11592 Federal Register / Vol. 66, No. 38 / Monday, February 26, 2001 / Notices

Paperwork@hcfa.gov, or call the Reports

Clearance Office at (410) 786–1326.

Written comments and

recommendations for the proposed

information collections must be mailed

within 60 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

HCFA, Office of Information Services,

Security and Standards Group, Division

of HCFA Enterprise Standards,

Attention: Dawn Willinghan (HCFA–R–

267), Room N2–14–26, 7500 Security

Boulevard, Baltimore, Maryland 21244–

1850.

Dated: February 14, 2001.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA Office

of Information Services, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 01–4568 Filed 2–23–01; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Proposed Collection; Comment

Request; Study of Physician

Researchers Concerning Research and

Clinical Care Activities

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

Department of Clinical Bioethics, 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: Study of

Physician Researchers Concerning

Research and Clinical Care Activities.

Type of Information Collection Request:

New. Need and Use of Information

Collection: In order to understand the

sometimes-conflicting obligations of

physicians involved in clinical research,

it is important to study their own

understanding of their work and

responsibilities as researchers and as

clinicians treating patients. This study

aims to gather this information through

interviews with physicians involved in

clinical research and other experts

knowledgeable about their work. In

particular, the study aims to identify

and examine what physicians

experience as the nature of the conflict

between their roles as caregiver and

researcher, physicians’ most recent case

of conflict between treatment and

research, pressures on physicians

involved in research and how they

address or resolve them, conflict

between caring for patients and gaining

generalizable knowledge, and the

influence of the work and institutional

setting on physicians undertaking

medical research. Frequency of

Response: Once for the survey

administration and for individuals

interviewed and on occasion thereafter.

Affected Public: Individuals. Type of

Respondents: Physicians involved in

clinical research and other interviewees

knowledgeable about their practices.

Annual Reporting Burden: The annual

reporting burden follows in the table

below. Annualized Cost to Respondents:

The annualized cost to respondents is

estimated at: $11,000. Capital Costs:

There are no capital costs to report.

Operating or Maintenance Costs: There

are no operating or maintenance costs to

report.

RESPONDENT AND BURDEN ESTIMATE INFORMATION

Type of

respondents

Estimated

number of

respondents

Estimated

number of

response per

respondent

Average burden hours per

response

Estimated total

annual burden

hours

requested

Physician Researchers .................................................................................... 250 1 .5 125

Physician Researchers .................................................................................... 80 1 1 80

Non-Physician-Researcher Interviewees ......................................................... 20 1 1 20

Total .......................................................................................................... 225

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. Elaine Draper,

Ph.D., J.D., Department of Clinical

Bioethics, NIH, Building 10, Room

1C118F, 9000 Rockville Pike, Bethesda,

MD 20892, or call non-toll-free number

(301) 435–8715 or E-mail your request,

including your address to:

EDraper@nih.gov.

Comments Due Date: Comments

regarding this information collection are

best assured of having their full effect if

received on or before April 27, 2001.

Dated: February 14, 2001.

David K. Henderson,

Deputy Director for Clinical Care.

[FR Doc. 01–4619 Filed 2–23–01; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Government-Owned Inventions;

Availability for Licensing

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

Federal Register / Vol. 66, No. 38 / Monday, February 26, 2001 / Notices 11593

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.

Coupled Calcium/Citrate Delivery

System and Method for Apheresis

Devices

Charles D. Bolan (CC), Susan F. Leitman

(CC), Herb Cullis

DHHS Reference No. E–001–01/0 filed 03

Nov 2000

Licensing Contact: Dale Berkley; 301/496–

7735 ext. 223; e-mail: berkleyd@od.nih.gov

The invention is a method and device

for eliminating the long recognized

physiologic symptoms caused by the

use of citrate anticoagulant in apheresis

procedures. The adverse effects caused

by citrate anticoagulants can be

prevented by administration of an

intravenous calcium infusion through

the return line, coupled to the rate of the

citrate infusion administered into the

draw line of apheresis devices. The

invention automatically couples the

calcium infusion rate to the citrate

anticoagulant rate. The device calculates

and administers the appropriate amount

of intravenous elemental calcium to

neutralize citrate symptoms, and

replaces calcium for donors and patients

receiving citrate infusions during the

performance of apheresis procedures.

