Federal Register / Vol. 63, No. 145 /Wednesday, July 29, 1998 / Notices 40531

Location: The meeting and the

technical workshop will be held at the

University of Maryland, Stamp Student

Union Building ‘‘Atrium,’’ College Park,

MD.

Contact: Roberta Morales, VA–MD

Regional College of Veterinary

Medicine, University of Maryland,

College Park, MD 20742–3711, 301–

935–6083, ext. 158, FAX 301–935–0149.

Registration: Send registration

information for both the meeting and

the workshop (name, title, firm name,

address, telephone and fax numbers) to

Jacqueline M. Williams, Center for Food

Safety and Applied Nutrition (HFS–

315), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–205–4224, FAX 202–205–4422, or

register on-line at ‘‘http://

www.foodsafety.gov/∼mow/jifsan.html’’.

There is no registration fee. If you need special accommodations

due to a disability, please contact

Roberta Morales at least 7 days in

advance.

SUPPLEMENTARY INFORMATION: On

January 25, 1997, the President

announced the National Food Safety

Initiative. As a part of this initiative, the

development of methods and models

directed for enhanced food safety risk

assessment, particularly for

microbiological pathogens and their

toxins were identified as priority needs. Risk assessment characterizes the

nature and magnitude of the risks to

human health associated with hazards,

and makes clear the assumptions and

degree of scientific certainty of the data

associated with risk estimates. Risk

assessments require specific information

on the hazard and on the exposed

population to provide meaningful

information for those making riskmanagement decisions. Although risk

assessment methods are fairly well

established for evaluating chemicals and

contaminants in food, risk assessment is

far less developed for foodborne

pathogens. The May 1997 National Food

Safety Report to the President noted that

intensive commitment is necessary to

develop critically needed methods for

analyzing food safety data and

addressing its uncertainty, and that

methods that account for variability of

living microbial pathogens are essential

to focus public resources on risks that

have the greatest consequences for

human health.

A component of this effort has been

the establishment of a joint Risk

Assessment Consortium of Federal

agencies with food safety riskmanagement responsibilities. The

purposes of the consortium are: To

advance the science of microbial food

safety risk assessment; to serve as

advisors for direction and review of Risk

Assessment Clearinghouse activities;

and to assist agencies in fulfilling their

specific food safety mandates. The

consortium seeks to comprehensively

cover risk assessment activities

including solicitation of expertise from

risk assessment professionals, scientists,

and interested parties from government,

industry, consumer organizations, and

academia. As a means of assuring that

the Risk Assessment Clearinghouse will

meet the needs of the diverse clientele

it is intended to serve, JIFSAN will take

the lead role in the development of the

clearinghouse and is seeking comments

from interested parties at an open

meeting and an open technical

workshop. This input will be used to

construct a draft framework document

that will define the users and their

needs, the scope, objectives,

mechanisms, and output of the

clearinghouse.

JIFSAN is a multi-disciplinary

research and education program

established by FDA and the University

of Maryland in 1996. JIFSAN is a major

component of the FDA food safety

program’s integration with academic

institutions to create intellectual

partnerships. The JIFSAN includes

research and outreach components from

the Center for Food Safety and Applied

Nutrition (CFSAN), the Center for

Veterinary Medicine (CVM), and the

University of Maryland. JIFSAN

combines resources from the primary

Federal public health agency

responsible for assuring the safety of the

nation’s food supply, a research

university, and public and private

partnerships to provide the scientific

basis for assuring a safe, wholesome

food supply. JIFSAN provides a neutral

environment in which experts from

industry, consumer and trade groups,

international organizations, government,

and academia can pool their resources

and ideas to provide the scientific base

for the development of sound public

health policy.

