Federal Register / Vol. 65, No. 201 / Tuesday, October 17, 2000 / Notices 61343

attitudes and behaviors by the mass

media.

Frequency of Response: The revised

NSPY data collection will continue over

a four-year period, ending in June 2003.

Each data collection wave will last

approximately 6 months. Affected

public: Individuals and households.

Type of Respondents: Children and

parents. The annual reporting burden,

which will drop substantially from the

original design, is as follows:

RESPONDENT AND BURDEN ESTIMATE

Type of respondents

Estimated

number of

respondents

Estimated

number of responses per

respondent

Average burden hours per

response

Estimated total

burden hours

requested

Estimated

annualized

burden 1/1/

01–5/31/02

Revised National Survey of Youth and Parents (Baseline 1/1/01–5/31/01)

Screener Respondent .......................................................... 15,498 1 .06 930 1 620

Youth 9–11 ........................................................................... 738 1 .60 443 1 295

Teens 12–18 ........................................................................ 1,189 1 .73 868 1 579

Parents ................................................................................. 1,369 1 .92 1,259 1 840

National Survey of Parents and Youth (Longitudinal 1/1/01–5/31/02)

Screener Respondent .......................................................... 4,739 1.2 .06 341 3 227

Youth 9–11 ........................................................................... 1,403 1.2 .60 1,010 3 673

Adolescents 12–18 .............................................................. 4,553 1.2 .90 3,934 3 2,622

Parents ................................................................................. 4,334 1.2 .90 4,680 3 3,120

Total .............................................................................. 2 33,823 ........................ .26 13,465 8,976

1 Interviewing of revised NSPY baseline respondents begins 1/01; earlier baseline data collected from 11/99–12/00.

2Some number of screener respondents are later also selected for a parent interview. The exact overlapping proportion cannot be estimated

at this time. 3Follow-up of NSPY respondents from the earlier baseline data collected (11/99–12/00) begins 1/01.

There are no Capital Costs to report.

There are no Operating or Maintenance

Costs to report. Because of the

sensitivity of collecting data from

families in households involving

children as young as 9 years old, and

the importance of minimizing costs for

repetitive, return visits to obtain

respondent cooperation, IDA provides a

reasonable cost incentive to reimburse

respondents for their time, as approved

by OMB.

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 revision in the

data collection 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

revision, 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 Susan David,

Project Officer; Division of Services,

Epidemiology and Prevention Research,

National Institute on Drug Abuse, Room

5153, MSC 9589, 6001 Executive Blvd.,

Bethesda, MD 20892–9589; or call nontoll-free number (301) 443–6504; or fax

to (301) 443–2636; or email your

request, including your address, to:

Sdavid@nida.nih.gov.

COMMENTS DUE DATE: Comments

regarding this information collection are

best assured of having their full effect if

received on or before December 18,

2000.

Dated: October 2, 2000.

Laura Rosenthal,

Executive Officer, NIDA.

[FR Doc. 00–26584 Filed 10–16–00; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Government-Owned Inventions;

Availability for Licensing

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: The inventions listed below

are owned by agencies 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.

Virus-Like Particles as Unlinked

Adjuvants

John Schiller, Bryce Chackerian, Joseph

Lee, Douglas Lowy (NCI), DHHS

Reference No. E–231–00/0 filed 20 Jul

2000.

Licensing Contact: Peter Soukas; 301/

496–7056 ext. 268; e-mail:

soukasp@od.nih.gov

This invention claims

immunostimulating or vaccine

compositions in which non-infectious

virus-like particles (VLPs) serve as

unlinked adjuvants. Co-administration

of VLPs with an antigen enhances

induction of high titer IgG antibodies to

self or foreign antigens and promotes T

cell responses to foreign antigens. The

61344 Federal Register / Vol. 65, No. 201 / Tuesday, October 17, 2000 / Notices

VLP-target antigen combination can be

administered alone or with a traditional

adjuvant. The VLPs of the current

invention are contemplated to comprise

capsid protein(s) of a virus assembled

into a shell resembling a virion, but not

containing pathogenic viral DNA or

RNA. The VLPs are unlinked, rather

than physically linked to the antigen

because this may reduce the

manufacturing complexity of the

vaccine. Unlinked VLP adjuvants, for

example papillomavirus VLPs, of the

invention have a number of advantages:

(1) They are non-inflammatory in

humans, (2) are potent at amplifying IgG

antibody responses to self antigens, (3)

induce a pronounced Th1 type of T cell

response, and (4) may provide two-fold

protection, against the virus

corresponding to the VLP type, as well

as against the disease associated with

the other component in the VLP-target

antigen combination.

System and Method for Representing

Knowledge in a Distributed System

Stephen J. Shaw (NCI), Serial No. 09/

470,684 filed 23 Dec 1999.