The invention fills a long standing need

to make apheresis procedures safer,

more economical, and more universally

applicable to a wider range of donors. In

addition, the invention significantly

shortens the amount of time necessary

for the apheresis procedure, by allowing

higher flow rates.

Adaptive Sensitivity Encoding

Incorporating Temporal Filtering

(TSENSE)

Peter Kellman, Elliot McVeigh (NHLBI)

DHHS Reference No. E–200–00/0

Licensing Contact: Dale Berkley; 301/496–

7735 ext. 223; e-mail: berkleyd@od.nih.gov

The invention is an accelerated

magnetic resonance imaging method

developed to reduce the total imaging

time for gated, segmented cine imaging

or to increase the frame rate when

imaging dynamic activity, such as heart

motion or brain activity. The invention

combines temporal filtering (e.g., the

UNFOLD method) with a known spatial

sensitivity encoding technique (SENSE

or SMASH) to achieve a new technique

that is the subject of the invention

(TSENSE) having a higher degree of

alias artifact rejection than could be

obtained using either temporal or spatial

filtering individually. The new

technique tracks changing coil

sensitivities over time, which may arise

due to chest wall or other body motions,

and provides time saving by eliminating

a separate reference acquisition. The

invention is thus a robust accelerated

imaging method that tolerates body

motion or change in scan plane without

the need to reacquire additional

reference images, and the method may

be used to reconstruct the full field-ofview with a large temporal bandwidth.

Endoluminal Radiofrequency

Cauterization System

Bradford J. Wood (CC)

DHHS Reference No. E–244–00/0 filed 07

Dec 2000

Licensing Contact: Dale Berkley; 301/496–

7735 ext. 223; e-mail: berkleyd@od.nih.gov

The invention is a device for

occluding the lumen of a hollow organ,

vessel or aneurysm by delivering radio

frequency energy to its inner wall. The

apparatus uses specialized electrodes

that contact the walls of the organ to

substantially conform to the inner

surface. RF energy is then applied to the

electrode at any of a broad range of

desired frequencies for selected times at

power levels of from 20 to 200 watts.

Delivery of RF energy may be regulated

by monitoring temperature, tissue

impedance or other parameters at or

near the site of the electrode. A

temperature sensor located near the

electrode allows microprocessor-based

control of the power delivered to the

electrode site as a function of tissue

temperature. The device has

applications in therapeutic thrombosis

of an aneurysm, stopping blood flow to

a tumor or bleeding vessel, or reducing

stricture or stenosis in, for example, a

bronchus, esophagus, intestine segment

or a blood vessel. The invention also

may be useful in reducing stenosis in a

coronary artery or to reduce a restenotic

lesion from intimal hyperplasia that

may occur after angioplasty.

Radio Frequency Probes for Tissue

Treatment and Methods of Use

Bradford J. Wood (CC)

DHHS Reference No. E–186–00/0 filed 10 Jul

2000

Licensing Contact: Dale Berkley; 301/496–

7735 ext. 223; e-mail: berkleyd@od.nih.gov

The invention is a device and method

for radio frequency (RF) treatment of

tissue that is designed to destroy or

damage selected tissue areas without

damaging surrounding material.

Improvements upon currently available

techniques include: easier percutaneous

deployment and placement, easier

imaging visualization, less bleeding

complications, and one-handed

deployment. Applications include the

treatment of metastatic cancer lesions in

the liver, kidney or other solid internal

organ. The invention can be used for

minimally invasive procedures. For

example, RF electrodes may be placed

percutaneously to treat a cancer lesion

in the liver. Standard medical imaging

techniques such as ultrasound can be

used to guide the RF electrode into the

proper position, and surface markings

made on the electrode improve the

ultrasound visibility of the instrument.

