30912 Federal Register / Vol. 61, No. 118 / Tuesday, June 18, 1996 / Notices

Division of Acute Care, Rehabilitation

Research, and Disability Prevention,

National Center for Injury Prevention

and Control, Centers for Disease Control

and Prevention (CDC), 4770 Buford

Highway, NE., Mailstop F–41, Atlanta,

Georgia 30341–3724, telephone (770)

488–4031.

Please refer to Announcement

Number 637 when requesting

information and submitting an

application.

Potential applicants may obtain a

copy of ‘‘Healthy People 2000’’ (Full

Report, Stock No. 017–001–00474–0) or

‘‘Healthy People 2000’’ (Summary

Report, Stock No. 017–001–00473–1)

through the Superintendent of

Documents, Government Printing

Office, Washington, DC 20402–9325,

telephone (202) 512–1800.

Atlanta, Georgia will be the host of

the 1996 Summer Olympics Games (July

19 through August 4, 1996). As a result

of this event, it is likely that the

Procurement and Grants Office (PGO)

may experience delays in the receipt of

both regular and overnight mail

deliveries. Contacting PGO employees

during this timeframe may also be

hindered due to the possible telephone

disruptions.

Dated: June 11, 1996.

Joseph R. Carter.

Acting Associate Director for Management

and Operations Centers for Disease Control

and Prevention (CDC).

[FR Doc. 96–15376 Filed 6–17–96; 8:45 am]

BILLING CODE 4163–18–P

[Announcement 622]

Improving Effectiveness of

Tuberculosis Prevention and Control

Programs in Developing Countries

Introduction

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1996

funds for a grant to provide education,

and technical assistance to improve the

quality, efficiency, and effectiveness of

programs for the prevention and control

of tuberculosis (TB) in the developing

countries of Central America (Mexico)

and Southeast Asia (Vietnam and the

Philippines), whose TB situation is of

strategic interest to the United States.

CDC is committed to achieving the

health promotion and disease

prevention objectives of ‘‘Healthy

People 2000,’’ a national activity to

reduce morbidity and mortality and

improve the quality of life. This

announcement is related to the priority

area of Immunization and Infectious

Diseases. (To order a copy of ‘‘Healthy

People 2000,’’ see the section WHERE TO

OBTAIN ADDITIONAL INFORMATION.)

Authority

This program is authorized under

Section 317E of the Public Health

Service Act (42 U.S.C. 247b–6) as

amended.

Smoke-Free Workplace

CDC strongly encourages all grant

recipients to provide a smoke-free

workplace and to promote the non-use

of all tobacco products, and Public Law

103–227, the Pro-Children Act of 1994,

prohibits smoking in certain facilities

that receive Federal funds in which

education, library, day care, health care,

and early childhood development

services are provided to children.

Eligible Applicant

Applications may be submitted by

public and private, nonprofit and forprofit organizations and governments

and their agencies. Thus, universities,

and colleges; and research institutions,

hospitals, other public and private

organizations, State and local

governments or their bona fide agents,

federally recognized Indian tribal

governments, Indian tribes or Indian

tribal organizations, and small,

minority- and/or women-owned

businesses are eligible to apply.

Applicants must be able to:

1. Demonstrate that their membership

is comprised of a wide variety of

members from governmental and nongovernmental organizations, and

individual members that can ensure the

success of the activities specified under

this program announcement;

2. Document a membership of at least

1,000 persons, including members from

each country whose TB situation is of

strategic interest to the United States,

i.e., Mexico, Vietnam and the

Philippines; and

3. Demonstrate experience in

providing ongoing technical assistance

and practical training for TB programs

in a number of countries in the

developing world.

Availability of Funds

Approximately $100,000 is available

in FY 1996 to fund one award. The

award is anticipated to begin on or

about September 1, 1996, for a 12-month

budget period within a three-year

project period. The funding estimate is

subject to change. Continuation awards

within the project period will be made

on the basis of satisfactory progress and

the availability of funds.

Purpose

The purpose of this grant is to support

and maintain collaborative relationships

with organizations to provide TB

education, technical assistance and

other TB information to TB program

managers and non-governmental

organizations in developing countries.

By providing TB education, information

and technical assistance, the

management of TB control programs in

developing countries will be improved

and the global control effort will be

enhanced as well as providing

additional potential impact on the TB

problem in the U.S.

