[Federal Register Volume 63, Number 106 (Wednesday, June 3, 1998)]
[Notices]
[Pages 30242-30243]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14720]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0359]


Program Priorities in the Center for Food Safety and Applied 
Nutrition; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting to solicit input on program priorities in the Center for Food 
Safety and Applied Nutrition (CFSAN). CFSAN is currently conducting a 
comprehensive review of its programs to set priorities and establish 
work product expectations. This meeting is intended to give the public 
an opportunity to provide input into the priority-setting process.

    Date and Time: The meeting will be held on June 24 and 25, 1998, 10 
a.m. to 5 p.m.

    Location: The meeting will be held in the auditorium at the Cohen 
Bldg., 330 Independence Ave. SW., Washington, DC.

    Contact: Tracy S. Summers, Center for Food Safety and Applied 
Nutrition (HFS-1), Food and Drug Administration, 200 C St. SW., 
Washington, DC 20204, 202-205-4850, FAX 202-205-5025, e-mail 
[email protected].

    Registration and Requests for Oral Presentations: Send registration 
information (name, title, firm name, address, telephone, and fax 
number) and requests to make oral presentations to the contact person 
by June 15, 1998. Written comments should be identified with the docket 
number found in brackets in the heading of this document and should be 
submitted by July 15, 1998, to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, 
MD 20857.
SUPPLEMENTARY INFORMATION: FDA's CFSAN is conducting a comprehensive 
review of all its programs to set priorities and establish reasonable 
work product expectations. Although implementation of the President's 
Food Safety Initiative (FSI) is clearly CFSAN's top priority, CFSAN has 
responsibility for many other important programs as well. (The 
Presidential initiative is aimed at reducing foodborne microbial 
illness by strengthening food safety practices and policies.) This 
meeting is intended to provide the public with an opportunity to 
provide input into the priority-setting process. This meeting will also 
serve as one of many activities undertaken by the agency to solicit 
input in accordance with section 406(b) of the Food and Drug 
Administration Modernization Act (FDAMA) of 1997 (Pub. L. 105-115) 
(codified at 21 U.S.C. 393(f)). Section 406 of FDAMA requires that FDA, 
after consultation with appropriate scientific and academic experts, 
health care professionals, representatives of patient and consumer 
advocacy groups, and the regulated industry, develop and publish in the 
Federal Register a plan for meeting all statutory obligations of the 
Federal Food, Drug, and Cosmetic Act.
    By way of example, in CFSAN's regulations program, work priorities 
are being assigned as follows: (1) The highest priority will be those 
regulations that enhance consumer safety, such as those issued to carry 
out the President's FSI; (2) those regulations that are mandated by 
statute; (3) health-related product labeling regulations; (4) 
regulations that will improve efficiency of operations; and (5) those 
additional regulations that have a major positive impact. The agency is 
interested in comments regarding the use of these criteria for setting 
priorities in CFSAN's other program areas. To facilitate comments on 
this issue, the appendix to this notice contains a list of major 
activities undertaken by FDA to ensure that foods are safe, wholesome, 
sanitary, and properly labeled, and that cosmetics are safe and 
properly labeled. Specific activities are listed in one of six general 
categories: Application review, injury reporting, product safety 
assurance, research, outreach, and enforcement.
    The agency is most interested at this time in receiving comments 
regarding program priorities outside of FSI, as other venues are 
available for interested persons to provide input regarding 
implementation of FSI across the Federal Government. (Information 
regarding public meetings on the implementation of FSI can be obtained 
by contacting Camille E. Brewer at 202-260-1784.) Moreover, because 
many FSI-related activities require that FDA collaborate with one or 
more of the other Federal agencies that have primary responsibility for 
food safety (e.g., the Centers for Disease Control and Prevention in 
the Department of Health and Human Services; the Food Safety and 
Inspection Service, the Agricultural Research Service and the 
Cooperative State Research, Education, and Extension Service in the 
Department of Agriculture; and the Environmental Protection Agency), 
comments on priorities in the FSI program at the meeting should be 
limited to those activities for which FDA has sole responsibility.
    To help focus comments, FDA requests that oral and/or written input 
regarding CFSAN program priorities address the following questions:
    1. With respect to products under the jurisdiction of CFSAN, do you 
believe there are issues that directly affect consumer safety that are 
not being adequately addressed?
    2. Beyond implementation of FSI, which program areas and/or 
activities do you believe should be top priorities for CFSAN, and why?
    3. The criteria being used to set priorities for CFSAN's 
regulations are described above. Should these same criteria be used to 
set priorities for work in CFSAN's other program areas? If not, what 
criteria should be used?
    4. FDA needs to ensure that its research programs provide the 
scientific information upon which regulatory decisions are made. In 
CFSAN, what do you believe should be the highest priority areas for 
conducting research?
    5. Because so much of our nation's food supply is either imported 
or exported, international activities, such as Codex, appear to be 
growing in importance. What level of priority do you believe should be 
given in CFSAN to international activities? Please identify specific 
activities in your answer.
    6. Finally, while not a public health issue, economic fraud affects 
both the industry and consumers. What level of priority do you believe 
should be given to addressing issues of economic fraud in the food 
supply?
    Transcripts of the meeting may be requested in writing from the 
Freedom of Information Office (HFI-35), Food and Drug Administration, 
5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 15 
working days after each meeting at a cost of 10 cents per page. The 
transcript of the meeting will be available for public examination at 
the Dockets Management Branch (address above) between 9 a.m. and 4 
p.m., Monday through Friday.
    Persons requiring a sign language interpreter or other special

[[Page 30243]]

accommodations should notify the listed contact person by June 15, 
1998. This will be an informal meeting conducted in accordance with 21 
CFR 10.65.

