Federal Register / Vol. 66, No. 85 / Wednesday, May 2, 2001 / Notices 21989

MSC 7934, Bethesda, MD 20892, or call

non-toll-free number (301) 435–0707 or

E-mail your request, including your

address to : Sorlie@nih.gov.

Comments Due Date: Comments

regarding this information collection are

best assured of having their full effect if

received on or before July 2, 2001.

Dated: April 19, 2001.

Peter J. Savage,

Acting Director, Division of Epidemiology and

Clinical Applications, National Heart, Lung,

and Blood Institute.

[FR Doc. 01–10932 Filed 5–1–01; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES (DHHS)

National Institutes of Health (NIH)

National Institutes of Health Clinical

Center (NIHCC); Opportunity for

Cooperative Research and

Development Agreement (CRADA)

SUMMARY: The National Institutes of

Health Clinical Center (NIHCC) is

seeking to enter at least one Cooperative

Research and Development Agreement

(CRADA). The goal is to develop and

implement an application specific

artificial neural network based

intelligent computing system for on-line

and off-line quality control of a process,

particularly a medical process, and

especially test result production in

clinical laboratory automated analyzers.

The development of this technology is

part of the ongoing activities of the

NIHCC. The term of any 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

1, 2001. Formal proposals should be

submitted to this office no later than

July 2, 2001. Proposals received after

this date will still be considered, but

only after all proposals received before

this date have been considered.

ADDRESSES: Questions concerning this

announcement, and all research

proposals, should be submitted to Bruce

D. Goldstein, Esq., Technology Transfer

Branch, National Cancer Institute,

National Institutes of Health, Suite 450,

6120 Executive Blvd., Rockville, MD

20852, Phone: 301–496–0477, Fax: 301–

402–2117. Scientific questions should

be addressed to James M. DeLeo, 6100

Executive Blvd., Suite 5C01, Rockville,

MD 20852; Phone (direct): 301–496–

3848; Fax: 301–496–3848; e-mail:

jdeleo@nih.gov. Inquiries directed to

obtaining patent license(s) related to

participation in the CRADA opportunity

should be addressed to Dale Berkley,

PhD., J.D., Senior Technology Licensing

Specialist, Office of Technology

Transfer, National Institutes of Health,

6011 Executive Blvd., Suite 325,

Rockville, MD 20852–3804, Phone: 301–

496–7735, Fax: 301–402–0220, e-mail:

Berkld@od.nih.gov.

SUPPLEMENTARY INFORMATION: A CRADA

is the anticipated joint agreement to be

entered into by NIHCC and a

collaborator pursuant to the Federal

Technology Transfer Act of 1986 (15

U.S.C. 3710 a), as amended. A CRADA

is an agreement designed to enable

certain collaborations between

Government laboratories and nonGovernment laboratories. It is not a

grant, and is not a contract for the

procurement of goods/services. THE

NIHCC IS PROHIBITED FROM

TRANSFERRING FUNDS TO A CRADA

COLLABORATOR. Under a CRADA, the

NIHCC can offer the selected

collaborator access to facilities, staff,

materials, and expertise. The

collaborator may contribute facilities,

staff, materials, expertise, and funding

to the collaboration. A CRADA

collaborator may elect an option to an

exclusive or non-exclusive license to

Government intellectual patent rights

arising under the CRADA, and may

qualify as an inventor or co-inventor of

new technology developed under the

CRADA. As between two or more

sufficient, overlapping research

proposals (where the overlap cannot be

cured), the NIHCC, as specified in 15

U.S.C. § 3710a(c)(4), will give special

consideration to small businesses, and

will give preference to business units

located in the U.S. that agree to

manufacture CRADA products in the

U.S.

The CRADA will employ a

generalized computational system and

method developed earlier at the

National Institutes of Health. This

technology was developed for the

purpose of detecting errors in processes

including, but not limited to, data

collection in laboratory automated

analyzers. The technology is capable of

early on-line detection of various types

of errors such as bias, precision, and

random errors. It may also be developed

as an off-line computational component.

