31330 Federal Register / Vol. 65, No. 96 / Wednesday, May 17, 2000 / Notices

Obtain Additional Information’’ section

of this announcement.

G. Evaluation Criteria

The application will be evaluated

individually against the following

criteria by an independent review group

appointed by CDC.

1. Background and Need (33 Points):

Extent to which applicant demonstrates

a clear understanding of the purpose

and objectives of this proposed

cooperative agreement and

demonstrates a clear understanding of

the requirements, responsibilities,

interactions, problems, constraints,

complexities, etc., that may be

encountered in conducting the project

and performing the studies.

2. Capacity and Personnel (33 Points):

Extent to which applicant demonstrates

past experience of professional

personnel in conducting studies similar

to those proposed in this cooperative

agreement. Extent to which applicant

demonstrates it has adequate

administrative personnel and support.

Extent to which applicant demonstrates

it has adequate scientific resources and

facilities (including certified BSL–3

laboratory) to successfully conduct the

activities.

3. Objectives and Technical Approach

(34 Points): Extent to which applicant

describes objectives of the proposed

project which are consistent with the

purpose and goals of this grant/

cooperative agreement program and

which are measurable and time-phased.

Extent to which applicant presents a

detailed operational plan for initiating

and conducting the project, which

clearly and appropriately addresses all

‘‘Recipient Activities.’’ Extent to which

applicant clearly identifies specific

assigned responsibilities of all key

professional personnel. Extent to which

the plan clearly describes applicant’s

technical approach/methods for

conducting the proposed studies and

extent to which the plan is adequate to

accomplish the objectives. Extent to

which applicant describes specific

study protocols or plans for the

development of study protocols that are

appropriate for achieving project

objectives. Extent to which applicant

describes adequate and appropriate

collaboration with CDC and/or others

during various phases of the project.

Extent to which applicant provides a

detailed and adequate plan for

evaluating study results and for

evaluating progress toward achieving

project objectives.

4. Budget (Not Scored): Extent to

which applicant presents a detailed,

line-item budget with a detailed

narrative justification (by line-item) that

is consistent with the purpose and

objectives of this cooperative agreement.

5. Animal Subjects (Not Scored): Does

the application adequately address the

requirements of PHS Policy on Humane

Care and Use of Laboratory Animals?

H. Other Requirements

Technical Reporting Requirements

Provide CDC with the original plus

two copies of:

1. Progress reports (semiannual);

2. Financial Status Report (FSR), no

more than 90 days after the end of the

budget period; and

3. Final FSR and performance report,

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 in the

application kit.

AR–3 Animal Subjects Requirements

AR–7 Executive Order 12372 Review

AR–10 Smoke-Free Workplace

Requirements

AR–11 Healthy People 2010

AR–12 Lobbying Restrictions

AR–15 Proof of Non-Profit Status

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

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

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

sections 241(a) 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 [ATSDR]

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 additional information,

contact: Merlin Williams, Grants

Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention, Room 3000,

2920 Brandywine Road, Atlanta, GA

30341–4146, Telephone: (770)488–2765,

E-mail address: mqw6@cdc.gov.

For program technical assistance,

contact: Dr. James N. Mills, Special

Pathogens Branch, Division of Viral and

Rickettsial Diseases, National Center for

Infectious Diseases, Centers for Disease

Control and Prevention, 1600 Clifton

Road, N.E., M/S G–14, Atlanta, Georgia

30333, Telephone: (404)639–1396.

Dated: May 11, 2000.

Henry S. Cassell, III,

Acting, Director, Procurement and Grants

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 00–12341 Filed 5–16–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement Number 00111]

Development and Testing of New

Medications for Treatment of Emerging

Infectious Diseases; Notice of

Availability of Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 2000

funds for a cooperative agreement

program for the development and

testing of new medications for emerging

infectious diseases. CDC is committed to

achieving the health promotion and

disease prevention objectives of

‘‘Healthy People 2010,’’ a national

activity to reduce morbidity and

mortality and improve the quality of

life. This announcement is related to the

focus areas of Immunization and

Infectious Diseases. For the conference

copy of ‘‘Healthy People 2010’’, visit the

internet site http://www.health.gov/

healthypeople.

The purpose of this program is for the

development and testing of new antiinfectious agents developed from

natural products primarily for use in

humans. Of particular, but not exclusive

interest are anti-infective agents for

parasitic diseases. Projects may include,

but are not limited to a range of

activities such as identifying promising

agents, purifying or creating them,

optimizing them for clinical use, and

testing them.

B. Eligible Applicants

Applications may be submitted by

public and private nonprofit

organizations and by governments and

their agencies; that is, universities,

colleges, research institutions, hospitals,

other public and private nonprofit

organizations, State and local

governments or their bona fide agents,

and federally recognized Indian tribal

governments, Indian tribes or Indian

tribal organizations.

Note: Public Law 104–65 states that

an organization described in section

501(c)(4) of the Internal Revenue Code

of 1986 that engages in lobbying

Federal Register / Vol. 65, No. 96 / Wednesday, May 17, 2000 / Notices 31331

activities is not eligible to receive

Federal funds constituting an award,

grant, cooperative agreement, contract,

loan, or any other form.

