Federal Register / Vol. 62, No. 18 / Tuesday, January 28, 1997 / Notices 4069

Type of respondents

Estimated

number of

respondents

Estimated

number of

responses

per respondent

Average

burden

hours per

response

Estimated

total annual

burden

hours requested

Annualized Totals ...................................................................................................... 17,315 .................... .................... 2,862

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.

DIRECT COMMENTS TO OMB: Written

comments and/or suggestions regarding

the item(s) contained in this notice,

especially regarding the estimated

public burden and associated response

time, should be directed to the: Office

of Management and Budget, Office of

Regulatory Affairs, New Executive

Office Building, Room 10235,

Washington, D.C. 20503, Attention:

Desk Officer for NIH. To request more

information on the proposed project or

to obtain a copy of the data collection

plans and instruments, contact: Chris

Thomsen, Acting Chief, Cancer

Information Service, RIB, OCC, OD, NCI,

Building 31, Room 10A16, 9000

Rockville Pike, Bethesda, MD 20892, or

call non-toll-free number (301) 496–

5583 ext. 239 or E-mail your request,

including your address to:

thomsenc@occ.nci.nih.gov

COMMENTS DUE DATE: Comments

regarding this information collection are

best assured of having their full effect if

received on or before February 27, 1997.

Dated: December 12, 1996.

Nancie L. Bliss,

OMB Project Clearance Liaison.

[FR Doc. 97–1982 Filed 1–27–97; 8:45 am]

BILLING CODE 4140–01–M

Government-Owned Inventions;

Availability for Licensing

AGENCY: National Institutes of Health.

ACTION: Notice.

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 U.S. 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). An

signed Confidential Disclosure

Agreement (CDA) will be required to

receive copies of the patent

applications.

Immunotoxin (MAB–RICIN), for the

Treatment of Focal Movement

Disorders

J Hott, R Youle, M Hallet, M Dalakas

(NINDS)

Serial No. 60/027,458 filed 19 Sep 96

Licensing Contact: Stephen Finley, 301/

496–7735 ext 215

This invention describes the use of an

immunotoxin designed to treat focal

dystonias that are currently being

treated by injections of botulinum toxin

(BTX) or by surgical myectomy. The

immunotoxin (ITX) is prepared from a

monoclonal antibody (MoAb35),

specific to the nicotinic acetylcholine

receptor in skeletal muscle, and is

covalently linked to the toxin, ricin. ITX

utilizes ricin’s alpha chain and beta

chain for its improved potency. ITX’s

potency was demonstrated by

intramuscular injections into a rat

model. The effects of intermuscular

injections of ITX were compared to that

of BTX. Even lower doses of ITX proved

more effective and longer lasting than

BTX in weakening muscle. The ITX

selectively removed muscle fiber at the

injection sites. It is believed that ITX

may have clinical applications to those

patients who have become refractory to

BTX, or when used in combination or in

place of BTX. In addition to the use of

ITX in the treatment of all focal

muscular spasms, ITX may prove useful

in the treatment of other disorders of

muscular spasms such as

blepharospasms, cervical dystonia, hand

dystonia, limb dystonia, hemifacial

spasm, bruxism, strabismus, VI nerve

palsy, for spasmodic, dysphonia, and

oromandibular dystonia. (portfolios:

Central Nervious System—Therapeutics,

neurological, other; Central Nervous

System—Therapeutics, neurological,

muscle relaxants; Internal Medicine—

Therapeutics, other)

Methods and Compositions for p300/

CBP-Associated Transcriptional CoFactor (P/CAF)

Y Nakatani, B Howard (NICHD)

Serial No. 60/022,273 filed 23 Jul 96

Licensing Contact: Ken Hemby, 301/

496–7735 ext 265

The adenoviral oncoprotein E1A

induces cell transformation by binding

to various cellular components, such as

the products of the retinoblastoma and

p300/CBP gene families. This invention

provides a transcriptional co-factor,

p300/CBP-associated factor (P/CAF),

which has intrinsic histone acetylase

activity and also competes with E1A for

binding to cellular targets. Also

provided are methods of screening for

compounds that affect P/CAF activity.

Methods for directed gene therapy to

provide functional wild-type or mutant

P/CAF to cells producing varying levels

of P/CAF protein are also provided.