Theoretical studies have demonstrated

significant advantages of this technology

over current state-of-the art quality

control practice in laboratory

instrument quality control monitoring.

The primary goal of the CRADA is to

use the developed system and method

to build practical and useful software

and/or hardware components for

application in real-world production or

assembly process environments such as

commercially available laboratory

automated analyzers and other

appropriate medical or non-medical

applications.

The described methods and system

are the subject of a U.S. patent

application filed November 26, 1998 by

the Public Health Service on behalf of

the Federal Government.

Commercialization of new CRADA

technology may require obtaining an

appropriate PHS license.

The collaborator in this endeavor is

expected to commit technical personnel

commensurate with the level of research

activities defined by the CRADA

Research Plan. It is anticipated that PHS

facilities and/or those of the collaborator

will be utilized, as appropriate, for the

research activities as defined by the

Research Plan. NIHCC anticipates, in

addition, that the Collaborator, as

appropriate, will provide funding for

the project.

Party Contributions

The NIHCC anticipates that its role

may include, but not be limited to, the

following:

(1) Plan research studies, interpret

research results, and, as appropriate,

jointly publish the conclusions with the

collaborator;

(2) Provide collaborator with access to

existing NIHCC research data, both

already collected and yet to be collected

(except for medical or other personal

data regarding identifiable patients);

(3) Provide staff, expertise, and

materials for the development and

testing of promising application

products;

(4) Provide work space and

equipment for testing of any prototype

products developed.

The NIHCC anticipates that the role of

the successful collaborator will include

at least the following:

(1) Provide significant intellectual,

scientific, and technical expertise in the

development of relevant products;

(2) Plan research studies, interpret

research results, and, as appropriate,

jointly publish the conclusions; and

(3) Provide NIHCC a supply of

necessary materials, access to necessary

proprietary technology and/or data, and

as necessary for the project, staff and

funding in support of the research goals.

Other contributions may be necessary

for particular proposals.

Selection Criteria

Proposals submitted for consideration

should address, as best as possible and

to the extent relevant to the proposal,

each of the following:

(1) Expertise:

A. Expertise in the research and

development of diagnostic, prognostic,

21990 Federal Register / Vol. 66, No. 85 / Wednesday, May 2, 2001 / Notices

and/or therapeutic products pertinent to

the technology; and

B. Ability to secure national

marketing and distribution of its

products (international distribution a

plus).

(2) Reliability as a research partner,

specifically:

A. Willingness to commit best effort

and to provide adequate and sustained

resources and/or funding, as

appropriate, to support the CRADA

studies;

B. Development of this technology, as

outlined in the CRADA Collaborator’s

proposal;

C. Ability to develop and produce

products in a timely manner, as

applicable (for example, as

demonstrated by a history of meeting

benchmarks in licenses);

D. Commitment to supporting the

advancement of scientific research, as

evidenced by a willingness to jointly

publish research results in a prompt

manner; and

E. Willingness to be bound by DHHS

and PHS policies regarding:

(i) the public distribution of research

tools,

(ii) the care and handling of animals,

and

(iii) protection of humans who are

subjects of research.

(3) Physical Resources:

A. An established headquarters, with

office space and basic office equipment;

B. Access to the organization during

business hours by telephone, facsimile,

courier, U.S. Post, e-mail, the WorldWide-Web, and, as appropriate, other

evolving information technologies; and

C. Sufficient financial and material

resources to support, at a minimum, the

anticipated activities of the CRADA to

meet the needs of NIHCC under the

proposal.

The collaborator is encouraged to

propose, in the written research

statement, related applications and

technologies other than those

specifically described herein.

Dated: April 23, 2001.

Kathleen Sybert,

Chief, TTB/NCI/NIH.

