58928 Federal Register / Vol. 69, No. 190 / Friday, October 1, 2004 / Notices 

TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN YEAR 21—Continued

Questionnaire No. of Respondents 

Annual Frequency per 

Response 

Total Annual 

Responses 

Hours per Response Total Hours 

Month 9 Questionnaire 1,875 1 1,875 .25 469

Month 10 Questionnaire 2,250 1 2,250 .42 945

Month 12 Questionnaire 2,250 1 2,250 .42 945

Total 8,625 3,304

1There are no capital costs or operating and maintenance costs associated with the collection of information.

The burden estimate is based on 

FDA’s experience with the 1993 to 1994 

survey mentioned in the previous 

paragraph and information available for 

the Diet History Questionnaire.

Dated: September 22, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–22052 Filed 9–30–04; 8:45 am] 

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

Preparation for the International 

Conference on Harmonization 

Meetings in Yokohama, Japan: 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 Yokohama, Japan’’ to 

provide information and receive 

comments on the International 

Conference on Harmonization (ICH) as 

well as the upcoming meetings in 

Yokohama, Japan. 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 

Experts Working Groups meetings in 

Yokohama, Japan on November 15 

through 18, 2004, at which discussion of 

the topics underway and the future of 

ICH will continue.

Date and Time: The meeting will be 

held on October 19, 2004, from 1:30 to 

3 p.m.

Location: The meeting will be held at 

5600 Fishers Lane, 3rd floor, 

Chesapeake Conference Room, 

Rockville, MD. For security reasons, all 

attendees are asked to arrive no later 

than 1:15 p.m., as you will be escorted 

from the front entrance of 5600 Fishers 

Lane to the Chesapeake Conference 

Room.

Contact Person: Sema Hashemi, Office 

of the Commissioner, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–3050, 

FAX 301–480–0716, e-mail: 

Sema.Hashemi@fda.hhs.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 October 15, 2004.

If you need special accommodations 

due to a disability, please contact Sema 

Hashemi 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, 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 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.

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 2:30 and 3 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 October 15, 2004, 

and submit a brief statement of the 

general nature of the evidence or 

arguments they which 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.

Federal Register / Vol. 69, No. 190 / Friday, October 1, 2004 / Notices 58929

The agenda for the public meeting 

will be made available on October 8, 

2004, on the Internet at http://

www.fda.gov/cder/meeting/

ICH_10192004.htm.

Dated: September 23, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–22053 Filed 9–30–04; 8:45 am] 

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of Inspector General 

Program Exclusions; Correction

AGENCY: Office of Inspector General, 

HHS.

ACTION: Notice of program exclusions; 

correction. 

SUMMARY: The HHS Office of Inspector 

GeneralPublished a document in the 

Federal Register of September 15, 2003, 

imposed exclusions. The document 

contained an incorrect exclusion type.

FOR FURTHER INFORMATION CONTACT:

Jacqueline Freeman, (410) 786–5197. 

Correction 

In the Federal Register of September 

15, 2004, in FR Doc. 20710, on page 

55641, correct the exclusion date to 

read:

LABONTE, MARY .................. 9/20/2004

SCOTTSDALE, AZ 

Dated: September 21, 2004. 

Katherine B. Petrowski, 

Director, Exclusions Staff, Office of Inspector 

General.

[FR Doc. 04–22046 Filed 9–30–04; 8:45 am] 

BILLING CODE 4150–04–P

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. 

Cytonectin, Cytonectin Gene and 

Cytonectin Inhibitors and Binding 

Ligands and Their Use in the Diagnosis 

and Treatment of Disease 

Soni J. Anderson et al. (NCI) 

U.S. Provisional Application No. 60/

553,977 Filed 18 Mar 2004 (DHHS 

Reference No. E–128–2004/0–US–01); 

U.S. Provisional Application No. 60/

578,068 Filed 09 Jun 2004 (DHHS 

Reference No. E–128–2004/1–US–01) 

Licensing Contact: Fatima Sayyid; 

(301) 435–4521; sayyidf@mail.nih.gov. 