Program Requirements

1. Identify and assess the TB-related

public health infrastructure, TB

informational needs, and training needs

of health care providers and TB control

program personnel in developing

countries contributing to the U.S.

immigrant population, and especially in

Mexico, Vietnam, and the Philippines.

2. Facilitate the incorporation of

epidemiologic principles in TB national

prevention and control programs and

expedite the dissemination of

epidemiologic findings in order to

improve these programs.

3. Encourage collaboration between

TB control programs in the Unites States

that have a high prevalence of TB

among the foreign born and developing

countries in their TB control efforts.

4. Identify and propose project

activities in response to findings in 1

through 3 above. These activities may

include training courses, support of

regional and international meetings

designed to improve information

transfer on a regional or international

basis, and epidemiologic studies that

can be used to improve the diagnosis

and treatment of TB and improve TB

control in developing countries

contributing to the U.S. immigrant

population, and especially in Mexico,

Vietnam, and the Philippines.

Evaluation Criteria

The application will be reviewed and

evaluated according to the following

criteria. (100 total points maximum)

1. Extent to which the applicant

understands the requirements,

problems, objectives, complexities, and

interactions required of this project (10

Points);

2. Degree to which the proposed

epidemiologic studies are realistic and

relevant to the purpose of this project

(10 Points);

3. Degree to which the proposed

programmatic plans are clearly stated,

realistic, time phased, and related to the

purpose of this project (20 Points);
Federal Register / Vol. 61, No. 118 / Tuesday, June 18, 1996 / Notices 30913

4. Adequacy of the plans for

administering the project. In addition,

the degree to which the applicant has

met the CDC Policy requirements

regarding the inclusion of women,

ethnic, and racial groups in the

proposed research. Specifically the

following items will be addressed (30

Points):

a. The proposed plan for the inclusion

of both sexes and racial and ethnic

minority populations for appropriate

representation.

b. The appropriateness of the

proposed justification when

representation is limited or absent.

c. Whether the design of the study is

adequate to measure differences when

warranted.

d. Whether the plans for recruitment

and outreach for study participants

include the process of establishing

partnerships with community(ies) and

recognition of mutual benefits.

5. Extent to which the professional

personnel involved proposed to be

involved in this project are qualified,

including evidence of past

achievements appropriate to this

project. (30 points)

6. Other—Not scored.

Budget

Consideration will be given to the

extent to which the budget is

reasonable, clearly justified, and

consistent with the intended use of

funds.

Human Subjects

Procedures adequate for the

protection of human subjects must be

documented: (1) Protections appear

adequate and no comments or concerns

are raised, or (2) protections appear

adequate, but comments are made

regarding the protocol, or (3) protections

appear inadequate and the Objective

Review Group (ORG) has concerns

related to human subjects; or (4)

disapproval of the application is

recommended because the research

risks are sufficiently serious and

protection against the risks are

inadequate resulting in unacceptability

of the entire application.

Executive Order 12372

This program is not subject to the

Executive Order 12372 review.

Public Health System Reporting

Requirements

This program is not subject to the

Public Health System Reporting

Requirements.

Catalog of Federal Domestic Assistance

Number

The Catalog of Federal Domestic

Assistance Number is 93.947, TB

Demonstration, Research, Public and

Professional Education Projects.

Other Requirements

Confidentiality: Applicants must have

in place systems to ensure the

confidentiality of all patient records.

Human Subjects: The applicant must

comply with the Department of Health

and Human Services Regulations, 45

CFR Part 46, regarding the protection of

human subjects. Assurances must be

provided to demonstrate that the project

will be subject to initial and continuing

review by an appropriate institutional

review committee. The applicant will be

responsible for providing assurance in

accordance with the appropriate

guidelines and form provided in the

application kit.

In addition to other applicable

committees, Indian Health Service (IHS)

institutional review committees also

must review the project if any

component of the IHS will be involved

or will support the research. If any

American Indian community is

involved, its tribal government must

also approve that portion of the project

applicable to it.

Women, Racial and Ethnic Minorities:

It is the policy of the CDC to ensure that

women and racial and ethnic groups

will be included in CDC-supported

research projects involving human

subjects, whenever feasible and

appropriate. Racial and ethnic groups

are those defined in OMB Directive No.

15 and include American Indian,

Alaskan Native, Asian, Pacific Islander,

Black and Hispanic. Applicants shall

ensure that women, racial and ethnic

minority populations are appropriately

represented in applications for research

involving human subjects. Where clear

and compelling rationale exist that

inclusion is inappropriate or not

feasible, this situation must be

explained as part of the application.

