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.
Federal Register / Vol. 63, No. 145 /Wednesday, July 29, 1998 / Notices 40533

ACTION: Notice.

SUMMARY: The Food and Drug

Administration’s (FDA’s) Office of Drug

Evaluation IV (ODE IV), Center for Drug

Evaluation and Research (CDER), is

announcing the availability of several

draft guidance documents on the

development of antimicrobial drug

products. A general draft guidance

document entitled ‘‘Developing

Antimicrobial Drugs—General

Considerations for Clinical Trials’’

discusses issues common to the

development of all antimicrobial drugs.

The companion draft guidance

documents address issues related to

developing drugs to treat individual

indications. These draft guidance

documents are intended to help

sponsors design clinical trials that will

yield information the agency can use to

determine whether the antimicrobial

drug under study is safe and effective in

the treatment of the specific infection

studied. Key elements of these draft

guidance documents will be discussed

at a July 29, 30, and 31, 1998, Anti–

Infective Drugs Advisory Committee

meeting.

DATES: Written comments on the draft

guidance documents may be submitted

by October 27, 1998. General comments

on agency guidance documents are

welcome at any time.

ADDRESSES: Copies of the draft guidance

documents are available on the Internet

at ‘‘http://www.fda.gov/cder/guidance/

index.htm’’. Submit written requests for

single copies of the draft guidance

documents to the Drug Information

Branch (HFD–210), Center for Drug

Evaluation and Research, Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857. Send one

self-addressed adhesive label to assist

that office in processing your requests.

Submit written comments on the draft

guidance documents to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

Requests and comments should be

identified with the docket number

found in brackets in the heading of this

document.

FOR FURTHER INFORMATION CONTACT:

Renata Albrecht, Center for Drug

Evaluation and Research (HFD–590),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–2336.

SUPPLEMENTARY INFORMATION: FDA’s

divisions of Anti–Infective Drug

Products, Special Pathogens and

Immunologic Drug Products, and Anti–

Viral Drug Products in CDER’s ODE IV

are issuing the first documents in a

series of draft guidance documents that

are intended to assist sponsors in

designing, carrying out, and analyzing

the results of clinical trials for the

development of antimicrobial drug

products. A general draft guidance

document entitled ‘‘Developing

Antimicrobial Drugs—General

Considerations for Clinical Trials’’

discusses issues common to all

antimicrobial drugs. The companion

draft guidance documents address

issues related to developing drugs to

treat individual indications. Key

elements from these draft guidance

documents and related issues will be

discussed at an Anti–Infective Drugs

Advisory Committee meeting on July 29,

30, and 31, 1998 (63 FR 34655, June 25,

1998).

In the Federal Register of July 21,

1998 (63 FR 39096), ODE IV announced

its plans for revising existing guidance

documents and preparing new guidance

documents on the development of

antimicrobial drug products for the

treatment of infections. ODE IV is

reviewing, updating, consolidating, and

revising its existing guidance

documents and identifying topics for

future guidance documents. In that

notice, ODE IV explained its plan and

requested public comment on topics for

future guidance document development.

The draft guidance documents are a part

of ODE IV’s guidance development plan. The general draft guidance document

being made available is entitled

‘‘Developing Antimicrobial Drugs—

General Considerations for Clinical

Trials.’’ The draft companion guidances

are being made available on individual

indications as follows: • Uncomplicated urinary tract

infections, • Uncomplicated and complicated

skin and skin structure infections, • Community-acquired pneumonia,

• Nosocomial pneumonia,

• Acute bacterial exacerbation of

chronic bronchitis, • Secondary bacterial infection of

acute bronchitis, • Acute otitis media,

• Acute uncomplicated gonorrhea,

• Acute sinusitus,

• Complicated urinary tract infections

and pyelonephritis, • Bacterial prostatitis,

• Early Lyme disease,

• Empiric therapy of febrile

neutropenia, • Vulvovaginal candidiasis,

• Streptococcal pharyngitis and

tonsillitis, • Bacterial meningitis, and

• Bacterial vaginosis. Additional guidances are under

development.

The information in these draft

guidance documents represents the

agency’s current thinking on developing

antimicrobial drug products. It does not

create or confer any rights for or on any

person and does not operate to bind

FDA or the public. An alternative

approach may be used if such approach

satisfies the requirements of the

applicable statute, regulations, or both.

Interested persons may submit written

comments on the draft guidance

documents to the Dockets Management

Branch (address above). 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. The draft guidance

documents and received comments may

be seen in the office above between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: July 23, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–20239 Filed 7–28–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0448]

Guidance on the Performance

Standard for Electrode Lead Wires and

Patient Cables; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance entitled

‘‘Guidance on the Performance Standard

for Electrode Lead Wires and Patient

Cables.’’ The guidance document

provides information on the

electrocution hazard posed by

unprotected patient electrical

connectors. This guidance is intended to

help affected parties understand the

steps needed to achieve compliance

with the performance standard for

electrode lead wires and patient cables.

DATES: Written comments concerning

this guidance must be received by

October 27, 1998.

ADDRESSES: Submit written requests for

single copies on a 3.5’’ diskette of the

guidance entitled ‘‘Guidance on the

Performance Standard for Electrode

Lead Wires and Patient Cables’’ to the

Division of Small Manufacturers