Federal Register / Vol. 66, No. 80 / Wednesday, April 25, 2001 / Notices 20819

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N–0053]

Medical Device Inspection Evaluation

Report; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a report entitled ‘‘Medical

Device Inspection Evaluation Report.’’

The report describes the outcomes of the

Medical Device Inspection Evaluation

pilot conducted between March 1, 1999,

and February 29, 2000. The report was

prepared by the University of California

at Irvine Statistical Consulting Center

from the information received on the

evaluation forms submitted by medical

device manufacturers who were

inspected for their compliance with the

quality system/good manufacturing

practices (QS/GMP) during the time of

the pilot.

DATES: Submit written comments on

this report at any time.

ADDRESSES: Submit written requests for

single copies of the report to the

Freedom of Information Office (HFI–35),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857.

Submit written comments on the report

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. See the

SUPPLEMENTARY INFORMATION section for

electronic access to the report.

FOR FURTHER INFORMATION CONTACT:

Denise Dion, Division of Emergency and

Investigational Operations (HFC–130),

Office of Regional Operations, Office of

Regulatory Affairs, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–5645,

FAX 301–443–6919.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of

a report entitled ‘‘Medical Device

Inspection Evaluation Report.’’ In the

Federal Register of January 28, 1999 (64

FR 4426, January 28, 1999), at the close

of all premarket and QS/GMP

inspections conducted between March

1, 1999, and February 29, 2000, an FDA

investigator provided a survey packet to

the device firm’s representative. This

survey packet included a questionnaire,

a postage-paid return envelope, and a

cover letter to the company explaining

the questionnaire’s purpose. FDA

officials; industry representatives; and

Dr. Anita Iannucci, the survey

coordinator/data analyst from the

University of California at the Irvine

Center for Statistical Consulting, signed

this cover letter. To maintain

confidentiality, the firms mailed their

completed questionnaires directly to the

university survey coordinator.

The purpose of the survey was to: (1)

Give firms an opportunity to provide

feedback to FDA and industry about

their inspection experience, (2) compare

the consistency of firms’ reactions to

inspections across different areas (both

domestic and international), and (3)

determine if the medical device

industry initiatives (preannounced

inspections and annotated FDA 483s)

were being followed. The survey was

also designed to determine if the

initiative caused officials in medical

device firms to view their FDA

inspections in a more positive light than

they had previously.

FDA’s Office of Regulatory Affairs

received the complete tabulation of the

responses, and purged of all identifying

information. FDA will be reviewing the

report to determine if areas of future

improvement can be identified. The

information will be used internally to

identify suggestions for training.

An FDA/industry committee

consisting of: Nancy Singer, AdvaMed;

Denise Dion, FDA; Lauren Andersen,

AdvaMed and Andersen Caledonia Ltd.;

Elaine Messa, Quintiles Consulting and

Former Director of the Los Angeles

District Office, FDA; Leif Olsen, AMDM

and BioWhittaker; and Susan Reilly,

ASQ Biomedical Division and Reilly

and Associates, worked with Dr.

Iannucci in designing the survey and

assisting in the evaluation of the results.

The committee members also assisted in

the preparation of the final report.

II. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments on the report

at any time. 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. A copy of the

report and received comments are

available for public examination in the

Dockets Management Branch between 9

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

Friday.

III. Electronic Access

Persons with access to the Internet

may obtain the document at http://

www.fda.gov/ora under the heading

‘‘Recent Publications.’’

Dated: April 18, 2001.

Dennis E. Baker,

Associate Commissioner for Regulatory

Affairs.

[FR Doc. 01–10165 Filed 4–24–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Agency Information Collection

Activities: Proposed Collection:

Comment Request

In compliance with the requirement

for opportunity for public comment on

proposed data collection projects

(section 3506(c)(2)(A) of Title 44, United

States Code, as amended by the

Paperwork Reduction Act of 1995, Pub.

L. 104–13), the Health Resources and

Services Administration (HRSA)

publishes periodic summaries of

proposed projects being developed for

submission to OMB under the

Paperwork Reduction Act of 1995. To

request more information on the

proposed project or to obtain a copy of

the data collection plans and draft

instruments, call the HRSA Reports

Clearance Officer on (301) 443–1129.

Comments are invited on: (a) Whether

the proposed collection of information

is necessary for the proper performance

of the functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

or other forms of information

technology.

Proposed Project: Project to Assess

Race, Ethnicity, and Gender of Clients

and Staff at Selected BPHC Supported

Programs—New.

The Office of Minority and Women’s

Health (OMWH), in the Bureau of

Primary Health Care (BPHC), Health

Resources and Services Administration

(HRSA), recognizes that information on

the race, ethnicity, and gender of clients

and staff employed at BPHC supported

programs is important in determining

the extent to which BPHC supported

programs reflect the populations they

serve. HRSA’s strategic goal is to assure

100% access to health care and to work