Federal Register / Vol. 63, No. 127 /Thursday, July 2, 1998 / Notices 36241

an entry on the World Wide Web for

easy access to information including

text, graphics, and files that may be

downloaded to a personal computer

with access to the Web. Updated on a

regular basis, the CDRH Home Page

includes the ‘‘Draft Guidance for Staff,

Industry and Third Parties: Third Party

Programs Under the Sectoral Annex on

Medical Devices to the Agreement on

Mutual Recognition Between the United

States of America and the European

Community (MRA),’’ device safety

alerts, access to Federal Register

reprints, information on premarket

submissions including lists of approved

applications and manufacturers’

addresses, small manufacturers

assistance, information on video

conferencing and electronic

submissions, mammography matters,

and other device-oriented information.

The CDRH Home Page may be accessed

at http://www.fda.gov/cdrh.

A text-only version of the CDRH Web

site is also available from a computer or

VT–100 compatible terminal by dialing

800–222–0185. The terminal settings are

8/1/N. After the modem answers, press

Enter several times and then select

menu choice 1: FDA BULLETIN BOARD

SERVICE. From there follow

instructions for logging in, and at the

BBS TOPICS PAGE, arrow down to the

FDA Home Page (do not select the first

CDRH entry). Then select Medical

Devices and Radiological Health. From

there select CENTER FOR DEVICES

AND RADIOLOGICAL HEALTH for

general information, or arrow down for

specific topics.

IV. Comments

Interested persons may, on or before

(insert date 30 days after publication in

the Federal Register), submit to Dockets

Management Branch (address above)

written comments regarding this draft

guidance. 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. The guidance

document and received comments may

be seen in the Dockets Management

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

Monday through Friday.

Dated: June 24, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–17600 Filed 7–1–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0453]

Agency Emergency Processing Under

OMB Review

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a proposed collection of

information has been submitted to the

Office of Management and Budget

(OMB) for emergency processing under

the Paperwork Reduction Act of 1995

(the PRA). The proposed collection of

information concerns the submission of

applications to recognized accreditation

bodies that will assess potential U.S.

Conformity Assessment Bodies (CAB’s)

seeking to be designated under the U.S./

European Community (EC) Mutual

Recognition Agreement (MRA) to assess

medical devices produced for the EC

market. This collection of information

also concerns the submission of thirdparty evaluation reports by EC CAB’s

under the program. FDA is requesting

OMB approval within 15 days of receipt

of this submission.

DATES: Submit written comments on the

collection of information by July 13,

1998.

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: Desk

Officer for FDA. All comments should

be identified with the docket number

found in brackets in the heading of this

document.

FOR FURTHER INFORMATION CONTACT:

Margaret R. Schlosburg, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION:

I. Background

FDA has requested emergency

processing of this proposed collection of

information under section 3507(j) of the

PRA and 5 CFR 1320.13. The

information is needed immediately in

order for potential CAB’s to be

designated in time to participate in

training for premarket and quality

systems evaluations scheduled for

October 14 through 23, 1998. The use of

normal clearance procedures would be

likely to result in the prevention or

disruption of this collection of

information and would delay the

implementation of the confidence

building activities authorized by the

U.S./EC MRA.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

The third-party program under the

U.S./EC MRA is intended to implement

that part of the U.S./EC MRA that covers

the exchange of quality system

evaluation reports for all medical

devices and premarket evaluation

reports for selected low-to-moderate risk

devices. Under the MRA, firms may

apply to become designated as a U.S.

CAB. Firms who are designated will be

qualified to conduct quality system

evaluations for all classes of devices and

product-type examinations and

verifications for selected devices based

on EC requirements under the voluntary

third-party program authorized by the

MRA. Firms designated as EC CAB’s

could, in turn, conduct quality system

evaluations for all classes of devices and

premarket 510(k) evaluations for

selected devices based on FDA

requirements. Under the voluntary

third-party program, reports of these

evaluations would be submitted by the

EC CAB’s to FDA. The EC CAB’s would

also be required to maintain copies of

their evaluation reports.

