Federal Register / Vol. 66, No. 125 / Thursday, June 28, 2001 / Notices 34455

BACTID—Microcomputer Programs

and Databases for the Identification of

Enterobacteriaceae, Vibrionaceae, and

Other Microorganisms

BACTID consists of a software

program coupled with a database

whereby the user enters a description of

an unknown microorganism which the

software compares to the database for

the purpose of identification of the

unknown. This program allows regional

diagnostic labs to access national

databases which provide for greater

sensitivity and specificity in

identification of unknowns without the

need to transfer samples to larger labs.

Inventor: John J. Farmer, U.S. Patent

Application SN: Application yet to be

filed. (CDC Ref. #: I–045–00)

Dated: June 22, 2001.

Joseph R. Carter,

Associate Director for Management and

Operation, Centers for Disease Control and

Prevention.

[FR Doc. 01–16245 Filed 6–27–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0208]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; Voluntary

National Retail Food Regulatory

Program Standards

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995.

DATES: Submit written comments on the

collection of information by July 30,

2001.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Wendy

Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

JonnaLynn P. Capezzuto, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–4659.

SUPPLEMENTARY INFORMATION: In

compliance with 44 U.S.C. 3507, FDA

has submitted the following proposed

collection of information to OMB for

review and clearance.

Voluntary National Retail Food

Regulatory Program Standards

FDA has developed the Voluntary

National Retail Food Regulatory

Program Standards (the National

Standards) to assist and promote the

uniform application of provisions of the

model FDA Food Code by several

thousand local, State, and tribal

jurisdictions that have primary

responsibility for the regulation or

oversight of retail level food operations.

The National Standards are intended to

serve as a guide to regulatory retail food

program managers in the design and

management of a retail food program

that is focused on the reduction of risk

factors know to cause foodborne illness.

The National Standards also promote

active management control by industry

of all risk factors that may cause

foodborne illness. Authority for

providing such assistance is derived

from section 311 of the Public Health

Service Act (42 U.S.C. 243), and

delegation of authority from the Public

Health Service to the Commissioner of

Food and Drugs related to food

protection is contained in 21 CFR

5.10(a)(2) and (a)(4). Under 31 U.S.C.

1535, FDA provides financial assistance

to other Federal agencies such as the

Indian Health Service. FDA has

established a section on the Internet at

http://vm.cfsan.fda.gov/ ̃dms/rettoc.html under ‘‘Federal/State Food

Programs—Retail Food Safety

References’’ to list jurisdictions that

have voluntarily elected to use the

National Standards.

Utilization of the National Standards

by local, State, and tribal regulatory

agencies is an important step to further

the goals of the President’s Council on

Food Safety and FDA program goals. All

regulatory agencies are encouraged to

voluntarily utilize the National

Standards as a guide for the design and

management of a retail food safety

program. There is no reporting or

recordkeeping requirement for those

jurisdictions that wish to utilize part or

all of the National Standards to enhance

or measure program performance.

Reporting is only a requirement for

those jurisdictions that request to be

listed in the FDA National Registry.

Jurisdictions that request listing in the

FDA National Registry of participating

regulatory agencies will be expected to

perform certain management tasks and

periodically report the results to FDA.

Voluntary listing in the FDA National

Registry requires that the following

tasks be performed by State, local, and

tribal program managers: (1) Conduct a

program self assessment, (2) conduct a

baseline survey of the regulated

industry, and (3) obtain an independent

outside audit. All three tasks must be

completed within a 3-year timespan.

The tasks must be performed in

accordance with the guidance provided

in the National Standards and the

results reported to FDA.

FDA based its estimate on the number

of State agencies (100) involved in Food

Code related regulatory programs, 300

local agencies with local ordinance

authority that may consider Food Code

adoption in any one year and 100 tribal

agencies. The presumption being that

those agencies most likely to utilize the

National Standards are also those

agencies with authority to adopt and

enforce the model FDA Food Code.

There is only one required report, the

FDA National Registry Report

(Appendix I), which is used to report

program self assessment, baseline

surveys of industry, and outside audits.

The time required to complete the

actual reporting document is minimal,

however, additional time is required to

analyze and review existing records,

conduct baseline inspections, and

secure an outside audit. The hour

burden estimate includes the time

required to review the instructions in

the National Standards, search existing

data sources, gather and maintain the

data needed, complete worksheets, and

review the collected information. The

estimate of 92 hours to complete a

program self assessment is based on the

average time reported by the four State

and three local jurisdictions that

participated in the National Standards

Pilot. The amount of time expended by

individual jurisdictions ranged from 40

to 215 hours. This range is reflective of

the difference in size between

jurisdictions. The baseline survey of

industry and the outside audit are

expected to require a similar amount of

time to complete.

