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.

Federal Register / Vol. 65, No. 96 / Wednesday, May 17, 2000 / Notices 31333

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.

Applicants must provide proof of

their non-profit status. See Attachment

I for additional requirements.

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 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 $862,000 will be

available in FY 2000 to fund one award.

It is expected that the awards will begin

on or about September 30, 2000 and will

be made for a 12-month budget period

within a project period of up to three

years. Funding estimates may change.

Continuation awards 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 following:

1. Identify a manager/coordinator

with the authority and responsibility to

conduct and manage all components of

the project.

2. Create the capacity to attract and

motivate persons to initiate and

maintain research interventions/

protocols.

3. Variables included in the program

are dependent on the acute or chronic

research questions. Study variables may

include blood pressure measures,

muscle tension/electromyographic

activity (EMG), signaling molecules,

biochemical markers and immunologic

profiles characteristic of the relaxation

response, electroencephalographic

measures (EEG), functional magnetic

resonance imaging (fMRI), measures of

heart rate/heart rate fluctuations, and

pain measures, as well as valid and

reliable, state or trait psychometric

measures (e.g., measures of belief

systems, spirituality, depression,

anxiety).

4. Evaluate the causal mechanisms

and effectiveness of a relaxation

approach which evokes

psychophysiological changes

(collectively known as the relaxation

response), that can, consequently,

maintain or improve physical and/or

mental health in one or more select

populations (e.g., healthy older adults

[e.g., 50 and above years of age], or

persons with a chronic disease/

disability or mood disturbance [e.g.,

arthritis, cancer, diabetes, depression or

anxiety disorders]).

a. Identify, and advance the

knowledge related to, the acute

psychophysiological response(s) and

reliability of the response(s) that occur

as a result of a single relaxation session

(i.e., to identify novel outcomes or new

knowledge about already known

outcomes).

b. Identify, and advance the

knowledge related to, chronic

psychophysiological responses (health

promotion/disease prevention benefits)

that occur as a result of involvement in

multiple ‘‘relaxation’’ sessions repeated

over a period of time (i.e., to identify

novel outcomes or new knowledge

about already known outcomes).

c. Identify and describe the

underlying processes, trigger, or causal

mechanisms that mediate the relaxation

approach, relaxation response and

related health outcomes relationships.

5. Evaluate, and ultimately identify

and describe characteristics

(determinants/correlates) of those who

initiate, adhere to, and benefit from, an

approach which evokes the relaxation

response; to include subject attributes

such as belief systems, healthy versus

chronic disease patients, gender, age,

and race/ethnicity.

6. Publish the results of the research

in journals and etc.

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 the program

plan. The narrative addressing the

scored criteria should be no more than

25 double-spaced pages, printed on one

side, with one inch margins, and

unreduced font. The application should

be organized in the following sections.

1. Executive Summary

Provide a clear and concise written

statement of the project’s purpose and

major objectives, an outline of the major

activities, and a time line of key

milestones.

2. Problem Statement and Evidence of

Need

a. Describe the literature and

demonstrate how mind (cognition) and

body (physiology) interact.

b. Describe the impact on one or more

health outcomes.

c. Synthesize state-of-the-art findings

regarding the effectiveness of an

approach that evokes the relaxation

response that has been used with

healthy persons and/or persons with

chronic disease or disability, including

documentation/referencing of the

applicants own systematic and ongoing

line of mind/body inquiry as evidenced

by publications and/or presentations at

professional scientific meetings.

d. Describe the unmet needs and

information gaps as they relate to

advancing a coordinated and

comprehensive effort to promote health

through the relaxation response, and

how this project would move toward

addressing these needs and gaps (i.e.,

purpose of the project).

3. Research Resources and

Organizational Capacity

a. Describe the applicant’s capability

to conduct the project, taking into

account its institutional experience,

evidence of leadership, and ability to

successfully do multi-disciplinary

research for those activities required.

b. Describe the applicant’s ability to

attract and retain subjects such as

establishing collaborations with one or

more community-based partner(s)

(health maintenance organizations;

health clinics; foundations, schools) that

can serve as a subject/patient/client

referral source.

c. Describe the applicant’s capacity to

provide evidence of effective

collaborations and linkages with

partners, to meet the requirements of the

project, including, if warranted,

documented letters of support and

commitments from those collaborating

entities.

d. Describe the capacity of the

applicant to gather necessary

confidential, demographic and health

outcome information regarding the

study participants’ characteristics that

predict engaging in, maintaining, and/or

benefitting from a relaxation approach,

including the kinds and sources of

information to be obtained, analyzed,

and publicized, the staff/organizations

charged with its control, and how these

data would be protected and used.

