Federal Register / Vol. 61, No. 118 / Tuesday, June 18, 1996 / Notices 30915

carcinoma cells has demonstrated to be

independent of latent TGFβ activation.

Other agents, however, have been

shown to activate latent TGFβ. TGFβactivating agents also exhibit anti-tumor

activity in vivo. Further development of

TGFβ-modulating agents, particularly

those useful for control of fibrosis, is

planned.

Particularly sought are companies

dedicated to the development of small

therapeutic molecules, such as peptides

and their analogs. Collaborators should

have particular in-house expertise

relating to peptide research and

development. It is anticipated that

fruitful collaboration will result from

sustained and meaningful contribution

on the part of the collaborator.

The CRADA aims will include

optimizing peptide and

peptridomimetic activity in vitro and in

vivo, preclinical development of the

synthetic peptides and mimetics, and

clinical studies as warranted. The

CRADA partner will enjoy the benefit of

a right of first refusal for a license (on

a reasonable commercial terms) to

government-owned rights in any

invention arising within the scope of the

CRADA. Furthermore, the CRADA

partner will be responsible for

reimbursement of government expenses

for patenting any resulting inventions

during the term of the CRADA.

The role of the National Cancer

Institute will include the following:

1. The government will continue in

vitro and in vivo preclinical

development of the peptides and

mimetics as inhibitors of tumor growth

and metastasis and as modulators of

TGF-β activity.

2. The government will provide

available data and expertise in

structure-function relationships and

conformational analysis of the active

peptides and peptidomimetics. These

data will be evaluated jointly in order to

assess an efficient research path.

3. As appropriate, the government

will initiate collaborative clinical trials

under its extramural clinical trials

network, thus ensuring the clinical

evaluation of the compounds.

The role of the collaborator will

include the following:

1. Prepare and characterize GMP

quality nonmetabolizable analogs (as

determined by both parties) of the active

peptides and provide these to the NCI

for characterization as angiogenesis and

metastasis inhibitors or as modulators of

TGF-β activity.

2. Provide funds for preclinical

development of the peptides in vitro

and for screening activities in

appropriate animal models.

3. Collaborate in the planning and

support for clinical development

leading to FDA approval and marketing.

Selection criteria for choosing the

CRADA partner will include, but are not

limited to, the following:

1. Experience in preclinical and

clinical drug development.

2. Experience and ability to produce,

package, market, and distribute

pharmaceutical products, particularly

peptides and peptide analogs, in the

United States.

3. A willingness to cooperate with the

Public Health Service in the collection,

evaluation, publication, and

maintenance of data from clinical trials

of investigational agents.

4. Willingness to share the costs

associated with the development of the

peptides and mimetics. These costs

include acquisition of synthesis or both

of the peptides and mimetics in

amounts adequate for clinical trials and

marketing.

5. Agreement to be bound by DHHS

rules and regulations regarding the use

of human subjects in clinical

investigations, intellectual property

rights, ethical treatment of animals, and

randomized clinical trials.

6. The aggressiveness of the

development plan, including the

appropriateness of milestone and

deadlines for preclinical and clinical

development.

7. 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 an irrevocable, nonexclusive, royalty-free license to the

Government (when a company

employee(s) is the sole inventor) or a

first option to negotiate an exclusive or

non-exclusive license to the company

on terms that are appropriate (when the

Government employee(s) is the sole or

a joint inventor).

Dated: June 7, 1996.

Barbara M. McGarey,

Deputy Director, Office of Technology

Transfer.

[FR Doc. 96–15363 Filed 6–17–96; 8:45 am]

BILLING CODE 4140–01–M

Prospective Grant of Exclusive

License: Gossypol Acetic Acid for the

Treatment of Cancer

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 an exclusive world-wide

license to practice the inventions

embodies in U.S. Patent No. 5,385,936

and U.S. Patent Applicant No. 08/

379,872 to Cary Medical Corporation of

Great Falls, Virginia. U.S. Patent No.