This invention is easily operated using

only one hand, allowing the operator’s

other hand to be free to operate a

medical imaging device or manage the

delivery of the RF energy. The RF probe

has an introducer that carries it to the

desired site where a number of RF

electrodes are deployed from the

introducer into the subject’s tissue. The

RF electrodes may be deployed by a

spring mechanism. The introducer has a

biodegradable occluder that reduces

tissue injury as the device is inserted

into the subject. The occluder is

displaced from the distal end of the

introducer as the device transitions to a

deployed state.

Modifications of HIV Env, Gag and Pol

Enhance Immunogenicity for Genetic

Immunization

Chakrabarti et al. (NIAID)

DHHS Reference Nos. E–275–00/0 filed 14

Aug 2000 and E–275–00/1 filed 14 Nov

2000

Licensing Contact: Carol Salata; 301/496–

7735 ext. 232; e-mail: salatac@od.nih.gov

Protective immunity against human

immunodeficiency virus-1 (HIV–1) is

likely to require recognition of linear

and conformation epitopes from

multiple HIV antigens. This invention

relates to modified HIV Env, Gag and

Pol DNA and proteins with improved

ability to elicit antibody and CTL

responses. The Env DNA has been

modified to expose the core protein for

optimal antigen presentation and

recognition. This invention also relates

to a Gag-Pol fusion protein that is a

polyprotein designed to maximize

epitope presentation. The effect of

11594 Federal Register / Vol. 66, No. 38 / Monday, February 26, 2001 / Notices

specific mutations in HIV–1 Env on

humoral and cellular immune responses

after DNA vaccination has been

investigated. The modifications of Env

enhance antibody production to this

viral protein that may facilitate the

generation of broadly neutralizing

antibodies to HIV. In addition, the

immune response to HIV–1 Gag and Pol

after plasmid DNA immunization with

Rev-independent expression vectors

encoding various forms of these proteins

has been examined. The Gag-Pol fusion

protein induced the most broad and

potent CTL responses to Gag and Pol in

DNA-vaccinated mice. These DNA

sequences and proteins may be

important immunogens for the

treatment and prevention of HIV

infection.

Mucosal Cytotoxic T Lymphocyte

Responses

Jay A. Berzofsky (NCI), Igor M. Belyakov

(NCI), Michael A. Derby (NCI), Brian L.

Kelsall (NIAID), Warren Strober (NIAID)

Serial Number 09/508,552 filed June 12,

2000; DHHS Reference No. E–268–97/4

filed January 10, 2001

Licensing Contact: Peter Soukas; 301/496–

7056, ext. 268; e-mail: soukasp@od.nih.gov

This invention claims methods and

compositions for inducing a protective

mucosal cytotoxic T lymphocyte (CTL)

response in a mammal involving

administering a soluble antigen or a

soluble antigen with one or more active

agents such as a cytokine or costimulatory molecule to a mucosal

surface or tissue. As a preferred

embodiment, the invention

contemplates intrarectal administration

of the peptide vaccine because the

inventors have shown that there is a

greater CTL response through intrarectal

administration rather than intranasal

administration. The synthetic peptide

vaccines utilized in the invention to

elicit protective immune responses after

mucosal infection comprise a

multideterminant helper peptide

containing a cluster of overlapping

helper epitopes (a PCLUS or cluster

peptide) colinearly synthesized with a

peptide epitope target for neutralizing

antibodies and CTL. The inventors have

generated data showing that an

intrarectally administered synthetic

multiepitope HIV/SIV peptide vaccine

administered to macaques in

conjunction with mutant E. coli heat

labile enterotoxin as an adjuvant

induces mucosal CTL responses that

provide better protection against

intrarectal SHIV infection when

compared to a subcutaneously

administered vaccine comprising the

same peptides inducing as high or

higher systemic CTL responses. The

invention is further described in

Belyakov et al., Proc. Natl. Acad. Sci.