4. Operational Approach

a. Describe the research question(s)

(that will advance the knowledge),

scientific methods, and data analyses to

31334 Federal Register / Vol. 65, No. 96 / Wednesday, May 17, 2000 / Notices

be employed to assess the acute

psychophysiological responses/benefits

(e.g., immediate but transient blood

pressure reductions), and reliability of

responses, associated with a relaxation

approach, including a theoretical or

scientific rationale for the measures

selected and, when appropriate,

evidence of the validity and reliability

of measures selected (e.g., measures of

state anxiety).

b. Describe the research question(s)

(that will advance the knowledge),

scientific methods, and data analyses to

be employed to evaluate the chronic

(e.g., reduction in resting blood pressure

in patients with hypertension) health

outcomes associated with a relaxation

approach, including a theoretical or

scientific rationale for the outcomes or

variables selected and, when

appropriate, evidence of the validity

and reliability of measures selected.

c. Describe the scientific methods to

evaluate the hypothesized causal

mechanisms that mediate the relaxation

approach, relaxation response, and

health outcomes relationship(s).

d. Describe the approach to (1) gather

information on the determinants related

to initiating, maintaining, and

benefitting from a relaxation approach,

including a brief review of currently

available evidence, and/or plans to

collect and analyze data that leads to an

understanding of correlates which may

predict who is attracted to initiating a

relaxation approach, adherence rates to

a relaxation approach, and the benefits

gained (based on factors such as

sociodemographic characteristics,

health status, and one or more

assessments related to belief systems,

positive or negative affect, or other

pertinent constructs); and (2) assess the

perceptions, outcome expectancies,

enjoyment, and/or actual response(s) or

outcomes of persons based on their

status as novice or experienced

practitioners of a relaxation approach.

5. Management Plan and Project Goals

and Objectives

a. Present a management work plan

for conducting the project, including the

process (approach and methods) by

which the applicant will meet

established goals and objectives.

b. Provide a description of specific

goals, objectives and time lines.

c. Provide a description of the major

tasks and responsibilities for key

positions including the applicant

organization (include an organization

chart and denote the relationship of this

project within the applicant

organization).

d. Describe how the applicant will

evaluate its work plan, all

collaborations, and activities related to

the scope of the project.

6. Budget Justification

Provide a line-item budget with a

detail narrative justification that is

consistent with the purpose and

objectives of this grant.

7. Human Subjects Research

Adequately address the requirements

of Title 45CFR Part 46 for the protection

of human subjects.

F. Submission and Deadline

Submit the original and two copies of

PHS–398 (OMB Number 0925–0001)

(adhere to the instructions on the Errata

Instruction Sheet for PHS–398). Forms

are in the application kit.

On or before July 14, 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. (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

Each application will be evaluated

individually against the following

criteria by an independent review group

appointed by CDC.

1. Problem Statement and Evidence of

Need—20 Points

This includes the degree to which the

applicant:

a. Describe (1) the literature

demonstrating how mind (cognition)

and body (physiology) interact, and (2)

impact on one or more health outcomes.

b. Synthesizes state-of-the-art findings

regarding the effectiveness of an

approach that evokes the relaxation

response that has been used with

healthy persons and/or persons with

chronic disease or disability, including

documentation/referencing of the

applicants own systematic and ongoing

line of mind/body inquiry as evidenced

by publications and/or presentations at

professional scientific meetings.

c. Describes the unmet needs and

information gaps as they relate to

advancing a coordinated and

comprehensive effort to promote health

through the relaxation response, and

how this project would move toward

addressing these needs and gaps (i.e.,

purpose of the project).

