1122 Federal Register / Vol. 62, No. 5 / Wednesday, January 8, 1997 / Notices

There are no Capital Costs, Operating

Costs, and/or Maintenance Costs to

report.

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 or

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 Dr. Shelia Hoar

Zahm, Project Officer, National Cancer

Institute, Executive Plaza North, Room

418, Rockville, MD 20892–7364, or call

non-toll-free number (301) 496–9093, or

FAX your request to (301) 402–1819, or

E-mail your request, including your

address, to ZahmS@epndce.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 7, 1997.

Dated: December 6, 1996.

Nancy L. Bliss,

OMB Project Clearance Liaison.

[FR Doc. 97–334 Filed 1–7–97; 8:45 am]

BILLING CODE 4140–01–M

National Institutes Of Health

National Eye Institute; National

Institute of Arthritis and

Musculoskeletal and Skin Diseases:

Licensing Opportunity and/or

Opportunity for a Cooperative

Research and Development Agreement

(CRADA) for the Use of Antiflammins

AGENCY: National Institutes of Health,

Public Health Service, HHS.

ACTION: Notice.

SUMMARY: The National Institutes of

Health is seeking licensees and/or

CRADA partners for the further

development and commercialization of

its patent portfolio for antiflammins.

The inventions claimed in U.S. Patent

No. 5,266,562 issued 30 Nov 1993,

‘‘Anti-Inflammatory Agents,’’ are

available for either exclusive or nonexclusive licensing (in accordance with

35 U.S.C. 207 and 37 CFR Part 404) and/

or further development under one or

more CRADAs in several clinically

important applications as described

below in the Supplementary

Information.

To speed the research, development

and commercialization of this new class

of drugs, the National Institutes of

Health is seeking one or more license

agreements and/or CRADAs with

pharmaceutical or biotechnology

companies in accordance with the

regulations governing the transfer of

Government-developed agents. Any

proposal to use antiflammins in the

treatment of inflammatory disease

processes will be considered.

ADDRESSES: CRADA proposals and

questions about this opportunity should

be addressed to: Ms. Sue Patow, Office

of Technology Transfer, National Heart,

Lung, and Blood Institute, Building 31,

Room 1B30, Bethesda, MD 20892 (301/

402–5579). CRADA proposals must be

received by the date specified below.

Licensing proposals and questions

about this opportunity should be

addressed to: Ms. Carol Lavrich, Office

of Technology Transfer, National

Institutes of Health, 6011 Executive

Boulevard, Rockville, MD 20852 (301/

496–7735 ext. 287). Respondees

interested in licensing the invention

will be required to submit an

Application for License to Public Health

Service Inventions. Respondees

interested in submitting a CRADA

proposal should be aware that it may be

necessary to secure a license to the

above patent rights in order to

commercialize products arising from a

CRADA agreement.

DATES: There is no deadline by which

license applications must be received.

CRADA proposals must be received on

or before April 8, 1997.

SUPPLEMENTARY INFORMATION:

Antiflammins are biologically active

synthetic oligopeptides, derived from

the sequence similarity between lipocortin-1 and uteroglobin, an antiflammatory protein. These peptides

have antiphospholipase A2 and

immunomodulatory properties. Because

of the great therapeutic potential of

specific and potent antiflammin drugs

that may be developed, scientists in

several Institutes at the National

Institutes of Health are examining the

use of antiflammins in the treatment of

Health are examining the use of

antiflammins in the treatment of a

variety of inflammatory processes,

including acute anterior ocular

inflammation (uveitis) and psoriasis.

Dr. Chi-Cho Chan, a clinical

investigator at the National Eye Institute

(NEI), has an IND for the use of

antiflammin 2 in acute anterior uveitis,

and seven patients have previously been

enrolled in a clinical trial. To date, no

toxicity has been observed in patients

treated with this drug. Dr. Chan and Dr.

Whitcup at the NEI are interested in

developing new topical formulations of

antiflammins and the initiation of multicenter randomized clinical trials of

antiflammins for the treatment of

anterior uveitis, post-operative ocular

inflammation, and allergic

conjunctivitis.

