Federal Register / Vol. 61, No. 104 / Wednesday, May 29, 1996 / Notices 26915

Organ Procurement Organizations

(OPO) as well as deficiencies noted

during periodic facility and laboratory

certification surveys. This information

is used to make decisions concerning

OPO redesignation, certification/

recertification of health care facilities

participating in the Medicare/Medicaid

Programs, and laboratories regulated by

CLIA. Frequency: Annually and

Biennially; Affected Public: State, Local

or Tribal Governments, Business or

other for-profit, Not-for-profit

institutions, Federal Government;

Number of Respondents: 49,200; Total

Annual Responses: 98,400; Total

Annual Hours Requested: 196,800.

To request copies of the proposed

paperwork collections referenced above,

call the Reports Clearance Office on

(410) 786–1326. Written comments and

recommendations for the proposed

information collections should be sent

by 5/31/96 to 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, D.C. 20503.

Dated: May 22, 1996.

Kathleen B. Larson,

Director, Management Planning and Analysis

Staff, Office of Financial and Human

Resources, Health Care Financing

Administration.

[FR Doc. 96–13519 Filed 5–28–96; 8:45 am]

BILLING CODE 4120–03–P–M

National Institutes of Health

National Cancer Institute: Opportunity

for a Cooperative Research and

Development Agreement (CRADA) for

the Scientific and Commercial

Development of Hydroxylated

Aromatic Protein Cross-Linking

Compounds for the Treatment of

Hyperproliferative Epithelial Lesions

AGENCY: National Institutes of Health,

PHS, DHHS.

ACTION: Notice.

SUMMARY: The Department of Health and

Human Services (DHHS) seeks a

company that can collaboratively

pursue the pre-clinical and clinical

development of Hydroxylated Aromatic

Protein Cross-Linking Compounds for

the treatment of hyperproliferative

epithelial lesions including skin

neoplasia, warts and other

hyperproliferative skin disorders. The

National Cancer Institute, Laboratory of

Cellular Carcinogenesis and Tumor

Promotion (LCCTP) has established that

this class of compounds (cinnamic acid

derivatives) may be effective in treating

hyperproliferative skin disorders. The

selected sponsor will be awarded a

CRADA for the co-development of this

agent with the National Cancer Institute.

ADDRESS: Questions about this

opportunity may be addressed to Jeremy

A. Cubert, M.S., J.D., Office of

Technology Development, NCI, 6120

Executive Blvd., MSC 7182, Bethesda

MD 20892–7182, Phone: (301) 496–

0477, Facsimile: (301) 402–2117, from

whom further information may be

obtained.

DATE: In view of the important priority

of developing new agents for the

treatment or prevention of cancer,

interested parties should notify this

office in writing no later than July 12,

1996. Respondents will then be

provided an additional 30 days for the

filing of formal proposals.

SUPPLEMENTARY INFORMATION:

‘‘Cooperative Research Development

Agreement’’ or ‘‘CRADA’’ means the

anticipated joint agreement to be

entered into by NCI pursaunt to the

Federal Technology Transfer Act of

1986 and amendments (including 104

P.L. 113) and Executive Order 12591 of

October 10, 1987 to collaborate on the

specific research project described

below.

The Government is seeking a

pharmaceutical company which, in

accordance with the requirements of the

regulations governing the transfer of

agents in which the Government has

taken an active role in developing (37

CFR 404.8), can further develop the

subject compounds through Federal

Food and Drug Administration approval

and to a commercially available status

to meet the needs of the public and with

the best terms for the Government. The

government has applied for a patent

application directed to methods for the

treatment for Hyperproliferative

Epithelial Lesions by Topical

Application of Hydroxylated Aromatic

Protein Cross-Linking-Compounds.

Methyl 2,5-dihydroxycinnamate (MC),

a cinnamic acid derivative, has been

shown to both inhibit cell growth and

chemically cross-link proteins. The

growth inhibitory and protein crosslinking activity of MC are independent

and complementary. The cross-linking

effect of the compounds is rapid and

leads to programmed cell death for

many cell types. At lower

concentrations, the compounds inhibit

tyrosine kinases and cell growth. The

compounds have been shown to be

effective in many cell types indicating

potential for topical treatment of a wide

range of localized hyperproliferative

epithelial disorders.