The meeting and 2-day technical

workshop are intended to ensure a wide

cross-section of input. The August 7,

1998, meeting will share information on

risk assessment applications in relation

to food safety concerns by providing an

overview of risk assessment and risk

analysis, including an historical

perspective, terminology, and

approaches. Examples of current and

potential applications in relation to food

uses will be discussed. Through an open

forum, input into the needs and

expectations of clearinghouse users will

be sought. The information obtained at

this meeting will be used to help

develop a framework for the scope of

clearinghouse activities. At the October 5 and 6, 1998, 2-day

technical workshop, an in-depth

evaluation by food safety and risk

assessment experts and the public of the

adequacy of the overall draft framework

will be addressed. The workshop will

include breakout sessions on topics

such as: Systems for cataloguing

information; criteria for transparent

evaluation of risk assessments; strategies

to promote public involvement;

solicitation and receipt of voluntary

data from industry, government, and

other interested parties; systems for

protection of the anonymity of

proprietary data; user access;

information dissemination and output

formats; infrastructure needs;

implementation priorities; and customer

service.

The outcome of the workshop will be

a refined framework draft that will be

used to guide further development of

the clearinghouse. Further opportunities

for comment and refinement will be

provided. Final program agendas will be posted

on the JIFSAN web page at ‘‘http://

www.foodsafety.gov/∼mow/jifsan.html’’.

Dated: July 24, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–20300 Filed 7–27–98; 4:44 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Relating Numbers of Foodborne

Pathogens to Human Illness; Public

Workshop

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

The Food and Drug Administration

(FDA) is announcing a public workshop

sponsored by the Joint Institute for Food

Safety and Applied Nutrition (JIFSAN).

This public workshop is being held to

explore issues essential to better the

general understanding of the risk of

illness associated with foodborne

microorganisms. The workshop is

intended to facilitate a scientific

discussion that will serve as a basis for

further dialogue with the greater

scientific community in structuring

approaches to dose-response modeling

of foodborne pathogens.

Date and Time: The public workshop

will be held on August 4, 1998, 8 a.m.

to 5 p.m.
40532 Federal Register / Vol. 63, No. 145 /Wednesday, July 29, 1998 / Notices

Location: The public workshop will

be held at the University of Maryland,

Stamp Student Union Building

‘‘Atrium,’’ College Park, MD.

Contact: June A. Bradlaw, Center for

Food Safety and Applied Nutrition

(HFS–508), Food and Drug

Administration, 200 C St. SW.,

Washington, DC 20204, 301–594–5883,

FAX 301–594–0517.

Registration: Send registration

information (name, title, firm name,

address, telephone and fax numbers) to

Jacqueline M. Williams, Center for Food

Safety and Applied Nutrition (HFS–

315), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–205–4224, FAX 202–205–4422.

Registration should be sent by August 3,

1998, or register on-line at ‘‘http://

www.foodsafety.gov/∼mow/jifsan.html’’.

There is no registration fee for this

workshop.

If you need special accommodations

due to a disability contact June A.

Bradlaw at least 7 days in advance.

SUPPLEMENTARY INFORMATION: On

January 25, 1997, the President

announced the National Food Safety

Initiative. As a part of this initiative, a

need was recognized for the

development of methods and models for

enhanced food safety risk assessment,

particularly for microbiological

pathogens and their toxins.

Risk assessment generally

characterizes the nature and magnitude

of the risks associated with hazards to

human health, and helps to clarify the

assumptions and degree of scientific

certainty of the data associated with risk

estimates. Risk assessments require

specific information on the hazard and

on the exposed populations to provide

meaningful information to public health

officials to develop and arrive at riskmanagement decisions. Although risk

assessment methods are fairly well

established for evaluating chemicals and

contaminants in food, risk assessment is

far less developed for foodborne

pathogens. The May 1997 National Food

Safety report to the President noted that

an intensive commitment is necessary to

fill this gap and develop critically

needed methods for analyzing food

safety data and addressing its

uncertainty.

