The Federal Register

Food Defense Workshop; Public Workshop

Fri, Nov 24 2006 11:00:00 GMT

The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Southwest Regional Office (SWRO), in cosponsorship with the Risk Management Small Business Development Center (RMSBDC), is announcing a public workshop entitled ``Food Defense Workshop.'' This public workshop is intended to provide information about food defense, the regulations authorized by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), and other related subjects to FDAregulated food facilities (farms, manufacturers, processors, distributors, retailers, and restaurants).

Date and Time: This public workshop will be held on March 29, 2007, from 8 a.m. to 5 p.m.

Location: The public workshop will be held at the Hoblitzelle Auditorium at the Bill Priest Campus of El Centro College, 1402 Corinth St., Dallas, TX 75215.

Contact: David Arvelo, Food and Drug Administration, Southwest Regional Office, 4040 North Central Expressway, Suite 900, Dallas, TX 7520

Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee; Notice of Meeting

Fri, Nov 24 2006 11:00:00 GMT

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on scientific disputes between the Center for Devices and Radiological Health and sponsors, applicants, and manufacturers.

Date and Time: The meeting will be held on December 15, 2006, from 9 a.m. to 5 p.m.

Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and C, 620 Perry Pkwy., Gaithersburg, MD.

Contact Person: Nancy CollazoBraier, Office of the Center Director (HFZ1), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 2402763959, nancy.braier@fda.hhs.gov, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area

Guidance for Industry, Food and Drug Administration Staff, Eye Care Professionals, and Consumers; Decorative,

Fri, Nov 24 2006 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for Industry, FDA Staff, Eye Care Professionals, and Consumers: Decorative, Non Corrective Contact Lenses.'' This guidance document explains recently enacted legislation under which all contact lenses are deemed devices within the meaning of the Federal Food, Drug, and Cosmetic Act (the act). All contact lenses, including decorative, noncorrective contact lenses, require premarket approval or clearance by FDA and may be dispensed only upon a lawful prescription order by an eye care professional. Although this guidance document is being immediately implemented, the agency welcomes comments at any time in accordance with the agency's good guidance practices (GGPs).

Guidance for Industry: Lead in Candy Likely to Be Consumed Frequently by Small Children; Recommended Maximum Level

Fri, Nov 24 2006 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry entitled ``Guidance for Industry: Lead in Candy Likely to Be Consumed Frequently by Small Children; Recommended Maximum level and Enforcement Policy,'' and a supporting document entitled ``Supporting Document for Maximum Recommended Level for Lead in Candy Likely to Be Consumed Frequently By Small Children.'' The guidance provides a maximum recommended lead level in candy likely to be consumed frequently by small children. FDA considers the recommended maximum level to be protective of human health and to be achievable with the use of good manufacturing practices in the production of candy and candy ingredients. The guidance states FDA's commitment to take enforcement action against candy containing lead at levels that may pose a health risk. These two documents are intended to assist candy manufacturers in achieving reduced lead levels in their products consistent with the agency's policy of