63954 Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices

carrier manual instructions related to

physicians’ services, as identified by the

Secretary. To the extent feasible and

consistent with statutory deadlines, the

consultation must occur before

publication of the proposed changes.

The Council submits an annual report

on its recommendations to the Secretary

and the Administrator of the Health

Care Financing Administration not later

than December 31 of each year.

The Council consists of 15 physicians,

each of whom has submitted at least 250

claims for physicians’ services under

Medicare or Medicaid in the previous

year. Members of the Council include

both participating and nonparticipating

physicians, and physicians practicing in

rural and underserved urban areas. At

least 11 members must be doctors of

medicine or osteopathy authorized to

practice medicine and surgery by the

States in which they practice. Members

have been invited to serve for

overlapping 4-year terms. In accordance

with section 14 of the Federal Advisory

Committee Act, terms of more than 2

years are contingent upon the renewal

of the Council by appropriate action

before the end of the 2-year term.

The Council held its first meeting on

May 11, 1992.

The current members are: Richard

Bronfman, D.P.M.; Wayne R. Carlsen,

D.O.; Gary C. Dennis, M.D.; Catalina E.

Garcia, M.D.; Mary T. Herald, M.D.;

Ardis Hoven, M.D.; Sandral Hullett,

M.D.; Jerilynn S. Kaibel, D.C.; Marie G.

Kuffner, M.D.; Marc Lowe, M.D.;

Katherine L. Markette, M.D.; Derrick K.

Latos, M.D.; Susan Schooley, M.D.;

Maisie Tam, M.D.; and Kenneth M.

Viste, Jr., M.D. The chairperson is

Kenneth M. Viste, Jr., M.D.

Council members will receive an

update on documentation guidelines,

physician practice expense, private

contracting, physician self referral rules,

privacy and confidentiality, regional

labaratory carriers, and other issues

related to implementation of the

Balanced Budget Amendment.

Individuals or organizations that wish

to make 5-minute oral presentations on

the agenda issues should contact the

Executive Director by 12 noon,

December 4, 1997, to be scheduled. The

number of oral presentations may be

limited by the time available. A written

copy of the oral remarks should be

submitted to the Executive Director no

later than 12 noon, December 10, 1997.

Anyone who is not scheduled to speak

may submit written comments to the

Executive Director by 12:00 noon,

December 10, 1997. The meeting is open

to the public, but attendance is limited

to the space available.

(Section 1868 of the Social Security Act (42

U.S.C. 1395ee) and section 10(a) of Pub. L.

92–463 (5 U.S.C. App. 2, section 10(a)); 45

CFR Part 11)

(Catalog of Federal Domestic Assistance

Program No. 93.773, Medicare—Hospital

Insurance; and Program No. 93.774,

Medicare—Supplementary Medical

Insurance Program)

Dated: November 27, 1997.

Nancy-Ann Min DeParle,

Administrator, Health Care Financing

Administration.

[FR Doc. 97–31594 Filed 12–2–97; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Cancer Institute; Opportunity

for a Cooperative Research and

Development Agreement (CRADA) for

the Scientific and Commercial

Development of Transgenic Mice That

Express Human Cytochrome P450

Genes

AGENCY: National Institutes of Health,

PHS, DHHS.

ACTION: Notice.

SUMMARY: The Department of Health and

Human Services (DHHS) seeks an

agreement with a pharmaceutical or

biotechnology company to effectively

pursue the development and

characterization of transgenic mice that

express human cytochrome P450 genes

CYP2D6 and CYP3A4. The National

Cancer Institute has data suggesting that

these animals may be useful in drug

development, carcinogen bioassays for

risk assessment, and the determination

of genetic regulatory mechanisms.

ADDRESSES: Proposals and questions

about this opportunity may be

addressed to Robert Dell’Orco, Ph.D.,

Technology Development and

Commercialization Branch, National

Cancer Institute, Executive Plaza South,

Suite 450, 6120 Executive Blvd.,

Rockville, MD 20852, tel: 301–496–

0477, fax: 301–402–2117.

