64974 Federal Register / Vol. 65, No. 211 / Tuesday, October 31, 2000 / Notices

designation of regional or national

intermediaries for classes of providers.

We make individual contract action

decisions after considering these factors

in terms of their relative significance

and impact on the effective and efficient

administration of the Medicare program.

In addition, if the cost incurred by the

intermediary or carrier to meet its

contractual requirements exceeds the

amount that we find to be reasonable

and adequate to meet the cost that must

be incurred by an efficiently and

economically operated intermediary or

carrier, these high costs may also be

grounds for adverse action.

VIII. Response to Public Comments

Because of the large number of items

of correspondence we normally receive

on Federal Register documents

published for comment, we are unable

to acknowledge or respond to them

individually. We will consider all

comments we receive by the date and

time specified in the Dates section of

this preamble, and, if we proceed with

a subsequent document, we will

respond to the comments in the

preamble of that document.

In accordance with the provisions of

Executive Order 12866, this notice was

reviewed by the Office of Management

and Budget.

IX. Federalism

We have reviewed this notice under

the threshold criteria of Executive Order

13132, Federalism. We have determined

that the notice does not significantly

affect the rights, roles, and

responsibilities of States.

(Catalog of Federal Domestic Assistance

Program No. 93.773, Medicare—Hospital

Insurance, and Program No. 93.774,

Medicare—Supplementary Medical

Insurance Program)

Dated: September 8, 2000.

Nancy-Ann Min DeParle,

Administrator, Health Care, Financing

Administration.

[FR Doc. 00–27955 Filed 10–30–00; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Government-Owned Inventions;

Availability for Licensing

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: The invention listed below is

owned by an agency of the U.S.

Government and is available for

licensing in the U.S. in accordance with

35 U.S.C. 207 to achieve expeditious

commercialization of results of federally

funded research and development.

ADDRESSES: Licensing information and a

copy of the U.S. patent application

referenced below may be obtained by

contacting J. R. Dixon, Ph.D., at the

Office of Technology Transfer, National

Institutes of Health, 6011 Executive

Boulevard, Suite 325, Rockville,

Maryland 20852–3804 (telephone 301/

496–7056 ext 206; fax 301/402–0220; email jd212g@NIH.GOV). A signed

Confidential Disclosure Agreement is

required to receive a copy of any patent

application.

Entitled: ‘‘USE OF 14–3–3σ AS A

DIAGNOSTIC MARKER AND

THERAPEUTIC TARGET’’—A Method

to Diagnosis and Determine the

Prognosis of Breast and/or Ovarian

Cancers.

Inventors: Drs. Olga Aprelikova (NCI)

and Edison T. Liu (NCI) DHHS Ref. No.

E–307–00/0, Filed with the USPTO on

September 7, 2000.

Breast cancer is one of the most

significant cancerous diseases that

affects women. At the current rate,

American women have a 1 in 8 risk of

developing breast cancer by age 95

(American Cancer Society, 1992).

Treatment of breast cancer at later stages

is often futile and disfiguring, making

early detection a high priority in

medical management of the disease.

Ovarian cancer, although less frequent

than breast cancer is often rapidly fatal

and is the fourth most common cause of

cancer mortality in American women.

Genetic factors contribute to an illdefined proportion of breast cancer

incidence, estimated to be about 5% of

all cases but approximately 25% of

cases diagnosed before age 40. Breast

cancer has been subdivided into two

types, early-age onset and late-age onset,

based on an inflection in the agespecific incidence curve around age 50.

Mutation of one gene, BRCA1, is

thought to account for approximately

45% of familial breast cancer, but at

least 80% of families with both breast

and ovarian cancer.

The 14–3–3σ checkpoint control gene

is significantly downregulated in

BRCA1 -/-cells. The cell cycle profile of

these cells treated with ionizing

radiation showed an inability to sustain

G2/M growth arrest typical for 14–3–3σ

deprived cells. In addition, 14–3–3σ has

been identified as a p53 inducible gene

after DNA damage. Thus, BRCA1

synergistically activates p53 dependent

transcription of 14–3–3σ gene. These

observations demonstrate the role of 14–

3–3σ, and the interaction of BRCA1,

p53, and 14–3–3σ in neoplastic

conditions, such as breast cancer or

ovarian cancer.

The technology disclosed in the E–

307–00/0 patent application is directed

to a method to identify an agent that

modulates 14–3–3σ. The 14–3–3σ

checkpoint control gene is significantly

downregulated in BRCA1 -/-cells. The

method includes incubating the agent

and a sample of interest, wherein the

sample is capable of expressing 14–3–

3σ, under conditions sufficient to allow

the compound of interest to interact

with the sample, and determining the

effect of the compound on the

expression or activity of 14–3–3σ. The

effect of an agent on the interaction of

14–3–3σ with p53 and/or BRCA1 can

also be assessed. A method is also

provided for determining the prognosis

of a subject diagnosed with a 14–3–3σassociated disorder. The method

includes contacting a sample from the

subject with a reagent that binds to 14–

3–3σ, detecting binding of the reagent to

14–3–3σ; and correlating the binding of

the reagent to the sample with the

prognosis of the disorder. The method

can also include detecting p53 and/or

BRCA1 mutations.

