Federal Register / Vol. 65, No. 191 / Monday, October 2, 2000 / Notices 58777

ANDA No. Drug Applicant

89–616 Isoetharine Inhalation Solution USP, 0.167%. Do.

89–617 Isoetharine Inhalation Solution USP, 0.2%. Do.

89–618 Isoetharine Inhalation Solution USP, 0.25%. Do.

Therefore, under section 505(e) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 355(e)) and under authority

delegated to the Director, Center for

Drug Evaluation and Research (21 CFR

5.82), approval of the applications listed

in the table in this document, and all

amendments and supplements thereto,

is hereby withdrawn, effective October

10, 2000.

Dated: September 12, 2000.

Janet Woodcock,

Director, Center for Drug Evaluation and

Research.

[FR Doc. 00–24844 Filed 9–29–00; 8:45 am]

BILLING CODE 4160–01–F

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 inventions listed below

are owned by agencies of the U.S.

Government and are 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. Foreign patent

applications are filed on selected

inventions to extend market coverage

for companies and may also be available

for licensing.

ADDRESSES: Licensing information and

copies of the U.S. patent applications

listed below may be obtained by writing

to the indicated licensing contact at the

Office of Technology Transfer, National

Institutes of Health, 6011 Executive

Boulevard, Suite 325, Rockville,

Maryland 20852–3804; telephone: 301/

496–7057; fax: 301/402–0220. A signed

Confidential Disclosure Agreement will

be required to receive copies of the

patent applications.

Method and Device for Analysis of

Biological Specimens

M. Emmert-Buck (NCI), C. Englert (NCI),

R. Bonner (NICHD), and L. Liotta

(NCI)

DHHS Reference No. E–197–00/0 filed

26 Jul 2000

Licensing Contact: Uri Reichman; 301/

496–7736 ext. 240; e-mail:

reichmau@od.nih.gov

The invention discloses methods for

selective analysis of cellular samples,

and more particularly it provides

methods for selective analysis of tissue

samples, such as tumors. The methods

include placing the tissue on a surface

such as membrane for example, and

activating the surface at selected sites

adjacent to the cells of interest. The

activated sites become permeable and

thus transferable to fluids. The cells

adjacent to the permeable sites can than

be selectively extracted and their

content analyzed by standard

biochemical procedures or by applying

the extract to microarray devices, such

as cDNA arrays, for analysis of gene

expression etc. The technique presents

a convenient alternative to existing

methods of tissue microdissection. For

further convenience, the technique can

be readily combined with a variety of

analytical devices such as microarrays

biochips or other devices which include

multiple regions carrying multiple

capture molecules.

Hepatitis A Virus Clones Adapted for

Growth in African Green Monkey

Kidney (AGMK) Cells and Vaccines

Comprising said Clones

Robert H. Purcell et al. (NIAID)

DHHS Reference No. E–008–95/0 filed

06 Aug 1999

Licensing Specialist: Carol Salata; 301/

496–7735 ext. 232; e-mail:

salatac@od.nih.gov

The present invention relates to

hepatitis A virus clones adapted to

growth in African Green Monkey

Kidney Cells intended to be used as a

live attenuated vaccine. Several cell

culture-adapted strains of hepatitis A

virus (HAV) are currently being used as

inactivated vaccines. However, the

inactivated vaccines have the limitation

that multiple doses are required for

effective immunization. Thus, a live

vaccine could have the advantage of

inducing life-long immunity following

administration of only a single dose.

Preclinical studies have been done

using virus isolates of this invention.

Preliminary observations suggest that

some of the HM–175 P39 virus isolates

analyzed may be promising candidates

for use as a live attenuated vaccine.

HM–175 P39 clone 15 appears to have

the growth and attenuation properties

that are desirable in a live vaccine for

HAV as it is partially attenuated for

tamarins and fully attenuated for

chimpanzees. HM–175 P39 clone 13

may also be a potential vaccine

candidate as it replicates efficiently in

tamarins, resulting in moderate

increases in serum liver enzyme and

early seroconversion to anti-HAV

positivity but is still fully attenuated for

chimpanzees.

