Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Notices 5517

reduce L. monocytogenes illnesses from

ready-to-eat foods. The plan focuses on

those food categories identified in the

draft risk assessment as either

warranting additional measures to

reduce L. monocytogenes contamination

or warranting collection of additional

data. Within HHS, FDA and CDC have

the primary responsibility for

implementation of this action plan.

Within USDA, FSIS has the primary

responsibility for implementation of this

plan, working in concert with other

USDA agencies through the Office of

Food Safety.

The action plan contains the

following eight action areas:

(1) Enhance consumer and health care

provider information and education

efforts;

(2) Develop and revise guidance for

processors, retailers, and food service/

institutional establishments that

manufacture or prepare ready-to-eat

foods;

(3) Develop and deliver training/

technical assistance to the regulated

industry and food safety regulatory

employees;

(4) Review and redirect enforcement

and regulatory strategies including

microbial product sampling;

(5) Propose new regulations and

revisions to existing regulations as

needed;

(6) Enhance disease surveillance and

outbreak response;

(7) Initiate projects with retail

operations such as delicatessens and

salad bars to pilot new L.

monocytogenes control measures

including employee practices; and

(8) Coordinate research activities to

refine the risk assessment, enhance

preventive controls, and support

regulatory, enforcement, and

educational activities.

As noted, the draft risk assessment

will be available, along with other

information, to assist HHS and USDA as

they consider the specific means to

implement the elements of the action

plan.

III. Electronic Access

The draft risk assessment document

and the risk management plan are

available electronically as follows:

Draft Risk Assessment Document www.cfsan.fda.gov

www.fsis.usda.gov

www.foodsafety.gov

www.foodriskclearinghouse.umd.edu

The Risk Management Action Plan www.cfsan.fda.gov

www.foodsafety.gov

www.fsis.usda.gov

Dated: January 11, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation, Food and Drug

Administration, HHS.

Thomas J. Billy,

Administrator, Food Safety Inspection

Service, USDA.

[FR Doc. 01–1439 Filed 1–18–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N–1075]

Public Health Impact of Vibrio

Parahaemolyticus in Raw Molluscan

Shellfish; Draft Risk Assessment

Document; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft risk assessment on

the relationship between Vibrio

parahaemolyticus in raw molluscan

shellfish, specifically oysters, and

human health. FDA began this

quantitative microbial risk assessment

(QMRA) in 1999, and the agency has

held three public meetings on the

framework of the assessment, the

assumptions, and the modeling

procedures. As part of the review

process, the agency is making this draft

risk assessment available and is seeking

comments on the technical aspects of

the draft risk assessment. A public

meeting to discuss the draft risk

assessment will be announced in a

future issue of the Federal Register.

DATES: Submit written comments on the

draft risk assessment by March 20, 2001.

ADDRESSES: The draft risk assessment is

available electronically on the FDA

Internet at www.foodsafety.gov/dms/fstoc.html. Hard copies of the draft risk

assessment will be available upon

request; fax requests to 1–877–366–

3322. The draft risk assessment may

also be reviewed at the Dockets

Management Branch (address below)

between 9 a.m. and 4 p.m., Monday

through Friday.

Submit written comments to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852. Two copies of comments are

to be submitted, except that individuals

may submit one copy. Comments must

be identified with the docket number

found in brackets in the heading of this

document.

FOR FURTHER INFORMATION CONTACT:

For specific technical information

contact: Marianne Miliotis, Vibrio

parahaemolyticus Risk Assessment

5518 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Notices

Team Leader, Center for Food

Safety and Applied Nutrition (HFS–

327), Food and Drug

Administration, 200 C St. SW.,

Washington, DC 20204, 202–205–

4824, FAX 202–205–4939, or email: mmilioti@cfsan.fda.gov.

For general information contact:

Sherri B. Dennis, Risk Assessment

Coordinator, Center for Food Safety

and Applied Nutrition (HFS–032),

Food and Drug Administration, 200

C St. SW., Washington, DC 20204,

202–260–3984, FAX 202–260–9653,

or e-mail: sdennis@cfsan.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of May 7, 1999

(64 FR 24664), FDA announced plans to

conduct a risk assessment to determine

the extent of exposure of consumers to

V. parahaemolyticus in raw molluscan

shellfish. On August 13, 1999 (64 FR

44226), FDA announced public

meetings to discuss issues related to the

risk models under development. You

may refer to these notices for

background.

II. The V. Parahaemolyticus QMRA

The goal of this QMRA is to provide

FDA with information that will assist

the agency with the review of current

programs relating to the regulation of V.

parahaemolyticus in raw molluscan

shellfish to ensure that such programs

protect the public health. QMRA is a

structured and systematic process of

collecting and evaluating data and

information to determine the risks to

human health from consumption of

pathogenic microorganisms. This draft

risk assessment evaluates factors that

most influence the prevalence of V.

parahaemolyticus in shellfish at harvest

and after harvest handling practices.

