Federal Register / Vol. 66, No. 103 / Tuesday, May 29, 2001 / Notices 29153

intrinsic reasons for choosing to donate

blood, as well as external reasons for

choosing to donate blood. Donors who

do not initially respond to the mail

survey will be given the opportunity to

complete the survey on a secured

website. Comparisons will be made

between one-time donors and repeat

donors will be premise that repeat

donors may have a stronger altruistic

impetus for donating than donors who

donate less frequently. Donors will be

asked about the donation experience,

the context in which he/she first

donated blood, and questions

addressing accessibility to donate. Using

the Self-Report Altruism Scale,

respondents will rate themselves based

on other personal behaviors that are

considered to exhibit social

responsibility and/or altruism.

Additionally, the study will examine

possible barriers to donation, such as

inconvenience, discomfort, and

confidentiality, among donors who have

not donated recently. With the majority

of the blood supply coming from

committed, repeat donors, information

regarding why an individual decides to

donate, and more importantly, what

motivates them to come back, will

provide valuable insight on possible

strategies to encourage increased

donation frequency among the current

blood donor population. It is also

important to gain perspective on why

only 50% of first time donors return to

donate again. Without successful

recruitment of new regular donors it is

impossible to sustain the blood supply

and availability. Assessment of possible

barriers to donation will provide areas

for focusing improvement in the blood

donation process. Blood availability

continues to be one of the most serious

problems facing the healthcare industry

and was recently compounded by new

Food and Drug Administration

regulations regarding deferring donors

who had traveled to or lived in the

United Kingdom for a cumulative

period of 6 months between 1980 and

1996. Data from this survey will provide

a valuable perspective for devising

strategies to increase blood donation the

U.S. These data will be invaluable to

NHLBI, FDA, and other government

agencies in helping formulate policy for

ensuring Americans that safe blood is

available when needed. Frequency of

Response: Once. Affected Public:

Individuals. Type of Respondents: Adult

Blood Donors. The annual reporting

burden is as follows: Estimated Number

of Respondents: 30,000; Estimated

Number of Respondents per

Respondent: 1; Average Burden Hours

Per Response: 0.25; and Estimated Total

Annual Burden Hours Requested: 7,500.

The annualized cost to respondents is

estimated at: $112,500 (based on $15 per

hour). There are no Capital Costs to

report. There are no Operating or

Maintenance Costs to report.

Type of respondents

Estimated number of respondents

Estimated number of respondents per respondent

Average burden

hours per response

Estimated total

annual burden

hours requested

Adult Blood Donors .......................................................................... 30,000 1 0.25 7,500

Request for Comments

Written comments and/or suggestions

from the public and affected agencies

should address 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 approprated 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

July 30, 2001.

FOR FURTHER INFORMATION CONTRACT: To

request more information on the

proposed project or to obtain a copy of

the data collection plans and

instruments, contact Dr. George J. Nemo,

Group Leader, Transfusion Medicine,

Scientific Research Group, Division of

Blood Diseases and Resources, NHLBI,

NIH, Two Rockledge Center, Suite

10042, 6701 Rockledge Drive, MSC

7950, Bethesda, MD 20892-7950, or call

(301) 435-0075, or e-mail your request

to: nemog@nih.gov.

Dated: May 17, 2001.

Donald Christoferson,

Executive Officer, NHLBI.

[FR Doc. 01–13344 Filed 5–25–01; 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

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.

Ocular Therapeutic Agent Delivery

Devices And Methods

Michael R. Robinson (NEI), Karl G.

Csaky (NEI), Peng Yuan (NEI),

Cynthia Sung (EM), Robert B.

Nussenblatt (NEI), Janine A. Smith

(NEI)

Serial No. 09/808,149, filed Mar. 15,

2001

Licensing Contact: Dale Berkley; 301/

496–7735 ext. 223; e-mail:

berkleyd@od.nih.gov

The invention is directed to ocular

implant devices for the delivery of

therapeutic agents to the eye in a

controlled and sustained manner.

