59006 Federal Register / Vol. 65, No. 192 / Tuesday, October 3, 2000 / Notices

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.

Name of Committee: Cardiovascular and

Renal Drugs 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 October 19, 2000, from 9 a.m. to 5 p.m.,

and on October 20, 2000, from 8:30 a.m. to

4 p.m.

Location: National Institutes of Health,

9000 Rockville Pike, Bldg. 10, Clinical

Center, Jack Masur Auditorium, Bethesda,

MD.

Contact Person: Joan C. Standaert, Center

for Drug Evaluation and Research (HFD–110),

Food and Drug Administration, Woodmont II

Bldg., 1451 Rockville Pike, Rockville, MD

20752, 419–259–6211, or John M. Treacy,

301–827–7001, or FDA Advisory Committee

Information Line, 1–800–741–8138 (301–

443–0572 in the Washington, DC area), code

12533. Please call the Information Line for

up-to-date information on this meeting.

Agenda: On October 19, 2000, the

committee will meet in closed session. On

October 20, 2000, the committee will discuss

dose response using data from approved

antihypertensive drugs.

Procedure: On October 20, 2000, from 8:30

a.m. to 4 p.m., the meeting will be 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 October 12,

2000. Oral presentations from the public will

be scheduled between approximately 8:30

a.m. to 9:30 a.m. on October 20, 2000. Time

allotted for each presentation may be limited.

Those desiring to make formal oral

presentations should notify the contact

person before October 12, 2000, 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

October 19, 2000, from 9 a.m. to 5 p.m., the

meeting will be closed to permit discussion

and review of trade secret and/or confidential

information regarding pending

investigational new drug applications and

new drug applications (5 U.S.C. 552b(c)(4)).

Notice of this meeting is given under the

Federal Advisory Committee Act (5 U.S.C.

app. 2).

Dated: September 22, 2000.

Bernard A. Schwetz,

Acting Deputy Commissioner.

[FR Doc. 00–25284 Filed 10–2–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1492]

Mutual Recognition Agreement,

Medical Device Annex; Confidence

Building Activities: Availability of Draft

Guidances

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of two draft guidance

documents entitled ‘‘Implementation

Plan for the Mutual Recognition

Agreement Between the European

Union and the United States of America:

Confidence Building Programme:

Overview’’ and ‘‘Implementation Plan

for the Mutual Recognition Agreement

Between the European Union and the

United States of America: Procedures

for Joint Confidence Building.’’ These

draft guidance documents have been

prepared jointly by FDA and the

Commission for the European

Communities (CEC’s) and are intended

to serve as guidance for all interested

parties participating in confidence

building activities under the medical

device annex to the Mutual Recognition

Agreement (MRA). While these draft

guidance documents reflect the latest

European Union (EU) edits, they have

not been accepted by FDA. FDA is

requesting comments on these

documents. FDA plans to provide its

comments on these documents and any

stakeholder comments the agency

receives to the CEC’s.

DATES: Submit written comments on

these draft guidance documents to

ensure their adequate consideration in

preparation of the final document by

November 2, 2000.

ADDRESSES: Submit written comments

concerning these draft guidance

documents to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. Comments

should be identified with the docket

number found in brackets in the

heading of this document. To expedite

the review process, if possible, FDA

requests that you send a copy of your

comments to the contact person,

Christine Nelson (address below) or by

e-mail to mcn@cdrh.fda.gov. See the

SUPPLEMENTARY INFORMATION section for

information on electronic access to

these documents. If you do not have

access to the Internet, submit written

requests for single copies on a 3.5′′

diskette of the draft guidance

documents listed above 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 selfaddressed adhesive labels to assist that

office in processing your requests, or fax

your request to 301–443–8818.

FOR FURTHER INFORMATION CONTACT:

Christine Nelson, Office of Health and

Industry Programs (HFZ–220), Center

for Devices and Radiological Health,

Food and Drug Administration, 1350

Piccard Dr., Rockville, MD 20850, 301–

443–6597, ext. 128, FAX 301–443–8818,

or e-mail mcn@cdrh.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

On June 27, 1997, the United States

and the EU signed an MRA that covers

a variety of product sectors including

telecommunication, electrical safety,

recreational crafts, pharmaceuticals, and

medical devices. The Medical Device

Annex to the MRA became effective

December 7, 1998, and initiated a 3-year

transition period during which both

sides will engage in confidence building

activities. Article 7 of the Medical

Device Annex provides that FDA and

the CEC’s will establish a joint

confidence building program to provide

sufficient evidence of the capabilities of

the nominated Conformity Assessment

Bodies (CAB’s) to perform quality

system or product evaluations to the

specifications of the parties. After the 3-

year period, the Medical Device Annex

would become operational if the

confidence building activities are

successfully completed.

The Medical Devices Annex covers

the exchange of quality systems

evaluation/inspection reports for all

medical devices and premarket

evaluations for selected low to medium

risk devices. A European CAB can

conduct inspections for all classes of

devices and 510(k) evaluations for

selected devices based on FDA

requirements for European device

manufacturers who wish to market their

devices in the United States. Similarly,

a U.S. CAB can conduct quality system

or type-testing evaluations based on EU

requirements for U.S. device

manufacturers who wish to market their

devices in the EU. In addition, an alert

system would be set up during the

transition period and maintained

thereafter, by which the parties will

notify each other when there is an

immediate danger to public health. As

part of that system, each party will

Federal Register / Vol. 65, No. 192 / Tuesday, October 3, 2000 / Notices 59007

notify the other party of any confirmed

problem reports, corrective actions, or

recalls.