This policy does not apply to research

studies when the investigator cannot

control the race, ethnicity and/or sex of

subjects. Further guidance to this policy

is contained in the Federal Register,

Vol. 60, No. 179, Friday, September 15,

1995, pages 47947–47951 (a copy is

included in the application kit).

Application Submission and Deadline

The original and two copies of the

application PHS Form 5161–1 (OMB

Number 0937–0189) must be submitted

to Van Malone, Grants Management

Officer, Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

(CDC), 255 East Paces Ferry Road NE.,

Room 300, Mailstop E–15, Atlanta, GA

30305, on or before July 29, 1996.

1. Deadline: Applications shall be

considered as meeting the deadline if

they are either:

(a) Received on or before the deadline

date, or

(b) Sent on or before the deadline date

and received in time for submission to

the objective review committee.

(Applicants must request a legibly dated

U.S. Postal Service postmark or obtain

a legibly dated receipt from a

commercial carrier or U.S. Postal

Service. Private metered postmarks shall

not be acceptable as proof of timely

mailing.)

2. Late Applications: Applications

that do not meet the criteria in 1.(a) or

1.(b) are considered late applications.

Late applications will not be considered

in the current competition and will be

returned to the applicant.

Where to Obtain Additional

Information

Questions on application procedures

and the application package, and

business management technical

assistance may be obtained from Juanita

Dangerfield, Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

(CDC), 255 East Paces Ferry Road, NE.,

Room 300, Mailstop E–15, Atlanta, GA

30305, telephone (404) 842–6577, fax:

(404) 842–6513, or Internet address:

jdd2@opspgo1.em.cdc.gov.

Programmatic technical assistance

may be obtained from: Harry Stern,

Division of Tuberculosis Elimination,

National Center for STD, HIV, and TB

Prevention, Centers for Disease Control

and Prevention (CDC), 1600 Clifton

Road, NE., Mailstop E–10, Atlanta, GA

30333, telephone (404) 639–8120.

Please refer to Announcement

Number 622 when requesting

information or submitting an

application.

Potential applicants may obtain a

copy of ‘‘Healthy People 2000’’ (Full

Report, Stock No. 017–001–00474–0) or

‘‘Healthy People 2000’’ (Summary

Report, Stock No. 017–001–00473–1)

referenced in the INTRODUCTION through

the Superintendent of Documents,

Government Printing Office,

Washington, DC 20402–9325, telephone

(202) 512–1800.

Atlanta, Georgia will be the host of

the 1996 Summer Olympics Games (July

19 through August 4, 1996). As a result

of this event, it is likely that the

Procurement and Grants Office (PGO)

may experience delays in the receipt of
30914 Federal Register / Vol. 61, No. 118 / Tuesday, June 18, 1996 / Notices

both regular and overnight mail

deliveries. Contacting PGO employees

during this time frame may also be

hindered due to the possible telephone

disruptions.

To the extent authorized, please

consider the use of voice mail, e-mail,

and facsimile transmissions to the

maximum extent practicable. Please do

not fax lengthy documents, or grant

applications.

This announcement will be available

on one of two Internet sites on the

publication date: CDC’s home page at

http://www.cdc.gov, or at the

Government Printing Office home page

(including free access to the Federal

Register) at http://www.access.gpo.gov.

Dated: June 11, 1996.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 96–15375 Filed 6–17–96; 8:45 am]

BILLING CODE 4163–18–P

National Institutes of Health

Licensing Opportunity and/or

Opportunity for a Cooperative

Research and Development Agreement

(CRADA) for the Scientific and

Commercial Development of Novel

Heparin-Binding Peptides

AGENCY: National Institutes of Health,

Public Health Services, DHHS.

ACTION: Notice.

SUMMARY: The National Institutes of

Health is seeking licensees and/or

CRADA partners for the further

development, evaluation, and

commercialization of novel heparinbinding peptides. The inventions

claimed in the patent applications

referenced below are available for either

exclusive or non-exclusive licensing (in

accordance with 35 U.S.C. 207 and 37

CFR Part 404) and/or further

development under a CRADA for

clinical and research applications

described below in Supplementary

Information.