Implants suitable for either

subconjunctival or intravitreal

placement are the subject of the

invention. These implants permit

29154 Federal Register / Vol. 66, No. 103 / Tuesday, May 29, 2001 / Notices

continuous release of therapeutic agents

into the eye over specified periods of

time, which can be weeks, months or

years. In one aspect of the invention a

therapeutic agent is included in both an

inner core or pellet and an exterior

composite matrix layer to provide a dual

mode release of the therapeutic agent.

That is, a loading dose is initially

delivered to the eye by the matrix layer

followed by a transition in release rate

to a relatively steady maintenance

dosage that is sustained over a

prolonged period of time. In another

aspect of the invention, methods for

making and using the implants are

described. The time-dependent delivery

of one or more drugs to the eye by this

invention makes it possible to maximize

the pharmacological and physiological

effects of the eye treatment for human

and veterinary applications.

Vessel Surface Reconstruction with a

Tubular Deformable Model

Yim et al. (CC)

DHHS Reference No. E–202–00/1, filed

Feb 15, 2001

Licensing Contact: Dale Berkley; 301/

496–7735 ext. 270; e-mail:

berkleyd@od.nih.gov

The invention is a method for

modeling a carotid or renal artery to

measure stenosis from 3D angiographic

data that may otherwise exhibit limited

image resolution and contrast. The

method reconstructs vessel surfaces

from 3D angiographic data using a

deformable model that employs a

tubular coordinate system. Vertex

merging is incorporated into the

coordinate system to maintain even

vertex spacing and to avoid problems of

self-intersection of the surface. This

method produces reconstructed surfaces

that have a realistic smooth appearance

and accurately represent vessel shape.

The method allows for an objective

evaluation of vessel shape and may

improve the precision of shape

measurements from 3D angiography.

User Friendly Integrated Database for

the Management of Animal Study

Proposals

Antonia F. Calzone (NIAAA), Etienne

Lamoreaux (NIAAA), Karen Montijo

(NIDDK)

DHHS Reference No. E–215–00/0

Licensing Contact: Dale Berkley; 301/

496–7735 ext. 223; e-mail:

berkleyd@od.nih.gov

The invention is a set of templates

written in FileMaker-ProTM script that

provides a convenient integrated

database management system for

tracking the care and disposition of

laboratory animals. This software is a

multifunction program that meets the

needs of facility veterinarians, animal

facility managers, and animal care

personnel with respect to in-house

records keeping and federal reporting

requirements. The invention builds on

the framework of the FileMaker ProTM

software, and results in a database

system that stores information pertinent

to all current Animal Study Proposals

(ASPs). This design permits users to

access the data from a networked

centralized Windows NT based server

using either a Macintosh or IBM

compatible workstation. The invention

comprises features that facilitate the

day-to-day management of the animal

facility as well as powerful information

storage capabilities.

Identification of New Malaria Parasite

Erythrocyte Binding Protein (BAEBL)

that Binds to Human Red Cells

Ghislaine D. Mayer, Louis H. Miller

(NIAID)

DHHS Reference No. E–328–00/0, filed

Apr 03, 2001

Licensing Contact: Carol Salata; 301/

496–7735 ext. 232; e-mail:

salatac@od.nih.gov

Malaria is endemic in many parts of

the world, particularly in tropical

regions such as Asia, Central America

and South America. Recent estimates of

the number of cases of malaria

worldwide are between five hundred

million and one billion. There are

approximately two to three hundred

million new cases of malaria each year

and malaria causes a minimum of one

million deaths each year. This invention

relates to the identification and

characterization of the binding

specificity of BAEBL, a novel

Plasmodium falciparum erythrocyte

binding ligand that interacts with

human erythrocytes in a sialic acid

dependent manner. This novel

Plasmodium falciparum erythrocyte

binding ligand is unique and quite

distinct from previously described

Plasmodium falciparum erythrocyte

binding proteins EBA–175. BAEBL may

be used as a malaria vaccine to block

human red cell recognition and

invasion.