(portfolios: Cancer—Diagnostics;

Cancer—Therapeutics, biological

response modifiers; Devices—Research

Tools and Materials, biologicals and

chemicals)

Conformationally Locked Nucleoside

Analogs

VE Marquez, JB Rodriquez, MC

Nicklaus, JJ Barchi Jr, MA Siddiqui

(NCI)

Serial Number 08/311,425 filed 23 Sep

94 (with priority to 24 Sep 93) and

Conformationally Locked Nucleoside

Analogs as Antiherpetic Agents

VE Marquez, MC Nicklaus, JJ Barchi Jr,

JB Rodriguez, MA Siddiqui (NCI)

Serial Number 60/023,565 filed 07 Aug

96

Licensing Contact: Robert Benson, 301/

496–7056 ext 267
4070 Federal Register / Vol. 62, No. 18 / Tuesday, January 28, 1997 / Notices

These inventions concern novel

nucleoside analogs comprising

carbocyclic-4′, 6′-cyclopropane-fused-2′,

3′-derivatives of ribo, deoxyribo and

dideoxyribo purines and pyrimidines,

and the corresponding nucleotides. The

first patent application describes an

anti-HIV utility. It has been foreign filed

as PCT/US94/10794. The second

application describes a new utility of

the deoxyribo derivatives of the first

application, namely as anti-Herpes

Virus agents. The thymidine analog, in

particular, showed good activity against

Herpes Simplex Type 1 and Herpes

Simplex Type 2 viruses, and EpsteinBarr virus as shown in an in vitro assay.

It showed better antiherpes activity than

acyclovir in a plaque reduction assay.

Descriptions of the invention are to be

found in Rodriguez et al., Tetrahedron

Letters 34: 6233–6236, 1993; Rodriguez

et al., J. Medicinal Chemistry 37: 3389–

3399, 1994; Siddiqui et al., Nucleosides

Nucleotides 15: 235–250, 1996 and

Marquez et al., J. Medicinal Chemistry

39: 3739–3747, 1996. (portfolio:

Infectious Diseases—Therapeutics, antiviralsa, AIDS)

Long Distance Sequencer Method: A

Novel Strategy for Large DNA

Sequencing Projects

K Hagiwara, CC Harris (NCI)

Serial No. 60/017,569 filed 15 May 96

Licensing Contact: Leopold J. Luberecki,

Jr., 301/496–7735 ext 223

The current invention represents an

improvement over existing technologies

used in sequencing long fragments of

DNA. Existing technologies allow for

the sequencing of a 10 kb fragment of

DNA in two to three months; the present

invention allows for such sequences to

be obtained in two to three weeks.

Specifically, the method consists of the

cloning of a long (5 kb or longer)

fragment of DNA into an appropriate

vector, followed by the generation of a

series of shorter fragments by a number

of restriction digests. A ‘‘vectorette

unit’’ is then ligated to each restriction

fragment. This vectorette unit is an

oligonucleotide 53 bases in length, and

has a unique sequence which is not

found in the human genome. Through

use of the vectorette as a ‘‘known end,’’

together with a specific primer, the DNA

is amplified via PCR and directly

sequenced using current technologies.

The investors have successfully used

this method to sequence a 35 kb

fragment of DNA.

This method appears to represent four

key advantages over existing sequencing

methods. First, the sequence of a long

fragment of DNA can be obtained far

more rapidly than is currently possible.

Second, as multiple cloning steps are

not necessary, it is easier to perform.

Third, a much smaller amount of DNA

is needed for this method than is

necessary when using currently

available sequencing techniques.

Fourth, because of its organized way of

sequencing, one can clearly identify the

region being sequenced. (portfolio:

Devices/Instrumentation—Research

Tools and Materials)

Hepatitis B Core Antigen Fusion

Proteins as Tumor Vaccines

LW Kwak, A Biragyn (NCI)

Serial No. 60/013,839 filed 21 Mar 96

Licensing Contact: Joseph Contrera, 301/

496–7056 ext 244

Hepatitis B Core Antigen (HBcAg)

represents a potentially potent carrier of

vaccines. Embodied in this invention

are a number of fusion proteins of

HBcAg. It has been shown that HBcAg

elicits a strong immune response, and it

was thought that if one were to attach

other weakly antigenic peptides of

choice to the HBcAg protein in order to

form a fusion protein, the antigenicity of

the attached peptide of choice would be

considerably enhanced. The fusion

proteins embodied in this invention,

which contain specific H-ras or MUC–

1 (human epithelial cell mucin)

peptides, have been shown to elicit

protective anti-tumor immunity in vivo.

This immunity is, in fact, superior to

that elicited through immunizing with

tumor antigen alone. These HBcAg

fusion proteins, therefore, are believed

to represent powerful new vaccines to

be used toward the prevention and

treatment of a wide variety of cancers.