5,385,936 is directed toward a method

of treating cancers using Gossypol

Acetic Acid (GAA). U.S. Patent

Application No. 08/379,872 is directed

toward the use of Gossypol for the

treatment of cancer. Patent rights in

these inventions have been assigned to

the United States of America.

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 sixty (60) 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.

Gossypol is a biphenolic compound

derived from crude cottonseed oil that

has been widely used in China as a male

contraceptive. Clinical trials have

demonstrated GAA’s efficacy against

gliomas and adrenal cancer. Clinical

trials are planned or underway for the

use of GAA in breast and prostate

cancer. GAA exhibits low toxicity

relative to other chemotherapeutic

agents and does not appear to cause

myelosuppression, significant hair loss,

cardiac failure or neurotoxicity. The

milder side effects of the use of GAA

include mild fatigue, muscle tremor, dry

mouth, dry skin, and occasional nausea.

Patients treated with GAA, therefore,

may be able to continue normal

activities.

ADDRESSES: Requests for a copy of the

issued patent, patent application,

inquiries, comments, and other

materials relating to the contemplated

license should be directed to: Allan

Kiang, Technology Licensing Specialist,

Office of Technology Transfer, National

Institutes of Health, 6011 Executive

Boulevard, Suite 325, Rockville,

Maryland 20852–3804; Telephone: (301)

496–7735 ext. 270; Fax: (301) 402–0220.

A signed Confidentiality Agreement will

be required to receive copies of the

patent application. Applications for a

license in the field of use filed in

response to this notice will be treated as

objections to the grant of the

contemplated license. Only written

comments and/or applications for a

license which are received by the NIH
30916 Federal Register / Vol. 61, No. 118 / Tuesday, June 18, 1996 / Notices

Office of Technology Transfer on or

before August 19, 1996 will be

considered. Comments and objections

will not be made available for public

inspection and, to the extent permitted

by law, will not be subject to disclosure

under the Freedom of Information Act,

5 U.S.C. 552.

Dated: June 6, 1996.

Barbara M. McGarey,

Deputy Director, Office of Technology

Transfer.

[FR Doc. 96–15364 Filed 6–17–96; 8:45 am]

BILLING CODE 4140–01–M

Substance Abuse and Mental Health

Services Administration (SAMHSA)

Notice of Meetings

Pursuant to Public Law 92–463,

notice is hereby given of the following

meetings of the SAMHSA Special

Emphasis Panel II in July.

A summary of the meetings may be

obtained from: Ms. Dee Herman,

Committee Management Liaison,

SAMHSA Office of Extramural

Activities Review, 5600 Fishers Lane,

Room 17–89, Rockville, Maryland

20857. Telephone: (301) 443–4783.

Substantive program information may

be obtained from the individual named

as Contact for the meetings listed below.

The meetings will include the review,

discussion and evaluation of individual

contract proposals. These discussions

could reveal personal information

concerning individuals associated with

the proposals and confidential and

financial information about an

individual’s proposal. The discussion

may also reveal information about

procurement activities exempt from

disclosure by statute and trade secrets

and commercial or financial information

obtained from a person and privileged

and confidential. Accordingly, the

meetings are concerned with matters

exempt from mandatory disclosure in

Title 5 U.S.C. 552b(c) (3),(4), and (6) and

5 U.S.C. App. 2, 10(d).

Committee Name: SAMHSA Special

Emphasis Panel II.

Meeting Date: July 9–10, 1996.

Place: Doubletree Hotel, Randolph

Conference Room, 1750 Rockville Pike,

Rockville, Maryland 20852.

Closed: July 9, 1996, 8:30 a.m.–5:00

p.m.; July 10, 1996, 8:30 a.m.–

adjournment.

Contact: Ferdinand W. Hui, Ph.D.,

Room 17–89, Parklawn Building,

Telephone: (301) 443–9912 and FAX:

(301) 443–3437.

Committee Name: SAMHSA Special

Emphasis Panel II.

Meeting Date: July 15, 1996.

Place: Residence Inn, Gatehouse

Conference Room. 7335 Wisconsin

Avenue, Bethesda, Maryland 20814.