Licensing Contact: Dale Berkley; 301/

496–7735 ext. 223; e-mail:

berkleyd@od.nih.gov

This invention relates to a knowledge

base (KB) system for storing data in a

computer system. More specifically, this

invention relates to systems and

methods for representing, manipulating,

and displaying knowledge consisting of

categories, entities and relationships

stored in a plurality of databases. The

invention contemplates providing a

user-friendly computer-based

distributed system of databases which

enables its users to create, use and share

a knowledge base of information

consisting of diverse entities related to

each other by semantically meaningful

links. The system generates a knowledge

base that allows individuals to store

information on a virtually unlimited

range of entities. Due to its design as a

distributed system, it is well suited to

preserve the autonomy and portability

of data belonging to each individual and

workgroup, while maintaining links of

that data to publicly available data

elsewhere in the system and even links

to information on entities external to the

system. Diverse strategies are employed

to simplify the implementation and use

of the system. Some unique features of

this software-based invention are: (1)

The ability to handle any number of

conceptually distinct categories of items

(such as people, events, institutions,

tasks, concepts, processes, document

types); (2) tools for creating

relationships between any two or more

objects, with the ability to categorize

types of relationships and decide which

categories they apply to; (3) use of

parent-child relationships to organize,

view and navigate information; (4)

flexibility in adding diverse categories

of objects and relationships, while

maintaining a simple underlying data

structure and programming

environment; and (5) the ability to view

complex relationships in flexible and

informative ways; (6) tools for managing

names which are indispensable for

finding the relevant objects; and (7)

efficient ways to search information and

filter retrievals to limit to relevant

information.

Peptides that Stabilize Protein Antigens

and Enhance Presentation to CD8+ T

Cells

Roger Kurlander, Elizabeth Chao, Janet

Fields (CC), DHHS Reference No. E–

172–99/0 filed 06 Dec 1999.

Licensing Contact: Peter Soukas; 301/

496–7056, ext. 268; e-mail:

soukasp@od.nih.gov

This invention relates to compositions

and methods for stabilizing an antigen

against proteolytic degradation and

enhancing its presentation to CD8+

cells. The invention claims ‘‘fusion

agents,’’ isolated molecules comprising

a hydrophobic peptide joined to an

epitope to which a CD8+ T cell response

is desired. Also claimed in the

invention are the nucleic acid sequences

that encode the fusion agents.

Recently, there has been great interest

in developing vaccines to induce

protective CD8+ T cell responses,

however, there are practical obstacles to

this goal. Although purified antigenic

peptides are effectively presented in

vitro, introduced in a purified form they

often do not stimulate effective T cell

responses in vivo because the antigens

are insufficiently immunogenic and too

easily degraded. Adjuvants or infectious

‘‘carriers’’ often can enhance these

immune responses, however, these

added agents can cause unacceptable

local or systemic side effects. The

present invention increases antigen

stability and promotes in vivo responses

in the absence of an adjuvant or active

infection.

The invention describes three variants

of lemA, an antigen recognized by CD8+

cells in mice infected with Listeria

monocytogenes. The antigenic and

stabilizing properties of lemA can be

accounted for by the covalent

association of the immunogenic

aminoterminal hexapeptide with the

protease resistant scaffolding provided

by amino acids 7 to 33 of the lemA

sequence (lemA(7–33)). Variants t-lemA,

and s-lemA bearing an antigenic

sequence immediately preceding

lemA(7–33), and lemS containing an

immunogenic sequence immediately

after lemA(7–33), each induce a CD8+ T

cell response and protect the crucial

immunogenic oligopeptide from

protease degradation. The site of antigen

insertion relative to lemA(7–33) can

influence antigen processing by

preferentially promoting processing

either in the cytoplasm or endosomal

compartment. Therefore, several

embodiments of the invention involve

the construction of antigen processing

protein molecules and their methods of

use. Alternatively, a DNA sequence

coding lemA(7–33) may be inserted at an

appropriate site to enhance the

immunogenicity of the antigenic

element coded by a DNA vaccine. In

sum, this invention is an attractive,

nontoxic alternative to protein/adjuvant

combinations in eliciting CD8 responses

in vivo and a useful element for

enhancing the efficiency with which

products coded by DNA vaccines are

processed and presented in vivo.

Because lemA(7–33) is particularly

effective in protecting oligopeptides

from proteases, this invention may have

particular usefulness in enhancing local

T cell at sites such as mucosal surfaces

where there may be high proteolytic

activity.

For more specific information about

the invention or to request a copy of the

patent application, please contact Peter

Soukas at the telephone number or email listed above. Additionally, please

see a related article published in the

Journal of Immunology at:

1999;163:6741–6747.

Major Neutralization Site of Hepatitis E

Virus and Use of this Neutralization

Site in Methods of Vaccination

Darren Schofield, Suzanne U. Emerson,

Robert H. Purcell (NIAID), DHHS

Reference No. E–043–00/0 filed 01 Dec

1999.