Heparin- and Sulfatide-Binding

Peptides From the Type I Repeats of

Human Thrombospondin and

Conjugates Thereof

DD Roberts, PJ Browning, J Bryant, JK

Inman, HC Krutzsch, N Guo (NCI)

Serial No. 08/487,568, filed 07 Jun 95,

which is a CIP of

Serial No. 08/215,085, filed 21 Mar 94,

which is a CIP of

Serial No. 07/801,812, which issued as

U.S. Patent No. 5,357,041 on 18 Oct 94.

To expedite the research,

development, and commercialization of

these compounds, the National

Institutes of Health is seeking a CRADA

with a pharmaceutical or biotechnology

company in accordance with the

regulations governing the transfer of

Government-developed agents. Any

proposal to use or develop these

compounds will be considered.

ADDRESSES: CRADA proposals and

questions about this opportunity should

be addressed to: Dr. Gary D. Colby,

Office of Technology Development,

National Cancer Institute, Executive

Plaza South, Suite 450, 6120 Executive

Boulevard MSC 7182, Bethesda, MD

20892–7182; telephone: 301/496–0477;

fax: 301/402–2117.

Licensing proposals and questions

about this opportunity should be

addressed to: Ms. Carol Lavrich,

Technology Licensing Specialist, Office

of Technology Transfer, National

Institutes of Health, 6011 Executive

Boulevard, Suite 325, Rockville,

Maryland 20852–3804; telephone: 301/

496–7735, ext. 287; fax: 301/402–0220.

Information about the patent

applications and pertinent information

not yet publicly described can be

obtained under a Confidential

Disclosure Agreement. Respondees

interested in licensing the invention(s)

will be required to submit an

Application for License to Public Health

Service Inventions. Respondees

interested in submitting a CRADA

proposal should be aware that it may be

necessary to secure a license to the

above patent rights in order to

commercialize products arising from a

CRADA.

DATES: There is no deadline by which

license applications must be received.

CRADA proposals must be received on

or before September 16, 1996.

SUPPLEMENTARY INFORMATION: These

inventions identify a family of related

peptides, peptide analogs, and

peptidomimetics useful for blocking or

modifying the biological activities of

heparin, sulfatides, fibronectin,

fibroblast growth factor and

transforming growth factor-β (TGFβ)

Among the activities exhibited by

compounds within this family of agents

are:

• Inhibition of tumor cell growth,

including inhibition of breast tumor

growth in a mouse xenograft model;

• Inhibition of Kaposi’s Sarcoma (SK)

cell proliferation and migration in

vitro and KS-like lesion formation in

vivo;

• Inhibition of endothelial and breast

carcinoma cell proliferation,

adhesion, and motility in vitro;

• Inhibition of angiogenesis in vivo;

• Specific, high affinity binding to

heparin and related sulfated

glycoconjugates, including preventing

interaction with adhesion molecules,

growth factors, cells, and heparindependent enzymes; and

• Activation of latent TGFβ.

The compounds within this family of

agents are based upon functional

sequences from the three type I repeats

of human endothelial cell

thrombospondin. The inventions

identify particular peptides, analogs,

and peptidomimetics that have

particularly advantageous properties

such as increased physiological

stability, enhanced activity, lack of

electrostatic charge, and increased

solubility. The inventions also describe

unique approaches to constructing

water-soluble conjugates which exhibit

a number of interesting and useful

biological activities.

It is expected that the high potency of

these agents will lower the effective

dose needed, and, subsequently, will

reduce the immunological response

against the peptides and the risks of

toxicity. Among the diseases for which

these agents may prove to be

particularly useful therapeutic agents

are:

• Kaposi’s sarcoma

• Breast carcinoma

• Melanoma

• Other epithelial cancers

• Other diseases involving abnormal

vascular proliferation

The inventors of these agents seek

collaborators for their ongoing research

and development efforts. Two research

projects for which collaborators are

particularly sought involve investigation

of means of controlling angiogenesis

and investigation of means for

modulating the activity of TGFβ,

particularly to control fibrosis, using the

agents described above.

Thrombospondin has been identified

as an anti-angiogenic factor in human

epithelial tissue. Certain agents

described above have shown particular

utility for inhibition of pathological

angiogenesis in vivo. These agents have

been engineered to decrease both

proteolytic degradation and the rapidity

of their clearance from the bloodstream

and to increase their biological activity.

These agents have been shown to

influence tumor cell adhesion and

growth in vitro and in vivo. Other

peptides have been shown to inhibit

tumorigenesis and metastasis in vivo.

Further development of agents, and

their application in therapeutic

capacities, is planned.

The antiproliferative activities of

certain agents upon epithelial and breast