A component of this effort has been

the establishment of a joint Risk

Assessment Consortium of Federal

agencies with food safety riskmanagement responsibilities. The role

of the consortium is: To advance the

science of microbial food safety risk

assessment; to serve as advisors for

direction and review of Risk Assessment

Clearinghouse activities; and to assist

agencies in fulfilling their specific food

safety regulatory mandates. Consistent

with these goals, JIFSAN will host an

open workshop that will explore issues

requisite to quantifying the risk of

illness associated with foodborne

pathogenic microorganisms. Guidance

in the development of this workshop

has been provided by the Risk

Assessment Consortium.

JIFSAN is a multi-disciplinary

research and education program

established by FDA and the University

of Maryland in 1996. JIFSAN is a major

component of the FDA’s integration

with academic institutions to create

intellectual partnerships. JIFSAN

includes research and outreach

components from the Center for Food

Safety and Applied Nutrition (CFSAN),

the Center for Veterinary Medicine

(CVM), and the University of Maryland.

JIFSAN combines resources from FDA,

the primary Federal public health

agency responsible for the safety of the

nation’s food supply, an established

research university, and public and

private partnerships to provide the

scientific basis for assuring a safe,

wholesome food supply. JIFSAN

provides a neutral environment in

which experts from industry, consumer

and trade groups, international

organizations, government, and

academia can pool their resources and

ideas to provide the scientific base for

the development of sound public health

policy.

The goal of this workshop is to

evaluate the current state of science for

quantifying dose-response relations for

foodborne pathogens and to identify

opportunities and alternative sources of

information that can be used to develop

enhanced dose-response models for

conducting microbial risk assessments.

Broad areas to be discussed will

include: (1) Current modeling of

foodborne pathogenic microorganisms,

(2) how traditional dose-response

models can be adapted to provide better

estimates of the severity and likelihood

of illness due to foodborne pathogens,

and (3) alternative approaches and

sources of information for elucidating

dose-response relations.

Speakers will consider scientific

principles and methods that can be used

or adapted to elucidate dose-response

relations for microorganisms that are

pathogenic in humans. This will

include detailed discussion concerning

how these relations can be modeled for

use in microbial risk assessment.

Discussions will focus on how these

data, which are often developed for

other purposes, can be useful for doseresponse models. Emphasis will be

placed on modeling susceptible

populations, use of animal models and

improvement of methods of data

collection.

The draft scientific agenda includes

the following presentations: Classical

and Modern Chemical Dose-Response

Models–Concepts and Applications in

Risk Assessment; Limitations of Current

Dose-Response Models for use in

Modeling Dose-Response for Pathogenic

Microorganisms; Linking In Vitro,

Animal and Human Studies Through

Mechanisms of Pathogenesis;

Correlating Host Resistance and

Susceptibility With Biomarkers From In

Vitro, Ex Vivo and Animal Models; Use

of Epidemiological Data in DoseResponse Models; Estimation of

Infective Dose Based on an Actual

Outbreak Investigation; and Suitability

of Small Human Clinical Studies to

Measure Pathogenesis of Foodborne

Pathogens. The agenda also includes

open discussion periods during which

participants will be encouraged to

discuss the merits of different

approaches for developing microbial

risk assessment dose-response models

and to identify additional approaches

not identified in the formal

presentations.

The workshop will serve as an initial

foray into issues and questions

surrounding the relationship between

the numbers of pathogenic

microorganisms consumed and the

resultant illness. The workshop is

intended to facilitate a scientific

discussion that will serve as a basis for

further dialogue with the greater

scientific community in structuring

approaches to dose-response modeling

of foodborne pathogens.

The program agenda and workshop

abstracts will be posted on the world

wide web (WWW) at ‘‘http://

www.foodsafety.gov/∼mow/jifsan.html’’.

Verbatim transcripts will also be posted

on the WWW after the workshop.

Dated: July 24, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–20299 Filed 7–24–98; 4:44 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0548]

Draft Guidances for Industry on the

Development of Antimicrobial Drug

Products; Availability

AGENCY: Food and Drug Administration,

HHS.