30740 Federal Register / Vol. 66, No. 110 / Thursday, June 7, 2001 / Notices

the OMB Desk Officer designated at the

following address: OMB Human

Resources and Housing Branch,

Attention: Allison Eydt, New Executive

Office Building, Room 10235,

Washington, DC 20503.

Dated: May 30, 2001.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA,

Office of Information Services, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 01–14370 Filed 6–6–01; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Child Health &

Human Development (NICHD):

Opportunity for Cooperative Research

and Development Agreement (CRADA)

SUMMARY: The National Institute of

Child Health & Human Development is

seeking at least one Collaborator to

participate in a CRADA to develop

computer software that will assist in the

diagnostic and clinical management of

amenorrhea.

DATES: On or before August 6, 2001,

interested parties should send informal

written notice to the Technology

Transfer Branch of the National Cancer

Institute (NCI TTB), acting on behalf of

NICHD, of the intent to file a formal

proposal. Formal proposals must be

submitted to the NCI TTB on or before

September 5, 2001. Proposals submitted

after September 5, 2001 will be

considered, but only after any and all

proposals submitted within the ninetyday period.

ADDRESSES: Inquiries and proposals

regarding this opportunity should be

addressed to: Bruce D. Goldstein, NCI

Technology Transfer Branch, Executive

Plaza South, 6120 Executive Blvd., Suite

450, Rockville, Maryland, 20852 (Phone

301–496–0477, Fax # 301–402–2117).

Scientific questions should be

addressed to: Dr. Lawrence Nelson,

Head, NICHD Gynecologic

Endocrinology Unit, Developmental

Endocrinology Branch, Building 10,

Room 10N262, Bethesda, MD 20892–

1862 (Phone (direct) 301–402–6608;

Phone (office) 301–496–4686; Fax 301–

402–0574; email

Lawrence__Nelson@nih.gov).

SUPPLEMENTARY INFORMATION: A CRADA

is the anticipated joint agreement to be

entered into by NICHD and a

collaborator pursuant to the Federal

Technology Transfer Act of 1986 (15

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

an agreement designed to enable certain

collaborations between Government

laboratories and non-Government

laboratories. It is not a grant, and is not

a contract for the procurement of goods/

services. The NICHD is prohibited from

transferring funds to a CRADA

collaborator.

Under a CRADA, the NICHD 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 property rights

arising under the CRADA, and may

qualify as an inventor or co-inventor of

new technology developed under the

CRADA. Any party is eligible to

participate; however, as between two or

more sufficient, overlapping research

proposals (where the overlap cannot be

cured), the NICHD, 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 that

products either embodying inventions

made under the CRADA or produced

through the use of such inventions will

be manufactured substantially in the

United States. In all other respects, the

decision whether to begin negotiating a

particular CRADA will turn on how

well the proposal addresses the

selection criteria below and how closely

the proposed research matches the

research interests of the NICHD.

The NICHD’s general objectives for all

CRADAs are the rapid publication of

research findings, and the timely

commercialization of prognostic,

diagnostic, or therapeutic products.

Specific CRADA research goals will be

tailored to the particular needs of the

NICHD laboratory, the expertise of the

collaborator and NICHD, and any

proprietary technology the collaborator

and/or NICHD brings to the project.

Under the present opportunity, the goals

of the CRADA are anticipated to

include, but not be limited to, the

development of the following

technology:

• Development of one or more

software packages for analyzing patient

data in cases of amenorrhea;

• Examination of possible automated

processes for conducting differential

diagnoses of conditions causing

amenorrhea; and

• Development of improved tools for

diagnosing conditions causing

amenorrhea, to be used by clinicians in

a clinical setting.

The software to be developed will be

able to collect standardized data from

patients with amenorrhea at the point of

care. This system will be used to collect

research data that will accurately

characterize the clinical presentation of

a broad range of disorders that may

present with a chief complaint of

amenorrhea. As this data is collected

and analyzed the findings will be used

to update the software. This iterative

process will build an effective

instrument that eventually can be used

by caregivers at the point of patient

contact to assist in the diagnosis and

management of amenorrhea. After the

system has been fully validated in a

research setting this ‘‘working model’’

may be modified so as to collect basic

screening data from women with

amenorrhea in preparation for a visit to

their health care provider. Thus, the

development of a successful system will

depend heavily on insight and

experience on how to best meet the

needs of the health care consumer as

well as the health care provider.

A strategy should be developed to

collect the patient data, link it to the

pertinent published medical literature

across disciplines, and provide a

process for guided investigation and

clinical decision making. Strategies

should also be developed to employ the

system for patient education, disease

prevention, and health promotion.

The term of the CRADA(s) will be up

to five (5) years, depending on the

proposal(s). Applicants are encouraged

to recommend in the written proposal

alternative, additional applications and

technologies to be developed.