DATES: In view of the important priority

of developing new drugs for the

treatment of cancer and methods for

determining carcinogenic risk,

interested parties should notify this

office in writing not later that January 2,

1998. Respondents will then be

provided an additional 30 days for filing

of formal proposals.

SUPPLEMENTARY INFORMATION:

‘‘Cooperative Research and

Development Agreement’’ or ‘‘CRADA’’

means the anticipated joint agreement to

be entered into by NCI pursuant to the

Federal Technology Transfer Act of

1986 and Executive Order 12591 of

April 10, 1987 as amended by the

National Technology Transfer

Advancement Act of 1995 to collaborate

on the specific research project

described below.

The National Cancer Institute seeks an

agreement with a pharmaceutical or

biotechnology company for joint

development and evaluation of

transgenic mice that express human

cytochrome P450 genes CYP2D6 and

CYP3A4 in a tissue specific manner that

reflects the expression in humans.

These two human P450 enzymes are

involved in the metabolism of over 75%

of the drugs that are now on the market;

however, these two enzymes are poorly

conserved between rodents and

humans. This poor conservation

precludes the use of unmodified rodent

model systems for the analysis of new

drugs with respect to their metabolism

by these two enzymes. The development

of a human P450 transgenic mouse

system will allow for the determination

of human metabolism and toxicity of

new drugs, the prediction of drug

interactions, and the definition of

pharmacokinetic parameters in an intact

animal system. Additionally, such a

system would avoid the utilization of

human liver tissue samples which forms

the basis of the current methods used in

the pharmaceutical industry. The

animal model would also form the basis

of carcinogen bioassays for human risk

assessment and allow for the analysis of

P450 gene regulation. In the proposed

studies, the animals will be used to

determine the tissue specific

degradation of drugs. Drugs known

through in vitro metabolism studies to

be metabolized by CPY2D6 and CYP3A4

will be administered to the transgenic

mice, and their pharmacokinetics will

be studied.

The Laboratory of Metabolism has

many years of experience in cloning and

characterizing human P450 genes. More

recently, the laboratory has developed a

series of knockout and transgenic mice

to study various aspects of the role of

cytochrome P450 enzymes in

carcinogenesis and drug metabolism;

and the development of transgenic mice

with the human CYP2D6 and CYP3A4

enzymes is a continuation of the

laboratory’s commitment to this

research area. The Laboratory of

Metabolism is interested in establishing

a CRADA with a company to assist in

the continuing development of transgeic

animals containing human cytochrome

P450 enzymes to study known drug

substrates and proprietary drug

candidates. The Government will
Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Notices 63955

provide all available expertise and

information to date 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 characterize

and test the animals.

Background information is available

from the above-referenced address.

Patent applications and pertinent

information not yet publicly described

can be obtained under a Confidential

Disclosure Agreement.

The CRADA aims include the rapid

publication of research results and the

timely exploitation of commercial

opportunities. The CRADA partner will

enjoy rights of first negotiation for

licensing Government rights to any

inventions arising within the scope of

the agreement. The license option and

commercialization of inventions shall

not conflict with NIH Guidelines for the

availability of transgenic/knockout

animals (http://www1.od.nih.gov/wals/

transgen.html).

The expected duration of the CRADA

will be 2 years.

The role of the Laboratory of

Metabolism in this CRADA will be as

follows:

1. Isolate and characterize genomic

clones of human CYP2D6 and CYP3A4.

2. Generate mice by standard

injections of oocyte pronuclei and

screen founders.

3. Characterize tissue specificity of

expression.

4. Jointly publish research results.

The role of the Collaborator will be:

1. Characterize in vitro metabolism

using hepatic microsomal fractions.

2. Evaluate in vivo pharmacokinetics

with probe substrates and proprietary

compounds.

3. Analyze the role of CYP2D6 and

CYP3A4 on bioavailability and efficacy

of test compounds.