[FR Doc. 01–10933 Filed 5–1–01; 8:45 am]

BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES (DHHS)

National Institutes of Health (NIH)

National Institutes of Health Clinical

Center (NIHCC) Opportunity for

Cooperative Research and

Development Agreement (CRADA)

SUMMARY: The National Institutes of

Health Clinical Center (NIHCC) is

seeking to enter at least one Cooperative

Research and Development Agreement

(CRADA). The goal is to develop and

implement application specific

computer-learned medical-outcome

indexes as partially described in the

April 2001 issue of the periodical

entitled ‘‘Advance for Administrators of

the Laboratory.’’ The development of

this technology is part of the ongoing

activities of the NIHCC. The term of any

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 June 1,

2001. Formal proposals should be

submitted to this office no later than

July 2, 2001. Proposals received after

this date will still be considered, but

only after all proposals received before

this date have been considered.

ADDRESSES: Questions concerning this

announcement, and all research

proposals, should be submitted to Bruce

D. Goldstein, Esq., Technology Transfer

Branch, National Cancer Institute,

National Institutes of Health, Suite 450,

6120 Executive Blvd., Rockville, MD

20852, Phone: 301–496–0477, Fax: 301–

402–2117. Scientific questions should

be addressed to James M. DeLeo, 6100

Executive Blvd., Suite 5C01, Rockville,

MD 20852; Phone (direct): 301–496–

3848; Fax: 301–496–3848; e-mail:

jdeleo@nih.gov. Inquiries directed to

obtaining patent license(s) related to

participation in the CRADA opportunity

should be addressed to Dale Berkley,

PhD., J.D., Senior Technology Licensing

Specialist, Office of Technology

Transfer, National Institutes of Health,

6011 Executive Blvd., Suite 325,

Rockville, MD 20852–3804, Phone: 301–

496–7735, Fax: 301–402–0220, e-mail:

Berkld@od.nih.gov.

SUPPLEMENTARY INFORMATION: A CRADA

is the anticipated joint agreement to be

entered into by NIHCC and a

collaborator pursuant to the Federal

Technology Transfer Act of 1986 (15

U.S.C. 3710 a), as amended. A CRADA

is an agreement designed to enable

certain collaborations between

Government laboratories and nonGovernment laboratories. It is not a

grant, and is not a contract for the

procurement of goods/services. THE

NIHCC IS PROHIBITED FROM

TRANSFERRING FUNDS TO A CRADA

COLLABORATOR. Under a CRADA, the

NIHCC can offer the selected

collaborator access to facilities, staff,

materials, and expertise. The

collaborator may contribute facilities,

staff, materials, expertise, and funding

to the collaboration. A CRADA

collaborator may elect an option to an

exclusive or non-exclusive license to

Government intellectual patent rights

arising under the CRADA, and may

qualify as an inventor or co-inventor of

new technology developed under the

CRADA. As between two or more

sufficient, overlapping research

proposals (where the overlap cannot be

cured), the NIHCC, as specified in 15

U.S.C. 3710a(c)(4), will give special

consideration to small businesses, and

will give preference to business units

located in the U.S. that agree to

manufacture CRADA products in the

U.S.

As used here, the expression

‘‘computer-learned medical outcome

indexes’’ refers to probability or degree

of membership values indicating

(‘‘indexing’’) particular medical

outcomes such as diagnostic categories,

preferred treatments, times to events,

and other medical classifications and

outcomes. These indexes and their

confidence intervals are computed using

laboratory and other patient data with

neural networks and other machinelearning computer programs which,

once trained, may run as background

tasks in laboratory instrument

computers, hospital information

systems, and various personnel

computers including desk, lap, and

palm top computers. These programs

could also be inscribed in hardware. It

is expected that medical index

computer programs will provide

valuable patient information at virtually

no extra cost, and that they will be in

everyday use in future clinical settings

to aid health care providers in making

important cost-effective patient

management decisions.

The described methods are the subject

of an Employee Invention Report filed

with the NIH Office of Technology

Transfer. Also the initial report and

characterization of the invention is

partially described in an article entitled

‘‘Computer-Learned Medical Outcome

Indexes, by Jim DeLeo,’’ in the April

2001 issue of Advance for

Administrators of the Laboratory.

Commercialization of new CRADA

technology may require obtaining an

appropriate PHS license to practice this

described prior art.

The collaborator in this endeavor is

expected to commit technical personnel