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