C. Availability of Funds

Approximately $1,500,000 is available

in FY 2000 to fund one award. It is

expected the award will begin on or

about September 1, 2000, and will be

made for a 12-month budget period

within a project period of up to three

years. The funding estimate may

change.

A continuation award within an

approved project period will be made

on the basis of satisfactory progress as

evidenced by required reports and the

availability of funds.

D. Program Requirements

In conducting activities to achieve the

purpose of this program, the recipient

will be responsible for the activities

under 1. (Recipient Activities) and CDC

will be responsible for conducting

activities under 2. (CDC Activities):

1. Recipient Activities

a. Develop and implement strategies

for selection of emerging infectious

disease(s) that affect humans and or

acquiring or developing new

medications for treatment of those

diseases using natural products. This

includes studying the pharmacologic

and biologic characteristics of natural

product structures and analogs and

designing molecules using computer

methods for known biochemical targets.

b. Use combinatorial methods to

optimize anti-infectives resulting from

these approaches.

c. Develop strategies and capacity to

produce adequate quantities of

compound, for example, by using an

automated organic synthesizer or other

technology.

d. Develop and implement a

systematic approach to in vitro testing

of drug candidates.

e. Conduct in vivo testing of

promising candidates if appropriate.

f. Develop a plan for enhancing

commercial interest in promising drugs.

g. Publish or disseminate results of

research.

2. CDC Activities

a. Provide technical assistance in the

design and conduct of the research, as

needed.

b. Perform selected laboratory tests, as

requested.

c. Provide biological materials (e.g.,

strains, reagents, etc.) as necessary or

appropriate.

d. Assist in the development of assays

for evaluating pharmacokinetics of new

drugs as necessary or appropriate.

e. Assist in the development of a

research protocol for Institutional

Review Board (IRB) review by all

cooperating institutions participating in

the research project. The CDC IRB will

review and approve the protocol

initially and on at least an annual basis

until the research project is completed.

E. Application Content

Use the information in the Program

Requirements, Other Requirements and

Evaluation Criteria sections to develop

the application content. Your

application will be evaluated on the

criteria listed, so it is important to

follow them in laying out your program

plan. The narrative should be no more

than 10 double spaced pages printed on

one side, with one inch margins and

unreduced font.

F. Submission and Deadline

Application

Submit the original and two copies of

PHS 5161–1 (OMB Number 0937–0189).

Forms are in the application kit.

On or before July 1, 2000, submit the

application to the Grants Management

Specialist identified in the ‘‘Where to

Obtain Additional Information’’ Section

of this announcement.

Deadline: Applications shall be

considered as meeting the deadline if

they are either:

(a) Received on or before the deadline

date; or

(b) Sent on or before the deadline date

and received in time for submission to

the independent review group.

(Applicants must request a legibly dated

U.S. Postal Service postmark or obtain

a legibly dated receipt from a

commercial carrier or U.S. Postal

Service. Private metered postmarks shall

not be acceptable as proof of timely

mailing.)

Late Applications: Applications

which do not meet the criteria in (a) or

(b) above are considered late

applications, will not be considered,

and will be returned to the applicant.

G. Evaluation Criteria

The application will be evaluated

against the following criteria by an

independent review group appointed by

CDC.

1. Background and Need (15 Points)

Extent to which applicant

demonstrates a clear understanding of

the background, purpose, and objectives

of the focus area being addressed and

the relevance of disease(s) to be studied.

Extent to which applicant demonstrates

that the proposed project addresses the

purpose. Extent to which the applicant

demonstrates that the proposed program

collaborates with and does not duplicate

existing rational development efforts.

2. Capacity (40 Points)

Extent to which applicant describes

adequate resources and facilities (both

technical and administrative) to use

natural products, computer-aided drug

design, and development of analogs of

known drugs to develop strategies for

producing adequate quantities of

compound, for example, by using

automated organic synthesis or other

technologies for conducting the project.

Extent to which applicant documents

that professional personnel involved in

the project are qualified and have past

experience and achievements in

research related to that proposed as

evidenced by curriculum vitae,

publications, etc. If applicable, extent to

which applicant includes letters of

support from participating nonapplicant organizations, individuals,

etc., and the extent to which such letters

clearly indicate the author’s

commitment to participate as described

in the operational plan.

