57638 Federal Register / Vol. 73, No. 193 / Friday, October 3, 2008 / Notices 

2950. The MAbs that are available for 

licensing are the following: 1129, 1153, 

1142, 1200, 1214, 1237, 1112, 1269, and 

1243. One of these MAbs, 1129, is the 

basis for a humanized murine MAb (see 

U.S. Patent 5,824,307 to humanized 

1129 owned by MedImmune, Inc.), 

recently approved for marketing in the 

United States. MAbs in the panel 

reported by Beeler et al. have been 

shown to be effective therapeutically 

when administered into the lungs of 

cotton rats by small-particle aerosol. 

Among these MAbs several exhibited a 

high affinity (approximately 109M-1) for 

the RSV F glycoprotein and are directed 

at epitopes encompassing amino acid 

262, 272, 275, 276 or 389. These 

epitopes are separate, nonoverlapping 

and distinct from the epitope recognized 

by the human Fab of U.S. Patent 

5,762,905 owned by The Scripps 

Research Institute. 

Applications: Research and drug 

development for treatment of respiratory 

syncytial virus. 

Inventors: Robert M. Chanock, Brian 

R. Murphy, Judith A. Beeler, and 

Kathleen L. van Wyke Coelingh (NIAID). 

Patent Status: HHS Reference No. B– 

056–1994/1—Research Tool. Patent 

protection is not being pursued for this 

technology. 

Licensing Status: Available for nonexclusive licensing under a Biological 

Materials License Agreement. 

Licensing Contact: Peter A. Soukas, 

J.D.; 301/435–4646; 

soukasp@mail.nih.gov. 

Neutralizing Monoclonal Antibodies to 

Respiratory Syncytial Virus 

Description of Technology: 

Respiratory syncytial virus (RSV) is the 

most common cause of bronchiolitis and 

pneumonia among infants and children 

under 1 year of age. Illness begins most 

frequently with fever, runny nose, 

cough, and sometimes wheezing. During 

their first RSV infection, between 25% 

and 40% of infants and young children 

have signs or symptoms of bronchiolitis 

or pneumonia, and 0.5% to 2% require 

hospitalization. Most children recover 

from illness in 8 to 15 days. The 

majority of children hospitalized for 

RSV infection are under 6 months of 

age. RSV also causes repeated infections 

throughout life, usually associated with 

moderate-to-severe cold-like symptoms; 

however, severe lower respiratory tract 

disease may occur at any age, especially 

among the elderly or among those with 

compromised cardiac, pulmonary, or 

immune systems. 

This invention is a human 

monoclonal antibody fragment (Fab) 

discovered utilizing phage display 

technology. The neutralizing 

monoclonal antibody was isolated and 

its binding site was identified. Fab F2– 

5 is a broadly reactive fusion (F) 

protein-specific recombinant Fab 

generated by antigen selection from a 

random combinatorial library displayed 

on the surface of filamentous phage. In 

an in vitro plaque-reduction test, the 

Fab RSVF2–5 neutralized the infectivity 

of a variety of field isolates representing 

viruses of both RSV subgroups A and B. 

The Fab recognized an antigenic 

determinant that differed from the only 

other human anti-F monoclonal 

antibody (RSV Fab 19) described thus 

far. A single dose of 4.0 mg of Fab 

RSVF2–5/kg of body weight 

administered by inhalation was 

sufficient to achieve a 2000-fold 

reduction in pulmonary virus titer in 

RSV-infected mice. The antigen-binding 

domain of Fab RSVF2–5 offers promise 

as part of a prophylactic regimen for 

RSV infection in humans. 

Application: Respiratory Syncytial 

Virus prophylaxis/therapeutic. 

Development Stage: The antibodies 

have been synthesized and preclinical 

studies have been performed. 

Inventors: Brian Murphy (NIAID), 

Robert Chanock (NIAID), James Crowe 

(NIAID), et al. 

