Federal Register / Vol. 66, No. 119 / Wednesday, June 20, 2001 / Notices 33105

the function of the agency, including

whether the information will have

practical utility; (2) evaluate the

accuracy of the agency’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) enhance the quality, utility, and

clarity of the information to be

collected; and (4) minimize the burden

of the collection of information on those

who are to respond, including the use

of appropriate automated, electronic,

mechanical, or other technological

collection techniques or other forms of

information technology.

Comments Due Date: Comments

regarding this information collection are

best assured of having their full effect if

received on or before August 20, 2001.

FOR FURTHER INFORMATION CONTACT: To

request more information on the

proposed project or to obtain a copy of

the data collection plans and

instruments, contact: Joseph T. Hughes,

Jr., Director, Worker Education and

Training Program, Division of

Extramural Research and Training,

NIEHS, P.O. Box 12233, Research

Triangle Park, NC 27709 or call non-tollfree number (919) 541–0217 or E-mail

your request, including your address to

wetp@niehs.nih.gov.

Dated: June 7, 2001.

Francine Little,

NIEHS, Associate Director for Management.

[FR Doc. 01–15461 Filed 6–19–01; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Government-Owned Inventions;

Availability for Licensing:

Conformationally Locked Nucleoside

Analogs as Antiherpetic Agents

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

contacting Peter A. Soukas, 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. 268; fax: 301/402–0220;

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

Confidential Disclosure Agreement will

be required to receive copies of the

patent applications.

SUPPLEMENTARY INFORMATION: These

inventions relate to therapeutics for

Herpes Simplex Virus (HSV), a major

public health threat. Results of a recent,

nationally representative study show

that genital herpes infection, caused by

HSV–2, is common in the United States.

Nationwide, 45 million people ages 12

and older, or one out of five of the total

adolescent and adult population, is

infected with HSV–2. Once infected

with HSV, people remain infected for

life. The inventors’ research has shown

that these compounds are significantly

more potent than current therapeutics

for HSV. Development of these

inventions would provide a significant

benefit to the public health in the form

of potentially lower cost therapeutics

based on the potency of the compounds.

Conformationally Locked Nucleoside

Analogues

Victor E. Marquez, Juan B. Rodriguez,

Marc C. Nicklaus, Joseph J. Barchi, Jr.,

Maqbool A. Siddiqui (NCI)

U.S. Patent 5,629,454 issued 13 May

1997; U.S. Patent 5,869,666 issued 9

Feb 1999; PCT/US94/10794 (issued as

European Patent Number 0720604

and Australian Patent Number

677441)

and

Conformationally Locked Nucleoside

Analogs as Antiherpetic Agents

Victor E. Marquez, Juan B. Rodriguez,

Marc C. Nicklaus, Joseph J. Barchi, Jr.,

Maqbool A. Siddiqui (NCI)

U.S. Patent 5,840,728 issued 23 Nov

1998

The compounds of the present

invention represent the first examples of

carbocyclic dideoxynucleosides that in

solution exist locked in a defined Ngeometry (C3′-endo) conformation

typical of conventional nucleosides.

These analogues exhibit increased

stability due to the substitution of

carbon for oxygen in the ribose ring. The

invention includes 4′-6′-cyclopropane

fused carbocyclic dideoxynucleosides,

2′-deoxynucleosides and

ribonucleosides as well as

oligonucleotides derived from these

analogues; the preferred embodiment of

the invention is carbocyclic-4′-6′-

cyclopropane-fused analogues of

dideoxypurines, dideoxypyrimidines,

deoxypurines, deoxypyrimidines,

purine ribonucleosides and pyrimidine

ribonucleosides. In addition,

oligonucleotides derived from one or

more of the nucleosides in combination

with the naturally occurring nucleosides

are within the scope of the present

invention.

