Federal Register / Vol. 73, No. 180 / Tuesday, September 16, 2008 / Notices 53427 

Thermal therapy for brain tumors 

Addenda (procedures) 

ICD–10 update and effect on MS–DRGs 

Cooperating Parties Update 

FOR FURTHER INFORMATION CONTACT: 

Amy Blum, Medical Systems Specialist, 

Classifications and Public Health Data 

Standards Staff, NCHS, 3311 Toledo 

Road, Room 2402, Hyattsville, Maryland 

20782, e-mail alb8@cdc.gov, telephone 

301–458–4106 (diagnosis), Mady Hue, 

Health Insurance Specialist, Division of 

Acute Care, CMS, 7500 Security Blvd., 

Baltimore, Maryland, 21244, e-mail 

marilu.hue@cms.hhs.gov, telephone 

410–786–4510 (procedures). 

Notice: Because of increased security 

requirements CMS has instituted 

stringent procedures for entrance into 

the building by non-government 

employees. Persons without a 

government I.D. will need to show an 

official form of picture I.D., (such as a 

drivers license), and sign-in at the 

security desk upon entering the 

building. Those who wish to attend a 

specific ICD–9–CM C&M meeting in the 

CMS auditorium must submit their 

name and organization for addition to 

the meeting visitor list. Those wishing 

to attend the September 24–25, 2008 

meeting must submit their name and 

organization by September 12, 2008 for 

inclusion on the visitor list. This visitor 

list will be maintained at the front desk 

of the CMS building and used by the 

guards to admit visitors to the meeting. 

Those who attended previous ICD–9– 

CM C&M meetings will no longer be 

automatically added to the visitor list. 

You must request inclusion of your 

name prior to each meeting you attend. 

Register to attend the meeting on-line 

at: http://www.cms.hhs.gov/apps/ 

events/. 

Notice: This is a public meeting. 

However, because of fire code 

requirements, should the number of 

attendants meet the capacity of the 

room, no additional attendees will be 

accepted into the meeting. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both CDC 

and the Agency for Toxic Substances 

and Disease Registry. 

Dated: September 5, 2008. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. E8–21599 Filed 9–15–08; 8:45 am] 

BILLING CODE 4160–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0038] 

Joint Meeting of the Antiviral Drugs 

Advisory Committee and the 

Nonprescription Drugs Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committees: Antiviral Drugs 

Advisory Committee and the 

Nonprescription Drugs Advisory 

Committee. 

General Function of the Committees: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on October 29, 2008, from 8 a.m. 

to 5 p.m. 

Location: Hilton, The Ballrooms, 1750 

Rockville Pike, Rockville, MD. The hotel 

telephone number is 301–468–1100. 

Contact Person: Paul Tran, Center for 

Drug Evaluation and Research (HFD– 

21), Food and Drug Administration, 

5600 Fishers Lane, (for express delivery, 

5630 Fishers Lane, rm. 1093) Rockville, 

MD 20857, 301–827–6793, FAX: 301– 

827–6776, e-mail: 

paul.tran@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), codes 

3014512531 and 3014512541. Please 

call the Information Line for up-to-date 

information on this meeting. A notice in 

the Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

agency’s Web site and call the 

appropriate advisory committee hot 

line/phone line to learn about possible 

modifications before coming to the 

meeting. 

Agenda: The committee will provide 

advice on types of studies and trial 

designs needed for an influenza 

antiviral MedKit for the treatment or 

prophylaxis of pandemic influenza and 

discuss publicly the proposed 

development program that would 

support an application for such a 

MedKit. Issues such as the role of 

personal MedKits, home stockpiling, 

non-prescription availability of 

influenza medications, and interfaces of 

home readiness with public health 

systems, will be raised in the course of 

the discussions. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ohrms/ 

dockets/ac/acmenu.htm, click on the 

year 2008 and scroll down to the 

appropriate advisory committee link. 

Procedure: 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 on or before October 15, 2008. 

