Federal Register / Vol. 63, No. 88 /Thursday, May 7, 1998 / Notices 25219

OMB control Nos.

148.120, .122, .124, .128 ........................................................................................................................................ 0938–0703.

Dated: April 28, 1998.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA Office

of Information Services, Information

Technology Investment Management Group,

Division of HCFA Enterprise Standards.

[FR Doc. 98–12095 Filed 5–6–98; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Cancer Institute: VHL and

MET Mutation Detection Technology:

Opportunities for Cooperative

Research and Development

Agreements (CRADAs) for the Joint

Evaluation and Development of

Methods to Detect Mutation in Both

Gene Sequences Using Nucleic Acid

Array Technology

The methods may include but are not

limited to spectroscopic partitioning

techniques and DNA chip technology.

The NCI is looking for multiple CRADA

Collaborators to develop independently

different aspects of this VHL and MET

mutation detection technology.

AGENCY: National Cancer Institute,

National Institutes of Health, PHS,

DHHS.

ACTION: Notice for CRADA

Opportunities.

SUMMARY: Pursuant to Federal

Technology Transfer Act of 1986 (FTTA,

15 U.S.C. 3710; and Executive Order

12591 of April 10, 1987, as amended by

the National Technology Transfer and

Advancement Act of 1995), the National

Cancer Institute (NCI) of the National

Institutes of Health (NIH) of the Public

Health Service (PHS) of the Department

of Health and Human Services (DHHS)

seeks Cooperative Research and

Development Agreements (CRADAs)

with pharmaceutical or biotechnology

companies to evaluate and develop

methods to detect mutations in both the

MET and VHL gene sequences using

nucleic acid array technology. Any

CRADA for the biomedical use of this

technology will be considered. The

CRADAs would have an expected

duration of one (1) to five (5) years. The

goals of the CRADAs include the rapid

publications of research results and

timely commercialization of products,

diagnostics and treatments that result

from the research. The CRADA

Collaborators will have an option to

elect a non-exclusive or exclusive

commercialization license to subject

inventions arising under the CRADAs

that are related to the DNA array

technology of the collaborators, which

are the subject of the CRADA Research

Plan, for diagnostics and research

supply and can apply for background

licenses to the existing patents listed

below, subject to any pre-existing

licenses already issued for other fields

of use. Licensing by NIH is subject to 35

U.S.C. 207 and 37 CFR Part 404.

ADDRESSES: Proposals and questions

about this CRADA opportunity may be

addressed to Dr. Thomas M. Stackhouse,

Technology Development &

Commercialization Branch, National

Cancer Institute-Frederick Cancer

Research & Development Center,

Fairview Center, Room 502, Frederick,

MD 21701 (phone: 301–846–5465, fax:

301–846–6820).

Scientitific inquiries—Dr. Berton

Zbar, Chief, Laboratory of

Immunobiology, National Cancer

Institute-Frederick Cancer Research &

Development Center, P.O. Box B,

Building 560, Room 12–68, Frederick

MD, 21702–1201 (phone: 301–846–1288

FAX: 301–846–6145).

EFFECTIVE DATE: Inquiries regarding

licensing and scientific matters may be

forwarded at any time. Confidential

CRADA proposals, preferably one page

or less, must be submitted to NCI on or

before July 6, 1998. Guidelines for

preparing full CRADA proposals will be

communicated shortly thereafter to all

respondents who have been selected.

SUPPLEMENTARY INFORMATION:

Technology Available

DHHS scientists have identified

mutations in the proto-oncogene c-MET,

and the von Hippel-Lindau disease

(VHL) tumor suppressor gene in human

cancers. c-MET is the receptor for

hepatocyte growth factor/scatter factor.

Germline mutations in the MET gene

have been detected in affected members

of families with an inherited

predisposition to develop papillry renal

carcinomas; somatic mutations in the

MET gene have been detected in a

subset of papillary renal carcinomas. All

mutations detected in the MET gene to

date were located in the tyrosine kinase

domain; all mutations were missense.

The VHL gene is mutated in patients

with von Hippel-Lindau disease, and in

sporadic clear cell carcinomas of the

kidney. Disease-causing mutations

include gender deletions (partial or

complete), missense and nonsense and

frame shift mutations.

About 30,000 individuals develop

kidney cancer each year. We anticipate

that the novel mutation detection

techniques for the MET and VHL genes

will be used in patients with sporadic

and inherited predispositions to renal

cancer. Possible uses would include

diagnosis and prognosis of kidney

cancer. In addition, these new methods

might be applied to the study of other

types of human neoplasia.

DHHS now seeks collaborative

arrangements for the joint evaluation

and development of methods to detect

mutations in both gene sequences using

nucleic acid array technology. The

methods may include but are not

limited to spectroscopic partitioning

techniques and DNA chip technology.

For collaborations with the commercial

sector, a Cooperative Research and

Development Agreement (CRADA) will

be established to provide equitable

distribution of intellectual property

rights developed under the CRADA. The

successful CRADA partner will

collaboratively develop and test known

mutations within the genes from

samples provided by the government.

CRADA aims will include rapid

publication of research results as well as

full and timely exploitation of any

commercial opportunities.

NCI’s VHL/MET Patents and Patent

Applications

1. Von Hippel-Lindau(VHL) Disease

Gene and Corresponding cDNA and

Methods for Detecting Carriers of the

VHL Disease Gene; United States Patent

5,654,138, issued August 5, 1997.

The role of the National Cancer

Institute in this CRADA will include,

but not be limited to:

1. Providing intellectual, scientific,

and technical expertise and experience

to the research project.

2. Providing the Collaborator with

samples of the subject gene sequences

for evaluation.