Appendix

Center for Food Safety and Applied Nutrition--List of Major 
Activities

(Italics indicates FSI activity)

I. Application Review

     Food and Color Additive Petitions
     GRAS Determinations
     Threshold of Regulation Determinations (food packaging)
     Product Notification (consultation with biotechnology 
firms)
     Food Additive Regulatory Management (FARM) System 
(automated workflow)
     Review of Scientific Data and Research (nonlab) (to 
support petition review/biotech)
     Notification Program for Infant Formula
     Notification Program for Dietary Supplements
     Notification for Nutrient Content and Health Claims Based 
on Authoritative Statements
     Nutrient Content and Health Claim Petitions
     Small Business Notifications
     Approval of Data Bases for Nutrition Labeling
     Temporary Marketing Permits
     Certificates of Free Sale

II. Injury Reporting

     Adverse Event Reporting/Monitoring
     Foodborne Active Surveillance Network (FoodNet)
     Coordination on Foodborne Disease Outbreaks
     DNA Fingerprinting (PulseNet)

III. Product Safety Assurance

Monitoring
     Good Laboratory Practices (GLP)/Bioresearch Monitoring
     Preventive Measures for Eggs
     Safety of Dietary Supplements/Herbal Products
     Monitoring of Prohibited Ingredients (cosmetics) and 
Adherence to GMP's
     Food Labeling and Packaging Survey (FLAPS)
     Priority-Based Assessment of Food Additives (PAFA)
     Monitoring the Safety of Imported Foods and Cosmetics
     Monitoring of Adverse Reactions to Food Products Reported 
by the Field
     Produce Initiative
     Seafood Decomposition--Investigation of Problems
     Epidemiological Support
     Monitoring Pesticide Residues
     Monitoring Microbial Pathogens
     Monitoring Chemical and Industrial Contaminants
     Monitoring Seafood Toxins
     Safety of Medical Foods
Compliance
     Lab Accreditation (e.g., milk labs)
     Low-Acid Canned Food and Acidified Food Regulations and 
Establishment Registration
     Development of GAP's and GMP's for Fresh Produce
     Electronic Inspection System (EIS)
     Import and Domestic Seafood Compliance Program Development 
and Evaluation
     Economic Fraud
     Regulation and Policy Development (centerwide)
     Economic Cost Benefit Analysis Studies (regulations)
     Nutrient Content Analyses
     Food Standards (including petitions to modify or 
establish)
HACCP
     International Shellfish Program
     Implementation of Seafood HACCP
     Juice HACCP and Warning Label Proposed Regulations
     HACCP at Retail (pilot)
Product Testing--This category includes laboratory testing of 
components/ingredients of foods and cosmetic products for safety.
     Indirect and Direct Food Additives
     Sample Analyses
     Infant Formula Samples
     Testing for Harmful Ingredients and Contaminants in 
Cosmetic Products

IV. Research

     Methods Development--This is research to develop new 
analytical methods or investigate known analytical methods for 
detecting and identifying microbial pathogens, chemical contaminants, 
and toxins in foods and cosmetics that can be potentially harmful to 
the public's health. Most of the research conducted in CFSAN falls into 
this category.

-- Analytical Methods Development to Detect Microbial Pathogens

     Risk Assessment--Developing or applying analytical methods 
to quantify exposure to or determine if a pathogen, chemical 
contaminant, or toxin poses a public health risk. This is the second 
largest category of research conducted in CFSAN.

-- Risk Assessment for the Food Safety Initiative: Interagency 
Consortium; Improve Modeling Techniques

    -- Mathematical and Statistical Support
    -- Pathology Data Analyses
    -- Pharmacokinetic and Pharmcodynamic Modeling
     Other Research-- Laboratory studies to obtain knowledge/
data necessary for application in methods development and/or risk 
assessment. This category also includes collaborative research efforts 
with academia and other food safety research concerns.

V. Outreach

     Technical Assistance and Education (consumers/industry/
retail/foreign countries)
     Codex Activities
     Guideline Development
     Voluntary Registration Program
     Mutual Recognition Agreements
     Federal/State Cooperative Programs (milk, shellfish, 
retail)
     Education on Food Safety
    -- Develop educational messages and materials
    -- Educate general public about safe food handling
    -- Educate children about safe food handling
    -- Educate vulnerable populations about safe food handling

VI. Enforcement

     Case Processing
     Recalls of Foods and Cosmetics

    Dated: May 28, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-14720 Filed 6-2-98; 8:45 am]
BILLING CODE 4160-01-F