25938 Federal Register / Vol. 65, No. 87 / Thursday, May 4, 2000 / Notices

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (Centers for

Disease Control), 2920 Brandywine

Road, Room 3000, Atlanta, GA 30341–

4146, Telephone (770) 488–2757, E-mail

address:coc9@cdc.gov.

For program technical assistance,

contact: Elijah West, National Center for

Chronic Disease Prevention and Health

Promotion, Centers for Disease Control

and Prevention (CDC), 4770 Buford

Highway, NE., Mailstop K–44, Atlanta,

GA 30341–3724, Telephone 404–488–

5549, E-mail address:ejw1@cdc.gov.

Dated: April 28, 2000.

Henry S. Cassell, III,

Acting Director, Procurement and Grants

Office, Center for Disease Control And

Prevention (CDC).

[FR Doc. 00–11094 Filed 5–3–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1220]

The Future of the International

Conference on Harmonization of

Technical Requirements for the

Registration of Pharmaceuticals for

Human Use (ICH); Notice of Public

Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of public meeting.

SUMMARY: The Food and Drug

Administration (FDA) is announcing a

public meeting entitled ‘‘The Future of

the International Conference on

Harmonization of Technical

Requirements for the Registration of

Pharmaceuticals for Human Use’’ to

solicit information and receive

comments on the future of the ICH. The

purpose of the meeting is to solicit

public input prior to the next Steering

Committee meeting in Brussels,

Belgium, July 2000, at which discussion

of the future of the ICH will be

continued.

DATES: The public meeting will be held

on May 16, 2000, from 10 a.m. to 2 p.m.

Registration must be received by May 9,

2000. Written and electronic comments

regarding the public meeting must be

submitted by May 20, 2000.

ADDRESSES: The public meeting will be

held in the Center for Drug Evaluation

and Research, Advisory Committee

Conference Room, 5630 Fishers Lane,

rm. 1066, Rockville, MD 20857.

Written submissions must be sent to

the Dockets Management Branch, Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

Two copies of any written 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. Electronic submissions must

be sent to the Dockets Management

Branch at http://www.fda.gov/scripts/

oc/dockets/comments/

commentsmain.cfm.

FOR FURTHER INFORMATION CONTACT:

Kimberly L. Topper, Center for Drug

Evaluation and Research (HFD–21),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–7001, FAX 301–827–6801, or

e-mail: Topperk@cder.fda.gov.

Registration: There is no registration

fee for this public meeting, but

registration by May 9, 2000, is required.

Participation is limited to the first 140

registrants due to limited space. FDA

employees are required to register to

attend the meeting. Interested persons

may register with the contact person via

e-mail at: topperk@cder.fda.gov or fax

301–827–6801 and provide the

following information: Name, affiliation,

address, phone, fax, and e-mail address.

Interested persons may also register by

mail with the contact person (address

above).

SUPPLEMENTARY INFORMATION:

I. Background

The 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 the following

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 and Welfare, the Japanese

Pharmaceutical Manufacturers

Association, 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 (IFPMA).

The ICH Steering Committee includes

representatives from each of the ICH

sponsors and the IFPMA, as well as

observers from the World Health

Organization, the Canadian

Therapeutics Products 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.

The ICH will present the Common

Technical Document and other

significant achievements at the ICH 5

Conference in San Diego in November

2000. In preparing for this meeting, the

ICH Steering Committee is evaluating

the future direction for the ICH,

including structure, processes, work

program, and global cooperation. FDA is

soliciting public input at this time to

assist the agency in these deliberations.

II. Issues To Be Discussed at the Public

Meeting

The issues to be discussed include the

following: (1) Administrative and

technical issues, (2) future participation,

(3) global cooperation, and (4) new topic

areas.

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 9, 2000, 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.

Federal Register / Vol. 65, No. 87 / Thursday, May 4, 2000 / Notices 25939

The full agenda for the public meeting

will be available on May 10, 2000, at the

Dockets Management Branch (address

above). Requests should be identified

with the Docket Number 00N–1220.

Dated: April 28, 2000.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 00–11246 Filed 5–2–00; 11:30 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–452]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration, HHS.