(portfolio: Cancer—Therapeutics,

immunoconjugates Mab; Cancer—

Therapeutics, immunoconjugates,

conjugate chemistry; Cancer—

Therapeutics, immunomodulators and

immunostimulants)

Substantially Pure Non-IL-2 T-Cell

Growth Factors

TA Waldmann, R Bamford, E Roessler,

CK Goldman, G Szakiel, JD Burton, C

Peters, AJ Grant, J Brennan, M Moos

(NCI)

Serial No. 08/572,423 filed 14 Dec 95

Licensing Contact: Jaconda Wagner,

301/496–7735 ext 284

The invention provides isolated

interleukin-T in human form, along

with the methods for isolating the

interleukin, and its respective non-IL–2

T-Cell growth factor and antibodies.

T cells play both regulatory and

effector functions in human immune

responses that are often mediated by

interleukins. Interleukins are highly

redundant and pleitrophic, controlling a

wide range of functions. Abnormalities

of interleukin and interleukin receptor

systems are observed with a broad array

of human diseases, including the forms

of leukemia and autoimmune diseases

such as rheumatoid arthritis that are

caused by human T-cell lymphotropic

virus-I. Thus, the invention could be

used to treat a disorder associated with

immune function, such as cancer, AIDS

or other immunodeficiencies, by

enhancing the immune system or, in

treating an immune disorder, such as

graft-versus-host disease, leukemia,

lymphoma or an allograft rejection, by

suppressing the immune system.

(portfolio: Internal Medicine—

Therapeutics, anti-inflammatory;

Cancer—Therapeutics, biological

response modifiers, growth factors)

Method of Preventing or Treating

Disease Characterized by Neoplastic

Cells Expressing CD40

RJ Armitag (Immunex), WC Fanslow

(Immunex), DL Longo (NCI), WJ

Murphy (NCI)

Serial No. 08/172,664 filed 23 Dec 93

and Serial No. 08/360,923 filed 21

Dec 94 (CIP)

Licensing Contact: Joseph Contrera, 301/

496–7056, ext 244

The subject invention proposes a

method for treating a mammal afflicted

with a neoplastic disease caused by

cells that express CD40. CD40 is a

receptor protein present on B cells,

monocytes, endothelial cells, and

various carcinomas. The ligand for

CD40 (CD40L) is present on activated T

cells. CD40 has been shown to play a

critical stimulatory role in normal B cell

development. It has been previously

demonstrated that signals that activate

normal cells can lead to inhibition of

neoplastic cells by inducing activationinduced cell death. Therefore,

inhibition of neoplactic cell growth can

be achieved through the use of CD40

stimulation. The invention discloses

monoclonal antibodies to CD40, CD40

ligands, and combinations thereof.

Oligomeric forms of CD40 ligands and

fusion protein ligands are also

disclosed. This invention is jointly

owned by the National Institutes of

Health and Immunex Corporation. All

fields of use are available for licensing.

(portfolio: Cancer—Therapeutics,

immunoconjugates, Mab)

Recombinant DNA Clone Encoding

Laminin Receptor

ME Sobel, LA Liotta, UM Wewer, MC

Jaye, WN Drohan (NCI)

Serial No. 06/911,863 filed 26 Sep 86,

which issued as U.S. Patent No.

4,861,710 on 29 Aug 89

Licensing Contact: Raphe Kantor, 301/

496–7735 ext 247
Federal Register / Vol. 62, No. 18 / Tuesday, January 28, 1997 / Notices 4071

A recombinant DNA clone that

encodes high-affinity cell surface

receptors for laminin, a glycoprotein

component of basement membranes,

offers an important tool for studying a

variety of normal and abnormal cell

processes including tumor metastases.

These laminin receptors have been

shown to inhibit metastases. These

recombinant receptors can be used in

diagnostic methods, to assess the

content of laminin receptor mRNA, and

to determine the pattern of laminin

receptor genes in different tissue and

tumor cell populations. (portfolio:

Cancer—Research Materials; Cancer—

Diagnostics, Mab based)

Dated: January 17, 1997.

Barbara M. McGarey,

Deputy Director, Office of Technology

Transfer.

[FR Doc. 97–2062 Filed 1–27–97; 8:45 am]

BILLING CODE 4140–01–M

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

National Cancer Institute Special

Emphasis Panel (SEP) meeting:

Name of SEP: Geographical and Statistical

Modeling of Exposure to OCCs/DAHs in LI

and Breast Cancer and the Environment on

Long Island.

Date: January 31, 1997.

Time: 2:30 p.m.

Place: Teleconference, Executive Plaza

North, Room 643B, 6130 Executive

Boulevard, Bethesda, MD 20892.

Contact Person: Robert Browning, Ph.D.,

Scientific Review Administrator, National

Cancer Institute, NIH, Executive Plaza North,

Room 643B, 6130 Executive Boulevard, MSC

7405, Bethesda, MD 20892–7405, Telephone:

301/496–7929.