The second invention discloses a

method for the treatment of herpes virus

infections by the administration of

cyclopropanated carbocyclic 2′-

deoxynucleosides to an affected

individual. This invention is a method

of administration of the compounds

described above. The compounds of this

invention are particularly efficacious

against herpes simplex viruses 1 and 2

(HSV–1 and HSV–2), Epstein-Barr Virus

(EBV) and human cytomegalovirus

(CMV), although the nucleoside

analogues of the invention may be used

to treat any condition caused by a

herpes virus. Specifically, the Nmethanocarba-T (Thymidine) analogue

has been shown to exhibit strong

activity against HSV–1 and HSV–2, and

moderate to strong activity against EBV.

Significantly, the anti-HSV activity of

the Thymidine analogue is stronger than

that of Acyclovir (shown in a plaque

reduction assay), a widely used antiHSV therapeutic. Furthermore, the

Thymidine analogue is also non-toxic

against stationary cells and is potent

against rapidly dividing cells. Dosage

amounts for the compounds are similar

to those of Acyclovir.

Descriptions of these inventions may

be found in Rodriguez et al., J.

Medicinal Chemistry 37:3389–3399

(1994) and Marquez et al., J. Medicinal

Chemistry 39:3739–3747 (1996).

5–Substituted Derivatives of

Conformationally Locked Nucleoside

Analogues

Victor Marquez, Pamela Russ (NCI)

DHHS Reference No. E–249–00/0, U.S.

S/N 60/220,934 filed 26 Jul 2000

This invention relates to 5-substituted

derivatives of conformationally locked

nucleoside analogues and methods of

using these derivatives as antiviral and

anticancer agents. The compounds

contemplated by the invention are

nucleoside analogues where the 5-

substituent is a halogen, alkyl, alkene,

halovinyl or alkyne group, and the

nucleotide base is cytosine or uracil.

The analogues are particularly effective

in treating viral infections, specifically

infections of DNA viruses such as

Herpes simplex virus (HSV), Varicella

zoster virus (VSV), Epstein Barr virus

(EBV), and Cytomegalovirus (CMV) as

well as members of the Poxviridae

family. The inventors have

33106 Federal Register / Vol. 66, No. 119 / Wednesday, June 20, 2001 / Notices

demonstrated in plaque reduction

assays that 5-substituted uracils (bromo,

iodo, and bromovinyl) attached to a

bicyclo[3.1.0]hexane template are thirty

times more potent than acyclovir against

HSV–1 and HSV–2.

Dated: June 11, 2001.

Jack Spiegel,

Director, Division of Technology Development

and Transfer, Office of Technology Transfer,

National Institutes of Health.

[FR Doc. 01–15459 Filed 6–19–01; 8:45 am]

BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Government-Owned Inventions;

Availability for Licensing: Cloned

Hepatitis C Virus (HCV) Genomes,

Chimeras, and Derivatives Thereof

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

contacting Peter A. Soukas, 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. 268; fax: 301/402–0220;

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

Confidential Disclosure Agreement will

be required to receive copies of the

patent applications.

SUPPLEMENTARY INFORMATION: Hepatitis

C virus (HCV) is a single stranded RNA

virus responsible for the majority of

non-A non-B hepatitis. Hepatitis C virus

(HCV) has a worldwide distribution and

is a major cause of liver cirrhosis and

hepatocellular carcinoma in the U.S.,

Europe, and Japan. For this reason,

development of a vaccine against

hepatitis C is of great importance. The

present inventions claim full-length

sequences of HCV, HCV chimeras and

HCV derivatives, and methods for using

these full-length sequences for a variety

of therapeutic and diagnostic

applications, including vaccines.

Cloned Genomes of Infectious Hepatitis

C Virus and Uses Thereof

Masayuki Yanagi, Jens Bukh, Suzanne

U. Emerson, Robert H. Purcell (NIAID)

Serial No. 09/014,416 filed 27 Jan 1998,

issued as U.S. Patent 6,153,421 on 28

Nov 2000; Serial No. 09/662,454 filed

14 Sep 2000; Canadian Application

2295552; Australian Application

84889/98; European Application

98935702.5

The current invention provides

nucleic acid sequences comprising the

genomes of infectious hepatitis C

viruses (HCV) of genotype 1a and 1b. It

covers the use of these sequences, and

polypeptides encoded by all or part of

the sequences, in the development of

vaccines and diagnostic assays for HCV

and the development of screening

assays for the identification of antiviral

agents for HCV. Additional information

can be found in Yanagi et al., (1997)

Proc. Natl. Acad. Sci., USA 94, 8738–

8743 and Yanagi et al. (1998) Virology

244, 151–172.