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding this burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Collection

Request: Reinstatement, with change, of

a previously approved collection; Title

of Information Collection: Ambulatory

Surgical Center Payment Rate Survey;

Form No.: HCFA–452 (OMB# 0938–

0434); Use: Section 1833(i)(2)(A)(i) of

the Act requires that, for the purpose of

estimating Medicare Part B payment

amounts for ASCs, the Secretary take a

survey not later than January 1, 1995,

and every fives years thereafter, of the

audited costs incurred by ASCs, based

upon a representative sample of

procedures and facilities; Frequency:

Once; Affected Public: Business or other

for-profit, Not-for-profit institutions;

Number of Respondents: 2,200; Total

Annual Responses: 2,200; Total Annual

Hours: 77,000.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, access HCFA’s Web

Site address at http://www.hcfa.gov/

regs/prdact95.htm, or E-mail your

request, including your address, phone

number, OMB number, and HCFA

document identifier, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collections must be mailed

within 60 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

HCFA, Office of Information Services,

Security and Standards Group, Division

of HCFA Enterprise Standards,

Attention: Julie Brown, Room N2–14–

26, 7500 Security Boulevard, Baltimore,

Maryland 21244–1850.

Dated: April 11, 2000.

John P. Burke, III,

Reports Clearance Officer, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 00–11134 Filed 5–3–00; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

Aquatic Nuisance Species Task Force

Great Lakes Panel

AGENCY: Fish and Wildlife Service,

Interior.

ACTION: Notice of meeting.

SUMMARY: This notice announces a

meeting of the Aquatic Nuisance

Species Task Force Great Lakes Panel on

Aquatic Nuisance Species. The meeting

topics are identified in the

SUPPLEMENTARY INFORMATION.

DATES: The Great Lakes Panel on

Aquatic Nuisance Species will meet

from 1:00 pm to 5:00 pm on May 10,

2000, and from 8:00 am to 12:00 noon

on May 11, 2000.

ADDRESSES: The meeting will be held at

the Holiday Inn—Downtown

Waterfront, Duluth, Minnesota.

FOR FURTHER INFORMATION CONTACT:

Sharon Gross, Executive Secretary,

Aquatic Nuisance Species Task Force at

703–358–2308 or Kathe GlassnerSchwayder at 734–665–9135.

SUPPLEMENTARY INFORMATION: Pursuant

to section 10(a)(2) of the Federal

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

I), this notice announces a meeting of

the Aquatic Nuisance Species Task

Force Great Lakes Panel on Aquatic

Nuisance Species. The Task Force was

established by the Nonindigenous

Aquatic Nuisance Prevention and

Control Act of 1990 (16 U.S.C. 4701–

4741).

Topics to be addressed at this meeting

include updates from subcommittees on

information/education, research

coordination and policy and legislation;

review and discussion of the

information/education strategy for

aquatic nuisance prevention and

control; review and discussion of the

Great Lakes Action Plan; and discussion

of current policy initiatives including

reauthorization of NISA, ballast water

standards, and Michigan State Ballast

Water Legislation.

Minutes of the meeting will be

maintained by the Executive Secretary,

Aquatic Nuisance Species Task Force,

Suite 851, 4401 North Fairfax Drive,

Arlington, Virginia 22203–1622.

Minutes for the meetings will be

available at this location for public

inspection during regular business

hours, Monday through Friday.

Dated: April 28, 2000.

Cathleen I. Short,

Aquatic Nuisance Species Task Force CoChair, Assistant Director—Fisheries.

[FR Doc. 00–11091 Filed 5–3–00; 8:45 am]

BILLING CODE 4310–55–M

DEPARTMENT OF THE INTERIOR

Bureau of Land Management

[CO–934–5700; COC62391, COC62392,

COC62431]

Notice of Proposed Reinstatement of

Terminated Oil and Gas Leases

Pursuant to the provisions of 30

U.S.C. 188(d) and (e), and 43 CFR

3108.2–3(a) and (b)(1), a petition for

reinstatement of oil and gas leases,

COC62391, COC62392, and COC62431,

for lands in San Miguel and Montrose

counties, Colorado, were timely filed

and were accompanied by all the

required rentals accruing from the date

of termination.

The lessee has agreed to the amended

lease terms for rentals and royalties at

rates of $10.00 per acre, or fraction

thereof, per year and 16 2/3 percent,

respectively.

The lessee has paid the required $500

administrative fee and $125 to

reimburse the Department for the cost of

this Federal Register notice. The lessee

has met all the requirements for

reinstatement of the lease as set out in

Section 31(d) and (e) of the Mineral

Lands Leasing Act of 1920 (30 U.S.C.

188), and Bureau of Land Management

is proposing to reinstate leases