63536 Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / Notices

Description: Wisconsin proposes to

limit the amount of exempt funds that

may be set aside as burial and related

expenses for SSI-related Medicaid

beneficiaries.

Date Received: March 9, 1994.

State Contact: Jean Sheil, Division of

Economic Support, Wisconsin

Department of Health and Social

Services, 1 West Wilson Street, Room

650, P.O. Box 7850, Madison, WI 53707,

(608) 266–0613.

Federal Project Officer: J. Donald

Sherwood, Health Care Financing

Administration, Office of Research and

Demonstrations, Mail Stop C3–16–26,

7500 Security Boulevard, Baltimore, MD

21244–1850.

3. Approved Conceptual Proposals

(Award of Waivers Pending)

No conceptual proposals were

awarded during the months of August

and September.

4. Approved Proposals

No proposals were approved during

the months of August and September.

5. Disapproved Proposals

No proposals were disapproved

during the months of August and

September.

6. Withdrawn Proposals

No proposals were withdrawn during

the months of August and September.

IV. Requests for Copies of a Proposal

Requests for copies of a specific

Medicaid proposal should be made to

the State contact listed for the specific

proposal. If further help or information

is needed, inquiries should be directed

to HCFA at the address above.

(Catalog of Federal Domestic Assistance

Program, No. 93.779; Health Financing

Research, Demonstrations, and Experiments)

Dated: November 30, 1995.

Bruce C. Vladeck,

Administrator, Health Care Financing

Administration.

[FR Doc. 95–30066 Filed 12–8–95; 8:45 am]

BILLING CODE 4120–01–P

National Institutes of Health

National Institute of Allergy and

Infectious Diseases: Licensing

Opportunity and/or Opportunity for a

Cooperative Research and

Development Agreement (CRADA) for

the Development of Influenza A PB2

Gene Technology

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: The National Institutes of

Health is seeking licensees and/or

CRADA Collaborators for the joint

research, development, evaluation, and

commercialization of its influenza A

polymerase basic 2 (PB2) patent

portfolio. The inventions claimed in

U.S. Patent Application Serial No. 08/

123,933 (‘‘Method for Generating

Influenza A Viruses Bearing Attenuating

Mutations in Internal Protein Genes,’’

filed September 20, 1993), and its

related patent applications, are available

for either co-exclusive or non-exclusive

licensing (in accordance with 35 U.S.C.

207 and 37 CFR Part 404) and/or further

development under one or more

CRADAs for important clinical and

research applications described below

in the Supplementary Information

section.

DATES: License applications must be

received on or before March 11, 1996.

CRADA proposals should be received

on or before April 11, 1996 for priority

consideration. However, CRADA

proposals submitted thereafter will be

considered until a suitable CRADA

Collaborator is selected.

ADDRESSES: CRADA proposals and

questions about this opportunity should

be addressed to: Claire T. Driscoll,

Technology Transfer Manager, National

Institute of Allergy and Infectious

Diseases, National Institutes of Health,

Building 31, Room 3B62, 9000 Rockville

Pike, Bethesda, MD 20892; Telephone:

301/496–2644; Fax: 301/402–7123; Email: cd68y@nih.gov.

Licensing proposals and questions

about this opportunity should be

addressed to: Cindy K. Fuchs, J.D.,

Technology Licensing Specialist, Office

of Technology Transfer, National

Institutes of Health, 6011 Executive

Boulevard, Suite 325, Rockville, MD

20852–3804; Telephone: 301/496–7735

ext. 232; Fax: 301/402–0220; E-mail:

CindylFuchs@nih.gov.

Information on the patent

applications and pertinent information

not yet publicly disclosed 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 agreement.

SUPPLEMENTARY INFORMATION: This

invention involves the use of modern

molecular virologic techniques to

introduce temperature sensitive (ts)

attentuating mutations into a

complementary DNA (cDNA) copy of

the influenza A polymerase basic 2

(PB2) protein gene and to recover

viruses bearing the mutant PB2 gene.

