33104 Federal Register / Vol. 66, No. 119 / Wednesday, June 20, 2001 / Notices

Type of respondents

Estimated

number of

respondents

Estimated

number of

responses per

respondent

Average burden

hours per

response

Estimated total

burden hours

requested

Women calling in (Eligibility Screening) .............................................. 63,000 1 0.25 15,750

Telephone Interview (CATI) ................................................................. 50,500 1 1.5 75,750

Questionnaires (self-administered) ...................................................... 50,500 1 1.0 50,500

Biological Collections ........................................................................... 50,500 1 3.0 2 151,500

Total .......................................................................................... 1 63,000 .......................... .............................. 293,500

1Expect 20% (12,500) ineligible after screening, + 500 incident cases.

2 Includes waiting and travel time, and scheduling appointment for blood draw.

Request for Comments: Written

comments and/or suggestions from the

public and affected agencies are invited

on one or more of the following points:

(1) Whether the proposed collection of

information is necessary for the proper

performance of the function of the

agency, including whether the

information will have practical utility;

(2) 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) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to 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.

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: Dr. Dale P.

Sandler, Acting Chief, Epidemiology

Branch, NIEHS, Building 101, A–304,

P.O. Box 12233, Research Triangle Park,

NC 27709 or call non-toll-free number

(919) 541–4668 or E-mail your request,

including your address to:

‘‘sandler@niehs.nih.gov.’’

Comments Due Date: Comments

regarding this information collection are

best assured of having their full effect if

received on or before August 20, 2001.

Dated: June 12, 2001.

Francine Little,

NIEHS, Associate Director for Management.

[FR Doc. 01–15460 Filed 6–19–01; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Environmental

Health Sciences; Division of

Extramural Research and Training;

Proposed Collection; Comment

Request; Hazardous Waste Worker

Training

SUMMARY: In compliance with the

requirement of section 3506(c)(2)(A) of

the Paperwork Reduction Act of 1995,

for opportunity for public comment on

proposed data collection projects, the

National Institute of Environmental

Health Sciences (NIEHS), the National

Institutes of Health (NIH) will publish

periodic summaries of proposed

projects to be submitted to the Office of

Management and Budget (OMB) for

review and approval.

Proposed Collection: Title: Hazardous

Waste Worker Training—42 CFR part

65. Type of Information Collection

Request: Revision of OMB No. 0925–

0348 and expiration date 10/31/2001.

Need and Use of Information Collection:

This request for OMB review and

approval of the information collection is

required by regulation 42 CFR part

65(a)(6). The National Institute of

Environmental Health Sciences (NIEHS)

was given major responsibility for

initiating a worker safety and health

training program under section 126 of

the Superfund Amendments and

Reauthorization Act of 1986 (SARA) for

hazardous waste workers and

emergency responders. A network of

non-profit organizations that are

committed to protecting workers and

their communities by delivering highquality, peer-reviewed safety and health

curricular to target populations of

hazardous waste workers and

emergency responders has been

developed. In thirteen years (FY 1987–

2000), the NIEHS Worker Training

program has successfully supported 20

primary grantees that have trained

nearly 1 million workers across the

country and presented over 54,000

classroom and hands-on training

courses, which have accounted for

nearly 16 million contact hours of actual

training. Generally, the grant will

initially be for one year, and subsequent

continuation awards are also for one

year at a time. Grantees must submit a

separate application to have the support

continued for each subsequent year.

Grantees are to provide information in

accordance with S65.4(a), (b), (c) and

65.6(a) on the nature, duration, and

purpose of the training, selection

criteria for trainees’ qualifications and

competency of the project director and

staff, cooperative agreements in the case

of joint applications, the adequacy of

training plans and resources, including

budget and curriculum, and response to

meeting training criteria in OSHA’s

Hazardous Waste Operations and

Emergency Response Regulations (29

CFR 1910.120). As a cooperative

agreement, there are additional

requirements for the progress report

section of the application. Grantees are

to provide their information in hard

copy as well as enter information into

the WETP Grantee Data Management

System. The information collected is

used by the Director through officers,

employees, experts, and consultants to

evaluate applications based on technical

merit to determine whether to make

awards. Frequency of Response:

Biannual. Affected Public: Non-profit

organizations. Type of Respondents:

Grantees. The annual reporting burden

is as follows: Estimated Number of

Respondents: 18; Estimated Number of

Responses per Respondent: 2; Average

Burden Hours Per Response: 10; and

Estimated Total Annual Burden Hours

Requested: 360. The annualized costs to

respondents is estimated at: $9,180.

There are no Capital Costs, Operating

Costs and/or Maintenance Costs to

report.

Request for Comments: Written

comments and/or suggestions from the

public and affected agencies should

address one or more of the following

points: (1) Evaluate whether the

proposed collection of information is

necessary for the proper performance of

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