These two draft guidance documents

entitled ‘‘Implementation Plan for the

Mutual Recognition Agreement Between

the European Union and the United

States of America: Confidence Building

Programme: Overview’’ and

‘‘Implementation Plan for the Mutual

Recognition Agreement Between the

European Union and the United States

of America: Procedures for Joint

Confidence Building’’ provide guidance

on how to implement confidence

building activities under the Medical

Device Annex of the MRA for quality

system evaluations and product

evaluations. Guidance on implementing

an alert system will be issued separately

at another time.

II. Significance of Guidance

These draft guidance documents are

intended to provide guidance. The draft

guidance documents were developed by

FDA and the European Commission

(EC) to further implementation of the

MRA. This current draft represents the

EC’s latest edits. FDA will be providing

comments to the EC and proposing

certain changes that are described in the

‘‘FDA Concerns’’ section of the guidance

document. These draft guidance

documents do not create or confer any

rights for or on any person and do not

operate to bind FDA or the public. An

alternative approach may be used if

such approach satisfies the

requirements of the applicable statute,

regulations, or both.

The agency has adopted good

guidance practices (GGP’s) which set

forth the agency’s policies and

procedures for the development,

issuance, and use of guidance

documents (62 FR 8961, February 27,

1997). These guidance documents are

issued as a draft Level 1 guidance

consistent with GGP’s.

III. Electronic Access

Persons interested in obtaining copies

of these draft guidance documents may

do so through the Internet at

www.fda.gov/cdrh/mra.

IV. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding

these draft guidance documents by

November 2, 2000. Two copies of any

comments are to be submitted, except

that individuals may submit one copy.

Comments should be identified with the

docket number found in brackets in the

heading of this document. A copy of the

draft guidance documents and received

comments may be seen in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday. To

expedite receipt and review, FDA

requests, if possible, that a copy of your

comments be sent to the contact person

(address above) or by e-mail to

mcn@cdrh.fda.gov.

Dated: September 22, 2000.

William K. Hubbard,

Senior Associate, Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–25351 Filed 10–2–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4563–N–16]

Notice of Proposed Information

Collection for Public Comment;

Contract and Subcontract Activity

AGENCY: Office of the Assistant

Secretary for Public and Indian

Housing, HUD.

ACTION: Notice

SUMMARY: The proposed information

collection requirement described below

will be submitted to the Office of

Management and Budget (OMB) for

review, as required by the Paperwork

Reduction Act. The Department is

soliciting public comments on the

subject proposal.

DATES: Comments Due Date: December

4, 2000.

ADDRESSES: Interested persons are

invited to submit comments regarding

this proposal. Comments should refer to

the proposal by name and/or OMB

Control number and should be sent to:

Mildred M. Hamman, Reports Liaison

Officer, Public and Indian Housing,

Department of Housing and Urban

Development, 451 7th Street, SW.,

Room 4238, Washington, DC 20410–

5000.

FOR FURTHER INFORMATION CONTACT:

Mildred M. Hamman, (202) 708–3642,

extension 4128, for copies of the

proposed forms and other available

documents. (This is not a toll-free

number).

SUPPLEMENTARY INFORMATION: The

Department will submit the proposed

information collection to OMB for

review, as required by the Paperwork

Reduction Act of 1995 (44 U.S.C.

Chapter 35, as amended).This Notice is

soliciting comments from members of

the public and affected agencies

concerning the proposed collection of

information to: (1) Evaluate whether the

proposed collection of information is

necessary for the proper performance of

the functions of the agency, including

whether the information will have

practical utility; (2) evaluate the

accuracy of the agency’s estimate of the

burden of the proposed collection of

information; (3) enhance the quality,

utility, and clarity of the information to

be collected; and (4) minimize the

burden of the collection of information

on those who are to respond, including

through the use of appropriate

automated collection techniques or

other forms of information technology;

e.g., permitting electronic submission of

responses.

This Notice also lists the following

information:

Title of Proposal: Contract and

Subcontract Activity.

OMB Control Number: 2577–0088.

Description of the need for the

information and proposed use: The

information provided to HUD by

Housing Agencies/Grantees will be used

to prepare an annual report on Minority

Business Enterprise (MBE) participation

in Public and Indian Housing Programs.

The report will be submitted to the

Department of Commerce pursuant to

Executive Order 12432. HUD will also

use the information to monitor and

evaluate Housing Agency performance.

HUD plans to collect this information

electronically over the Internet.

Agency form number: HUD–2516.

Members of affected public: State,

Local or Tribal Government, Small

Businesses or Organizations.

Estimation of the total number of

hours needed to prepare the information

collection including number of

respondents, frequency of response, and

hours of response: 3,400 respondents

annually, one hour per response, 3,400

total burden hours.

Status of the proposed information

collection: Extension, without change.

Authority: Section 3506 of the Paperwork

Reduction Act of 1995, 44 U.S.C. Chapter 35,

as amended.

Dated: September 27, 2000.

Milan Ozdinec,

General Deputy Assistant, Secretary for Public

and Indian Housing.

BILLING CODE 4210–33–M