Federal Register / Vol. 66, No. 79 / Tuesday, April 24, 2001 / Notices 20665

Common Technical Document (CTD)

and possibilities for new topics. The

purpose of the meeting is to solicit

public input prior to the next Steering

Committee and Expert Working Group

meetings in Tokyo, Japan, May 21 to 24,

2001, at which discussion of the CTD

and possible new topics will be

continued.

Date and Time: The public meeting

will be held on May 8, 2001, 10:30 a.m.

to 2 p.m.

Location: The public meeting will be

held at 5630 Fishers Lane, rm. 1066,

Rockville, MD 20852.

Contact: Kimberly Topper, Center for

Drug Evaluation and Research, Food

and Drug Administration, 5630 Fishers

Lane, Rockville, MD 20852, 301–827–

7001, FAX 301–827–6801, or email:

Topperk@cder.fda.gov.

Registration and Requests for Oral

Presentations: Send registration

information (including name, title, firm

name, address, telephone, and fax

number), and written material and

requests to make oral presentations to

the contact person by May 1, 2001.

If you need special accommodations

due to a disability, please contact

Kimberly Topper at least 7 days in

advance.

SUPPLEMENTARY INFORMATION:

I. Background

The International Conference on

Harmonisation of Technical

Requirements for the Registration of

Pharmaceuticals for Human Use (ICH)

was established in 1990 as a joint

regulatory/industry project to improve,

through harmonization, the efficiency of

the process for developing and

registering new medicinal products in

Europe, Japan, and the United States

without compromising the regulatory

obligations of safety and effectiveness.

In recent years, many important

initiatives have been undertaken by

regulatory authorities and industry

associations to promote international

harmonization of regulatory

requirements. FDA has participated in

many meetings designed to enhance

harmonization and is committed to

seeking scientifically based harmonized

technical procedures for pharmaceutical

development. One of the goals of

harmonization is to identify and then

reduce differences in technical

requirements for medical product

development among regulatory

agencies. The ICH was organized to

provide an opportunity for

harmonization initiatives to be

developed with input from both

regulatory and industry representatives.

The ICH is concerned with

harmonization among three regions: The

European Union, Japan, and the United

States. The six ICH sponsors are the

European Commission; the European

Federation of Pharmaceutical Industries

Associations; the Japanese Ministry of

Health, Labor, and Welfare; the Japanese

Pharmaceutical Manufacturers

Association; the Center for Drug

Evaluation and Research and the Center

for Biologics Evaluation and Research,

FDA; and the Pharmaceutical Research

and Manufacturers of America. The ICH

Secretariat, which coordinates the

preparation of documentation, is

provided by the International

Federation of Pharmaceutical

Manufacturers Associations. The ICH

Steering Committee includes

representatives from each of the ICH

sponsors and Canadian Therapeutics

Programme, and the European Free

Trade Area. The ICH process has

achieved significant harmonization of

the technical requirements for the

approval of pharmaceuticals for human

use in the three ICH regions. The

current ICH process and structure can

be found on the Internet at http://

www.ifpma.org/ich1.html.

II. Issues To Be Discussed at the Public

Meeting

The issues to be discussed include the

following: (1) ICH overview and

procedures, (2) CTD, and (3)

possibilities for new topics (e.g., biotech

and postmarketing surveillance).

Interested persons may present data,

information, or views orally or in

writing, on issues pending at the public

meeting. Oral presentations from the

public will be scheduled between

approximately 10:30 a.m. and 2 p.m.

Time allotted for oral presentations may

be limited to 10 minutes. Those desiring

to make oral presentations should notify

the contact person by May 1, 2001, and

submit a brief statement of the general

nature of the evidence or arguments

they wish to present, the names and

addresses, phone number, fax, and email of proposed participants, and an

indication of the approximate time

requested to make their presentation.

The agenda for the public meeting

will be available on May 2, 2001, at the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852, under Docket Number 01N0167.

Transcripts: Transcripts of the

meeting may be requested in writing

from the Freedom of Information Office

(HFI–35), Food and Drug

Administration, 5600 Fishers Lane, rm.

