34452 Federal Register / Vol. 66, No. 125 / Thursday, June 28, 2001 / Notices

Dated: June 22, 2001.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 01–16247 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 Transmission of Human

Immunodeficiency Virus (HIV) Among

Men Who Have Sex With Men (MSM)

AGENCY: Centers for Disease Control and

Prevention, DHHS.

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 (EpiB), has an

opportunity for collaboration to evaluate

the safety and preliminary efficacy of

topical microbicides for rectal

application to reduce HIV transmission.

These evaluations will include in-vitro

assays, macaque studies, and phase I/

phase II trials in MSM.

SUMMARY: The Division of HIV/AIDS

Prevention-Surveillance and

Epidemiology (DHAP–SE) of the

National Center for 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 developed for

vaginal use that are ready for phase III

trials. The selected company and CDC

would execute an ‘‘Agreement’’ to

evaluate the company’s microbicides for

safety and acceptability of topical

microbicides designed for vaginal

application to reduce HIV transmission

when applied to the rectal mucosa.

These evaluations will include in-vitro

assays, macaque studies, and phase I/

phase II trials in MSM. 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 by

MSM as well has heterosexual men and

women.

Confidential proposals, preferably 10

pages or less (excluding appendices),

are solicited from companies with

patented or licensed agents which have

undergone sufficient clinical testing to

be: (1) Currently under an IND approved

by the Food and Drug Administration

(FDA); (2) have completed at least one

phase I and one phase II trial for vaginal

application of the microbicide as of

December 31, 2001; and (3) be planning

to begin a phase III trial for vaginal use

which is anticipated to begin enrollment

prior to December 31, 2002.

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 and:

(1) Will have at least one phase I and

one phase II trial for vaginal use

completed by December 31, 2001;

(2) Will have a phase III trial for

vaginal use planned to begin enrollment

prior to December 31, 2002;

(3) Have manufacturing arrangements

for production of clinical trial-grade

product (and applicator if necessary)

under Good Manufacturing Process (cGMP) standards; and

(4) Are willing to provide a

formulation and dosage appropriate for

rectal application.

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

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.

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