Federal Register / Vol. 66, No. 250 / Monday, December 31, 2001 / Notices 67535

Professional Medical Personnel

claiming; and (3) an activity code

structure that does not meet the

requirement to account for all the

activities performed by time study

participants. As a result, CMS found

that SPA 98–020 did not comply with

applicable Medicaid requirements,

including those related to methods of

administration under section 1902(a)(4)

of the Act and implementing CMS

regulations.

The CMS found that the flawed

methodology means that the claim

which would be authorized by SPA 98–

020 are not reasonable and necessary for

the proper and efficient administration

of the State plan. This conclusion is

based on the CMS review of the

proposed activity code definitions,

sampling methodology, documentation

requirements, interagency agreement,

and indirect cost rate. Therefore, after

consulting with the Secretary as

required by Federal regulation, CMS

informed Ohio of its decision to

disapprove this amendment.

The notice to Ohio announcing an

administrative hearing to reconsider the

disapproval of its SPA reads as follows:

Section 1116 of the Social Security Act

(42 U.S.C. section 1316); 42 CFR section

430.18

(Catalog of Federal Domestic Assistance

Program No. 13.714, Medicaid

Assistance Program)

Dated: December 11, 2001.

Thomas A. Scully,

Administrator, Center for Medicare &

Medicaid Services.

[FR Doc. 01–32110 Filed 12–28–01; 8:45 am]

BILLING CODE 4163–18–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0580]

Preparation for ICH Meetings in

Brussels, Belgium, Including Progress

on Implementation of the Common

Technical Document; Notice of Public

Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of public meeting.

SUMMARY: The Food and Drug

Administration is announcing a public

meeting entitled ‘‘Preparation for ICH

Meetings in Brussels, Belgium,

Including Progress on Implementation

of the Common Technical Document

(CTD)’’ to solicit information and

receive comments on the International

Conference on Harmonisation (ICH) as

well as the upcoming meetings in

Brussels, Belgium. The purpose of the

public meeting is to solicit public input

prior to the next Steering Committee

and Expert Working Group meetings in

Brussels, Belgium, February 4 through

7, 2002, at which discussion of the

implementation of the CTD and the

future of ICH will continue.

Date and Time: The public meeting

will be held on January 17, 2002, from

10:30 a.m. to 2 p.m.

Location: The public meeting will be

held in the Center for Drug Evaluation

and Research, Advisory Committee

Conference Room, at 5630 Fishers Lane,

rm. 1066, Rockville, MD 20857.

Contact: Kimberly Topper, Center for

Drug Evaluation and Research, Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–827–

7001, FAX 301–827–6801, e-mail:

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 January 10, 2002.

If you need special accommodations

due to a disability, please contact

Kimberly Topper (address above) at

least 7 days in advance.

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.

SUPPLEMENTARY INFORMATION: The ICH

of Technical Requirements for the

Registration of Pharmaceuticals for

Human Use 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. ICH was organized to provide

an opportunity for harmonization

initiatives to be developed with input

from both regulatory and industry

representatives. ICH is concerned with

harmonization among three regions: The

European Union, Japan, 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 Centers for Drug

Evaluation and Research and 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.

Interested persons may present data,

information, or views orally or in

writing, on issues pending at the public

meeting. Oral presentations from the

public meeting will be scheduled

between approximately 11:30 a.m. and 1

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

January 10, 2002, 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 e-mail of

proposed participants, and an

indication of the approximate time

requested to make their presentation.

The agenda for the public meeting

will be made available on January 10,

2002, under Docket Number 01N–0580

at the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852, between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: December 26, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–32123 Filed 12–26–01; 3:36 pm]

BILLING CODE 4160–01–S