Department of Health and Human Services June 21, 2006 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry entitled ``Recommendations for the Early Food Safety Evaluation of New Non- Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use.'' The guidance provides recommendations to developers of new plant varieties, including bioengineered plant varieties, on the early food safety evaluation of new non-pesticidal proteins. The guidance describes procedures for submitting an early food safety evaluation of such proteins to the agency.

The Food and Drug Administration (FDA) San Francisco District, in cooperation with AdvaMed's Medical Technology Learning Institute, is announcing a public workshop on FDA device regulations. This 2-day public workshop for start up and small device manufacturers and their suppliers will include both industry and FDA perspectives and a question and answer period. Date and Time: The public workshop will be held on July 12, 2006, from 8:30 a.m. to 5:30 p.m. and July 13, 2006, from 8:30 a.m. to 5 p.m. Location: The public workshop will be held at The Marriott Fremont, 46100 Landing Pkwy., Fremont, CA 94538, 510-413-3710, FAX: 510-413- 3710. For further hotel information and driving directions, go to https://Marriott.com/property/propertypage/sjcfm. (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.) Contact: For FDA: Eric Anderson, Office of Regulatory Affairs (HFR- PA1530), Food and Drug Administration, 96 North Third St., San Jose, CA 95115, 408-291-7548, ext. 115, FAX: 408-291-7228, e-mail: eric.anderson@fda.hhs.gov. For AdvaMed: Krystine McGrath, 202-434-7237, FAX: 202-434-7850, e- mail: kmcgrath@advamed.org. Registration: Send registration information (including name, title, firm name, address, telephone, and fax number) and the registration fee of $495.00 per person to the AdvaMed contacts (see Contact). The registration fee for FDA employees is waived. To register via the Internet go to https://www.advamedmtli.org/mtli/fda.cfm. (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.) Payment forms accepted are major credit cards (MasterCard, Visa, or American Express) or company check. If you wish to pay by check, contact Krystine McGrath (see Contact). For more information on the meeting, or for questions on registration, contact Krystine McGrath (see Contact). Attendees are responsible for their own accommodations. The registration fee will be used to offset the expenses of hosting the workshop, including meals (breakfasts and lunches), refreshments, meeting rooms, and training materials. It also includes a networking reception on July 12, 2006. Space is limited; therefore, interested parties are encouraged to register early. There will be no onsite registration. If you need special accommodations due to a disability, please contact Eric Anderson (see Contact) at least 7 days in advance of the workshop.