00-16067. 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) 2001. 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:

Written comments by August 25, 2000.

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. 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, 200 C St., SW Washington, DC 20204, 202-260-5290, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

On February 10, 2000, CFSAN released a document entitled “2000 CFSAN Program Priorities.” The document, a copy of which is available on CFSAN's web page (www.cfsan.fda.gov),, constitutes the Center's priority workplan for a 9-month period, from January 1, 2000, through September 30, 2000, the end of the fiscal year. Henceforth, to be consistent with the Federal budgetary cycle, the priority-setting process and development of annual workplans will be done on a fiscal year basis. The 2000 workplan is based on input we received from our stakeholders (see 64 FR 47845, September 1, 1999), 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?”

Approximately half of the 2000 workplan consists of activities implementing the President's Food Safety Initiative (FSI). This is consistent with the fact that currently, approximately half the Center's resources are devoted to FSI work (i.e., all activities related to pathogen reduction in food.) Outside of FSI, the workplan identifies five program areas and six cross-cutting areas that need emphasis. The five program areas are: (1) Premarket review of food ingredients; (2) nutrition, health claims, and labeling; (3) dietary supplements; (4) chemical and other contaminants; and (5) cosmetics.

The six cross cutting areas are: (1) Enhancing the science base, (2) international activities, (3) emerging areas such as food biotechnology, (4) enhancing regulatory processes, (5) focused economic-based regulations, and (6) management initiatives.

In keeping with last year's format, the workplan contains two lists of activities in most major sections of the document, i.e., the “A” list and the “B” list. Because we condensed this year's plan to three-fourths of the year (9 months), our goal will be to fully complete at least three-quarters of the “A” list activities. 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 has responsibility for many important ongoing activities that are not identified in the workplan. For example, the Center'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 we need to address in 2000. In addition, the workplan does not address the myriad of unanticipated issues which often require a substantial investment of CFSAN resources (e.g., response to outbreaks of foodborne illness).

II. 2001 CFSAN Program Priorities

FDA is requesting comments concerning the establishment of program priorities in CFSAN for FY 2001. The input will be used to develop CFSAN's 2001 workplan. The workplan will set forth the Center's program priorities for October 1, 2000, through September 30, 2001. FDA intends to make the 2001 workplan available in October 2000.

The format of the 2001 workplan will be similar to the 2000 workplan. Moreover, FDA expects there will be considerable continuity between the 2000 and 2001 workplans. For example, a broad program area targeted for enhancement in the 2000 plan is improving the safety of imported food; five specific activities are identified to implement the Imported Foods Action Plan. As the initiative to prevent importation of unsafe food requires a multiyear effort, ensuring the safety of imported food will continue to be a high priority in the 2001 workplan. The same is true for the Egg Safety Action Plan. FDA requests comments on other broad program areas that should continue to be a priority in FY 2001.

In addition, because the 2000 workplan, as noted above, was a condensed (i.e., 9-month) plan, our goal for FY 2000 will be to fully complete at least three-quarters of the “A” list activities. FDA requests comments on those “A” list activities in the 2000 plan that, if not completed, should be carried over to the 2001 workplan. FDA also requests comments on the FY 2000 “B” list activities that should be elevated to the “A” list for completion in FY 2001. Finally, FDA requests comments on new program areas or activities that should be a high priority for FY 2001.

Interested persons may submit to the Dockets Management Branch (address above) written comments regarding this notice by August 25, 2000. 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 19, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.