30242 Federal Register / Vol. 63, No. 106 /Wednesday, June 3, 1998 / Notices

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: May 28, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–14760 Filed 6–2–98; 8:45 am]

BILLING CODE 4160–01–F

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

tsummers@bangate.fda.gov.

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
Federal Register / Vol. 63, No. 106 /Wednesday, June 3, 1998 / Notices 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

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Request for Nominations of

Candidates to Serve on the National

Vaccine Advisory Committee,

Department of Health and Human

Services

The Public Health Service (PHS) is

soliciting nominations for possible

membership on the National Vaccine

Advisory Committee (NVAC). This

committee studies and recommends

ways to encourage the availability of an

adequate supply of safe and effective

vaccination products in the States;

recommends research priorities and

other measures the Director of the

National Vaccine Program should take

to enhance the safety and efficacy of

vaccines; advises the Director of the

Program in the implementation of

sections 2102, 2103, and 2104, of the

PHS Act; and identifies annually, for the

Director of the Program, the most