Anticipated Party Contributions

The role of NICHD may include the

following:

(1) Plan research studies, interpret

research results, and jointly publish the

conclusions with the collaborator;

(2) Provide collaborator with access to

existing NICHD research data (both

already collected and yet to be

collected);

(3) Provide staff, expertise, &

materials for the development and

testing of promising products; and

(4) Provide work space and

equipment for testing of any prototype

systems developed.

The role of the successful collaborator

will include the following:

(1) Provide significant intellectual,

scientific, and technical expertise in the

development and manufacture of

relevant products;

(2) Plan research studies, interpret

research results, and jointly publish the

conclusions with NICHD;

Federal Register / Vol. 66, No. 110 / Thursday, June 7, 2001 / Notices 30741

(3) As necessary for the project,

provide to NICHD any specialized or

unusual equipment, access to necessary

proprietary technology and/or data; and

(4) As necessary for the project,

provide 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 qualifications:

(1) Expertise:

A. Expertise in the research and

development of high quality software

utilizing artificial intelligence;

B. Experience in determining and

meeting the needs of health care

consumers; and

C. Demonstrated ability in the

production and verification of software

products.

(2) Reliability as a research partner:

A. Develops and produces products in

a timely manner (for example, as

demonstrated by a history of meeting

benchmarks in licenses);

B. Indications of high levels of

satisfaction by industry with the

collaborator’s products; and

C. Commitment to supporting the

advancement of scientific research, as

evidenced by a willingness to publish

research results in a prompt manner;

and

D. Willingness to be bound, to the

extent applicable, by DHHS and PHS

policies regarding:

(i) The rapid, public distribution of

pure research tools,

(ii) The care and handling of animals,

and

(iii) Human subjects 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 any evolving

communication technologies; and

C. Sufficient financial and material

resources to support, at a minimum, the

anticipated activities of the CRADA.

Dated: May 31, 2001.

Kathleen Sybert,

Chief, TTB/NCI/NIH.

[FR Doc. 01–14365 Filed 6–6–01; 8:45 am]

BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute on Aging; Amended

Notice of Meeting

Notice is hereby given of a change in

the meeting of the National Institute on

Aging Special Emphasis Panel, June 7,

2001, 2:30 p.m. to June 7, 2001, 4 p.m.,

7201 Wisconsin Avenue, Bethesda, MD,

20892 which was published in the

Federal Register on May 24, 2001. 66

FR 28756.

The meeting scheduled for June 7,

2001 will now be held on June 20, 2001.

The meeting is closed to the public.

Dated: May 31, 2001.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 01–14359 Filed 6–6–01; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Mental Health;

Notice of Closed Meetings

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby give of the following meetings.

The meetings will be closed to the

public in accordance with the

provisions set forth in sections

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

as amended. The grant applications and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the grant

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Institute of

Mental Health Special Emphasis Panel.

Date: July 2–3, 2001.

Time: 8:30 am to 5 pm.

Agenda: To review and evaluate grant

applications.

Place: Governor’s House Hotel, 17th &

Rhode Island Avenue, NW., Washington, DC

20036.

Contact Person: Richard E. Weise, PhD.,

Scientific Review Administrator, National

Institute of Mental Health, DEA, National

Institutes of Health, 6001 Executive

Boulevard, Room 6140, MSC9606, Bethesda,

MD 20892–9606, 301–443–1340,

rweise@mail.nih.gov.

Name of Committee: National Institute of

Mental Health Special Emphasis Panel.

Date: July 12, 2001.

Time: 8 am to 6 pm.

Agenda: To review and evaluate grant

applications.

Place: Holiday Inn, 8120 Wisconsin

Avenue, Bethesda, MD 20814.

Contact Person: Houmam H. Araj, PhD.,

Scientific Review Administrator, Division of

Extramural Activities, National Institute of

Mental Health, NIH, Neuroscience Center,

6001 Executive Blvd., Room 6150, MSC 9608,

Bethesda, MD 20892–9608, 301–443–1340.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.242, Mental Health Research

Grants; 93.281, Scientist Development

Award, Scientist Development Award for

Clinicians, and Research Scientist Award;

93.282, Mental Health National Research

Service Awards for Research Training,

National Institutes of Health, HHS)

Dated: May 31, 2001.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 01–14360 Filed 6–6–01; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Arthritis and

Musculoskeletal and Skin Diseases;

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.

The meeting will be closed to the

public in accordance with the

provisions set forth in sections

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

as amended. The grant applications and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the grant

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Institute of

Arthritis and Musculoskeletal and Skin

Diseases Special Emphasis Panel.

Date: July 18, 2001.

Time: 3 pm to 5 pm.

Agenda: To review and evaluate grant

applications.

Place: Bethesda Marriott, 5151 Pooks Hill

Road, Bethesda, MD 20892.

Contact Person: Aftab A. Ansari, PhD,

National Institutes of Health, NIAMS,

Natcher Building, 45 Center Drive, Room

5AS25N, Bethesda, MD 20892, 301–594–

4952.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.846, Arthritis,