Federal Register / Vol. 66, No. 125 / Thursday, June 28, 2001 / Notices 34453

Selection Criteria

In addition to evidence of the ability

to fulfill the roles described above,

proposals submitted for consideration

should address, as best as possible and

to the extent relevant to the proposal,

each of the following:

(1) Data on the in-vitro anti-HIV

activity of the agent;

(2) Animal, human, and in-vitro data

on the safety of the agent when applied

to mucosal surfaces;

(3) Data on the effects of the agent on

rectal mucosa (if available); and

(4) Data on the in-vitro activity of the

agent against other sexually transmitted

organisms.

Dated: June 22, 2001.

Joseph R. Carter,

Associate Director for Management and

Operations, Centers for Disease Control and

Prevention.

[FR Doc. 01–16243 Filed 6–27–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Opportunity To Collaborate in the

Evaluation of Topical Microbicides To

Reduce Heterosexual Transmission of

Human Immunodeficiency Virus (HIV)

AGENCY: Centers for Disease Control and

Prevention, Department of Health and

Human Services.

ACTION: Opportunities for collaboration

for evaluation of topical microbicides.

The Centers for Disease Control and

Prevention (CDC), National Center for

HIV, STD, and TB Prevention

(NCHSTP), Division of HIV/AIDS

Prevention-Surveillance and

Epidemiology (DHAP–SE),

Epidemiology Branch (EpiBr), has an

opportunity for collaboration to evaluate

the safety and preliminary efficacy of

topical microbicides designed for

vaginal application to reduce HIV

transmission. These evaluations will

include in-vitro assays, macaque

studies, and phase I/phase II trials in

heterosexual women and men.

SUMMARY: The Division of HIV/AIDS

Prevention-Surveillance and

Epidemiology (DHAP–SE) of the

National Center of HIV, STD, and TB

Prevention (NCHSTP) at the Centers for

Disease Control and Prevention (CDC) of

the Department of Health and Human

Services (DHHS) seeks one or more

pharmaceutical, biotechnological, or

other companies who hold a proprietary

position on microbicides that are ready

for phase I/phase II trials. The selected

company and CDC will execute an

‘‘Agreement’’ to evaluate the company’s

microbicides for safety and preliminary

efficacy of topical microbicides

designed for vaginal application to

reduce HIV transmission.

These evaluations will include invitro assays, macaque studies, and

phase I/phase II trials in heterosexual

women and men. Each collaboration

would have an expected duration of two

(2) to five (5) years. The goals of the

collaboration include the timely

development of data to further the

identification and commercialization of

effective topical microbicides and the

rapid publication of research findings to

increase the number of HIV prevention

technologies proven effective and

available for use.

Confidential proposals, preferably 10

pages or less (excluding appendices),

are solicited from companies with

patented or licensed agents which have

undergone sufficient preclinical testing

to be either (1) currently under an IND

application approved by the Food and

Drug Administration (FDA) or (2)

prepared to submit an IND application

to the FDA by December 31, 2001.

DATES: Formal proposals must be

submitted no later than July 30, 2001.

ADDRESSES: Formal proposals should be

submitted to Jeff Efird, MPA,

Epidemiology Branch, Division of HIV/

AIDS Prevention—Surveillance and

Epidemiology, NCHSTP, CDC, 1600

Clifton Road, Mailstop E–45, Atlanta,

GA 30333; Phone: (direct) 404–639–

6136, (office) 404–639–6130; Fax: 404–

639–6127; e-mail: JLE1@cdc.gov.

Scientific questions should be

addressed to Dawn K. Smith, MD.,

Epidemiology Branch, Division of HIV/

AIDS Prevention—Surveillance and

Epidemiology, NCHSTP, CDC, 1600

Clifton Road, Mailstop E–45, Atlanta,

GA 30333; Phone: (direct) 404–639–

6165, (office) 404–639–6146; Fax: 404–

639–6127; e-mail: Dsmith1@cdc.gov.

