Federal Register / Vol. 62, No. 69 / Thursday, April 10, 1997 / Notices 17627

entered into by LHNCBC pursuant to the

Federal Technology Transfer Act of

1986, as amended by the National

Technology Transfer Act (Pub. L. 104–

113 (1996)) and by Executive Order

12591 of April 10, 1987. The Computer

Science Branch, LHNCBC, NLM is

presently developing a system to

automate key decisions in the design

and execution of machine learning

applications. The system, termed

‘‘cultural coevolution’’ (COEV), uses

object oriented intelligent agent

techniques to synergistically integrate

many different machine learning

approaches into a single framework. The

described methods are the subject of a

provisional patent application (60/

018,191) filed by the Government.

Under the present proposal, the goal

of the CRADA will be the development

of the following parameters:

• Improved speed of the algorithm;

• Improved portability of the system;

• Integration of ‘‘data warehousing’’

functions to enable compatibility with a

wide variety of database formats,

remedy gaps or errors in the data (‘‘data

cleaning’’) and to identify target

concepts for learning;

• Development of a user interface to

enable system set up and configuration,

monitor algorithm progression, adjust

the algorithm as necessary, and display

the results in a comprehensive and

useful format.

Party Contributions

The role of the LHNCBC includes the

following:

(1) Provide Collaborator with COEV

system information necessary for the

further development of the COEV

system;

(2) Provide staff, expertise, and

materials for the further development of

the COEV system;

(3) Evaluate the work product of

Collaborator to ensure progress toward

meeting the CRADA goals; and

(4) Provide work space and

equipment for production and testing of

any components or improvements of the

COEV system.

The role of the successful Collaborator

will include the following:

(1) Provide funding, if and as

necessary, in support of the

development of the COEV system;

(2) Provide expertise and assistance in

the production and marketing of any

products resulting from this CRADA;

(3) Provide staff, expertise, and

materials for the development of the

COEV system under this CRADA; and

(4) Provide quality assurance testing,

operator training, and user support for

any products resulting from this

CRADA.

Selection Criteria

Proposals submitted for consideration

should fully address each of the

following qualifications:

(1) Expertise

A. Demonstrated expertise in

translating sophisticated statistical or

machine learning methods to successful

products;

B. Demonstrated expertise in software

engineering, data warehousing, data

visualization;

C. Demonstrated ability to secure

national and international marketing

and distribution of software;

D. Demonstrated expertise in

overseeing all aspects of product

development;

E. Demonstrated intellectual ability to

guide development of product line

which addresses the requirement of

LHNCBC;

F. Demonstrated expertise in serving

and supporting a significant client base;

and

G. Familiarity with application of data

mining techniques to biomedical fields.

(2) Reputation

The successful Collaborator must be

recognized in the software industry for:

A. Producing, marketing and

supporting data mining and related

applications;

B. Indications of high levels of

satisfaction by software experts and

users of data mining products and;

C. The range of products and services

it produces.

(3) Physical Resources

A. An established headquarters with

offices, space, and equipment;

B. Access to the organization during

business hours by telephone, mail, email, the Internet, and other evolving

technologies; and

C. Sufficient financial and

technological resources to support, at a

minimum, the current activities of the

CRADA to meet the needs of LHNCBC.

Dated: April 1, 1997.

Thomas D. Mays,

Director, Office of Technology Development,

National Cancer Institute, National Institutes

of Health.

[FR Doc. 97–9238 Filed 4–9–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute on Aging;

Opportunity for a Clinical TrialCooperative Research and

Development Agreement (CT–CRADA)

for Phase II Clinical Trial on the Use of

Minocycline to Treat Osteoporosis

AGENCY: National Institutes of Health,

PHS, DHHS.

ACTION: Notice.

SUMMARY: The National Institute of

Aging (NIA) is seeking a Collaborator to

participate in a CT–CRADA to run a

Phase II clinical trial on the use of

minocycline to treat osteoporosis, and to

assist in the development of analogues

to minocycline.

The term of the CT–CRADA will be

up to five (5) years.

DATES: Interested parties should notify

this office in writing of their intent to

file a formal proposal no later than June

9, 1997. Formal proposals must be

submitted to this office no later than

July 9, 1997.

ADDRESSES: Inquiries and proposals

regarding this opportunity should be

addressed to Bruce D. Goldstein, J.D.;

Office of Technology Development,

National Cancer Institute; Executive

Plaza South, Suite 450; 6120 Executive

Blvd., MSC 7182, Bethesda, Maryland,

20892 (Telephone No. 301–496–0477;

FAX No. 301–402–2117).

SUPPLEMENTARY INFORMATION: A CRADA

is the anticipated joint agreement to be

entered into by NIA pursuant to the

Federal Technology Transfer Act of

1986, as amended by the National

Technology Transfer Act (Pub. L. 104–

113 (Mar. 7, 1996)) and by Executive

Order 12591 of April 10, 1987. NIA has

recently published a discovery by its

staff that minocycline, an antibiotic

related to tetracycline, increases bone

mineral density, improves bone strength

and formation, and slows bone

resorption in old laboratory animals

with surgically-induced menopause.

Bone, 19:637–644 (Dec. 1996).