4. Jointly publish research results.

Selection criteria for choosing the

CRADA partner will include but not be

limited to:

1. Ability to collaborate with NCI on

further research and development of

this technology. Demonstration of

experience and expertise in this or

related areas of technology and the

ability to provide intellectual

contribution to the ongoing research and

development. Ability to accomplish

objectives according to an appropriate

timetable to be outlined in the

Collaborator’s proposal.

2. Willingness to comply with NIH

IRP Guidelines for the Availability of

Transgenic/Knockout Animals (http://

www1.od.nih.gov/wals/transgen.html).

The proposal should specifically

address the methods by which the

animals will be made available.

3. Demonstration of the resources

(facilities, personnel and expertise)

necessary to perform research,

development and commercialization of

this technology.

4. Commitment of reasonable effort

and resources on research, development

and commercialization of this

technology.

5. Expertise in the commercial

development, production, marketing

and sales of products related to this area

of technology.

6. The level of financial support the

Collaborator will supply for CRADArelated Government activities.

7. A willingness to cooperate with the

National Cancer Institute in the

publication of research results.

8. An agreement to be bound by the

DHHS rules involving human subjects,

patent rights and ethical treatment of

animals.

9. A willingness to accept the legal

provisions and language of the NIH

model CRADA with modifications to

address selection criteria #2 and other

minor modifications.

10. Provisions for distribution of

patent rights to any 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 (when a

company employee is the sole inventor)

or (2) an option to negotiate an

exclusive or nonexclusive license to the

company on terms that are appropriate

(when the Government employee is the

sole inventor).

Dated: November 21, 1997.

Kathleen Sybert,

Acting Director, Technology Development

and Commercialization Branch, National

Cancer Institute, NIH.

[FR Doc. 97–31638 Filed 12–2–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Cancer Institute; Notice of

Closed Meeting

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

National Cancer Institute Special

Emphasis Panel (SEP) meeting:

Name of SEP: Cancer Genetics Network—

Informatics and Information Technology

Group.

Date: December 9–10, 1997.

Time: December 9–7:30 p.m. to Recess.

December 10—8:00 a.m. to Adjournment.

Place: Ramada Inn—Rockville, 1775

Rockville Pike, Rockville, MD 20852.

Contact Person: Gerald Lovinger, Ph.D.,

Scientific Review Administrator, National

Cancer Institute, NIH, Executive Plaza North,

Room 630C, 6130 Executive Boulevard, MSC

7405, Bethesda, MD 20892–7405, Telephone:

301/496–7987.

Purpose/Agenda: To review, discuss and

evaluate grant applications.

This notice is being published less

than 15 days prior to the meeting due

to the urgent need to meet timing

limitations imposed by the review and

funding cycle.

The meeting will be closed in

accordance with the provisions set forth

in secs. 552b(c)(4) and 552b(c)(6), Title

5, U.S.C. Applications and the

discussions could reveal confidential

trade secrets or commercial property

such as patentable material and

personal information concerning

individuals associated with the

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

(Catalog of Federal Domestic Assistance

Program Numbers: 93.393, Cancer Cause and

Prevention Research; 93.394, Cancer

Detection and Diagnosis Research; 93.395,

Cancer Treatment Research; 93.396, Cancer

Biology Research; 93.397, Cancer Centers

Support; 93.398, Cancer Research Manpower;

93.399, Cancer Control)

Dated: November 25, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–31636 Filed 12–02–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Cancer Institute; Notice of

Closed Meeting

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 meeting

of the National Cancer Institute Special

Emphasis Panel (SEP):

Name of SEP: Informatics Support for

Breast and Colon Cancer Cooperative Family

Registries.

Date: December 8, 1997.

Time: 9:00 a.m. to Adjournment.

Place: Executive Plaza North, Conference

Room C, 6130 Executive Boulevard,

Bethesda, MD 20892.

Contact Person: Courtney M. Kerwin,

Ph.D., M.P.H., Scientific Review

Administrator, National Cancer Institute,

NIH, Executive Plaza North, Room 630I, 6130