Attenuated Host-Range Restricted

Dengue Viruses Derived by SiteDirected Mutagenesis of the Conserved

3’-Stem and Loop Structure in Genomic

RNA for Use as Vaccines

Lingling Zeng, Lewis Markoff (CBER/

FDA)

DHHS Reference No. E–067–98/2, filed

Mar 02, 2001

Licensing Contact: Carol Salata; 301/

496–7735 ext. 232; e-mail:

salatac@od.nih.gov

Although flaviviruses cause a great

deal of human suffering and economic

loss, there is a shortage of effective

vaccines. The present invention is

directed toward vector stage replicationdefective flaviviruses that are

replication-defective in mosquito

vectors that transmit them to humans.

The replication-defective flaviviruses of

the present invention demonstrate a

limited ability to replicate in the vector

organisms that transmit flaviviruses

from one host to another. More

specifically, the present invention is

directed toward the construction and

propagation of flaviviruses that possess

3’-noncoding regions altered in such a

way as to prevent or severely limit viral

reproduction in a vector organism. Not

only is the dengue 1 mutant replication

defective in mosquitoes, but it is also

attenuated and immunogenic in

monkeys. Moreover, it protects against

challenge, thus it has strong potential as

a dengue vaccine.

A Chimeric Protein Comprising NonToxic Pseudomonas Exotoxin A and

Type IV Pilin Sequences

David FitzGerald (NCI)

DHHS Reference No. E–283–00/0, filed

Dec 21, 2000

Licensing Contact: Carol Salata; 301/

496–7735 ext. 232; e-mail:

salatac@od.nih.gov

This invention provides candidate

chimeric vaccines that generate

antibodies which interfere with

adherence of Pseudomonas aeruginosa

exotoxin A to epithelial cells and

neutralize the cytotoxicity of exotoxin

A. This invention specifically relates to

a chimeric protein wherein key

sequences from a Type IV pilin protein

are inserted into a non toxic version of

Pseudomonas aeruginosa exotoxin A.

Pilin is a protein that is present on the

surface of bacteria and other

microorganisms, including P.

aeruginosa. The key sequences are

known to interact with asialoGM1

receptors on human epithelial cells, and

allow bacteria and other

microorganisms to adhere to epithelial

cells and colonize. The present

invention may be particularly useful for

cystic fibrosis patients who are prone to

infections with P. aeruginosa. Also, this

invention could be a broad approach to

vaccines against all gram negative

bacteria, not just Pseudomonas

aeruginosa. Pilin epitopes of other gram

negative bacteria could be inserted into

the Pseudomonas aeruginosa exotoxin A

and used as a vaccine against that

specific bacteria.

Dr. FitzGerald and his colleagues have

demonstrated that the chimeric protein

reacted with asialoGM1, a receptor on

Federal Register / Vol. 66, No. 103 / Tuesday, May 29, 2001 / Notices 29155

epithelial cells and blocked adherence

of P. aeruginosa on epithelial cells.

When the chimeric protein was injected

into rabbits, the rabbits produced

antibodies that blocked bacterial

adherence and neutralized the cell

killing activity of native exotoxin A.

A Plasmid for Expression of a More

Soluble Form of HIV Integrase Protein

in E. coli

Robert Craigie (NIDDK)

DHHS Reference No. E–110–01/0

Licensing Contact: Sally Hu; 301/496–

7056 ext. 265; e-mail: hus@od.nih.gov

The invention describes a plasmid

that provides a convenient method for

producing large quantities of integrase

protein. This integrase protein is more

soluble because amino acid residue

Phe185 is changed to Lsy. This change

does not affect the in vitro activity of the

protein, but the improved solubility

facilitates large-scale purification and

handling. Since HIV integrase is a

candidate target for antiviral drugs and

an assay system or a source of HIV

integrase is required to identify lead

compounds, this invention could be

very useful for an efficient means of

producing integrase protein on a large

scale. The integrase protein could be

used in screening for integrase

inhibitors that could be developed as

anti-HIV drugs. This invention is

available for licensing through a

Biological Materials License, as no

patent application exists.

Benzoylalkylindolepyridinium

Compounds and Pharmaceutical

Compositions Comprising Such

Compounds

William G. Rice, Mingjun Huang, Robert

W. Buckheit, Jr., David G, Covell,

Grzegorz Czerwinski, Christopher

Michejda, and Vadim Makarov (NCI)

DHHS Reference Nos. E–278–98/0 and

E–278–98/1, filed Dec 18, 2000

Licensing Contact: Sally Hu; 301/496–

7056 ext. 265; e-mail: hus@od.nih.gov

The present invention provides novel

antiviral compounds active against HIV.

