Federal Register / Vol. 69, No. 203 / Thursday, October 21, 2004 / Notices 61855

Revised Draft Agenda 

Scientific Advisory Committee on 

Alternative Toxicological Methods 

October 20, 2004 

U.S. Environmental Protection 

Agency, Building C, Room C111 

(Auditorium sections A. and B), 109 

T.W. Alexander Drive, Research 

Triangle Park, NC 27709. (A photo ID is 

required to access the EPA campus.)

8:30 a.m.

• Call to Order and Introductions 

• Welcome and Remarks from the 

National Institute of Environmental 

Health Sciences (NIEHS) and the 

National Toxicology Program (NTP) 

• Welcome and Remarks from the 

Interagency Coordinating Committee on 

the Validation of Alternative Methods 

(ICCVAM) Chair 

• Update on Activities of the National 

Toxicology Program (NTP) Interagency 

Center for the Evaluation of Alternative 

Toxicological Methods (NICEATM) and 

ICCVAM 

• Update on the European Center for 

the Validation of Alternative Methods 

(ECVAM) Workshop Recommendations 

and Validation Studies 

• Evaluation of the Under-Prediction 

Rate for the in vivo Rabbit Dermal 

Irritation Test 

Æ Public Comment 

• Preliminary Evaluation of the 

Under-Prediction Rate for the in vivo

Rabbit Ocular Irritation Test 

Æ Public Comment 

12 p.m.: Lunch Break (on your own, the 

EPA campus has a cafeteria) 

1 p.m. 

• ICCVAM Nominations 

Æ Public Comment 

• NTP Roadmap 

Æ Public Comment 

• ICCVAM Perspectives on Proposed 

OECD Draft guidance Document on the 

Validation and International Acceptance 

of New or Updated Test methods for 

Hazard Assessment (Guidance 

Document 34) 

• General Discussion 

4:30 p.m.: Adjourn

Dated: October 8, 2004. 

Samuel Wilson, 

Deputy Director, National Institute of 

Environmental Health Sciences.

[FR Doc. 04–23559 Filed 10–20–04; 8:45 am] 

BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive 

License: Human Parvovirus B19 

Vaccine

AGENCY: National Institutes of Health, 

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: This is notice, in accordance 

with 35 U.S.C. 209(c)(1) and 37 CFR 

404.7(a)(1)(i), that the National 

Institutes of Health (NIH), Department 

of Health and Human Services, is 

contemplating the grant of a worldwide 

exclusive license to practice the 

inventions embodied in PCT/US89/

04948 filed November 14, 1989, and 

National Stage filed in Australia (patent 

no. 631159), Canada (patent no. 

1284268), Israel (patent no. 92298) and 

Japan (patent no. 2755817), entitled 

‘‘Parvovirus Capsids’’; U.S. patent no. 

5,508,186, U.S. patent no. 6,132,732, 

U.S. patent no. 6,001,371, U.S. patent 

no. 5,827,647, entitled ‘‘B19 Parvovirus 

Capsids’’ ; U.S. patent no. 5,916,563, 

U.S. patent no. 6,558,676 entitled 

‘‘Parvovirus Capsids’’; and PCT/NL90/

00130 filed September 11, 1990, and 

National Stage filed in Europe (patent 

no. 0491824), Austria (patent no. 

122395), Denmark (patent no. 0491824), 

Germany (patent no. 69019359), 

Netherlands (patent no. 8902301), Spain 

(patent no. 2073036) and United States 

(patent nos. 6,204,044, 6,287,815 and 

6,379,885), entitled ‘‘Human Parvovirus 

B19 Proteins and Virus-like Particles, 

Their Production and Their Use in 

Diagnostic Assays and Vaccines’’ to 

Viral Antigens, Inc., having a place of 

business in Memphis, Tennessee. The 

patent rights in these inventions have 

been assigned or exclusively licensed to 

the United States of America.

DATES: Only written comments and/or 

application for a license which are 

received by the NIH Office of 

Technology Transfer on or before 

January 19, 2005, will be considered.

ADDRESSES: Requests for a copy of the 

patent application, inquiries, comments 

and other materials relating to the 

contemplated license should be directed 

to: Susan Ano, Office of Technology 

Transfer, National Institutes of Health, 

6011 Executive Boulevard, Suite 325, 

Rockville, MD 20852–3804; e-mail: 

anos@od.nih.gov; telephone: (301) 435–

5515; Facsimile: (301) 402–0220.

SUPPLEMENTARY INFORMATION: This 

technology describes a method of 

producing non-infectious recombinant 

human parvovirus B–19 capsids 

composed of viral proteins VP1 and VP2 

or VP2. The technology further relates to 

diagnostic assays utilizing the 

recombinantly produced parvovirus 

capsid proteins, or antibodies to such 

proteins. The technology also describes 

a vaccine effective against parvovirus 

B19 infection, consisting of the 

recombinant capsid proteins. Data from 

the inventors show that the 

configuration of the vaccine optimal for 

eliciting neutralizing antibodies 

comprises approximately twenty five 

percent (25%) VP1 and seventy five 

percent (75%) VP2. In another 

embodiment, the technology describes 

the use of parvovirus B19 viral capsids 

as a gene delivery system for proteins. 

The prospective exclusive license will 

be royalty bearing and will comply with 

the terms and conditions of 35 U.S.C. 

209 and 37 CFR 404.7. The prospective 

exclusive license may be granted unless, 

within 90 days from the date of this 

published notice, NIH receives written 

evidence and argument that establishes 

that the grant of the license would not 

be consistent with the requirements of 

35 U.S.C. 209 and 37 CFR 404.7. 

The field of use may be limited to 

development of vaccines for parvovirus 

B19. 

The licensed territory will be 

worldwide exclusive. 

Properly filed competing applications 

for a license filed in response to this 

notice will be treated as objections to 

the contemplated license. Comments 

and objections submitted in response to 

this notice will not be made available 

for public inspection, and, to the extent 

permitted by law, will not be released 

under the Freedom of Information Act, 

5 U.S.C. 552.

Dated: October 14, 2004. 

Steven M. Ferguson, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health.

[FR Doc. 04–23561 Filed 10–20–04; 8:45 am] 

BILLING CODE 4140–01–P

DEPARTMENT OF HOMELAND 

SECURITY 

Directorate of Science and Technology 

[Docket No. DHS–2004–0008] 

Notice of Meeting of Homeland 

Security Science and Technology 

Advisory Committee

AGENCY: Office of the Under Secretary 

for Science and Technology, DHS.

ACTION: Notice.

SUMMARY: The Homeland Security 

Science and Technology Advisory