FDA Proposed FY07 Budget Briefing

The Food and Drug Administration is holding a telebriefing on FDA's Fiscal Year (FY) 2007 budget request to Congress on Monday, February 27, 2006 at 10:00 a.m. EST. To participate in the telebriefing, stakeholders can call a toll-free number 800-857-7403

Kathleen Heuer, Chief Financial Officer, Associate Commissioner, Office of Management will conduct the telebriefing and will discuss the agency's budget request, which covers the period of October 1, 2006 to September 30, 2007, and includes $1.55 billion in budget authority and $402 million in industry user fees. The budget request reflects FDA's resolve to advance its most critical public health initiatives within the constraints of the current budget environment. Carefully developed to safeguard the health of Americans, the FDA agenda for the next fiscal year is designed to fulfill the agency's foremost responsibilities and advance the Administration's public health goals and priorities.

The proposed increase of $70.8 million over the current budget will enable FDA to focus its staff and resources on priority initiatives, including:

• Preparedness for the potential threat of pandemic influenza
• Protection of the food supply from bioterrorism
• Diverse initiatives to realize the promise of molecular medicine
• Strengthening the safety of drugs and human tissues for transplantation
• Meeting statutory obligations under the animal drug and medical devices user fee
  programs.

For additional information on FDA's FY07 budget request, see:

• Office of Management Budget Formulation and Presentation: FDA Budget Summary;
• FDA News: FDA's FY 2007 Budget Request Highlights Mission Priorities and Fiscal Responsibility;
• Congressional Testimony

FDA Provides Guidance on 'Whole Grain' for Manufacturers

The Food and Drug Administration (FDA) issued draft guidance on what the term "whole grain" may include. The guidance (Draft Guidance - Guidance for Industry and FDA Staff: Whole Grain Label Statements) clarifies that FDA considers "whole grain" to include cereal grains that consist of the intact, ground, cracked or flaked fruit of the grains whose principal components -- the starchy endosperm, germ and bran -- are present in the same relative proportions as they exist in the intact grain. Such grains may include barley, buckwheat, bulgur, corn, millet, rice, rye, oats, sorghum, wheat and wild rice.

The draft guidance states that although rolled and "quick oats" can be called "whole grains" because they contain all of their bran, germ and endosperm, other widely used food products may not meet the "whole grain" definition. For example, FDA does not consider products derived from legumes (soybeans), oilseeds (sunflower seeds) and roots (arrowroot) as "whole grains." The draft guidance specifically recommends that pizza only be labeled as "whole grain" or "whole wheat" when its crust is made entirely from whole grain flours or whole wheat flour, respectively.

Currently, manufacturers can also make factual statements about whole grains on food labels such as "10 grams of whole grains" or "1/2 ounce of whole grains."

Submit written or electronic comments by April 18, 2006 to the Division of Documents Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to Dockets Open for Comment using the docket number 2006D-0066.

Office of Food Safety, Defense, and Outreach

CFSAN Web site: http://www.cfsan.fda.gov/