36240 Federal Register / Vol. 63, No. 127 /Thursday, July 2, 1998 / Notices

for Disease Control and Prevention

(CDC), 255 East Paces Ferry Road, NE.,

Room 314, Mailstop E–18, Atlanta,

Georgia 30305, Telephone (404) 842–

6801, Email address: gcg4@cdc.gov.

Programmatic technical assistance

may be obtained from Frederick Angulo,

DVM, PhD, Medical Epidemiologist,

National Centers for Infectious Diseases,

Division of Bacterial and Mycotic

Diseases, Foodborne and Diarrheal

Diseases Branch, Centers for Disease

Control and Prevention (CDC), 1600

Clifton Road, NE., Mailstop A–38,

Atlanta, Georgia 30333, Telephone (404)

639–2840, Facsimile: (404) 639–2205,

Email address: fja0@cdc.gov.

You may also obtain this

announcement from one of two Internet

sites on the actual publication date:

CDC’s homepage at http://www.cdc.gov

or at the Government Printing Office

homepage (including free on-line access

to the Federal Register at http://

www.access.gpo.gov).

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 98–17592 Filed 7–1–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Docket No. 98D–0375]

Draft Guidance for Staff, Industry and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; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance entitled

‘‘Draft Guidance for Staff, Industry and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).’’ Under the Sectoral

Annex on Medical Devices (Medical

Devices Annex), FDA has agreed to

designate Conformity Assessment

Bodies (CAB’s). CAB’s will be third

parties (i.e., private individuals or

organizations outside of FDA)

authorized to perform premarket and

quality system evaluations consistent

with the Medical Devices Annex.

Assuming the MRA enters into force

and a final rule becomes effective, when

finalized, this draft guidance will apply

to CAB’s seeking to be designated under

the Medical Devices Annex, and it will

assist those who are interested in

participating in this program as CAB’s

or as applicants pursuing premarket and

quality system evaluations consistent

with the Medical Devices Annex.

DATES: Written comments by August 3,

1998.

ADDRESSES: Submit written comments

on the guidance to the Dockets

Management Branch, (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857. Comments should be identified

with the docket number found in

brackets in the heading of this

document. If you do not have access to

the World Wide Web, submit written

requests for single copies of the

guidance document entitled ‘‘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)’’

on 3.5’’ diskette to the Division of Small

Manufacturers Assistance (HFZ–220),

Center for Devices and Radiological

Health, Food and Drug Administration,

1350 Piccard Dr., Rockville, MD 20850.

Send two self addressed adhesive labels

to assist that office in processing your

request, or fax your request to 401–443–

8818. See the SUPPLEMENTARY

INFORMATION section for electronic

access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: John

F. Stigi, Division of Small

Manufacturers Assistance (HFZ–220),

Center for Devices and Radiological

Health, Food and Drug Administration,

1350 Piccard Dr., Rockville, MD 20850,

301–443–6597 or FAX 301–443–8818.

SUPPLEMENTARY INFORMATION:

I. Background

FDA has participated in negotiations

on an international agreement on

medical devices concluded in June 1997

between the United States and the

European Community (EC). These

negotiations resulted in the drafting of

the MRA, which includes a special

section pertaining to medical devices

and is referred to as the Medical Devices

Annex. After completion of a 3-year

transition period, the Medical Devices

Annex provides for normal endorsement

of premarket and quality system

evaluation reports of conformity

assessment produced by equivalent

third parties, the CAB’s.

The MRA was signed in London on

May 18, 1998, but it has not entered into

force. FDA has published a proposed

rule on the portions of the MRA

affecting FDA-regulated products (63 FR

17744, April 10, 1998); the comment

period closed on May 11, 1998.

In order to establish confidence in the

conformity assessment process, CAB’s

will be required to participate in

rigorous joint activities to demonstrate

their proficiency to conduct evaluations.

Upon implementation of this program,

CAB evaluations will be exchanged and

normally endorsed by both FDA and the

EC for the marketing of medical devices.

FDA intends to use the National

Voluntary Conformity Assessment

System Evaluation (NVCASE)

administered by the National Institute of

Standards and Technology (NIST) of the

U.S. Department of Commerce to

recognize one or more accreditation

bodies that, in turn, will assess potential

U.S. CAB’s seeking to be designated

under the Medical Devices Annex, to

evaluate medical devices produced for

the EC market. FDA will consider the

recommendations made by the

recognized accreditation bodies under

NVCASE from June 1, 1998, to October

1, 1998, and then designate U.S. CAB’s

that meet criteria for technical

competence established in the Medical

Devices Annex. This draft guidance

provides information regarding the

process for CAB’s to become eligible for

designation under the Medical Devices

Annex.

II. Significance of Guidance

This draft guidance document

represents the agency’s current thinking

on guidance for staff, industry, third

parties, and 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. It does

not create or confer any rights for or on

any person and does not operate to bind

FDA or the public. An alternative

approach may be used if such approach

satisfies the applicable statute,

regulations, or both. This guidance is

not final nor is it in effect at this time.

The agency has adopted Good

Guidance Practices (GGP’s) that set forth

the agency’s policies and procedures for

the development, issuance, and use of

guidance documents (62 FR 8961,

February 27, 1997). This guidance is

issued as a Level 1 guidance consistent

with GGP’s.

III. Electronic Access

Persons interested in obtaining a copy

of the draft guidance may do so using

the World Wide Web. CDRH maintains
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: