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