Inquiries directed to ‘‘Agreement’’

documents related to participation in

this opportunity should be addressed to

Thomas E. O’Toole, MPH, Deputy

Director, Technology Transfer Office,

CDC, 1600 Clifton Road, Mailstop E–67,

Atlanta, GA 30333; Phone: (direct) 404–

639–6270, (office) 404–639–6270; Fax:

404–639–6266; e-mail: TEO1@cdc.gov.

SUPPLEMENTARY INFORMATION:

Technology Available

One mission of the Epidemiology

Branch of DHAP–SE/NCHSTP is to

develop and evaluate biomedical

interventions to reduce HIV

transmission. To this end, the EpiBr is

establishing contracts to conduct phase

I and phase II trials of topical

microbicides. EpiBr also funds research

in the Division of AIDS, STD, and TB

Laboratory Research (DASTLR) of the

National Center for Infectious Diseases

(NCID) at CDC and with external

laboratories to conduct macaque studies

and in-vitro studies in support of

human microbicide trials. The goal of

these efforts is to provide scientific and

technical expertise and key resources

for the evaluation of topical

microbicides through late preclinical,

phase I, phase II, and proof-of-concept

clinical trials.

Technology Sought

EpiBr now seeks potential

collaborators having licensed or

patented agents for use as vaginal

microbicides which:

(1) Have laboratory or animal model

evidence of anti-HIV activity;

(2) Have been formulated for vaginal

application;

(3) Are not entering phase III clinical

trial in the next 12 months;

(4) Have an IND and are currently in

phase I clinical trial or have not yet

submitted an IND application but have

sufficient preclinical data to do so by

December 31, 2001; and

(5) Have manufacturing arrangements

for production of clinical trial-grade

product (an applicator if necessary)

under Good Manufacturing Process (cGMP) standards.

NCHSTP and Collaborator

Responsibilities

The NCHSTP anticipates that its role

may include, but not be limited to, the

following:

(1) Providing intellectual, scientific,

and technical expertise and experience

to the research project;

(2) Planning and conducting

preclinical (in-vitro and in-vivo)

research studies of the agent and

interpreting results;

(3) Publishing research results;

(4) Depending on the results of these

preclinical investigations, NCHSTP may

elect to conduct additional research

with macaques to evaluate safety and/or

efficacy proof-of-concept; and

(5) Depending on the results of

preclinical and/or macaque studies and

FDA approval, NCHSTP may elect to

conduct phase I/II clinical trials of the

agent.

The NCHSTP anticipates that the role

of the successful collaborator(s) will

include the following:

(1) Providing intellectual, scientific,

and technical expertise and experience

to the research project;

(2) Participating in the planning of

research studies, interpretation of

34454 Federal Register / Vol. 66, No. 125 / Thursday, June 28, 2001 / Notices

research results and, as appropriate,

joint publication of conclusions;

(3) Providing NCHSTP access to

necessary proprietary technology and/or

data in support of the research

activities; and

(4) Providing NCHSTP clinical grade

(c-GMP) agent for use in preclinical and

clinical studies covered in this

collaboration.

Other contributions may be necessary

for particular proposals.

Selection Criteria

In addition to evidence of the ability

to fulfill the roles described above,

proposals submitted for consideration

should address, as best as possible and

to the extent relevant to the proposal,

each of the following:

(1) Data on the in-vitro anti-HIV

activity of the agent;

(2) Animal and other data on the

safety of the agent when applied to

mucosal surfaces;

(3) Data on the effects of the agent on

vaginal commensal microbial

organisms; and

(4) Data on the in-vitro activity of the

agent against other sexually transmitted

organisms.

Dated: June 22, 2001.

Joseph R. Carter,

Associate Director for Management and

Operations, Centers for Disease Control and

Prevention.

[FR Doc. 01–16244 Filed 6–27–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Government-Owned Inventions;

Availability for Licensing

AGENCY: Centers for Disease Control and

Prevention, Technology Transfer Office,

Department of Health and Human

Services

ACTION: Notice.

The inventions named in this notice

are owned by agencies of the United

States Government and are available for

licensing in the United States (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 U.S. 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 Thomas E. O’Toole, M.P.H.,

Deputy Director, Technology Transfer

Office, Centers for Disease Control and

Prevention (CDC), Mailstop E–67, 1600

Clifton Rd., Atlanta, GA 30333,

telephone (404) 498–0170, facsimile

(404) 498–0095, and e-mail tto@cdc.gov.