3. Planning research studies and

interpreting research results.

4. Publishing research results.

The role of the CRADA Collaborator

may include, but not be limited to:

1. Providing significant intellectual,

scientific, and technical expertise or

experience to the research project.

2. Planning research studies and

interpreting research results.
25220 Federal Register / Vol. 63, No. 88 /Thursday, May 7, 1998 / Notices

3. Providing technical expertise and/

or financial support for (e.g. facilities,

personnel and expertise) for CRADArelated Government activities.

4. Accomplishing objectives

according to an appropriate timetable to

be outlined in the CRADA

Collaborator’s proposal.

5. The willingness to commit best

effort and demonstrated resources to the

research, development and

commercialization of this technology.

6. The demonstration of expertise in

the commercial development,

production, marketing and sales of

products related to this area of

technology.

8. The willingness to cooperate with

the National Cancer Institute in the

timely publication of research results.

9. The agreement to be bound by the

appropriate DHHS regulating to human

subjects, and all PHS policies relating to

the use and care of laboratory animals.

10. The willingness to accept the legal

provisions and language of the CRADA

with only minor modifications, if any.

These provisions govern the equitable

distribution of patent rights to CRADA

inventions.

Dated: April 26, 1998.

Kathleen Sybert,

Acting Director, Technology Development &

Commercialization Branch, National Cancer

Institute, National Institutes of Health.

[FR Doc. 98–12110 Filed 5–6–98; 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 Cooperative

Research and Development Agreement

(CRADA) To Develop a Vaccine for

Pneumonia

AGENCY: National Institutes of Health

(NIH), PHS, DHHSNIA, NIH, PHS,

DHHS.

ACTION: Notice.

SUMMARY: The National Institute on

Aging (NIA) is seeking a Collaborator to

participate in a Cooperative Research

and Development Agreement (CRADA)

to develop a vaccine for pneumonia.

The term of the CRADA will be up to

five (5) years.

ADDRESESS: Inquiries and proposals

regarding this opportunity should be

addressed to Bruce D. Goldstein, J.D.,

Technology Development and

Commercialization Branch, National

Cancer Institute, 6120 Executive Blvd.,

EPS Suite 450, Rockville, Maryland

20852, telephone number 301–496–

0477, FAX number 301–402–2117.

DATES: interested parties are advised to

notify this office in writing of their

intent to file a formal proposal no later

than FIFTEEN (15) days from the date

of this advertisement. Formal proposals

must be submitted to this office no later

than TWENTY (20) days from the date

of this notice.

SUPPLEMENTARY INFORMATION: A CRADA

is the anticipated joint agreement to be

entered into by NIA pursuant to the

Federal Technology Transfer Act of

1986, a amended by the National

Technology Transfer Act (Pub. L. 104–

113 (Mar. 7, 1996)) and by Executive

Order 12591 of April 10, 1987. The NCI

owns U.S. Patent No. 4,455,032,

concerning the use of phosphocholine

hapten conjugates in vaccines, which

presently is not licensed. NIA is now

planning to develop a vaccine for

pneumonia utilizing the invention in

the NCI patent.

Under the present proposal, the

specific goals of the CRADA will be the

development of the following

technology:

• Development of one or more

vaccines utilizing the phosphocholinehapten technology;

• and preclinical evaluation of the

candidate vaccines.

Party Contributions

The role in NIA includes the

following:

(1) Develop, in cooperation with the

Collaborator, candidate pneumonia

vaccines;

(2) Conduct preclinical trials of

candidate vaccines in small mammal

models;

(3) Provide staff, expertise, &

materials for the development and

testing of promising vaccines, and

provide work space and equipment for

testing of the prototype vaccines; and

(4) Jointly evaluate and publish the

data generated with Collaborator.

The role of the successful Collaborator

will include the following:

(1) Provide an adequate supply of at

least one mutually agreeable, GMPgrade carrier system, and provide

expertise and assistance in the

development and use of its vaccine

carrier system(s);

(2) Provide resources, staff, expertise,

and funding, as necessary, in support of

the research goals; and

(3) Develop and market any promising

vaccines.

Selection Criteria

Proposals submitted for consideration

should fully address each of the

following qualifications:

(1) Expertise:

A. Demonstrated expertise in

developing and producing high quality

pharamacuetical compositions;

B. Demonstrated ability to secure

national and/or international marketing

and distribution of pharmaceutical

compositions;

C. Demonstrated intellectual ability to

guide development of product line

which addresses the requirements of

NIA;

(2) Reputation: The successful

Collaborator must be recognized in the

pharmaceutical industry for:

A. Producing quality pharmaceutical

products;

B. Indications of satisfaction by

industry experts with the Collaborator’s

products; and

C. Commitment to the research and

development of new pharmaceuticals.

(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 resources to

support, at a minimum, the current

activities of the CRADA to meet the

needs of NIA.

Dated: April 26, 1998.

Kathleen Sybert,

Acting Director, Technology Development &

Commercialization Branch, National Cancer

Institute, National Institutes of Health.

[FR Doc. 98–12109 Filed 5–6–98; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Center for Scientific Review; 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 given of the following Center

for Scientific Review Special Emphasis

Panel (SEP) meetings:

Purpose/Agenda: To review individual

grant applications.

Name of SEP: Microbiological and

Immunological Sciences.

Date: May 12, 1998.

Time: 1:00 p.m.

Place: NIH, Rockledge 2, Room 4182,

Telephone Conference.

Contact Person: Dr. William Branche,

Scientific Review Administrator, 6701

Rockledge Drive, Room 4182, Bethesda,

Maryland 20892, (301) 435–1148.

Name of SEP: Clinical Sciences.

Date: May 13, 1998.