These compounds, referred to as

benzoylalkylindolepyridinium

compounds (BAIPs) are effective against

HIV isolates that have developed

mutations rendering conventional drugs

ineffective. BAIPs apparently do not

require intracellular phosphorylation

nor bind to the reverse transcriptase

(RT) active site, which distinguishes

their mechanism of action from the

dideoxynucleoside (ddN) and acyclic

nucleoside phosphonate (ANP)

nucleoside analog drugs. ddN and ANP

have proven clinically effective against

limiting human immunodeficiency

virus (HIV) infection, but resistance

rapidly emerges due to mutations in and

around the RT active site. The BAIPs

also may be distinguished from nonnucleoside reverse transcriptase

inhibitors (NNRTIs), in part because the

BAIPs bind to a different site on the RT

enzyme. The usage of NNRTIs is limited

by the rapid emergence of resistant

strains also. Moreover, unlike the

NNRTIs, BAIPs of the present invention

have been shown to be effective against

HIV–1, HIV–2 and simian

immunodeficiency virus (SIV)

proliferation. Thus, BAIPs are broadly

antiviral, non-nucleoside reverse

transcriptase inhibitors (BANNRTIs).

This abstract modifies an abstract for

this technology published in the

Federal Register on Tuesday, February

13, 2001 (66 FR 10027).

Dated: May 17, 2001.

Jack Spiegel,

Director, Division of Technology Development

and Transfer, Office of Technology Transfer,

National Institutes of Health.

[FR Doc. 01–13345 Filed 5–25–01; 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.

Combined Inhibition of

Phosphodiesterase-4 (PDE–4) and

Phosphodiesterase-3 (PDF–3) as a

Therapy for Th1 Mediated

Autoimmune Diseases

Dr. Bibiana Bielekova et al. (NINDS)

DHHS Reference No. E–077–00/0, filed

Dec 22 2000

Licensing Contact: Marlene Shinn; 301/

496–7056 ext. 285; e-mail:

shinnm@od.nih.gov

Hyperactive Th1-mediated immune

responses are thought to be involved in

the pathogenesis of many autoimmune

diseases, including rheumatoid arthritis,

diabetes, inflammatory bowel disease,

vitiligo, and multiple sclerosis among

others. Immune cells are known to

produce primarily two classes of

phosphodiesterases (PDE), the PDE4 and

the PDE3 classes. Inhibitors of these

PDEs have been shown to down-regulate

the expression or production of Th1

cytokines and have either no effect or

augment the production of Th2

cytokines, therefore making them good

candidates for the treatment of Th1-

mediated autoimmune diseases.

The NIH announces a new technology

wherein PDE–4 and PDE–3 inhibitors

are used in combination and a

synergistic enhancement of therapeutic

activity is achieved. This results in a

more potent immunomodulatory effect

on the immune cells and could lead to

the administration of lower dose rate of

the inhibitors. This new form of

treatment will alleviate side effects

through the use of a lower dose rate for

each and will make for a more effective

therapy.

Determination of AM-Binding Proteins

and the Association of Adrenomedullin

(AM) Therewith

F. Cuttitta et al. (NCI)

DHHS Reference No. E–256–99/1 filed,

Sep 08 2000 (Note: This invention is

related to E–206–95/3, filed Aug 18

1996, the disclosure of which is

incorporated herein.)

Licensing Contact: Matthew Kiser; 301/

496–7056 ext. 224; e-mail:

kiserm@od.nih.gov

The present invention provides

methods for the isolation, identification,

and purification of adrenomedullin

(AM)-binding proteins. Methods for

utilizing the purified AM-binding

proteins, or functional portions thereof,

to diagnose, treat, and monitor AMrelated diseases are described. A second

aspect of this technology discloses the

identification and isolation of a novel

complex between AM and a specific

AM-binding protein 1 (AMBP–1),

designated factor H (fH). The

identification of small molecule