12A–16, Rockville, MD 20857,

approximately 15 working days after the

meeting at a cost of 10 cents per page.

Dated: April 18, 2001.

Ann M. Witt,

Acting Associate Commissioner for Policy.

[FR Doc. 01–10068 Filed 4–23–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Exchange of Letters Between the Food

and Drug Administration and Japan

Concerning the Exchange of Certain

Information on Pharmaceutical

Products

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is providing

notice of an exchange of letters between

FDA, Department of Health and Human

Services, United States of America and

the Inspection and Guidance Division,

Pharmaceutical and Medical Safety

Bureau, Ministry of Health and Welfare,

Japan. The parties concluded this

exchange of letters on December 27,

2000. These letters express the

intentions of the United States and

Japan to exchange information on

matters useful to preserving the safety,

quality, and efficacy of pharmaceutical

products in the markets of the United

States and Japan.

DATES: Cooperation under the exchange

of letters began December 27, 2000.

FOR FURTHER INFORMATION CONTACT:

Joseph Famulare, Division of

Manufacturing and Product Quality

(HFD–320), Office of Compliance,

Center for Drug Evaluation and

Research, Food and Drug

Administration, 7520 Standish Pl.,

Rockville, MD 20855, 301–827–0590.

SUPPLEMENTARY INFORMATION: In

accordance with 21 CFR 20.108(c),

which states that all written agreements

and memoranda of understanding

between FDA and others shall be

published in the Federal Register, the

agency is publishing notice of this

exchange of letters.

Dated: April 11, 2001.

Ann M. Witt,

Acting Associate Commissioner for Policy.

BILLING CODE 4160–01–S

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[FR Doc. 01–10017 Filed 4–23–01; 8:45 am]

BILLING CODE 4160–01–C

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4653–05]

Notice of Proposed Information

Collection for Public Comment: Notice

of Funding Availability and Application

for the Tribal Colleges and Universities

Program

AGENCY: Office of the Assistant

Secretary for Policy Development and

Research, 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: June 25,

2001.

ADDRESSES: Interested persons are

invited to submit comments regarding

this proposal. Comments should refer to

the proposal by name or OMB Control

Number and be sent to: Reports Liaison

Officer, Office of Policy Development

and Research, U.S. Department of

Housing and Urban Development, 451

7th Street, SW, Room 8226, Washington,

DC 20410.

FOR FURTHER INFORMATION CONTACT: Jane

Karadbil, Office of University

Partnerships—telephone (202) 708–

1537. This is not a toll-free number.

Copies of the proposed forms and other

available documents to be submitted to

OMB may be obtained from Ms.

Karadbil.

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

entities concerning the proposed

information collection 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

information to be collected; and (4)

Minimize the burden of collection of

information on those who are to

respond; including through the use of

appropriate technology, e.g., permitting

electronic submission of responses.

This Notice also lists the following

information:

Title of the Proposal: Notice of

Funding Availability and Application

Kit for the Tribal Colleges and

Universities Program (TCUP).

Description of the need for the

information and proposed use: The

information is being collected to select

grantees in this statutorily-created

competitive grant program. The

information is also being used to

monitor the performance of grantees to

ensure that they meet statutory and

program goals and requirements.

Members of the affected public: Tribal

colleges and universities seeking

assistance to build, expand, renovate,

and equip their own facilities.

Estimation of the total number of

hours needed to prepare the information

collection including the number of

respondents, frequency of response, and

hours of response: Information pursuant

to submitting applications will be

submitted once. Information pursuant to

grantee monitoring requirements will be

semi-annually and at the completion of

the grant.

The following chart details the

respondent burden on an annual basis:

Number of

respondents

Total annual

responses

Hours per

response Total hours

Application ....................................................................................................... 32 32 80 2,560

Semi-annual reports ........................................................................................ 9 18 16 288

Final reports ..................................................................................................... 9 9 16 144

Recordkeeping ................................................................................................. 9 9 24 216

3,208