Purpose/Agenda: To evaluate and review

grant applications.

This notice is being published less

than 15 days prior to the meeting due

to the urgent need to meet timing

limitations imposed by the review and

funding cycle.

The meeting will be closed in

accordance with the provisions set forth

in secs. 552b(c)(4) and 552b(c)(6), Title

5, U.S.C. Applications and the

discussions could reveal confidential

trade secrets or commercial property

such as patentable material and

personal information concerning

individuals associated with the

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

(Catalog of Federal Domestic Assistance

Program Numbers: 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.)

Dated: January 21, 1997.

Paula N. Hayes,

Acting Committee Management Officer, NIH.

[FR Doc. 97–1979 Filed 1–27–97; 8:45 am]

BILLING CODE 4140–01–M

National Cancer Institute; Notice of

Planning Group Meeting

Notice is hereby given that the

National Cancer Institute will hold a

public meeting of a Planning Group

which will assist NCI in establishing a

Director’s Consumer Liaison Group

(DCLG). The Planning Group meeting

will begin at 8:30 a.m. on March 13,

1997 and will end at 1:00 p.m. on March

14, 1997 at the Holiday Inn (Bethesda,

MD). All sessions of the Planning Group

meeting are open to the public.

However, seating is limited and will be

on a first-come, first served basis.

A temporary DCLG Planning Group of

NCI staff and consumer-advocates was

formed to help in establishing the

DCLG. The purpose of the DCLG is to:

(1) Help develop and establish

processes, mechanisms, and criteria for

identifying appropriate consumeradvocates to serve on a variety of

program and policy advisory

committees responsible for advancing

the mission of the NCI; (2) serve as a

primary forum for discussing issues and

concerns and exchanging viewpoints

that are important to the broad

development of NCI programmatic and

research priorities, e.g., the

development of the annual Bypass

Budget; and (3) establish and maintain

strong collaborations between NCI and

the cancer advocacy community to

reach common goals. The DCLG,

consisting of approximately 15

consumer-advocates who are involved

in cancer advocacy and/or voluntary

organizations, will meet several times a

year. NCI anticipates that the activities

and initiatives developed by NCI, in

conjunction with the DCLG, will serve

as models for consumer participation.

Nominations for the members of the

DCLG will be solicited from the cancer

advocacy community. The first meeting

of the DCLG is planned for late June

1997. A notice of the date and location

of this meeting will be published in the

Federal Register at a later date.

The objectives of the Planning Group

are to: (1) define the initial role of the

DCLG; and (2) define the DCLG

membership solicitation process, as well

as the criteria, categories, and rating

system to identify and rank potential

members of the DCLG. Development of

criteria for membership on the DCLG

will include identification of categories

of members needed to ensure balance

and diversity of representation. To

identify DCLG members, the process

selected by the Planning Group to

announce and invite submission of

names of consumer-advocates to serve

on the DCLG will be followed.

Nominees will be screened for eligibility

according to a set of criteria and

categories developed by the DCLG

Planning Group. Consumer-advocates

who are on the Planning Group will be

unable to serve as members of the DCLG

in its first year of operation, but their

organizations may be represented by

another individual.

To provide input to the Planning

Group, members of advocacy or

voluntary organizations related to

cancer are invited to submit eligibility

criteria and categories that could be

used to identify individuals who could

serve on the DCLG. These criteria and

categories will be used to help the

Planning Group to develop the process

for identifying DCLG members.

Submissions on criteria and categories

should be mailed to Ms. Fran Oscar at

Palladian Partners, 7315 Wisconsin

Avenue, Suite 440W, Bethesda, MD

20814, or sent to her by FAX to (301)

986–5047 or by E-mail to

palladianp@.aol.com. They must be

received no later than 5:00 p.m. (EST)

on February 15, 1997 to be included in

the materials provided to the Planning

Group prior to the meeting. Submissions

received after that date and time will be

accepted, but may not be included in

the materials considered by the

Planning Group members at the March

13–14 meeting. All submission must be

accompanied by the following

information: (1) Name and address of

individual making the submission; and

(2) name and address of cancer

advocacy or voluntary organization with

which they are affiliated.

Individuals who plan to attend the

meeting and need special assistance,

such as sign language interpretation or

other special accommodations, should

call Ms. Elaine Lee, Office of Liaison

Activities, NCI at (301) 496–0644 or

contract her by FAX (301) 402–2594 or

E-mail (leee@od.nci.nih.gov) in advance

of the meeting, by February 15, 1997.

For additional information, contact Ms.

Lee.