The LCCTP, Division of Basic

Sciences, NCI is interested is

establishing a CRADA with a company

to assist in the continuing development

of these compounds. The Government

will provide all available expertise and

information to date and will jointly

pursue pre-clinical and clinical studies

as required, giving the company full

access to existing data and data

developed pursuant to the CRADA. The

successful company will provide the

necessary scientific, financial and

organizational support to establish

clinical efficacy and possible

commercial status of the subject

compounds.

The expected duration of the CRADA

will be two (2) to five (5) years.

The role of the National Cancer

Institute, includes the following:

1. Selection of appropriate compounds for

in vitro screening.

2. Selection of appropriate compounds for

in vivo screening.

3. Conduct in vitro screening of

appropriate compounds.

4. Identify chemical basis of activity for

class of compounds.

5. Conduct in vivo testing of appropriate

compounds.

6. Evaluation of test results.

7. Preparation of manuscripts for

publication.

8. Relevant Government intellectual

property rights are available for licensing

through the Office of Technology Transfer,

National Institutes of Health. For further

information contact Allan Kiang, J.D., NIH

Office of Technology Transfer, 6011

Executive Blvd., Suite 325, Rockville, MD

20852, Phone: (301) 496–7735 (ext. 270);

Facsimile: (301) 402–0220.

The role of the collaborator company,

includes the following:

1. Conduct in vitro screening of

appropriate compounds.

2. Identify chemical basis of activity for

class of compounds.

3. Conduct in vivo testing of appropriate

compounds.

4. Evaluation of test results.

5. Develop vehicle for delivery of

compounds to patients.

6. Conduct pre-clinical and clinical trials

of appropriate candidate compounds.

Criteria for choosing the company

include its demonstrated experience

and commitment to the following:

1. Scientific expertise in and

demonstraterd commitment to the treatment

of skin related disorders.

2. Scientific expertise in and demonstrated

commitment to the development of drug

delivery systems.

3. Experience in preclinical and clinical

drug development.

4. Experience and ability to produce,

package, market and distribute

pharmaceutical products.

5. Experience in the monitoring, evaluation

and interpretation of the data from
26916 Federal Register / Vol. 61, No. 104 / Wednesday, May 29, 1996 / Notices

investigational agent clinical studies under

an IND.

6. A willingness to cooperate with the NCI

in the collection, evaluation, publication and

maintaining of data from pre-clinical studies

and clinical trials regarding the subject

compounds.

7. Provide defined financial and personnel

support for the CRADA to be mutually agreed

upon.

8. An agreement to be bound by the DHHS

rules involving human and animal subjects.

9. The aggressiveness of the development

plan, including the appropriateness of

milestones and deadlines for preclinical and

clinical development.

10. Provisions for equitable distribution of

patent rights to any CRADA inventions.

Generally the rights of ownership are

retained by the organization which is the

employer of the inventor, with (1) an

irrevocable, nonexclusive, royalty-free

license to the Government and (2) an option

for the collaborator to elect an exclusive or

nonexclusive license to Government owned

rights under terms that comply with the

appropriate licensing statutes and

regulations.

Dated: May 1, 1996.

Thomas D. Mays,

Director, Office of Technology Development,

OD, NCI.

[FR Doc. 96–13375 Filed 5–28–96; 8:45 am]

BILLING CODE 4140–01–M

Notice of Meeting of the Advisory

Committee to the Director, NIH

Pursuant to Public Law 92–463,

notice is hereby given of the meeting of

the Advisory Committee to the Director,

NIH, June 17, 1996, Conference Room

10, Building 31, National Institutes of

Health, Bethesda, Maryland 20892.

The entire meeting will be open to the

public from 9:00 a.m. to adjournment.

The topics proposed for discussion

include (1) Report from the NIH AIDS

Research Program Evaluation Group; (2)

Report on Intramural Research Program;

(3) Discussion of Misconduct in

Science; (4) Discussion of Issues Related

to Co-Funding with other Organizations;

and (5) Status of Reinvention Activities.

Attendance by the public will be limited

to space available.

Ms. Janice Ramsden, Program

Assistant, Office of the Deputy Director,

National Institutes of Health, 1 Center

Drive MSC 0159, Bethesda, Maryland

20892–0159, telephone (301) 496–0959,

fax (301) 496–7451, will furnish the

meeting agenda, roster of committee

members, and substantive program

information upon request. Any

individual who requires special

assistance, such as sign language

interpretation or other reasonable

accommodations, should contact Ms.