Publication: JE Crowe et al. Isolation 

of a second recombinant human 

respiratory syncytial virus monoclonal 

antibody fragment (Fab RSVF2–5) that 

exhibits therapeutic efficacy in vivo. J 

Infect Dis. 1998 Apr;177(4):1073–1076. 

Patent Status: HHS Reference No. E– 

001–1996/0—U.S. and Foreign Rights 

Available. 

Licensing Status: Available for 

exclusive or non-exclusive licensing. 

Licensing Contact: Peter A. Soukas, 

J.D.; 301/435–4646; 

soukasp@mail.nih.gov. 

Human Neutralizing Monoclonal 

Antibodies to Respiratory Syncytial 

Virus and Human Neutralizing 

Antibodies to Respiratory Syncytial 

Virus 

Description of Technology: This 

invention is a human monoclonal 

antibody fragment (Fab) discovered 

utilizing phage display technology. It is 

described in Crowe et al. , Proc Natl 

Acad Sci USA. 1994 Feb 15;91(4):1386– 

1390 and Barbas et al. , Proc Natl Acad 

Sci USA. 1992 Nov 1;89(21):10164– 

10168. This MAb binds an epitope on 

the RSV F glycoprotein at amino acid 

266 with an affinity of approximately 

109M-1. This MAb neutralized each of 

10 subgroup A and 9 subgroup B RSV 

strains with high efficiency. It was 

effective in reducing the amount of RSV 

in lungs of RSV-infected cotton rats 24 

hours after treatment, and successive 

treatments caused an even greater 

reduction in the amount of RSV 

detected. 

Applications: Research and drug 

development for treatment of respiratory 

syncytial virus. 

Inventors: Robert M. Chanock 

(NIAID), Brian R. Murphy (NIAID), 

James E. Crowe Jr. (NIAID), et al. 

Patent Status: U.S. Patent 5,762,905 

issued 09 Jun 1998 (HHS Reference No. 

E–032–1993/1–US–01); U.S. Patent 

6,685,942 issued 03 Feb 2004 (HHS 

Reference No. E–032–1993/1–US–02); 

U.S. Patent Application No. 10/768,952 

filed 29 Jan 2004 (HHS Reference No. E– 

032–1993/1–US–03). 

Licensing Status: Available for nonexclusive licensing. 

Licensing Contact: Peter A. Soukas, 

J.D.; 301/435–4646; 

soukasp@mail.nih.gov. 

Dated: September 26, 2008. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E8–23437 Filed 10–2–08; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2); notice 

is hereby given of the following 

meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; Early 

Diagnosis Using Nanotechnology-Based 

Imaging and Sensing. 

Date: October 23, 2008. 

Time: 1 p.m. to 3 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 6116 

Executive Boulevard, Room 406, Rockville, 

MD 20852, (Telephone Conference Call). 

Contact Person: Joyce C. Pegues, PhD, 

Scientific Review Officer, Special Review 

mstockstill on PROD1PC66 with NOTICES

Federal Register / Vol. 73, No. 193 / Friday, October 3, 2008 / Notices 57639 

and Logistics Branch, Division of Extramural 

Activities, NIH National Cancer Institute, 

6116 Executive Boulevard, Room 7149, 

Bethesda, MD 20892–8329, 301–594–1286, 

peguesj@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: September 26, 2008. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E8–23454 Filed 10–2–08; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Aging Special Emphasis Panel, Sleep, 

Circadian Function and Cardiometabolic 

Disease. 

Date: October 31, 2008. 

Time: 1 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute on Aging, 

Gateway Building, 7201 Wisconsin Avenue, 

2C212, Bethesda, MD 20892. (Telephone 

Conference Call) 

Contact Person: Elaine Lewis, PhD, 

Scientific Review Administrator, Scientific 

Review Office, National Institute on Aging, 

Gateway Building, Suite 2C212, MSC–9205, 

7201 Wisconsin Avenue, Bethesda, MD 

20892, 301–402–7707, 

elainelewis@nia.nih.gov. 

