Federal Register / Vol. 66, No. 125 / Thursday, June 28, 2001 / Notices 34451

d. The extent to which plans for

representation at the annual meeting of

awardees reflect the intent to actively

collaborate with other awardees through

this meeting.

3. Plan of Operation (45 Points)

a. The extent to which the application

provides evidence that key personnel

have the ability and program skills to

develop and carry out the proposed

activities;

b. The extent to which the applicant

and malaria-endemic partners have

demonstrated a collaborative review of

the priority needs for malaria in the

malaria-endemic country;

c. The extent to which the applicant

clearly defines objectives and justifies

these objectives in relation to the

proposed focus of the plan to address

priority issues for the malaria-endemic

country RBM program;

d. The adequacy of the plan to carry

out major project components (e.g., in

both the applicant and malaria-endemic

country: leadership, staffing,

administrative coordination, planning,

and measurement activities), including

a timetable that provides major

milestones for implementing activities;

e. The degree to which the plan is

consistent with malaria prevention best

practices and RBM principles;

f. If capacity building for public

health in malaria is proposed, the extent

to which the planned activities relate to

capacity improvements that will benefit

RBM activities in the partner country;

g. The degree to which the applicant

has met the CDC Policy requirements

regarding the inclusion of women,

ethnic, and racial groups in the

proposed research. This includes:

(1) The proposed plan for the

inclusion of both sexes and racial and

ethnic minority populations for

appropriate representation.

(2) The proposed justification when

representation is limited or absent.

(3) A statement as to whether the

design of the study is adequate to

measure differences when warranted.

(4) A statement as to whether the

plans for recruitment and outreach for

study participants include the process

of establishing partnerships with

community(ies) and recognition of

mutual benefits.

4. Evaluation Plan (15 Points)

The extent to which (a) the applicant

describes a detailed plan for monitoring

the implementation of the activities and

evaluating the extent to which the

proposed activities strengthen local and

national capacity for malaria prevention

and control, and (b) the monitoring and

evaluation plan builds on existing

monitoring and evaluation systems in

the project area and can demonstrate

progress towards RBM objectives.

5. Budget (Not Scored)

The extent to which the budget is

detailed, clear, justified, describes inkind or other project support, and is

consistent with the proposed program

activities.

6. Human Subjects (Not Scored)

Does the application adequately

address the requirements of Title 45

CFR Part 46 for the protection of human

subjects? (Not scored; however, an

application can be disapproved if the

research risks are sufficiently serious

and protection against risks is so

inadequate as to make the entire

application unacceptable.)

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two

copies of—

1. annual progress reports;

2. financial Status Report (FSR), no

more than 90 days after the end of the

budget period; and

3. final financial and performance

reports, no more than 90 days after the

end of the project period.

Send all reports to the Grants

Management Specialist identified in the

‘‘Where to Obtain Additional

Information’’ section of this

announcement.

The following additional

requirements are applicable to this

program. For a complete description of

each, see Attachment I of the

announcement in the application kit.

AR–1 Hunman Subjects Requirements

AR–2 Requirements for Inclusion of

Women and Racial and Ethnic

Minorities in Research

AR–9 Paperwork Reduction Act

Requirements

AR–10 Smoke-Free Workplace

Requirements

AR–11 Healthy People 2010

AR–12 Lobbying Restrictions

AR–14 Accounting System

Requirements

AR–15 Proof of Non-Profit Status

AR–22 Research Integrity

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

sections 301(a), 307, and 317(k)(2) of the

Public Health Service Act, [42 U.S.C.

sections 241(a), 2421, and 247b(k)(2)], as

amended. The Catalog of Federal

Domestic Assistance number is 93.283.

J. Where To Obtain Additional

Information

This and other CDC announcements

can be found on the CDC home page

Internet address—http://www.cdc.gov

Click on ‘‘Funding’’ then ‘‘Grants and

Cooperative Agreements.’’

To obtain business management

technical assistance, contact: Merlin

Williams, Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention,

2920 Brandywine Road, Room 3000,

Atlanta, GA 30341–4146, Telephone:

770–488–2765, Email address:

mqw6@cdc.gov.

For program technical assistance,

contact: Richard W. Steketee, MD, MPH

or Craig Leutzinger, Division of Parasitic

Diseases, National Center for Infectious

Diseases, Centers for Disease Control

and Prevention, 1600 Clifton Road,

Atlanta, GA 30333, Telephone: 770–

488–7760, Fax: 770–488–7761, Email

address: ris1@cdc.gov or cll1@cdc.gov.

Dated: June 22, 2001.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 01–16248 Filed 6–27–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Center for Disease Control and

Prevention

Program Announcement Number

01163 Correction

AGENCY: Centers for Disease Control and

Prevention, HHS

ACTION: Program announcement number

01163 correction.

SUMMARY: The Centers for Disease

Control and Prevention published

Program Announcement 01163 for HIV

Prevention Projects for CommunityBased Organizations Targeting Young

Men of Color Who Have Sex With Men

FOR FURTHER INFORMATION CONTACT:

David A. Wilson, 770–488–2692

Correction

In the Federal Register of June 21,

2001, in FR Vol 66, No. 120, Page 33254,

first line, third column, correct date to

read On or Before July 31, 2001. On

Page 33255, second column, under J.

Where to Obtain Additional

Information, third paragraph, phone

number for David A. Wilson should

read: 770–488–2692.

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.