm name, address, telephone and fax numbers, e-mail, and credit card information or a company check for the fee to Pharma Conference Inc., P.O. Box 291386, Kerrville, TX, 78029-1386. To register by overnight mail, the address is Pharma Conference Inc., 819 Water St., suite 350, Kerrville, TX, 78028.

If you need special accommodations due to a disability, please notify Pharma Conference Inc., once you receive your registration confirmation so these needs can be passed on to the conference venue.

Dated: March 17, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.