Name of Committee: National Institute on 

Aging Special Emphasis Panel SWAN. 

Date: November 3, 2008. 

Time: 1:30 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Gateway Building, 7201 Wisconsin 

Avenue, Suite 2C212, Bethesda, MD 20814. 

(Telephone Conference Call) 

Contact Person: Alicja L. Markowska, PhD, 

DSC, National Institute on Aging, 7201 

Wisconsin Avenue, Suite 2C212, Bethesda, 

MD 20892, 301–496–9666, 

markowsa@nia.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.866, Aging Research, 

National Institutes of Health, HHS) 

Dated: September 26, 2008. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E8–23445 Filed 10–2–08; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Office of the Secretary 

[Docket No. DHS–2008–0007] 

Privacy Act of 1974; Department of 

Homeland Security Advisory 

Committees System of Records 

AGENCY: Privacy Office; DHS. 

ACTION: Notice of Privacy Act system of 

records. 

SUMMARY: In accordance with the 

Privacy Act of 1974 and as part of the 

Department of Homeland Security’s 

ongoing effort to review and update 

legacy system of record notices, the 

Department of Homeland Security 

proposes to consolidate two legacy 

record systems: FEMA/ADM–3– 

Advisory Committee Files (55 FR 37182 

September 7, 1990) and DOT/CG 586 

Chemical Transportation Industry 

Advisory Committee (65 FR 19475 April 

11, 2000) into one system, titled 

Department of Homeland Security 

Advisory Committees. This system will 

allow the Department of Homeland 

Security to collect and maintain 

information on advisory committee 

members and applicants. Categories of 

individuals, categories of records, and 

the routine uses of these legacy system 

of records notices have been 

consolidated and updated to better 

reflect the Department’s advisory 

committee record systems. This 

consolidated system will be included in 

the Department of Homeland Security’s 

inventory of system records. 

DATES: Submit comments on or before 

November 3, 2008. 

ADDRESSES: You may submit comments, 

identified by docket number DHS– 

2008–0007 by one of the following 

methods: 

• Federal e-Rulemaking Portal: 

http://www.regulations.gov. Follow the 

instructions for submitting comments. 

• Fax: 1–866–466–5370. 

• Mail: Hugo Teufel III, Chief Privacy 

Officer, Privacy Office, Department of 

Homeland Security, Washington, DC 

20528. 

• Instructions: All submissions 

received must include the agency name 

and docket number for this rulemaking. 

All comments received will be posted 

without change and may be read at 

http://www.regulations.gov, including 

any personal information provided. 

• Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: For 

general questions and privacy issues 

please contact: Hugo Teufel III (703– 

235–0780), Chief Privacy Officer, 

Privacy Office, Department of Homeland 

Security, Washington, DC 20528. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Pursuant to the savings clause in the 

Homeland Security Act of 2002, Public 

Law 107–296, Section 1512, 116 Stat. 

2310 (November 25, 2002), the 

Department of Homeland Security 

(DHS) and its components and offices 

have relied on preexisting Privacy Act 

systems of records notices for the 

collection and maintenance of records 

that concern any individual who serves 

on a DHS-wide and/or component 

specific advisory committee. 

As part of its efforts to streamline and 

consolidate its records systems, DHS is 

establishing a new agency-wide system 

of records under the Privacy Act (5 

U.S.C. 552a) for DHS advisory 

committees. This record system will 

allow all component parts of DHS to 

collect and preserve the required 

personally identifiable information 

needed for members who apply for or 

participate in DHS advisory committees. 

The system will consist of both 

electronic and paper records and will be 

used by DHS and its components and 

offices to maintain records of Federal 

government employees and other 

persons who participate in DHSsponsored Federal advisory committees. 

The data will be collected by individual 

name, name of committee, and/or other 

unique personal identifier. The 

collection and maintenance of this 

information will assist DHS in 

maintaining a list of members of the 

various Federal advisory committees, 

internal committees, and interagency 

committees to provide DHS with 

information on committee functions, 

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