Please note that a signed Confidential

Disclosure Agreement will be required

to receive copies of unpublished patent

applications.

Apparatus for Applying Chemicals to

Rodents

This invention comprises a method of

controlling Lyme disease by preventing

the maturation of deer ticks on whitefooted mice by exposing the mice to

insecticides as they enter food-baited

boxes. Other tick- and flea-borne

diseases can also be controlled by this

method.

Inventors: Gary O. Maupin et al. U.S.

Patent Application SN: 09/595,034 (CDC

Ref. #: I–031–00).

Control of Arthropod Vectors of

Parasitic Diseases

This invention comprises a method of

controlling Lyme disease by preventing

the maturation of deer ticks on whitefooted mice by exposing the mice to

insecticides as they enter food-baited

boxes. Other tick- and flea-borne

diseases can also be controlled by this

method.

Inventors: Gary O. Maupin et al. U.S.

Patent Application SN: 09/595,035 (CDC

Ref. #: I–032–00).

Control of Arthropods in Rodents

This invention comprises a method of

controlling Lyme disease by preventing

the maturation of deer ticks on whitefooted mice by exposing the mice to

insecticides as they enter food-baited

boxes. Other tick- and flea-borne

diseases can also be controlled by this

method.

Inventors: Gary O. Maupin et al. U.S.

Patent Application SN: 09/595,177 (CDC

Ref. #: I–041–00).

Method for Monitoring Local Reaction

Associated With Injections

A simple and inexpensive method to

give patients a guideline for determining

the severity of an adverse reaction that

may occur at the site of injection.

Patients can be instructed to notify

health care providers if an inflammatory

response spreads beyond a measured

distance from the location of injection.

Inventor: Laurie Kamimoto, U.S.

Patent Application SN: 60/238,691 (CDC

Ref. #: I–036–00).

Auscultory Training System

This invention provides for the

precise reproduction of recorded

sounds. Under ordinary conditions, a

sound signal is distorted by the

amplifier, speakers, and the

surroundings. This invention modifies

the signal delivered to the speaker in

such a way as to precisely reproduce the

signal as it was originally recorded. The

graphical user-interface allows for the

easy selection and playback of

individual components of a larger sound

recording. This invention could have

applications as a diagnostic screening

tool, as a telemedicine tool, and as a

teaching tool to instruct the user on the

various body sounds, such as lung,

bowel, or heart sounds.

Inventors: Walter McKinney et al.

U.S. Patent Application SN: To be

assigned, filed 4.30.2001. (CDC Ref. #: I–

037–00).

Peptide Vaccines Against Group A

Streptococci

The invention is a vaccine comprised

of three synthetic peptides of 20–25

amino acids in length from different M

proteins. The synthetic peptides can be

recognized by M type-specific

antibodies and are capable of eliciting

functional opsonic antibodies in mice.

The vaccine may have the potential to

eliminate over 85% of Group A

Streptococci infections and reduce by

85% the nasopharyngeal reservoir of

Group A Streptococci in the United

States.

Inventors: Bernard Beall et al. U.S.

Patent Application SN: To be assigned,

filed 5.18.2001. (CDC Ref. #: I–039–00)

DNA Synthesis by the Cooperative

Action of DNA Polymerase and

Nuclease

Confirmation of a diagnosis of an

infectious agent usually depends upon

the detection of the causative agent or

its signature effect on the immune

system. Nucleic acid detection methods

offer the greatest sensitivity but depend

upon specific hybridization of a primer

or a probe, thus they can only be used

to detect nucleic acids. This invention

comprises a novel method of diagnostic

detection which retains the sensitivity

of nucleic acid based amplification

methods while allowing detection of

non-nucleic acid targets such as

antibodies, surface proteins, or other

antigenic components. Thus, no specific

sequence information need be known

about the potential target.

Inventors: Yuri Khudyakov, U.S.

Patent Application SN: (CDC Ref. #: I–

043–00)