Federal Register / Vol. 66, No. 44 / Tuesday, March 6, 2001 / Notices 13545

shellfish and human health. Notice of

availability of the draft risk assessment

was previously published in the Federal

Register of January 19, 2001.

Date and Time: The meeting will be

held on March 20, 2001, 9 a.m. to 3 p.m.

Location: The meeting will be held at

the Hilton Hotel-Crystal City, 2399

Jefferson Davis Hwy., Arlington, VA

22202.

Contact: Catherine M. DeRoever,

Center for Food Safety and Applied

Nutrition (HFS–6), Food and Drug

Administration, 200 C St. SW.,

Washington, DC 20204, 202–205–251,

FAX 202–205–4970, e-mail

cderoeve@cfsan.fda.gov.

Agenda: FDA is seeking comments on

the draft risk assessment in the

following areas: (1) The assumptions

made, (2) the modeling technique, (3)

the data used, and (4) the transparency

of the draft risk assessment document.

FDA will review and evaluate all public

comments and make modifications to

the risk assessment, as appropriate.

Registration and Requests for Oral

Presentation: Send registration

information (including name, title, firm

name, address, telephone, and fax

number) to the contact person by March

14, 2001. Interested persons may

present data, information, or views

orally or in writing, on the draft risk

assessment on the relationship between

V. parahaemolyticus in raw molluscan

shellfish and human health. Written

submissions must also be made to the

contact person by March 14, 2001. Time

allotted for each presentation may be

limited. If you wish to make a formal

oral presentation, you should notify the

contact person before March 14, 2001,

and be prepared to provide a brief

statement of the general nature of the

evidence you wish to present.

If you need special accommodations

due to a disability, please contact

Catherine M. DeRoever (address above)

at least 7 days in advance.

Transcripts: 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 the

meeting at a cost of 10 cents per page.

Dated: February 28, 2001.

Ann M. Witt,

Acting Associate Commissioner for Policy.

[FR Doc. 01–5462 Filed 3–1–01; 4:23 pm]

BILLING CODE 4162–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N–1168]

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. 00-048N]

Relative Risk to Public Health From

Foodborne Listeria Monocytogenes

Among Selected Categories of Readyto-Eat Foods; Draft Risk Assessment

Document and Risk Management

Action Plan; Availability; Extension of

Comment Period

AGENCY: Food and Drug Administration,

HHS, and Food Safety and Inspection

Service, USDA.

ACTION: Notice; extension of comment

period.

SUMMARY: The Food and Drug

Administration (FDA), in cooperation

with the Food Safety and Inspection

Service (FSIS) of the U.S. Department of

Agriculture (USDA), and the Centers for

Disease Control and Prevention,

published a notice of availability of a

draft risk assessment on the relationship

between foodborne Listeria

monocytogenes and human health and a

proposed risk management action plan

for L. monocytogenes in the Federal

Register of January 19, 2001. Interested

persons were given until March 20,

2001, to comment on these documents.

Because a public meeting to receive

comments on these documents has been

scheduled close to the end of the

comment period and in response to the

requests of the National Food Processors

Association and the LM Working Group

for an extension of the comment period,

FDA and FSIS are extending the

comment period until May 21, 2001.

DATES: Submit written comments by

May 21, 2001.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Docket No. 99N–1168, Food

and Drug Administration, 5630 Fishers

Lane, rm. 1060, Rockville, MD 20852.

Two copies of any comments are to be

submitted, except that individuals may

submit one copy. Received comments

may be reviewed at the FDA Dockets

Management branch (address above)

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

through Friday.

Submit one original and two copies of

written comments to FSIS Docket Clerk,

Docket No. 00–048N, U.S. Department

of Agriculture, Food Safety and

Inspection Service, rm. 102, Cotton

Annex, 300 12th Street SW.,

Washington, DC 20250–3700. All

comments submitted in response to this

notice will be available for public

inspection in the Docket Clerk’s office

between 8:30 a.m. and 4:30 p.m.,

Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

For information concerning the draft

risk assessment document: 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,

e–mail: sdennis@cfsan.fda.gov.

For information concerning the risk

management action plan: Kathy

Gombas, Center for Food Safety and

Applied Nutrition (HFS–615), Food

and Drug Administration, 200 C St.

SW., Washington, DC 20204, 202–

205–4231, FAX 202–260–0136, e–

mail: kgombas@cfsan.fda.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of January 19, 2001,

(66 FR 5515), the Department of Health

and Human Services and USDA

announced the availability of two

documents: A draft risk assessment on

the relationship between foodborne L.

monocytogenes and human health and a

draft risk management action plan.