The draft risk assessment also evaluates

preventive and intervention strategies,

as well as the FDA and Interstate

Shellfish Sanitation Conference

guideline of up to 10,000 viable V.

parahaemolyticus cells per gram of

seafood. The draft risk assessment

follows the framework recommended by

both the National Academy of Sciences

and the Codex Alimentarius

Commission. This structured framework

involves the following steps:

• Hazard identification. The

collection and critical review of data

and information on V.

parahaemolyticus.

• Exposure assessment. The

determination of the likelihood of

ingesting pathogenic V.

parahaemolyticus by eating raw

molluscan shellfish harboring the

organism and the amount of pathogenic

V. parahaemolyticus present when

consumed.

• Hazard characterization/doseresponse. The relationship of the levels

of V. parahaemolyticus ingested with

the frequency and magnitude of illness

using epidemiological investigations

and clinical trials.

• Risk characterization. The

integration of dose-response and

exposure assessments into a complex

model to estimate risk of illness and

range of uncertainty associated with this

estimate. The risk assessment process

also involves the identification of data

gaps and the development of reasonable

assumptions if data are unavailable.

FDA began this QMRA in 1999.

Recognizing the public health

importance of this pathogen, the

scientific knowledge and data currently

available were rigorously evaluated to

assure that this assessment will serve to

facilitate several processes, including

the formulation of effective guidance for

the industry, regulators, and consumers

and the evaluations of risk mitigation

strategies.

As part of a peer evaluation of the

draft risk assessment, FDA is seeking

comments in the following areas: (1)

The assumptions, (2) the modeling

technique, (3) the data sets used, and (4)

transparency of the document. FDA

intends to review and evaluate all

public comments and make

modifications to the assessment, as

appropriate.

As noted previously, the draft risk

assessment is available electronically on

FDA’s website and may be reviewed in

the agency’s Dockets Management

Branch.

Dated: December 18, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–1440 Filed 1–18–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4644–N–03]

Federal Property Suitable as Facilities

To Assist the Homeless

AGENCY: Office of the Assistant

Secretary for Community Planning and

Development, HUD.

ACTION: Notice.

SUMMARY: This Notice identifies

unutilized, underutilized, excess, and

surplus Federal property reviewed by

HUD for suitability for possible use to

assist the homeless.

EFFECTIVE DATE: January 19, 2001.

FOR FURTHER INFORMATION CONTACT:

Clifford Taffet, Department of Housing

and Urban Development, Room 7262,

451 Seventh Street SW, Washington, DC

20410; telephone (202) 708–1234; TTY

number for the hearing- and speechimpaired (202) 708–2565, (these

telephone numbers are not toll-free), or

call the toll-free Title V information line

at 1–800–927–7588.

SUPPLEMENTARY INFORMATION: In

accordance with the December 12, 1988

court order in National Coalition for the

Homeless v. Veterans Administration,

No. 88–2503–OG (D.D.C.), HUD

publishes a Notice, on a weekly basis,

identifying unutilized, underutilized,

excess and surplus Federal buildings

and real property that HUD has

reviewed for suitability for use to assist

the homeless. Today’s Notice is for the

purpose of announcing that no

additional properties have been

determined suitable or unsuitable this

week.

Dated: January 11, 2001.

John D. Garrity,

Director, Office of Special Needs Assistance

Programs.

[FR Doc. 01–1398 Filed 1–18–01; 8:45 am]

BILLING CODE 4210–29–M

DEPARTMENT OF THE INTERIOR

Office of the Secretary; Notice of

Deadline for Submitting Completed

Applications To Begin Participation in

the Tribal Self-Governance Program in

Fiscal Year 2002 or Calendar Year 2002

AGENCY: Office of Self-Governance,

Interior.

ACTION: Notice of application deadline.

SUMMARY: In this notice, the Office of

Self-Governance (OSG) establishes a

March 1, 2001, deadline for tribes/

consortia to submit completed

applications to begin participation in

the tribal self-governance program in

fiscal year 2002 or calendar year 2002.

DATES: Completed application packages

must be received by the Director, Office

of Self-Governance by March 1, 2001.

ADDRESSES: Application packages for

inclusion in the applicant pool should

be sent to the Director, Office of SelfGovernance, U.S. Department of the

Interior, Mail Stop 2548, 1849 C Street,

NW., Washington DC 20240.

FOR FURTHER INFORMATION CONTACT: Dr.

Kenneth D. Reinfeld, U.S. Department of

the Interior, Office of Self-Governance,

1849 C Street NW., Mail Stop 2548,

Washington DC 20240; Telephone 202–

208–5734.