Oral presentations from the public will 

be scheduled between approximately 

1:30 p.m. and 2:30 p.m. Those desiring 

to make formal oral presentations 

should notify the contact person 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 on 

or before October 6, 2008. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by October 7, 2008. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Paul Tran at 

least 7 days in advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/oc/advisory/ 

default.htm for procedures on public 

conduct during advisory committee 

meetings. 


ebenthall on PROD1PC60 with NOTICES
53428 Federal Register / Vol. 73, No. 180 / Tuesday, September 16, 2008 / Notices 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: September 10, 2008. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E8–21574 Filed 9–15–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0484] 

Preparation for International 

Conference on Harmonization 

Meetings in Brussels, Belgium; Public 

Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of meeting. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting entitled ‘‘Preparation for 

ICH meetings in Brussels, Belgium’’ to 

provide information and receive 

comments on the International 

Conference on Harmonization (ICH) as 

well as the upcoming meetings in 

Brussels, Belgium. The topics to be 

discussed are the topics for discussion 

at the forthcoming ICH Steering 

Committee Meeting. The purpose of the 

meeting is to solicit public input prior 

to the next Steering Committee and 

Expert Working Groups meetings in 

Brussels, Belgium, November 10 to 13, 

2008, at which discussion of the topics 

underway and the future of ICH will 

continue. 

Date and Time: The meeting will be 

held on Tuesday, October 21, 2008, 

from 3 p.m. to 5:30 p.m. 

Location: The meeting will be held at 

5600 Fishers Lane, 3rd floor, Conference 

Rooms D and E, Rockville, MD 20857. 

For security reasons, all attendees are 

asked to arrive no later than 2:45 p.m., 

as you will be escorted from the front 

entrance of 5600 Fishers Lane to 

Conference Rooms D and E. 

Contact Person: All participants must 

register with Tammie Jo Bell, Office of 

the Commissioner, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, by email: 

tammie.bell@fda.hhs.gov or fax: 301– 

827–0003. 

Registration and Requests for Oral 

Presentations: Send registration 

information (including name, title, firm 

name, address, telephone, and fax 

number), written material and requests 

to make oral presentation, to the contact 

person by October 14, 2008. 

If you need special accommodations 

due to a disability, please contact 

Tammie Jo Bell 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–66, Rockville, MD 20857, 

approximately 15 working days after the 

meeting at a cost of 10 cents per page. 

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. 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, 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 Manufactures 

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 (IFPMA). 

The ICH Steering Committee includes 

representatives from each of the ICH 

sponsors and Health Canada, the 

European Free Trade Area and the 

World Health Organization. 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 at the following Web site: 

http://www.ich.org. 

Dated: September 9, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–21573 Filed 9–15–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: The inventions listed below 

are owned by an agency of the U.S. 

Government and are available for 

licensing in the U.S. in accordance with 

35 U.S.C. 207 to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

ADDRESSES: Licensing information and 

copies of the U.S. patent applications 

listed below may be obtained by writing 

to the indicated licensing contact at the 

Office of Technology Transfer, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 325, Rockville, 

Maryland 20852–3804; telephone: 301– 

496–7057; fax: 301–402–0220. A signed 

Confidential Disclosure Agreement will 

be required to receive copies of the 

patent applications. 

Use of Razoxane for the Treatment of 

Alzheimer’s Disease 

Description of Technology: 

Abnormalities in the metabolism of the 

transition metals, iron and copper, have 

been demonstrated to play a crucial role 

in the pathogenesis of various 

neurodegenerative diseases, including 

Alzheimer’s disease (AD) and 

Parkinson’s disease (PD). Excessive iron 

accumulation in the brain occurs in 

both AD and PD. High levels of reactive 

iron can increase oxidative stressinduced neuronal vulnerability, 

increase the toxicity of environmental or 

endogenous toxins, and accelerate 

hallmark pathologies of these diseases. 

As an example among many, the 

expression level of amyloid-b precursor 

protein (APP) that generates the AD 

neurotoxic peptide, amyloid-b (Ab), is 


ebenthall on PROD1PC60 with NOTICES