Viral RNA (vRNA) transcribed in vitro

from the PB2 DNA is transfected into

avian kidney cells in the presence of an

influenza A helper virus. The PB2 gene

of the helper virus, which restricts its

replication in mammalian cells, is

substituted by the transfected mutant

PB2 gene, which is known to function

efficiently in mammalian cells. Using

this system it has been possible to

introduce three attenuating temperature

sensitive mutations into the PB2 gene

and to recover an infectious virus

bearing this triple mutant gene. The

virus bearing this mutant gene was

highly attenuated in animals, was stable

genetically even after prolonged

replication in immunosuppressed

rodents, and induced resistance to

challenge with wild type influenza A

virus. This gene can now be transferred

from a donor virus to new epidemic or

pandemic variants of influenza A virus

as they appear in nature. The end result

is a live attenuated reassortant influenza

A virus vaccine that not only contains

an attenuating PB2 gene from the

attenuated donor but also the protective

antigens, i.e., the hemagglutinin and

neuraminidase glycoproteins, from the

newly emerged wild type virus. Such a

reassortant virus can serve as a

protective vaccine, when administered

into the respiratory tract of a vaccine,

against disease caused by the epidemic

influenza A viruses.

To speed the research, development,

and commercialization of these agents,

the NIH is seeking one or more license

agreements and/or CRADAs with

pharmaceutical or biotechnology

companies in accordance with the

regulations governing the transfer of

Government-developed agents.

Proposals relating to any biomedical

area will be considered.

The CRADA aims will include the

rapid publication of research results

consistent with protection of proprietary

information and patentable inventions

as well as the timely exploitation of

commercial opportunities. The CRADA

Collaborator will enjoy the benefits of

first negotiation for licensing

Government rights to any inventions

arising under the agreement and will

advance funds payable upon signing the

CRADA to help defray Government

expenses for patenting such inventions

and other CRADA-related costs.

The role of the National Institute of

Allergy and Infectious Diseases will be

as follows:
Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / Notices 63537

1. Provide the PB2 technology to the

CRADA Collaborator.

2. Jointly develop a series of donor

viruses containing the mutant PB2 gene

with or without a second nonhemaglutinin (HA), non-neuraminidase

(NA) attenuating gene.

3. Jointly produce a series of

reassortants bearing current H1 or H3

hemagglutinins (HAs) for evaluation in

clinical trials in humans.

4. Jointly produce experimental

vaccines and evaluate them in clinical

trials.

The role of the Collaborator(s) will be

to:

1. Participate in joint activities 2–4

above.

2. Evaluate a variety of mammalian

cell lines for production of live

attenuated virus vaccines in lieu of

production in the allantoic cavity of

eggs.

Selection criteria for choosing the

CRADA Collaborator(s) will include but

are not limited to the following:

1. The ability to collaborate with the

NIAID on further research and

development of this technology. This

ability can be demonstrated through

experience and expertise in this and

related areas of technology.

2. The demonstration of adequate

resources to perform the research,

development, and commercialization of

this technology (e.g., personnel,

expertise, and facilities) and accomplish

objectives according to an appropriate

timetable to be outlined in the CRADA

Collaborator’s proposal.

3. The ability to perform clinical

testing or trials, and obtain IND, ELA/

PLA and FDA approval for a new

vaccine or other products based on this

technology.

4. The demonstration of expertise in

the commercial development,

production, marketing and sales of

products related to this technology.

5. The level of financial support to

CRADA Collaborator will provide for

CRADA-related Government activities.

6. The willingness to cooperate with

the NIAID in the timely publication of

research results consistent with the

protection of proprietary information

and patentable inventions that may arise

during the period of the CRADA.

7. Agreement to be bound by DHHS

rules and regulations involving human

subjects, patent rights, ethical treatment

of animals, and randomized clinical

trails.