Comments were sought on the technical

aspects of the draft risk assessment in

the following areas: (1) The assumptions

made, (2) the modeling technique, (3)

the data used, and (4) the transparency

of the draft risk assessment document.

The agencies also invited comments on

the risk management strategies as

presented in the draft action plan.

Interested persons were given until

March 20, 2001, to comment on the

draft risk assessment and draft risk

management action plan. Because a

public meeting to receive comments on

these documents has been scheduled

close to the end of the comment period,

and in response to the requests of the

National Food Processors Association

and the LM Working scheduled close to

the end of the comment period, and in

response to the requests of the National

Food Processors Association and the LM

Working Group for an extension of the

comment period, FDA and FSIS are

extending the comment period until

May 21, 2001.

To be considered, submit written

comments to FDA Dockets Management

Branch or the FSIS Dockets Clerk

(addresses above) by May 21, 2001.

Printed copies of the draft risk

assessment and the risk management

action plan may be requested by faxing

your name and mailing address with the

13546 Federal Register / Vol. 66, No. 44 / Tuesday, March 6, 2001 / Notices

names of the documents you are

requesting to the CFSAN Outreach and

Information Center at 1–877–366–3322.

The documents may be reviewed at the

FDA Dockets Management Branch or the

FSIS Docket Clerk’s Office at the

addresses and hours noted above. The

draft risk assessment and the draft risk

management action plan documents are

also available electronically as follows:

www.cfsan.fda.gov, www.fsis.usda.gov,

www.foodsafety.gov. The draft risk

assessment is also available

electronically at

www.foodriskclearinghouse.umd.edu.

Dated: February 28, 2001.

Ann M. Witt,

Acting Associate Commissioner for Policy.

[FR Doc. 01–5378 Filed 3–1–01; 4:23 pm]

BILLING CODE 4160–01–S

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; Extension of

Comment Period

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; extension of comment

period.

SUMMARY: The Food and Drug

Administration (FDA) published a

notice of availability of a draft risk

assessment on the relationship between

Vibrio parahaemolyticus in raw

shellfish and human health in the

Federal Register of January 19, 2001 (66

FR 5517). Interested persons were given

until March 20, 2001, to comment on

the draft risk assessment. Because a

public meeting has been scheduled

close to the end of the comment period,

FDA is extending the comment period

until May 21, 2001, in order to allow

additional time for public comment.

DATES: Submit written comments by

May 21, 2001.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1060, 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. Received

comments may be reviewed at the

Dockets Management branch (address

above) between 9 a.m. and 4 p.m.,

Monday through Friday.

FOR FURTHER 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: In the

Federal Register of January 19, 2001 (66

FR 5517), FDA announced the

availability of a draft risk assessment on

the relationship between Vibrio

parahaemolyticus in raw molluscan

shellfish and human health. Comments

were sought on the technical aspects of

the draft risk assessment in the

following areas: (1) The assumptions

made, (2) the modeling technique, (3)

the data used, and (4) the transparency

of the draft risk assessment document.

Interested persons were given until

March 20, 2001, to comment on the risk

assessment. Because a public meeting to

receive comments on the draft risk

assessment has been scheduled close to

the end of the comment period, FDA is

extending the comment period until

May 21, 2001, to allow additional time

for public comment.

To be considered, written comments

must be received by May 21, 2001, by

the agency’s Dockets Management

Branch (address above).

A printed copy of the draft risk

assessment may be requested by faxing

your name and mailing address with the

name of the document you are

requesting to the CFSAN Outreach and

Information Center at 1–877–366–3322.

The documents may be reviewed at the

Dockets Management Branch at the

address and hours noted above. The

draft risk assessment is available

electronically as follows:

www.cfsan.fda.gov,

www.foodsafety.gov, and

www.foodriskclearinghouse.umd.edu.

Dated: February 28, 2001.

Ann M. Witt,

Acting Associate Commissioner for Policy.

[FR Doc. 01–5461 Filed 3–1–01; 4:23 pm]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–214]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration, HHS.

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding this burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Independent

Diagnostic Testing Facility and

Supporting Regulations contained in 42

CFR 401.33; Form No.: HCFA–R–214

(OMB# 0938–0721); Use: The

information collection requirements

associated with an Independent

Diagnostic Testing Facilities involve

documentation of proficiency of

medical personnel and of resources;

Frequency: Quarterly; Affected Public:

Business or other for-profit, Federal

Government and State, local and tribal

government; Number of Respondents:

500; Total Annual Responses: 500; Total

Annual Hours: 42.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, access HCFA’s Web

Site address at http://www.hcfa.gov/

regs/prdact95.htm, or E-mail your

request, including your address, phone

number, OMB number, and HCFA

document identifier, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collections must be mailed