Dr. John DiGiovanna, an investigator

in the National Institute of Arthritis and

Musculoskeletal and Skin Diseases

(NIAMS), is studying the use of

antiflammins to treat psoriasis, a

hyperproliferative inflammatory skin

disease. Dr. DiGiovanna would like to

continue these studies with a

collaborator capable of expanding these

studies to include other inflammatory

skin diseases such as atopic and contact

dermatitis, as well as develop animal

and in vitro models to study the effects

of antiflammins on skin.

In addition, Dr. Dimitrios T.

Boumpas, also of NIAMS, is studying

the use of anti-inflammatory/

immunosuppressive compounds to treat

psoriatic arthritis, rheumatoid arthritis,

and systemic lupus erythematosus. Dr.

Boumpas would like to initiate studies

with a collaborator to investigate the

effects of antiflammins in animal

models of these diseases including

toxicity studies and its use and toxicity

in patients with autoimmune rheumatic

diseases.

CRADA aims include the rapid

publication of research results and the

timely exploitation of commercial

opportunities. The CRADA partner(s)

will enjoy rights of first negotiation for

licensing Government rights to any

inventions arising under the agreement

and will be expected to advance funds

payable upon signing the CRADA to

help defray Government expenses for

patenting such inventions and other

CRADA-related costs.

The role of the NEI and NIAMS in

these CRADAs will be as follows:

1. Provide the Collaborator(s) with

samples of the subject compounds for

pharmaceutical evaluation.

2. Continue the detailed

physicochemical characterization of the

test compounds as well as research on

their mechanism of biological action,

and publish these results and provide
Federal Register / Vol. 62, No. 5 / Wednesday, January 8, 1997 / Notices 1123

all data to the Collaborator as soon as

they become available.

3. Conduct controlled clinical trials of

antiflammin formulations that have

been determined to have therapeutic

potential in ocular and skin

inflammatory diseases.

The role of the Collaborator(s) will be

to:

1. Perform an exhaustive evaluation of

these compounds with respect to their

biological activities and to develop

appropriate vehicles for drug delivery

for disease processes covered under the

CRADA. The Collaborator(s) will supply

data to the NEI and/or NIAMS in a

timely fashion.

2. Synthesize and formulate structural

variants of these subject compounds to

optimize desired effects.

3. Expand the basic toxicological data

as needed in preparation for additional

clinical studies.

4. Conduct basic studies designed to

better understand the potential for

antiflammins in the treatment of

inflammatory diseases, bioavailability

and how to best administer these agents.

5. Support the execution of clinical

trials designed to evaluate efficacy and

toxicity. This may include providing

pharmaceutical grade compound,

equipment and supplies, and support

personnel.

6. Provide new and improved

formulations in appropriate vehicles.

Selection criteria for choosing the

CRADA partner(s) will include but not

be limited to:

1. Ability to complete the quality

pharmacological evaluations required

according to an appropriate timetable to

be outlined in the Collaborator’s

proposal. The target commercial

application as well as the strategy for

evaluating the test agents’ potential in

that capacity must be clearly delineated

therein.

2. The level of financial support the

Collaborator will supply for CRADArelated Government activities.

3. A willingness to cooperate with the

NEI and NIAMS in publication of

research results.

4. An agreement to be bound by the

DHHS rules involving human subjects,

patent rights, ethical treatment of

animals, and randomized clinical trials.

5. Agreement with provisions for

equitable distribution of patent rights to

any inventions developed under the

CRADA(s). Generally, the rights of

ownership are retained by the

organization which is the employer of

the inventor, with (1) an irrevocable,

non-exclusive, royalty-free license to the

Government (when a company

employee is the sole inventor) or (2) an

option to negotiate an exclusive or nonexclusive license to the company on

terms that are appropriate (when the

Government employee is the sole

inventor).

Dated: December 23, 1996.