Method of Predicting Susceptibility to

HIV Infection or Progression of HIV

Disease

Michael W. Smith, Hyoung Doo Shin,

Stephen J. O’Brien (NCI)

DHHS Reference No. E–066–99/0 filed

09 Apr 1999 and DHHS Reference No.

E–066–99/1 filed 06 Apr 2000

Licensing Contact: J. P. Kim; 301/496–

7056 ext. 264; e-mail:

kimj@od.nih.gov

This invention identifies the

importance of a variant in the IL 10 gene

(–592–5′A) that is commonly found in

the population with HIV–1/AIDS.

Individuals that inherit one or two

copies of this form of IL 10 are at a

greater risk for progression from HIV–1

infection to the development of clinical

AIDS or death. The effects of IL 10–592

are particularly evident 5 years after

infection. The gene variant and its

product may be of diagnostic value in

testing to determine treatment regimens

for patients and mimicking the effect of

the IL 10–5′A gene variant may be

useful in developing therapies for HIV

infection. The polymorphism of the

present invention can be used in

association with other alleles, such as

CCR5–D32, CCR2–64I, CCR5– +.P1.+,

HLA–B35 and HLA homozygosity, to

determine an individual’s susceptibility

to HIV infection, and provide a

prognosis for disease progression in

those who have been infected. The

potential therapies derived from the IL

10–592 genetic variant may be

particularly applicable to patients on

triple drug therapy since these patients

have generally been infected for a

number of years prior to treatment.

58778 Federal Register / Vol. 65, No. 191 / Monday, October 2, 2000 / Notices

Isolation of Cellular Material Under

Microscopic Visualization

Liotta et al. (NCI)

Serial No. 08/203,780 filed 01 Mar 1994,

issued as U.S. Patent No. 5,843,644;

Serial No. 08/544,388 filed 10 Oct

1995, issued as U.S. Patent No.

5,843,657; Serial No. 08/882,699 filed

25 Jun 1997; Serial No. 08/925,894

filed 08 Sep 1997, issued as U.S.

Patent No. 6,010,888; Serial No. 09/

388,805 filed 02 Sep 1999

Licensing Contact: J. P. Kim; 301/496–

7056 ext. 264; e-mail:

kimj@od.nih.gov

The present technology provides

methods and devices for the isolation

and analysis of cellular samples on a

molecular or genetic level. More

particularly, the invention relates to

methods and devices for the

microdissection, for example, utilizing

laser capture microdissection (LCM),

and the diagnosis and analysis of

cellular samples which may be used in

combination with a number of different

technologies that allow for analysis of

enzymes, antigens, mRNA, DNA, and

the like from pure populations or

subpopulations of particular cell types.

Nucleic Acid Constructs Containing

HIV Genes with Mutated Inhibitory/

Instability Regions and Methods of

Using Same

George N. Pavlakis, Barbara K. Felber

(NCI)

Serial No. 07/858,747 filed 27 Mar 1992;

U.S. Patent 5,972,596 issued 26 Oct

1999; U.S. Patent 5,965,726 issued 12

Oct 1999; Serial No. 09/414,117 filed

08 Oct 1999; PCT/US93/02908

Licensing Contact: Carol Salata; 301/

496–7735 ext. 232; e-mail:

salatac@od.nih.gov

This invention describes methodology

for modifying the inhibitory/instability

sequences (INS) of mRNA by making

multiple nucleotide substitutions

without altering the coding capacity of

the mRNA of interest. Mutating INS

allows for or increases the expression of

genes that would otherwise have not

been expressed or would have been

poorly expressed because of the INS

normally present on the mRNA

transcript. This novel approach also

improves the stability of the mRNA.

