03-14106. Program Priorities in the Center for Food Safety and Applied Nutrition; Request for Comments

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; request for comments.

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) 2004. 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 4, 2003.

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.

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, 301-436-1697, or e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

On March 10, 2003, CFSAN released a document entitled “2003 CFSAN Program Priorities.” The document, a copy of which is available on CFSAN's Web site (www.cfsan.fda.gov), constitutes the center's priority work plan for FY 2003, i.e., October 1, 2002, through September 30, 2003. (Copies also are available from the contact person listed in the FOR FURTHER INFORMATION CONTACT section.) The 2003 work plan is based on input we received from our stakeholders as well as input generated internally. Throughout the priority-setting process, we focus on one central question: “Where do we do the most good for consumers?”

The FY 2003 work plan focuses heavily on ensuring the security of our country's food supply as a primary goal. With the enactment in June 2002 of the Public Health Security and Bioterrorism Preparedness and Response Act (Public Law 107-188), much of our effort during the current fiscal year will focus on issuing the necessary regulations to implement this statute. We will also continue to enhance our level of emergency preparedness, particularly our laboratory preparedness.

The FY 2003 work plan continues to place a high priority on food safety, food additives, and dietary supplements, and also highlights our desire to revitalize our nutrition program. In December 2002, FDA announced a major initiative to enhance “Consumer Health Information for Better Nutrition.” Accordingly, this year's plan includes the steps needed to implement that initiative, including increased enforcement against unsubstantiated claims on food and dietary supplement products.

Outside of these priorities, the FY 2003 work plan identifies eight other program areas and cross-cutting areas that need emphasis: (1) Cosmetics; (2) enhancing the science base; (3) international activities; (4) food biotechnology; (5) enhancing internal processes; (6) focused economic-based regulations; (7) equal employment opportunity/diversity initiatives; and (8) management initiatives.

The FY 2003 work plan contains two lists of activities—the “A-list” and the “B-list.” Our goal is to fully complete at least 90 percent of the 145 “A-list” activities by the end of the fiscal year, September 30, 2003. Activities on the “B-list” are those we plan to make progress on, but may not complete, before the end of the fiscal year.

CFSAN intends to issue a mid-year progress report on what program priority activities already have been completed to date in FY 2003 as well as any adjustments in the work plan (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 work plan. For example, the center's base programs in data collection, research, and enforcement are important and ongoing. Rather, the work plan addresses primarily those initiatives representing something new or different that we need to address in 2003 as well as priority initiatives that are being continued from the 2002 work plan. In addition, the work plan 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. 2004 CFSAN Program Priorities

FDA is requesting comments concerning the establishment of program priorities in CFSAN for FY 2004, and the input will be used to develop CFSAN's 2004, work plan. The work plan will set forth the center's program priorities for October 1, 2003, through September 30, 2004. FDA intends to make the 2004 work plan available in the fall of 2003.

The format of the 2004 work plan will be similar to last year's work plan. FDA expects there will be considerable continuity and followthrough between the 2003 and 2004 work plans. For example, new initiatives aimed at increasing the security of our country's food supply and revitalizing our nutrition program will continue to be a high priority in FY 2004.

FDA is in the process of developing a major strategic plan and has identified the following five top priority areas for the agency: (1) A strong FDA; (2) efficient risk management; (3) patient and consumer safety; (4) better informed consumers; and (5) counter-terrorism. Action items implementing the strategic plan will be incorporated into CFSAN's priorities for FY 2004.

As noted in the previous paragraphs, many of the “B-list” activities are 2-year projects that we are positioning to be candidates for the “A-list” next year. FDA requests comments on which “B-list” activities should be elevated to the “A-list” for completion in 2004. Finally, as noted, FDA requests comments on new program areas or activities that should be added as a high priority for FY 2004.

III. Comments

Interested persons may submit to the Dockets Management Branch (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper 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: May 28, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.