8. The willingness to accept the

language and legal provisions of the NIH

model CRADA with only minor

modifications, if any. These provisions

govern the equitable distribution of

patent rights to any inventions

developed under the CRADA. Generally,

the rights of ownership are retained by

the organization which is the employer

of the inventor, with (1) The grant of an

irrevocable, non-exclusive, royalty-free

license for research purposes to the

Government when the CRADA

Collaborator’s employee(s) is/are the

sole inventor(s), or (2) the grant of an

option to negotiate an exclusive or nonexclusive license to the CRADA

Collaborator when a Government

employee(s) is/are the sole inventor(s).

Dated: November 30, 1995.

Barbara M. McGarey,

Deputy Director, Office of Technology

Transfer.

[FR Doc. 95–30004 Filed 12–8–95; 8:45 am]

BILLING CODE 4140–01–M

National Institute on Deafness and

Other Communication Disorders;

Amended Notice of Meeting

Notice is hereby given of the

rescheduling of the meeting of the Ad

Hoc Clearinghouse Subcommittee of the

National Deafness and Other

Communication Disorders Advisory

Council, the notice of which was

published in the Federal Register 60 FR

55849 on November 3, 1995. This

meeting could not be convened on

November 16 due to the partial

shutdown of the Federal Government. It

is rescheduled for December 18 from

11:00 a.m. to 1:00 p.m., as a telephone

conference call originating in room

3C05, Building 31, 9000 Rockville Pike,

Bethesda, Maryland. The meeting will

be open to the public, limited to space

available.

Dated: December 4, 1995.

Susan K. Feldman,

Committee Management Officer, NIH.

[FR Doc. 95–30001 Filed 12–8–95; 8:45 am]

BILLING CODE 4140–01–M

Consensus Development Conference

on Physical Activity and

Cardiovascular Health

Notice is hereby given of the NIH

Consensus Development Conference on

‘‘Physical Activity and Cardiovascular

Health,’’ which will be held December

18–20, 1995, in the Natcher Conference

Center of the National Institutes of

Health, 9000 Rockville Pike, Bethesda,

Maryland 20892. The conference begins

at 8:30 a.m. on December 18, at 8 a.m.

on December 19, and at 9 a.m. on

December 20.

Over the past 25 years, the United

States has experienced steady declines

in the death toll from cardiovascular

disease (CVD), primarily in coronary

heart disease and stroke. Despite these

declines, heart disease remains the

number one and stroke the third leading

cause of death. Lifestyle improvements

by the American public and better

control of the risk factors for heart

disease and stroke have been a major

factor in this decline.

Cardiovascular disease is of

multifactorial etiology. Modifiable risk

factors include high blood pressure,

high blood cholesterol, obesity,

smoking, diabetes, and physical

inactivity. In contrast to the positive

trends observed with the reduction of

high blood pressure and high blood

cholesterol, overweight and physical

inactivity have been on the increase. In

light of this, the accumulating evidence

of the risk of cardiovascular disease

associated with a sedentary lifestyle and

the role of physical activity in the

prevention and treatment of CVD and

other CVD risk factors needs to be

examined.

In 1991, 58 percent of adults reported

that they exercised sporadically or not

at all. Data from the 1990 Youth Risk

Behavior Survey suggests that

adolescents are less active than they

were a decade ago. Only 37 percent of

teenagers in grades 9 through 12

reported performing at least 20 minutes

of vigorous exercise at least three or

more times per week. About 50 percent

of students reported they did not

participate in physical education (PE)

classes. Of those who reported

participating in PE classes, 25 percent

said they do not do any physical

activity.

Physical activity not only

independently protects against the

development of cardiovascular disease

but also has effects through the CVD risk

factors of high blood pressure, high

blood cholesterol, diabetes mellitus/

insulin resistance, and overweight. The

type, frequency, and intensity of the

physical activity, however, remains

controversial. Some experts suggest that

moderate forms of physical activity can

help prevent cardiovascular disease,

while others suggest it must be vigorous

and sustained.

Physical activity is also important in

the treatment and management of

patients with CVD or its risk factors,

including patients who have stable

angina, have suffered a myocardial

infarction, or have heart failure.

Physical activity is an important

component of cardiac rehabilitation but

questions remain regarding the type,

frequency, and intensity needed for

patients.

In addition, to potential benefits,

questions remain regarding risks