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These two draft guidance documents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These draft guidance documents are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 These draft guidance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of these draft guidance documents may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these draft guidance documents by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draft guidance documents and received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.

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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.

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[FR Doc. 00–25289 Filed 10–2–00; 8:45 am]

BILLING CODE 4210–33–C