17626 Federal Register / Vol. 62, No. 69 / Thursday, April 10, 1997 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Submission for OMB Review;

Comment Request; Clinical,

Laboratory, and Epidemiologic

Characterization of Individuals at High

Risk of Cancer

SUMMARY: Under the provisions of

Section 3506(c)(2)(A) of the Paperwork

Reduction Act of 1995, the National

Cancer Institute (NCI), the National

Institutes of Health (NIH) has submitted

to the Office of Management and Budget

(OMB) a request to review and approve

the information collection listed below.

This proposed information collection

was previously published in the Federal

Register on December 16, 1996, pages

66052–66053 and allowed 60 days for

public comment. Only one comment

from the public was received; it was a

request for additional information about

the project. The purpose of this notice

is to allow an additional 30 days for

public comment. The National Institutes

of Health may not conduct or sponsor,

and the respondent is not required to

respond to, an information collection

that has been extended, revised, or

implemented on or after October 1,

1995, unless it displays a currently valid

OMB control number.

PROPOSED COLLECTION:

Title: Clinical, Laboratory, and

Epidemiologic Characterization of

Individuals at High Risk of Cancer. Type

of Information Collection Request:

Extension of OMB No. 0925–0194

(Expiration date 04/30/97). Need and

Use of Information Collection: This

ongoing research study will identify

cancer-prone persons in order to learn

about cancer risk and cancer causes in

individuals and families. The primary

objectives of this research study are to

utilize clinical, laboratory, and

epidemiologic approaches in studies of

individuals and families at high risk of

cancer to identify and further

characterize cancer susceptibility

factors. Respondents are members of

families in which multiple cancers are

thought to have occurred. Information

about the occurrence of cancer is

collected and reviewed to determine

eligibility for further etiologic study.

Participation is entirely voluntary. The

findings will lead to a better

understanding of the causes and risk

factors for selected cancers, which may

reduce cancer incidence, and promote

the earlier diagnosis of some cancers.

Frequency of Response: One time.

Affected Public: Individuals or

households. Type of Respondents:

Adults. The annual reporting burden is

as follows: Estimated Number of

Respondents: 600 per year; Estimated

Number of Responses per Respondent:

1; Average Burden Hours Per Response:

.75; and Estimated Total Annual Burden

Hours Requested: 450. The annualized

cost to respondents is estimated at

$4,500. There are no Capital Costs to

report. There are no Operating 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 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: Dr.

Margaret Tucker, Chief, Genetic

Epidemiology Branch, National Cancer

Institute, NIH, Executive Plaza North,

Room 439, 6130 Executive Blvd.,

Bethesda, MD 20892, or call non-tollfree number (301) 496–4375, or E-mail

your request, including your address to:

tuckerp@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 May 12, 1997.

Dated: April 1, 1997.

Nancie L. Bliss,

OMB Project Clearance Liaison.

[FR Doc. 97–9240 Filed 4–9–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES (DHHS)

National Institutes of Health (NIH)

National Library of Medicine (NLM);

Opportunity for a Cooperative

Research and Development Agreement

for Research and Development of Data

Mining, Data Warehousing and

Visualization Techniques to

Commercial Products

AGENCY: Lister Hill National Center for

Biomedical Communications, NLM,

NIH, DHHS.

ACTION: Advertisement.

SUMMARY: The Lister Hill National

Center for Biomedical Communications

(LHNCBC), an R&D division of the

National Library of Medicine, seeks a

Cooperative Research and Development

Agreement (CRADA) with a software

company with a reputation in the

software engineering research and

development and marketing

communities as demonstrated by the

quality of its information products and

successful application of sophisticated

statistical or machine learning methods

to commercial products. Of particular

interest is application of data mining,

data warehousing and visualization

techniques to areas of interest including

drug design, medical care, fraud

detection, and medical administration.

The Collaborator must be able to

collaborate with NLM staff to produce

high quality information products. The

Collaborator must have a demonstrated

record of success in privately producing

and marketing information resources.

The term of the CRADA will be up to

five (5) years.

DATES: Interested parties should notify

this office in writing of their interest in

filing a formal proposal no later than

June 9, 1997, and then will have an

additional thirty (30) days to submit a

formal proposal.

ADDRESSES: Inquires and proposals

regarding this opportunity should be

addressed to Jeremy A. Cubert, M.S.,

J.D. (Tel. #301–496–0477, FAX

#301–402–2117), Office of Technology

Development, National Cancer Institute,

6120 Executive Blvd., Suite 450,

Rockville, MD 20852. Inquiries

regarding obtaining patent license(s)

needed for participation in the CRADA

opportunity may be addressed to John

Fahner-Vihtelic, Office of Technology

Transfer, National Institute of Health,

6011 Executive Blvd., Suite 325,

Rockville, MD 20852, Phone: (301) 496–

7735 (ext. 285); FAX: (301) 402–0220.

SUPPLEMENTARY INFORMATION: A CRADA

is the anticipated joint agreement to be
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