Cytonectin is a 35K molecular weight 

protein that displays ion-independent 

adherence properties, is expressed in a 

variety of organs and tissues and is 

evolutionarily conserved from human to 

rodent and avian species. Within the 

body it is thought to serve the function 

of ‘‘super glue’’ contributing to cell-cell 

interactions and 3-dimensional tissue 

structure and a physiologic ‘‘do not 

attack’’ signal molecule that prevents 

tissue destruction by cells of monocyte 

lineage including odontoclasts in 

secondary teeth. It also plays an 

important role in the pathology 

associated with cancer, arthritis, 

Alzheimer’s and Parkinson’s disease. 

The present invention relates to 

cytonectin, to polynucleotides that 

encode cytonectin, to inhibitors and 

antibodies that bind to cytonectin and to 

the use of compositions in the diagnosis 

and treatment of cytonectin-related 

diseases and conditions. 

Genetic Fingerprint of Acute Stroke 

Alison E. Baird (NINDS) 

U.S. Provisional Application No. 60/

575,279 Filed 27 May 2004 (DHHS 

Reference No. E–306–2003/0–US–01) 

Licensing Contact: Fatima Sayyid; 

(301) 435–4521; sayyidf@mail.nih.gov. 

Stroke is the third leading cause of 

death and the leading cause of adult 

disability in developed countries. 

Despite the prevalence and burden of 

this disease, stroke precipitants and 

pathophysiological mechanisms in 

individual patients are often unknown. 

It is also difficult to accurately predict 

whether a stroke will lead to only minor 

neurological sequelae or more serious 

medical consequences. Although animal 

experiments in focally ischemic brain 

tissue have indicated that there are 

alterations in gene expression following 

a stroke, gene expression profiling has 

not yet been applied to clinical human 

stroke, primarily because brain tissue 

samples are inaccessible and rarely 

justified. 

The present provisional patent 

application discloses methods of 

determining whether a subject had an 

ischemic stroke, methods of 

determining the prognosis of a subject 

who had an ischemic stroke, as well as 

methods of determining an appropriate 

treatment regimen for a subject who had 

an ischemic stroke. 

Inhibition of Smad3 To Prevent Fibrosis 

and Improve Wound Healing 

Anita B. Roberts et al. (NCI) 

U.S. Patent Application No. 10/299,886 

Filed 18 Nov 2002 (DHHS Reference No. 

E–070–2000/0–US–06), claiming 

priority to PCT Application No. PCT/

US00/13725 Filed 19 May 2000 (DHHS 

Reference No. E–070–2000/0–PCT–01)

Licensing Contact: Marlene ShinnAstor; (301) 435–4426; 

shinnm@mail.nih.gov. 

Millions of dollars are spent each year 

to heal chronic non-healing wounds and 

in the treatment of severe burn patients. 

The NIH announces a new technology 

that may lead to improved approaches 

to treatment of burn patients and the 

reduction of scarring and more rapid 

closure of both acute (surgical) and 

chronic wounds (e.g., diabetic, 

decubitus, and venus statis ulcers). 

Smad2 and Smad3 are highly 

homologous cytoplasmic proteins which 

function to transduce signals from 

Transforming Growth Factor–beta 

(TGF–beta) and activin receptors to 

promoters of target genes found in the 

nucleus. This new technology indicates 

that interference with specific signaling 

pathways downstream of TGF–beta may 

be more selective and have a better 

outcome than approaches aimed at 

blocking all effects of this pleiotropic 

cytokine. 

Specifically, it is proposed that 

elimination or inhibition of Smad3 may 

interfere with fibrogenic mechanisms 

and reduce the accumulation of scar 

tissue associated with high dose 

radiation and wound healing, while 

increasing the rate of re-epithelialization 

of wounds.