FDA estimates the burden of this

collection as follows:
36242 Federal Register / Vol. 63, No. 127 /Thursday, July 2, 1998 / Notices

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Item No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

Requests for designation as U.S. CAB 12 1 12 24 288

Premarket reports by EC CAB’s 20 5 100 40 4,000

Quality system reports by EC CAB’s 20 5 100 32 3,200

Total 7,488

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

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

Item No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

Records of evaluation of premarket submissions by

EC CAB’s 20 5 100 10 1,000

Records of evaluation of quality systems 20 5 100 10 1,000

Total 2,000

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

The burdens are explained as follows:

II. Reporting

A. Requests for Designation as U.S. CAB

Under this program, U.S. firms may

apply for designation as a U.S. CAB.

Such designation will enable that firm

to perform third-party evaluations of

U.S. products for export to the EC.

Likewise, European firms may apply to

be designated as EC CAB’s, which will

enable them to perform third-party

evaluations of products to be exported

to the United States. The application for

nomination as an EC CAB does not

represent a paperwork burden subject to

the PRA because the designation

procedure is an internal process which

is required by, and administered by,

European authorities. Only the

application for designation as a U.S.

CAB represents a paperwork burden

under the PRA. The agency anticipates,

based on discussions with the National

Institute of Science and Technology of

the U.S. Department of Commerce and

officials of other standards

organizations, that approximately 12

applications for designation as U.S.

CAB’s will be received.

B. Premarket Reports

Under this program, EC CAB’s will be

able to perform third-party evaluations

for certain products produced in Europe

for export to the United States. EC

CAB’s would be required to submit to

FDA reports of their evaluations. Based

upon information gathered during the

negotiation of the U.S./EC MRA, the

agency anticipates that European

manufacturers will request third-party

evaluation for approximately 100

medical device products annually. The

agency further estimates, based on

dialogue with EC officials, that 20 firms

will be designated to act as EC CAB’s.

C. Quality System Reports

Under this program, EC CAB’s will be

able to perform third-party evaluations

of the quality systems established by

manufacturers of European products

produced for export to the United

States. EC CAB’s would be required to

submit to FDA reports of their

evaluations. Based upon information

gathered during the negotiation of the

U.S./EC MRA, the agency anticipates

that European manufacturers will

request third-party evaluations for

approximately 100 medical device

products annually. The agency

estimates that 20 EC CAB’s will perform

these evaluations.

III. Recordkeeping

As stated previously, firms designated

as EC CAB’s will be able to perform

third-party evaluations of quality

systems and premarket submissions for

certain products produced for export to

the United States. Such evaluation will

be conducted consistent with FDA’s

regulatory requirements, and FDA will

require the reviewers to keep, in their

records, a copy of the report that they

submit to FDA for each evaluation. The

agency anticipates that 100 premarket

reports and 100 quality system reports

will be generated and required to be

maintained by EC CAB’s annually.

Thus, the agency estimates that 100

records of evaluations of quality systems

and premarket submissions will be

retained by the designated EC CAB’s.

Based on experience with the Third

Party Review Pilot Program, which was

announced in the Federal Register of

April 3, 1996 (61 FR 14789), the agency

anticipates that each recordkeeper will

require no more than 2 hours of

recordkeeping per review. The agency is

estimating 5 reviews per respondent;

therefore, the total number of hours per

recordkeeper is 10.

Dated: June 24, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–17602 Filed 7–1–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Request for Nominations for

Nonvoting Representatives of

Consumer and Industry Interests on

Public Advisory Panels or Committees

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is requesting

nominations for nonvoting consumer

representatives and nonvoting industry

representatives to serve on certain

device panels of the Medical Devices

Advisory Committee in the Center for

Devices and Radiological Health

(CDRH). Nominations will be accepted

for current vacancies and for those that

will or may occur through June 30,

1999.

FDA has a special interest in ensuring

that women, minority groups,

individuals with disabilities, and small

businesses are adequately represented

on advisory committees and, therefore,