3. Objectives and Technical Approach

(45 Points Total)

a. Extent to which applicant describes

measurable and time-phased objectives

of the proposed project which are

consistent with the purpose of the focus

area being addressed. (10 points)

b. Extent to which applicant presents

a detailed operational plan for initiating

and conducting the project which

clearly and appropriately addresses all

recipient activities for the specific

programmatic focus area being

addressed. Extent to which applicant

clearly identifies specific assigned

responsibilities of all key professional

personnel. Extent to which the plan

clearly describes applicant’s technical

approach/ methods for conducting the

proposed studies and extent to which

the approach/methods are feasible,

appropriate, and adequate to

accomplish the objectives. Extent to

which applicant describes specific

study protocols or plans for the

development of study protocols that are

appropriate for achieving project

objectives. Extent to which applicant

clearly describes collaboration with

others during various phases of the

project. (25 points)

c. 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 (a) the

proposed plan for the inclusion of both

sexes and racial and ethnic minority

populations for appropriate

representation, (b) the proposed

31332 Federal Register / Vol. 65, No. 96 / Wednesday, May 17, 2000 / Notices

justification when representation is

limited or absent, (c) a statement as to

whether the design of the study is

adequate to measure differences when

warranted and

(d) 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. (5 points)

4. Evaluation

Extent to which applicant provides a

detailed and adequate plan for

evaluating progress toward achieving

project process and outcome objectives.

(5 points)

5. Budget (Not Scored)

Extent to which the line-item budget

is detailed, clearly justified, and

consistent with the purpose and

objectives of this program.

6. Human Subjects (Not Scored)

Does the application adequately

address the requirements of Title 45

CFR Part 46 for the protection of human

subjects?

7. Animal Subjects (Not Scored)

Does the application adequately

address the requirements of PHS Policy

on Humane Care and Use of Laboratory

Animals?

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two

copies of

1. progress reports (semiannual);

2. financial status report, 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 in the

application kit.

AR–1 Human Subjects Requirements

AR–2 Requirements for Inclusion of

Women and Racial and Ethnic

Minorities in Research

AR–3 Animal Subjects Requirements

AR–7 Executive Order 12372 Review

AR–10 Smoke-Free Workplace

Requirements

AR–11 Healthy People 2010

AR–12 Lobbying Restrictions

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

section 301(a) and 317(k)(2) of the

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

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

amended. The Catalog of Federal

Domestic Assistance number is 93.283.

J. Where To Obtain Additional

Information

To obtain additional information,

contact: Andrea Wooddall, Grants

Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention, Room 3000,

2920 Brandywine Road, Atlanta, GA

30341–4146, Telephone number 770–

488–2749, Email address ayw3@cdc.gov

For program technical assistance,

contact: Sue Binder, M.D., Division of

Parasitic Diseases, National Center for

Infectious Diseases, Centers for Disease

Control and Prevention, 4770 Buford

Highway, N.E., Atlanta, GA 30333,

Telephone number 770–488–7793,

Email address scb1@cdc.gov

Dated: May 11, 2000.

Henry S. Cassell, III,

Acting, Director, Procurement and Grants

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 00–12343 Filed 5–16–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 00118]

Mind/Body Research Program; Notice

of Availability of Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 2000

funds for a grant to conduct mind/body

research.

CDC is committed to achieving the

health promotion and disease

prevention objectives of ‘‘Healthy

People 2010’’ a national activity to

reduce morbidity and mortality and

improve the quality of life. This

announcement is related to the focus

areas of Disability and Secondary

Conditions, and Physical Activity and

Fitness. Other health objectives for the

nation can ultimately be addressed

through mind/body research because

approaches that evoke the relaxation

response may impact positively on a

variety of chronic health conditions and

disabilities targeted by the 2010

objectives.

For the conference copy of ‘‘Healthy

People 2010’’, visit the internet site:

<http://www.health.gov/

healthypeople>.

The purpose of this program is to

generate knowledge through basic and

clinical research about the effectiveness

of a relaxation or stress reduction

approach such as meditation or

progressive muscle relaxation that

evokes changes in psychophysiology

and can, consequently, impact

positively on physical and mental

health. These psychophysiology

outcomes, collectively labeled the

relaxation response, include decreased

heart rate, blood pressure, muscle

tension, metabolism, breathing rate, and

brain wave activity. Project objectives

and activities should add to the

literature, and include those that

articulate the acute (changes that occur

as a result of a single session) and

chronic (changes that occur as a result

of numerous sessions repeated over

time) benefits of an approach that

evokes the relaxation response. Such

efforts should be highlighted by

identifying and advancing knowledge

about the causal mechanisms

underlying the neural and systemic

adaptations that trigger the relaxation

response (e.g., acute transient change in

systolic and diastolic blood pressure)

and related chronic health outcomes

(e.g., reductions in resting systolic and

diastolic blood pressure in patients with

hypertension). In addition, a goal of this

project should be to identify

determinants or correlates that assist in

predicting who will initiate, maintain,

and benefit from an approach that

evokes the relaxation response. In this

regard, identifying and understanding

how important sociodemographic

variables, health status and belief

systems, influence use and effectiveness

of an approach that evokes the

relaxation response are desired study

outcomes.

Numerous medical conditions,

including hypertension, pain, and stress

related mood disturbance, have

responded favorably to treatment using

approaches that evoke the relaxation

response. Little is known about the

processes that account for the

improvements in health. This project

requires that multi-disciplinary and

well controlled study(ies) with healthy

or clinical populations be conducted to

investigate the physiological basis for

treatment of modality effectiveness, as

well as psychosocial attributes

influencing successful treatment

response.