Accordingly, NIA has begun to organize

Phase II clinical trials.

Under the present proposal, the

specific goals of the CT–CRADA will be

the development of the following

technology:

• Development of one or more

protocols for the clinical trial of

minocycline in the treatment of

osteoporosis;

• Execution of clinical trials;

• Joint publication of research results;

and
17628 Federal Register / Vol. 62, No. 69 / Thursday, April 10, 1997 / Notices

• Development of improved

derivatives of minocycline.

Party Contributions

The role of NIA includes the

following:

(1) Develop and file, in consultation

with Collaborator, any and all regulatory

applications for the use of minocycline

in the treatment of osteoporosis;

(2) Provide staff, expertise, and

materials for the development and

execution of protocols, and for the

development and testing of promising

minocycline analogues;

(3) Together with the Collaborator,

evaluate the results of joint research,

and to ensure progress toward meeting

the CT–CRADA goals; and

(4) Provide work space and

equipment for testing of any prototype

pharmaceutical compositions

developed.

The role of the successful Collaborator

will include the following:

(1) Provide staff, expertise, and

materials for the development and

production of pharmaceutical

compositions;

(2) Purchase or manufacture an

adequate supply of minocycline;

(3) Together with NIA, evaluate the

results of joint research, and to ensure

progress toward meeting the CT–

CRADA goals;

(4) Provide funding in support of the

clinical trials; and

(5) Provide resource to develop and

market any promising analogues to

minocycline.

Selection Criteria

Proposals submitted for consideration

should fully address each of the

following qualifications:

(1) Expertise

The successful Collaborator should

have the following expertise:

A. Demonstrated expertise in

developing and producing high quality

pharmaceutical compositions;

B. Demonstrated ability to secure

national and/or international marketing

and distribution of pharmaceutical

compositions;

C. Demonstrated expertise in

overseeing all aspects of product

development;

D. Demonstrated intellectual ability to

guide development of product line

which addresses the requirements of

NIA.

(2) Reputation

The successful Collaborator should be

recognized in the pharmaceutical

industry for each of the following:

A. Producing quality pharmaceutical

products;

B. Indications of high levels of

satisfaction by industry experts with the

Collaborator’s products; and

C. Strong commitment to the research

and development of new

pharmaceuticals.

(3) Physical Resources

The successful Collaborator should be

able to demonstrate it will have the

following material resources as of the

commencement of research under the

CT–CRADA:

A. An established headquarters with

offices, space, and equipment;

B. Adequate means for

communication with the Collaborator

during business hours, such as by

telephone, mail, e-mail, the Internet,

and other evolving technologies; and

C. Sufficient financial resources to

support, at a minimum, the current

activities of the CT–CRADA to meet the

needs of NIA.

Dated: March 26, 1997.

Thomas D. Mays,

Director, Office Technology Development,

National Cancer Institute, NIH.

[FR Doc. 97–9239 Filed 4–9–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Child Health and

Human Development; 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 Institute of Child Health and

Human Development Special Emphasis

Panel (SEP) meeting:

Name of SEP: Specialized Clinical

Fellowships (Teleconference).

Date: May 5, 1997.

Time: 1:00 p.m.—adjournment.

Place: 6100 Executive Boulevard, 6100

Building Room 5E03, Rockville, Maryland

20852.

Contact Person: Hameed Khan, Ph.D.,

Scientific Review Administrator, NICHD,

6100 Executive Boulevard, 6100 Building,

Room 5E01, Rockville, Maryland 20852,

Telephone: 301–496–1485.

Purpose/Agenda: To evaluate and review

grant applications.

The meeting will be closed in accordance

with the provisions set forth in sections

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

discussions of these applications 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 Nos. [93.864, Population Research

and No. 93.865, Research for Mothers and

Children, National Institutes of Health].)

Dated: April 7, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–9297 Filed 4–9–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Neurological

Disorders and Stroke, Division of

Extramural Activities; 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:

Name of Committee: National Institute of

Neurological Disorders and Stroke Special

Emphasis Panel (Telephone Conference Call).

Date: April 23, 1997.

Time: 9:00 a.m.

Place: National Institutes of Health, 7550

Wisconsin Avenue, Room 9C10, Bethesda,

MD 20892.

Contact Person: Dr. Howard Weinstein/Mr.

Phillip Wiethorn, Scientific Review

Administrator, National Institutes of Health,

7550 Wisconsin Avenue, Room 9C10,

Bethesda, MD 20892, (301) 496–9223.

Purpose/Agenda: To review and evaluate

an SBIR Phase II Contract Proposal.

The meeting will be closed in accordance

with the positions set forth in sections

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

Applications and/or proposals and the

discussions could reveal confidential trade

secrets or commercial property such as

patentable material and personal information

concerning individuals associated with the

applications and/or proposals, the disclosure

of which would constitute a clearly

unwarranted invasion of personal privacy.

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.

(Catalog of Federal Domestic Assistance

Program No. 93.853, Clinical Research

Related to Neurological Disorders; No.

93.854, Biological Basis Research in the

Neurosciences).

Dated: April 7, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–9298 Filed 4–9–97; 8:45 am]

BILLING CODE 4140–01–M