Licensing Contact: Carol Salata; 301/

496–7735 ext. 232; e-mail:

salatac@od.nih.gov

Hepatitis E is endemic in many

countries throughout the developing

world, in particular on the continents of

Africa and Asia. The disease generally

affects young adults and has a very high

mortality rate, up to 20%, in pregnant

women. This invention relates to the

identification of a neutralization site of

hepatitis E virus (HEV) and neutralizing

antibodies that react with it. The

neutralization site is located on a

polypeptide from the ORF2 gene (capsid

gene) of HEV. This neutralization site

was identified using a panel of

chimpanzee monoclonal antibodies that

are virtually identical to human

antibodies. Since this neutralization site

Federal Register / Vol. 65, No. 201 / Tuesday, October 17, 2000 / Notices 61345

is conserved among genetically

divergent strains of HEV, the

neutralizing monoclonal antibodies may

be useful in the diagnosis, treatment

and/or prevention of hepatitis E.

Furthermore, immunogens that

encompass this neutralization site may

be used in vaccination to effectively

prevent, and/or reduce the incidence of

HEV infection. Polypeptides containing

this neutralization site may be useful in

evaluating vaccine candidates for the

production of neutralizing antibodies to

HEV.

Viral Glycoprotein Subunit Vaccine

Richard Compans, Ranjit Ray, U.S.

Patent 4,790,987 issued 13 Dec 1988.

Licensing Contact: Peter Soukas; 301/

496–7056 ext. 268; e-mail:

soukasp@od.nih.gov

The present invention relates to a

vaccine composition useful in the

prevention of virus-caused disease

comprising as its active agent at least

one immunogenically effective amount

of immunogenic viral envelope

glycoprotein complexed with a lipid.

These subunit vaccine compositions are

useful for the prevention of viral

infections including influenza virus,

parainfluenza virus, herpes virus,

paramyxoviruses, rabies virus, and

human T-cell lymphotrophic viruses.

The patent also discloses a method for

preparing the vaccine compositions. A

novel feature of the invention is the

utilization of a dialyzable detergent for

solubilization of the active component,

which allows a relatively simple

purification process on a large scale.

Thus, these vaccines are easier to

prepare than other glycoprotein subunit

vaccines and retain their antigenicity to

a greater extent than formalininactivated subunit vaccines.

Dated: October 5, 2000.

Jack Spiegel,

Director, Division of Technology Development

and Transfer, Office of Technology Transfer,

National Institutes of Health.

[FR Doc. 00–26585 Filed 10–16–00; 8:45 am]

BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Center for Research

Resources; 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 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 Center for

Research Resources Special Emphasis Panel

Comparative Medicine.

Date: October 24, 2000.

Time: 3 pm to 4 pm.

Agenda: To review and evaluate grant

applications.

Place: Office of Review, National Center for

Research Resources, 6705 Rockledge Drive,

Bethesda, MD 20892, (Telephone Conference

Call).

Contact Person: Sybil A. Wellstood, PhD,

Scientific Review Administrator, Office of

Review, National Center for Research

Resources, 6705 Rockledge Drive, MSC 7965,

Room 6018, Bethesda, MD 20892–7965, 301–

435–0814.

This notice is being published less than 15

days prior to the meeting due to the timing

limitations imposed by the review and

funding cycle.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.306, Comparative Medicine,

93.306; 93.333, Clinical Research, 93.333;

93.371, Biomedical Technology; 93.389,

Research Infrastructure, National Institutes of

Health, HHS)

Dated: October 5, 2000.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 00–26569 Filed 10–16–00; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Center for Research

Resources; 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 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 Center for

Research Resources Special Emphasis Panel,

Comparative Medicine.

Date: October 27, 2000.

Time: 3 p.m. to 4 p.m.

Agenda: To review and evaluate grant

applications.

Place: Office of Review, National Center for

Research Resources, 6705 Rockledge Drive,

Bethesda, MD 20892, (Telephone Conference

Call).

Contact Person: Sybil A. Wellstood, PHD,

Scientific Review Administrator, Office of

Review, National Center for Research

Resources, 6705 Rockledge Drive, MSC 7965,

Room 6018, Bethesda, MD 20892–7965, 301–

435–0814.

This notice is being published less than 15

days prior to the meeting due to the timing

limitations imposed by the review and

funding cycle.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.306, Comparative Medicine,

93.306; 93.333, Clinical Research, 93.333;

93.371, Biomedical Technology; 93.389,

Research Infrastructure, National Institutes of

Health, HHS)

Dated: October 4, 2000.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 00–26573 Filed 10–16–00; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Human Genome Research

Institute; 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) and 552b(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 Human

Genome Research Institute Special Emphasis

Panel.

Date: October 27, 2000.

Time: 8 a.m. to 6 p.m.

Agenda: To review and evaluate grant

applications.