Because only one of the three tasks is

required per year, the average annual

reporting burden is estimated to be 92

hours per year for each participating

jurisdiction. Because the records of

establishment inspections,

investigations, and enforcement

activities are routinely maintained and

accepted management practices already

necessitate the collection of some

required information and maintenance

of records, the recordkeeping burden is

minimal.

In the Federal Register of May 9, 2001

(66 FR 23715), the agency requested

comments on the proposed collections

34456 Federal Register / Vol. 66, No. 125 / Thursday, June 28, 2001 / Notices

of information. No significant comments

were received.

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Standard No. No. of Respondents Annual Frequency

per Response

Total Annual

Responses Hours per Response Total Hours

92 500 1 500 92 46,000

1There are no capital costs or operating and maintenance costs associated with this collection of information.

2Includes the use of Forms FDA 3519 and 3520.

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

Standard No. No. of

Recordkeepers

Annual Frequency

per Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

3,4, and 62 500 1 500 5 2,500

1There are no capital costs or operating and maintenance costs associated with this collection of information.

2The standards incorporate the best program management practices currently in use in the regulatory community. The recommended policies,

procedures, and standard operating procedures contained in the various national standards are considered usual and customary management

practices for State, local, and tribal agencies that regulate the retail segment of the food industry.

Dated: June 20, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–16195 Filed 6–27–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

General and Plastic Surgery Devices

Panel of the Medical Devices Advisory

Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). At least one portion of the

meeting will be closed to the public.

Name of Committee: General and

Plastic Surgery Devices Panel of the

Medical Devices Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on July 17, 2001, 10 a.m. to 5 p.m.

Location: Hilton, Salons D and E, 620

Perry Pkwy., Gaithersburg, MD.

Contact: David Krause, Center for

Devices and Radiological Health (HFZ–

410), Food and Drug Administration,

9200 Corporate Blvd., Rockville, MD

20850, 301–594–3090, ext. 141, or FDA

Advisory Committee Information Line,

1–800–741–8138 (301–443–0572 in the

Washington, DC area), code 12519.

Please call the Information Line or

access the Internet address of http://

www.fda.gov/cdrh/panelmtg.html for

up-to-date information on this meeting.

Agenda: The committee will discuss,

make recommendations, and vote on a

premarket approval application for an

interactive wound and burn bressing.

Background information, including the

agenda and questions for the committee,

will be made available to the public on

July 16, 2001, on the Internet at http:/

/www.fda.gov/cdrh/panelmtg.html.

Procedure: On July 17, 2001, from

10:30 a.m. to 5 p.m., the meeting is open

to the public. Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by July 3, 2001. Oral

presentations from the public will be

scheduled between approximately 11

a.m. and 11:30 a.m., and between

approximately 3 p.m. and 3:30 p.m.

Time allotted for each presentation may

be limited. Those desiring to make

formal oral presentations should notify

the contact person before July 3, 2001,

and submit a brief statement of the

general nature of the evidence or

arguments they wish to present, the

names and addresses of proposed

participants, and an indication of the

approximate time requested to make

their presentation.

Closed Committee Deliberations: On

July 17, 2001, from 10 a.m. to 10:30

a.m., the meeting will be closed to

permit FDA to present to the committee

trade secret and/or confidential

commercial information (5 U.S.C.

552b(c)(4)) relating to pending issues

and applications.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: June 19, 2001.

Bonnie Malkin,

Special Assistant to the Senior Associate

Commissioner.

[FR Doc. 01–16196 Filed 6–27–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Anesthesiology and Respiratory

Therapy Devices Panel of the Medical

Devices Advisory Committee; Notice of

Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). At least one portion of the

meeting will be closed to the public.

Name of Committee: Anesthesiology

and Respiratory Therapy Devices Panel

of the Medical Devices Advisory

Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on July 16, 2001, 10 a.m. to 5 p.m.

Location: Corporate Bldg., conference

room 20B, 9200 Corporate Blvd.,

Rockville, MD.

Contact: Michael Bazaral, Center for

Devices and Radiological Health (HFZ–

450), Food and Drug Administration,

9200 Corporate Blvd., Rockville, MD

20850, 301–443–8611, ext. 140, or FDA

Advisory Committee Information Line,

1–800–741–8138 (301–443–0572 in the