These methods can be used to increase

the production of protein from many

genes producing, for example, growth

hormone, interferons, interleukins, and

HIV Gag and env. DNA constructs are

described which encode Gag protein

which is highly expressed and does not

require HIV rev for production. Thus it

is a potentially useful HIV DNA vaccine.

Assays have also been developed to

facilitate detection of the boundaries of

INS sequences of any mRNA.

Dated: September 20, 2000.

Jack Spiegel,

Director, Division of Technology Development

and Transfer, Office of Technology Transfer,

National Institutes of Health.

[FR Doc. 00–25175 Filed 9–29–00; 8:45 am]

BILLING CODE 4140–01–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. Foreign patent

applications are filed on selected

inventions to extend market coverage

for companies and may also be available

for licensing.

ADDRESS: Licensing information and

copies of the U.S. patent application

listed below may be obtained by

contacting Susan S. Rucker, J.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. 245; fax: 301/402–0220;

e-mail: ruckers@od.nih.gov. A signed

Confidential Disclosure Agreement will

be required to receive a copy of the

patent application.

HGF–SF Monoclonal Antibody

Combinations

B Cao, S Koochekpou, M Oskarsson, D

Bjurickovic, M Fivash, R Fisher and

GR Vande Woude (NCI)

Serial No. 60/164,173 filed 09 Nov 1999

The invention described and claimed

in this application relates to a

composition which comprises a

combination of two or more antibodies

which specifically bind one or more

epitopes of the growth factor known as

hepatocyte growth factor/scatter factor

(HGF/SF) which is able to inhibit HGF/

SF signaling. In particular, the

antibodies which specifically bind to

HGF/SF are monoclonal antibodies.

Hepatocyte Growth Factor (HGF)

activates migration and proliferation of

endothelial cells and is angiogenic,

acting through the tyrosine kinase

receptor encoded by the Met

protooncogene. In addition, HGF/SF

displays a unique feature in inducing

‘‘branching morphogenesis’’, a complex

program of proliferation and

motogenesis in a number of different

cell types. Moreover, HGF is involved in

the invasive behavior of several tumor

cells both in vivo and in vitro. This

combination of antibodies may be useful

in drug screening assays, detection of

HGF/SF expression or activity or in

treating HGF/SF related diseases such as

cancer.

Dated: September 21, 2000.

Jack Spiegel,

Director, Division of Technology Development

and Transfer Office of Technology Transfer

National Institutes of Health.

[FR Doc. 00–25176 Filed 9–29–00; 8:45 am]

BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Notice of Meeting: Chronic Fatigue

Syndrome Coordinating Committee

In accordance with section 10(a) of

the Federal Advisory Committee Act, as

amended (5 U.S.C., Appendix 2), notice

is hereby given of a meeting of the

Chronic Fatigue Syndrome Coordinating

Committee.

Name: Chronic Fatigue Syndrome

Coordinating Committee

Time and Date: Wednesday, October 25,

2000, from 9 a.m. to 4:30 p.m.

Place: Hubert H. Humphrey Building,

Room 800, 200 Independence Avenue, SW.,

Washington, DC 20201.

Status: Open to the public, limited only by

the space available. The meeting room will

accommodate approximately 100 people.

Individuals who plan to attend and need

special assistance, such as sign language

interpretation or other reasonable

accommodations, should notify the Contact

Person listed below in advance of the

meeting.

Notice: In the interest of security, the

Department has instituted stringent

procedures for entrance to the Hubert H.

Humphrey Building by non-government

employees. Thus, persons without a

government identification card will need to

provide a photo ID and must know the

subject and room number of the meeting in

order to be admitted into the building.

Visitors must use the Independence Avenue

entrance.

Purpose: The Committee is charged with

providing advice to the Secretary, the

Assistant Secretary for Health, and the

Commissioner, Social Security

Administration (SSA), to assure interagency

coordination and communication regarding

chronic fatigue syndrome (CFS) research and