USA 1998 Feb 17;95(4):1709–14 and

Belyakov et al., J. Clin. Invest. 102:

2072–2081, 1998.

A Novel Chimeric Protein for

Prevention and Treatment of HIV

Infection

Edward A. Berger (NIAID), Christie M. Del

Castillo

Serial No. 60/124,681 filed 16 Mar 1999 and

PCT/US00/06946 filed 16 Mar 2000

Licensing Specialist: Peter Soukas; 301/496–

7056 ext. 268; e-mail: soukasp@od.nih.gov

This invention relates to bispecific

fusion proteins effective in viral

neutralization. Specifically, the

invention is a genetically engineered

chimeric protein containing a soluble

extracellular region of human CD4

attached via a flexible polypeptide

linker to a single chain human

monoclonal antibody directed against a

CD4-induced, highly conserved HIV

gp120 determinant involved in

coreceptor interaction. Binding of the

sCD4 moiety to gp120 induces a

conformational change that enables the

antibody moiety to bind, thereby

blocking Env function and virus entry.

This novel bispecific protein displays

neutralizing activity against genetically

diverse primary HIV–1 isolates, with

potency at least 10-fold greater than the

best described HIV–1 neutralizing

monoclonal antibodies. The agent has

considerable potential for prevention of

HIV–1 infection, both as a topical

microbicide and as a systemic agent to

protect during and after acute exposure

(e.g. vertical transmission; postexposure prophylaxis). It also has

potential utility for treatment of chronic

infection. Such proteins, nucleic acid

molecules encoding them, and their

production and use in preventing or

treating viral infections are claimed.

Antimicrobial Magainin Peptides

Michael A. Zasloff, Hao-Chia Chen, Judith H.

Brown, John L. Morell, Charng-Ming

Huang (NICHD)

Serial No. 07/280,363 filed 12/06/1988, now

U.S. Patent 5,221,732; Serial No. 07/

021,493 filed 03/04/1987, now U.S. Patent

4,810,777; Serial No. 07/834,992 filed 02/

14/1992, now U.S. Patent 5,567,681; Serial

No. 07/963,007 filed 10/19/1992, now U.S.

Patent 5,643,876

Licensing Contact: Peter Soukas; 301/496–

7056 ext. 268; e-mail: soukasp@od.nih.gov

First isolated from the skin of the

African clawed frog Xenopus laevis,

magainin peptides have been shown by

the inventors to have broad-spectrum

antimicrobial properties. Both synthetic

and natural magainin peptides are

active against many species of bacteria

and fungi and induce osmotic lysis of

protozoa. Magainin peptides are water

soluble, nonhemolytic at effective

antimicrobial concentrations, have

molecular weights of 2500 or less and

are amphiphilic. Compositions and

methods for their use are claimed in the

patents. These inventions are available

for nonexclusive or exclusive licensing.

The inventions are further described in

Zasloff et al., P.N.A.S. USA 1987

Aug.;84(15):5449–53; Marion et al.,

FEBS Lett. 1988 Jan.18;227(1):21–6;

Soravia et al., FEBS Lett. 1988 Feb.

15;228(2):337–40; Westerhoff et al.,

P.N.A.S. USA 1989 Sep.;86(17):6597–

601; and Gwadz et al., Infect. Immun.

1989 Sep.; 57(9):2628–33.

Dated: February 15, 2001.

Jack Spiegel,

Director, Division of Technology Development

and Transfer, Office of Technology Transfer,

National Institutes of Health.

[FR Doc. 01–4616 Filed 2–23–01; 8:45 am]

BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Government-Owned Inventions;

Availability for Licensing

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.

Plasmids Expressing START Domains

of StAR and MLN64

Dr. Yosuke Tsujishita and Dr. James Hurley

(NIDDK)

DHHS Reference No. E–020–01/0

Licensing Contact: Marlene Shinn; 301/496–

7056 ext. 285; e-mail: shinnm@od.nih.gov