02-15778. Program Priorities in the Center for Food Safety and Applied Nutrition; Request for Comments

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is requesting comments concerning the establishment of program priorities in the Center for Food Safety and Applied Nutrition (CFSAN) for fiscal year (FY) 2003. As part of its annual planning, budgeting, and resource allocation process, CFSAN is reviewing its programs to set priorities and establish work product expectations. This notice is being published to give the public an opportunity to provide input into the priority-setting process.

DATES:

Submit written or electronic comments by August 20, 2002.

ADDRESSES:

Submit written comments concerning this document to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/​dockets/​ecomments. Comments should be identified with the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Donald J. Carrington, Center for Food Safety and Applied Nutrition (HFS-666), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, e-mail: [e-mail], 301-436-1697.

SUPPLEMENTARY INFORMATION:

I. Background

On January 28, 2002, CFSAN released a document entitled “2002 CFSAN Program Priorities.” The document, a copy of which is available on CFSAN’s Web page (www.cfsan.fda.gov),, constitutes CFSAN's priority workplan for fiscal year 2002, i.e., October 1, 2001, through September 30, 2002. (See FOR FURTHER INFORMATION CONTACT for copies.) The 2002 workplan is based on input we received from our stakeholders (see 66 FR 37480, July 18, 2001), as well as input generated internally. Throughout the priority-setting process, we focused on one central question: “Where do we do the most good for consumers?”

In addition to adding a new emphasis on enhancing the security of the Nation’s food supply, the FY 2002 workplan continues to place a high priority on food safety, food additives, dietary supplements, and food biotechnology. In this year’s workplan, the Food Safety and Security section has been broadened by including additional food safety strategies: Food Allergens; Transmissible Spongioform Encephalopathies; and Chemical Contaminants, Pesticides and Other Hazards. Outside of these priorities, the workplan identifies eight other program areas and cross-cutting areas that need emphasis: (1) Nutrition, health claims and labeling; (2) cosmetics; (3) completing the move of CFSAN offices and laboratories to a new facility in College Park, MD; (4) enhancing the science base; (5) international activities; (6) enhancing internal processes; (7) focused economic-based regulations; and (8) management initiatives.

The FY 2002 workplan contains two lists of activities—the “A” list and the “B” list. Our goal is to fully complete at least 90 percent of the “A” list activities by the end of the fiscal year, September 30, 2002. Activities on the “B” list are those we plan to make progress on, but may not complete before the end of the fiscal year. Some activities on the “B” list are highlighted with an asterisk. These are the highest priority “B” list activities, most of which are 2-year projects that we are positioning to be on the “A” list the following year.

CFSAN intends to issue a progress report on what program priority activities already have been completed to date in FY 2002, as well as any adjustments in the workplan (i.e., additions or deletions) for the balance of the fiscal year.

CFSAN has responsibility for many important ongoing activities that are not identified in the workplan. For example, CFSAN's base programs in data collection, research, and enforcement are important and are ongoing. Rather, the workplan addresses primarily those initiatives representing something new or different that CFSAN needs to address in 2002, as well as priority initiatives that are being continued from the 2001 workplan. In addition, the workplan does not address the myriad of unanticipated issues that often require a substantial investment of CFSAN resources (e.g., response to outbreaks of foodborne illness).

II. 2003 CFSAN Program Priorities

FDA is requesting comments concerning the establishment of program priorities in CFSAN for FY 2003. The input will be used to develop CFSAN’s 2003 workplan. The workplan will set forth CFSAN’s program priorities for October 1, 2002, through September 30, 2003. FDA intends to make the 2003 workplan available in the fall of 2002.

The format of the 2002 workplan will be similar to last year’s workplan. FDA expects there will be considerable continuity and follow-through between the 2002 and 2003 workplans. For example, new initiatives aimed at increasing the security of our country's food supply will continue to be a high priority in FY 2003. Moreover, a number of goals inherently require a multiyear effort. For example, in 2003, progress will continue towards development of a centralized adverse event reporting system. FDA requests comments on other broad program areas that should continue to be a priority in FY 2003, or new areas that need to be initiated.

In addition, as noted, the 2002 workplan highlights certain “B” list activities with an asterisk. Many of these are 2-year projects that we are positioning to be candidates for the “A” list next year. FDA requests comments on which “B*” and regular “B” list activities (i.e., those not designated with an asterisk) should be elevated to the “A” list for completion in 2003. Finally, as noted, FDA requests comments on new program areas or activities that should be added as a high priority for FY 2003.

Interested persons may submit to the Dockets Management Branch (see ADDRESSES) written comments regarding this notice by August 20, 2002. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the office between 9 a.m. and 4 p.m., Monday through Friday.

Dated: June 17, 2002.

Margaret M. Dotzel,

Associate Commissioner for Policy.