Barbara M. McGarey,

Deputy Director, Office of Technology

Transfer.

[FR Doc. 97–333 Filed 1–7–97; 8:45 am]

BILLING CODE 4140–01–M

National Institutes of Health

National Center for Research

Resources: Licensing Opportunity

and/or Opportunity for a Cooperative

Research and Development Agreement

(CRADA) for the Development of

Technologies and Applications for

Spatial and Temporal Control of Gene

Expression Using a Heat Shock

Protein Promoter in Combination With

Local Heat

AGENCY: National Institutes of Health,

PHS, HHS.

ACTION: Notice.

SUMMARY: The National Center for

Research Resources (NCRR) and

collaborating institutes of the NIH are

seeking CRADA partners and/or

licensees for the development of

different technologies and applications

to provide a safe and efficient

introduction of exogenous genes under

the control of a heat-sensitive promoter

and to assess the efficacy of spatial and

temporal control of gene expression

using MRI guided FUS. This project is

with the In Vivo NMR Research Center,

NCRR, in a collaborative study with the

National Institute on Aging, the

National Heart Lung and Blood

Institute, and the National Institute of

Dental Research of the National

Institutes of Health, Bethesda, Maryland

The NCRR has applied for patents

claiming this core technology. Nonexclusive and/or exclusive licenses for

these patents covering core aspects of

this project are available (in accordance

with 35 U.S.C. 207 and 37 CFR Part 404)

to interested parties.

DATES: There is no deadline by which

license applications or CRADA

proposals must be received.

ADDRESSES: CRADA capability

statements/proposals and questions

about this opportunity should be

addressed to Mr. Tom Ingalls,

Technology Transfer Specialist, NCRR,

Bldg. 12A/Room 4057, Bethesda,

Maryland 20892–2490; Phone: 301/496–

6235.

Licensing applications and licensing

inquiries regarding this technology

should be addressed to Mr. Larry

Tiffany, Office of Technology Transfer,

6011 Executive Boulevard, Suite 325,

Rockville, Maryland 20852–3804;

Phone: 301/496–7735, ext. 206; Fax:

301/402–0220.

Information on the patent and patent

applications and pertinent information

not yet publicly described can be

obtained under a Confidential

Disclosure Agreement. Respondees

interested in licensing the invention(s)

will be required to submit an

Application for License to Public Health

Service Inventions. Respondees

interested in submitting a CRADA

proposal should be aware that it may be

necessary to secure a license to the

above patent rights in order to

commercialize products arising from a

CRADA agreement.

SUPPLEMENTARY INFORMATION: In many

instances, it is desirable to express

exogenous genes only in certain tissues,

and/or at will at certain times, and/or

only to a certain degree. However,

current gene transfer and exogenous

gene expression protocols do not

provide adequate means of

simultaneously controlling which cells

in a heterogeneous population are

transformed and when, where, and to

what degree the transferred genes are

expressed. Here, we seek to accomplish

the spatial and local control of

expression of exogenous genes using a

heat-inducible promoter (such as the

inducible hsp70 promoter) in

combination with local heat, preferably

provided by Magnetic Resonance

Imaging (MRI) guided Focused

Ultrasound (FUS).

The goals of this project are to use the

respective strengths of both parties to

achieve one or more of the following:

1. Evaluate the feasibility and safety

of gene therapy utilizing a range of

suitable vectors as a treatment approach

to carry out a systemic gene transfer in

which the therapeutic gene is under the

control of a heat-sensitive promoter

showing negligible constitutive

expression at normal body temperature.

2. Evaluate the feasibility of

controlling the local and temporal

induction of gene expression

(pharmacokinetics) using local heat

provided by Magnetic Resonance

Imaging guided Focused Ultrasound.

3. Develop and evaluate gene therapy

products for use in experimental animal

models and for human use based on the

above control of expression.

It is anticipated that the commercial

collaborator(s) will participate in

ongoing studies on one or more of the

research projects involving:

1. The transfer of genes for various

lymphokines into experimental animal