The above mentioned invention is

available for licensing on an exclusive

or non-exclusive basis.

Dated: October 23, 2000.

Jack Spiegel,

Director, Division of Technology Development

& Transfer, Office of Technology Transfer.

[FR Doc. 00–27890 Filed 10–30–00; 8:45 am]

BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Office of the Director, National

Institutes of Health; Amended Notice

of Meeting

Notice is hereby given of a change in

the meeting of the Director’s Council of

Public Representatives, October 31–

November 1, 2000, National Institutes of

Health, 9000 Rockville Pike, Building

31, Conference Room 6, Bethesda, MD

20982 which was published in the

Federal Register on October 10, 2000,

65 FR 60200–60201.

The dates, times, and location of the

meeting are the same but the agenda has

changed to discuss human research

protections and medical applications

research. The meeting is open to the

public.

Federal Register / Vol. 65, No. 211 / Tuesday, October 31, 2000 / Notices 64975

Dated: October 17, 2000.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 00–27887 Filed 10–30–00; 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.

The meeting will be closed to the

public in accordance with the

provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,

as amended. The grant applications and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the grant

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Cancer

Institute Special Emphasis Panel, NCI

Scholars Program: RFA CA–01–007.

Date: November 14, 2000.

Time: 6 pm to 8 pm.

Agenda: To review and evaluate grant

applications.

Place: The Georgetown Holiday Inn, 2101

Wisconsin Ave, NW, Washington, DC 20007.

Contact Person: Mary Bell, PhD, Scientific

Review Administrator, Grants Review

Branch, Division of Extramural Activities,

National Cancer Institute, National Institutes

of Health, 6116 Executive Boulevard, Room

8058, Bethesda, MD 20892, 301/496–7878.

This notice is being published less than 15

days prior to the timing limitations imposed

by the review and funding cycle.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.392, Cancer Construction,

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, National Institutes of Health,

HHS)

Dated: October 19, 2000.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 00–27879 Filed 10–30–00; 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.

The meeting will be closed to the

public in accordance with the

provisions set forth in sections

552b(c)(4) and 552b(c)(6), title 5 U.S.C.,

as amended. The grant applications and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the grant

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Cancer

Institute Special Emphasis Panel, Molecular

Target Drug Discovery For Cancer.

Date: November 29, 2000.

Time: 8 am to 5 pm

Agenda: To review and evaluate grant

applications.

Place: Double Tree Hotel, 1750 Rockville

Pike, Rockville, MD 20852.

Contact Person: Lalita D. Palekar, PhD,

Scientific Review Administrator, Special

Review, Referral and Resources Branch,

Division of Extramural Activities, National

Cancer Institute, National Institutes of

Health, 6116 Executive Boulevard, Room

8066, Bethesda, MD 20892–7405, (301) 496–

7575.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.392, Cancer Construction;

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, National Institutes of Health,

HHS)

Dated: October 19, 2000.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 00–27880 Filed 10–30–00; 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 meeting of the

Board of Scientific Counselors, National

Cancer Institute.

The meeting will be closed to the

public as indicated below in accordance

with the provisions set forth in sections

552b(c)(6) and 552b(c)(9)(B), Title 5

U.S.C. as amended. The discussions

could reveal information of a personal

nature where disclosure would

constitute a clearly unwarranted

invasion of personal privacy and the

premature disclosure of discussions

related to personnel and programmatic

issues would be likely to significantly

frustrate the subsequent implementation

or recommendations.

Name of Committee: Board of Scientific

Counselors, National Cancer Institute,

Subcommittee B—Basic Sciences.

Date: November 13, 2000.

Time: 8:30 am. 5:30 pm.

Agenda: Discussion of personnel and

programmatic issues and review and evaluate

individual Principal Investigators.

Place: National Cancer Institute, Building

31, C Wing, 6th Floor, Conference Room 6,

9000 Rockville Pike, Bethesda, MD 20892.

Contact Person: Florence Farber, PhD,

Executive Secretary, Institute Review Office,

Office of the Director, National Cancer

Institute, National Institutes of Health, 6116

Executive Boulevard, Room 7017, Rockville,

MD 20852, (301) 496–7628.

(Catalogue of Federal Domestic Assistance

Program Nos. 93–392, Cancer Construction;

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, National Institutes of Health, HHS)

Dated: October 18, 2000.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 00–27881 Filed 10–30–00; 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.

The meeting will be closed to the

public in accordance with the

provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,

as amended. The grant applications and

the discussions could disclose

confidential trade secrets or commercial