Ramsden no later than June 12, 1996.

Dated: May 22, 1996.

Susan K. Feldman,

Committee Management Officer, NIH.

[FR Doc. 96–13364 Filed 5–28–96; 8:45 am]

BILLING CODE 4140–01–M

National Institutes of Health (NIH)

Meeting; Alternative Medicine Program

Advisory Council

Pursuant to sec. 10(d) of the Federal

Advisory Committee Act, as amended (5

U.S.C. Appendix 2), notice is hereby

given of the meeting of the Alternative

Medicine Program Advisory Council on

June 13, 1996, from 8 a.m. to 5 p.m. and

on June 14, 1996, from 8 a.m. to 11 a.m.

in Conference Room 6, Building 31C,

the National Institutes of Health, 9000

Rockville Pike, Bethesda, Maryland.

The entire meeting will be open to the

public. The purpose of the meeting will

be to update the Council on the

activities of the Office of Alternative

Medicine and to seek the Council’s

advice on strategic planning for

alternative medicine research.

The Council will discuss the priorities

voted upon at the February Council

meeting and how the Office of

Alternative Medicine might implement

these activities. Attendance by the

public will be limited to space available.

Ms. Beth Clay, Committee

Management Officer, Office of

Alternative Medicine, NIH, 9000

Rockville Pike, Building 31, Room 5B37

Mail Stop 2182, Bethesda, Maryland

20892, phone (301) 594–1990, fax (301)

402–4741, E-Mail:

bethclay@helix.nih.gov, will furnish the

meeting agenda, roster of committee

members, and substantive program

information upon request.

Individuals who plan to attend and

need special assistance, such as sign

language interpretation or other

reasonable accommodations, should

contact Ms. Clay at the above location

no later than June 3, 1996.

Dated: May 22, 1996.

Susan K. Feldman,

Committee Management Officer, NIH.

[FR Doc. 96–13373 Filed 5–28–96; 8:45 am]

BILLING CODE 4140–01–M

Workshop on the Role of Dietary

Supplements for Physically Active

People

Notice is hereby given of the NIH

Workshop on ‘‘The Role of Dietary

Supplements For Physically Active

People,’’ which will be held June 3–4,

1996, in the Natcher Conference Center

of the National Institutes of Health, 9000

Rockville Pike, Bethesda, Maryland

20892. The conference begins at 8 a.m.

on both days.

Scientific research linking dietary

supplements to health over the life span

can be viewed as a relatively new area

of research. In the early part of this

century, nutrition sciences and dietary

recommendations were focused on the

identification and treatment of

nutritional deficiency diseases.

Although the American people have

been consuming vitamin and mineral

supplements for decades, the direct

relationship between diet and health

and, therefore, the potential role for

nutrients beyond the minimum levels

required to avoid deficiencies, has

become apparent only within the last 15

years. The possible roles of other food

components and derivatives of natural

products in promoting health and

preventing disease are also now being

recognized. The publication of the

Surgeon General’s Report on Nutrition

and Health and the Diet and Health

report from the National Academy of

Sciences further highlighted the breadth

of understanding of the diet-health

relationship. Scientific research on the

characterization of the potential roles of

individual nutrients and compounds as

dietary supplements has grown

dramatically in the 1990s.

Dietary supplements in the United

States are usually defined as comprising

plant extracts, enzymes, vitamins,

minerals, and hormonal products that

are available without prescription and

may be consumed in addition to the

regular diet. Considerable research on

the effects of dietary supplements has

been conducted in Asia and Europe,

where plant products have a long

tradition of use. The overwhelming

majority of supplements have not been

studied scientifically, and therefore, it is

important to conduct research to

determine the benefits and risks of the

use of promising dietary supplements

and to interpret available scientific

information so that the public may

understand its contents. One strong and

continuing public health message to the

American people, based on such

scientific information, is that moderate

exercise should become a part of their

daily lives. Physical activity has been

shown to reduce the risk of

cardiovascular disease through its

effects on high blood pressure, high

blood cholesterol, diabetes mellitus/

insulin resistance, and obesity.

Americans should heed the advice of

health professionals and adopt a more

physically active lifestyle that includes

a planned exercise component. This

scientific workshop will focus on the

role of dietary supplements for