Cloned Genome of Infectious Hepatitis

C Virus of Genotype 2a and Uses

Thereof

Jens Bukh, Masayuki Yanagi, Robert H.

Purcell, Suzanne U. Emerson (NIAID)

DHHS Reference No. E–100–99/0, U.S.

S/N 60/137,693 filed 04 Jun 1999;

DHHS Reference No. E–100–99/1,

PCT/US00/15466 filed 02 Jun 2000

The current invention provides a

nucleic acid sequence comprising the

genome of infectious hepatitis C viruses

(HCV) of genotype 2a. The encoded

polyprotein differs from those of the

infectious clones of genotypes 1a and 1b

(U.S. Patent 6,153,421) by

approximately thirty (30) percent. It

covers the use of this sequence and

polypeptides encoded by all or part of

the sequence, in the development of

vaccines and diagnostic assays for HCV

and the development of screening

assays for the identification of antiviral

agents for HCV. Additional information

can be found in Yanagi et al. (1999),

Virology 262, 250–263.

HCV/BVDV Chimeric Genomes and

Uses Thereof

Jae-Hwan Nam, Jens Bukh, Robert H.

Purcell, Suzanne U. Emerson (NIAID)

DHHS Reference No. E–102–99/0, U.S.

S/N 60/137,817 filed 04 June 1999;

DHHS Reference No. E–102–99/1,

PCT/US00/15527 filed 02 Jun 2000

The current invention provides

nucleic acid sequences comprising

chimeric viral genome of hepatitis C

Virus (HCV) and bovine viral diarrhea

viruses (BVDV). The chimeric viruses

are produced by replacing the structural

region or a structural gene of an

infectious BVDV clone with the

corresponding region or gene of an

infectious HCV. It covers the use of

these sequences and polypeptides

encoded by all or part of the sequences

in the development of vaccines and

diagnostic assays for HCV and the

development of screening assays for the

identification of antiviral agents for

HCV.

Infectious cDNA Clone of GB Virus B

and Uses Thereof

Jens Bukh, Masayuki Yanagi, Robert H.

Purcell, Suzanne U. Emerson (NIAID)

DHHS Reference No. E–173–99/0, U.S.

S/N 60/137,694 filed 04 Jun 1999;

DHHS Reference No. E–173–99/1,

PCT/US00/15293 filed 02 Jun 2000

The current invention provides

nucleic acid sequences comprising the

genomes of infectious GB virus B, the

most closely related member of the

Flaviviridae to hepatitis C virus (HCV).

It also covers chimeric GBVB–HCV

sequences and polypeptides for use in

the development of vaccines and

diagnostic assays for HCV and the

development of screening assays for the

identification of antiviral agents for

HCV. Additional information can be

found in Bukh et al. (1999), Virology

262, 470–478.

Dated: June 11, 2001.

Jack Spiegel,

Director, Division of Technology Development

and Transfer, Office of Technology Transfer,

National Institutes of Health.

[FR Doc. 01–15462 Filed 6–19–01; 8:45 am]

BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of the Secretary

White House Commission on

Complementary and Alternative

Medicine Policy; Notice of Meeting

Pursuant to section 10(a) of the

Federal Advisory Committee Act, as

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

is given of a meeting of the White House

Commission on Complementary and

Alternative medicine Policy.

The purpose of this public meeting is

to convene the Commission to discuss

possible Federal policy regarding

complementary and alternative

medicine (CAM). The main focus of the

meeting is the development and

discussion of draft recommendations

that may be included in the Interim and