Closed: July 15, 1996, 8:30 a.m.–5:00

p.m.

Contact: Ferdinand W. Hui, Ph.D.,

Room 17–89, Parklawn Building,

Telephone: (301) 443–9912 and FAX:

(301) 443–3437.

Committee Name: SAMHSA Special

Emphasis Panel II.

Meeting Date: July 24–26, 1996.

Place: Chevy Chase Holiday Inn,

Palladium Room, 5520 Wisconsin,

Avenue, Chevy Chase, Maryland 20815.

Closed: July 24–25, 1996, 8:30 a.m.–

5:00 p.m.; July 26, 1996, 8:30 a.m. to

adjournment.

Contact: Constance M. Burtoff, M.A.,

Room 17–89, Parklawn Building,

Telephone: (301) 443–2437 and FAX:

(301) 443–3437.

Dated: June 12, 1996.

Jeri Lipov,

Committee Management Officer, SAMHSA.

[FR Doc. 96–15393 Filed 6–17–96; 8:45 am]

BILLING CODE 4162–20–P

DEPARTMENT OF THE INTERIOR

Bureau of Land Management

[AZ–020–06–5440–A137; AZA–29495]

Notice of Realty Action, Recreation

and Public Purposes (R&PP) Act

Classification and Conveyance;

Arizona

AGENCY: Bureau of Land Management,

Interior.

ACTION: Sale of Public Land in Pima

County.

SUMMARY: The following public lands in

Pima County, Arizona have been

examined and through the land use

planning process have been determined

to be suitable for disposal to Pima

County Property Division under the

provisions of the Recreation and Public

Purposes Act, as amended (43 U.S.C.

869 et seq.) Pima County proposes to

use the lands for a transfer station for

sanitary waste from the area. The land

will not be patented until at least 60

days after the date of publication of this

notice in the Federal Register.

Gila and Salt River Meridian, Arizona

T. 13 S., R. 5 W.,

Sec. 24, W1⁄2SW1⁄4SW1⁄4SW1⁄4.

The area described contains 5 acres in

Pima County.

The patent, when issued, will be

subject to the following terms,

conditions and reservations:

1. A right-of-way for ditches and

canals constructed by the authority of

the United States.

2. Those rights for transmission line

purposes granted to U.S. West

Communications by Right-of-Way

Number AZAR–017163.

3. Those rights the grazing permittee,

James Gould, may have to continue

current grazing use for two years from

receipt of a cancellation notice. (Grazing

Record No. 022407).

4. Provisions of the Recreation and

Public Purposes Act and to all

applicable regulations of the Secretary

of the Interior.

DATES: Upon publication of this Notice

in the Federal Register, the land

described above will be segregated from

appropriation under the public land

laws, including the general mining laws,

except for lease or conveyance under

the Recreation and Public Purposes Act

and leasing under the mineral leasing

laws. By no later than August 2, 1996,

interested persons may submit

comments regarding the proposed lease/

conveyance or classification of the lands

to the District Manager, Phoenix District

Office, 2015 West Deer Valley Road,

Phoenix, Arizona 85027.

FOR FURTHER INFORMATION CONTACT:

Hector Abrego or Bob Hale, at the

address shown above or call (602) 780–

8090.

CLASSIFICATION COMMENTS: Interested

parties may submit comments involving

the suitability of the land for a sanitary

waste transfer site. Comments on the

classification are restricted to whether

the land is physically suited for the

proposal, whether the use will

maximize the future use of the land,

whether the use is consistent with local

planning and zoning or if the use is

consistent with state and federal

programs.

APPLICATION COMMENTS: Interested

parties may submit comments regarding

the specific use proposed in the

application and plan of development,

whether the Bureau of Land

Management followed proper

administrative procedures in reaching

the decision, or any other factor not

directly related to the suitability of the

land for a sanitary waste transfer site.

Any adverse comments will be reviewed

by the State Director. In the absence of

any adverse comments, the

classification will become effective 60

days from the date of the publication of

this notice in the Federal Register.