61854 Federal Register / Vol. 69, No. 203 / Thursday, October 21, 2004 / Notices 

is as follows: Estimated Number of 

Respondents: See table below. 

Estimated Number of Responses per 

Respondents: See table below. Average 

Burden Hours Per Response: 0.25 hour 

for initial screening, 0.5 hour for dust 

mite eligibility screening, 1.5 hours for 

each baseline visit and 1 hour for each 

follow-up home visit (6- and 12-month); 

and Estimated Total Burden Hours 

Requested: 690.5. The average annual 

burden hours requested is 112.5 for the 

initial screening, 140 for the dust mite 

eligibility screening, 216 for the baseline 

visit, 122 for the 6-month follow-up and 

100 for the 12-month follow-up visits. 

The annualized cost to respondents is 

estimated at $13,810 (assuming $20 

hourly wage × 690.5 hours). There are 

no Capital Costs to report. There are no 

Operating or Maintenance Costs to 

report.

Type of respondents 

Estimated 

number of respondents 

Estimated 

number of responses per 

respondent 

Average burden hours per 

response 

Estimated total 

burden hours 

requested 

Eligibility screening .......................................................................................... 450 1 0.25 112.5 

Dust mite level eligibility screening .................................................................. 1 280 1 0.5 140 

Baseline visit .................................................................................................... 2 144 1 1.5 216 

6-month follow-up ............................................................................................ 122 1 1 122 

12-month follow-up .......................................................................................... 3 100 1 1 100 

Total .......................................................................................................... 4 1,096 ........................ ........................ 690.5 

1Expect approximately 60% of the participants to satisfy the initial eligibility criteria. 

2Expect approximately 50% of the participants who met initial eligibility to satisfy the dust mite level screening eligibility criteria. 3Expect approximately 30% attrition rate over the 12 month period. 

4 Individuals who participate in each step of data collection are counted more than once, for each phase of data collection. Total number of 

unduplicated respondents is 450. 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of the function of the 

agency, including whether the 

information will have practical utility; 

(2) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information, including the validity of 

the methodology and assumptions used; 

(3) ways to enhance the quality, utility, 

and clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection of information 

on those who are to respond, including 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology.

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact: Leslie Elliott, 

Laboratory of Respiratory Biology, 

NIEHS, Building 101, A2–05, P.O. Box 

12233, Research Triangle Park, NC 

27709 or call non-toll-free number (919) 

541–1161 or e-mail your request, 

including your address to: 

elliott1@niehs.nih.gov.

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication.

Dated: October 8, 2004. 

Rich Freed, 

NIEHS, Associate Director for Management.

[FR Doc. 04–23560 Filed 10–20–04; 8:45 am] 

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Public Health Service 

National Institutes of Health 

National Institute of Environmental 

Health Sciences; Amended Notice of a 

Meeting of the Scientific Advisory 

Committee on Alternative 

Toxicological Methods: Availability of 

Video Casting and a Public Telephone 

Call-In Line 

This notice announces the availability 

of video casting and a public telephone 

call-in line for the October 20, 2004 

meeting of the Scientific Advisory 

Committee on Alternative Toxicological 

Methods (SACATM). The meeting will 

be held at the U.S. Environmental 

Protection Agency (EPA), 109 T.W. 

Alexander Drive, Research Triangle 

Park, NC (Building C, Room C111, 

Auditorium sections A. and B). 

Additional information about this 

SACATM meeting was published in a 

previous Federal Register notice 

(September 8 (Volume 69, Number 173) 

pages 54298—54299). 

The National Toxicology Program 

(NTP) is making plans to video cast the 

SACATM meeting through the Internet 

at http://www.niehs.nih.gov/external/

video.htm. The following information is 

required for telephone access: 

• USA Toll Free Number: 800–857–

1738 (required). 

• Passcode: 50250 (required). 

• Leader Name: Kristina Thayer 

(required). 

• Press *6 to mute and unmute. 

The NTP has reserved 50 telephone 

lines for this call and access availability 

will be on a first come first served basis. 

Comments from the phone will be 

solicited during public comment 

periods identified on the agenda (see 

below for revised draft agenda). 

Telephone comments should not exceed 

two minutes in length and each 

organization is allowed only one oral 

slot (in person or by the telephone) per 

agenda topic. Calls will be taken as time 

permits and at the discretion of the 

SACATM chairperson. Every effort will 

be made to accommodate callers, but the 

total time allotted for comments 

received via the telephone will be 30 

minutes for the entire meeting. Priority 

will be given to callers who register to 

make public comments in advance of 

the meeting. Registration to present oral 

public comments or to submit written 

comments can be completed online at 

the SACATM meeting site (http://ntpserver.niehs.nih.gov/

index.cfm?objectid=26F6530D-BA27–

9B29–FAE1657CB6DB907D). Details 

about the meeting, Internet access and 

telephone call-in are also available at 

this site. The video casting and public 

telephone call-in are new remote access 

options for SACATM, thus their 

technical quality can not be guaranteed. 

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