2. Research Resources and

Organizational Capacity—15 points

a. The capability of the applicant to

conduct the project, taking into account

its institutional experience, evidence of

leadership, and ability to successfully

do multi-disciplinary research for those

activities required.

b. The ability of the applicant to

attract and retain subjects such as

establishing collaborations with one or

more community-based partner(s)

(health maintenance organizations;

health clinics; foundations, schools) that

can serve as a subject/patient/client

referral source.

c. The capacity of the applicant to

provide evidence of effective

collaborations and linkages with

partners, to meet the requirements of the

project, including, if warranted,

documented letters of support and

commitments from those collaborating

entities.

d. The capacity of the applicant to

gather necessary confidential,

demographic and health outcome

information regarding the study

participants’ characteristics that predict

engaging in, maintaining, and/or

benefitting from a relaxation approach,

including the kinds and sources of

information to be obtained, analyzed,

and publicized, the staff/organizations

charged with its control, and how these

data would be protected and used.

3. Operational Approach—(Total 50

Points)

a. Describe the research question(s)

(that will advance the knowledge),

scientific methods, and data analyses to

be employed to assess the acute

psychophysiological responses/benefits

(e.g., immediate but transient blood

pressure reductions), and reliability of

responses, associated with a relaxation

approach, including a theoretical or

scientific rationale for the measures

selected and, when appropriate,

evidence of the validity and reliability

of measures selected (e.g., measures of

state anxiety). (10 points)

b. The research question(s) (that will

advance the knowledge), scientific

methods, and data analyses to be

employed to evaluate the chronic (e.g.,

reduction in resting blood pressure in

patients with hypertension) health

outcomes associated with a relaxation

approach, including a theoretical or

scientific rationale for the outcomes or

Federal Register / Vol. 65, No. 96 / Wednesday, May 17, 2000 / Notices 31335

variables selected and, when

appropriate, evidence of the validity

and reliability of measures selected. (10

points)

c. The scientific methods to evaluate

the hypothesized causal mechanisms

that mediate the relaxation approach,

relaxation response, and health

outcomes relationship(s). (20 points)

d. The approach to (1) gather

information on the determinants related

to initiating, maintaining, and

benefitting from a relaxation approach,

including a brief review of currently

available evidence, and/or plans to

collect and analyze data that leads to an

understanding of correlates which may

predict who is attracted to initiating a

relaxation approach, adherence rates to

a relaxation approach, and the benefits

gained (based on factors such as

sociodemographic characteristics,

health status, and one or more

assessments related to belief systems,

positive or negative affect, or other

pertinent constructs); and (2) assess the

perceptions, outcome expectancies,

enjoyment, and/or actual response(s) or

outcomes of persons based on their

status as novice or experienced

practitioners of a relaxation approach.

(10 points)

4. Management Plan and Project Goals

and Objectives—15 Points

a. The management work plan for

conducting the project, including the

process (approach and methods) by

which the applicant will meet

established goals and objectives.

b. The presentation of those specific

goals, objectives and time lines.

c. The description of the major tasks

and responsibilities for key positions

including the applicant organization

(include an organization chart and

denote the relationship of this project

within the applicant organization).

d. The description of how the

applicant will evaluate his/her work

plan, all collaborations, and activities

related to the scope of the project.

e. 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.

5. Budget Justification—Not Scored

This criteria includes the adequacy of

the budget justification and its

relationship to program operations and

services. Each line item of the budget

must be well justified in a detailed

narrative with special attention given to

contractual requests including the

responsibilities of consultants,

percentage time equivalents, hourly or

daily rates, etc.

The relevance of this section to the

other evaluation criteria will be

measured on the extent to which the

budget narrative is reasonable, clearly

documented, accurate, and consistent

with the purpose of this announcement.

6. Human Subjects—Not Scored

Does the application adequately

addresses the requirements of Title 45

CFR Part 46 for the protection of human

subjects?

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two

copies of:

1. Annual progress reports;

2. Financial status report, due no

more than 90 days after the end of each

budget period; and

3. Final financial status and

performance reports, due 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–8 Public Health System Reporting

Requirements

AR–9 Paperwork Reduction Act

Requirements

AR–10 Smoke-Free Workplace

Requirements

AR–11 Healthy People 2010

AR–12 Lobbying Restrictions

AR–14 Accounting Systems

Requirements

AR–15 Proof of Non-Profit Status

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under the

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

Health Service Act, (42 U.S.C. 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 announcement and other CDC

program 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: Cynthia Collins, Grants

Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Announcement 000118,

Centers for Disease Control and

Prevention (CDC), 2920 Brandywine

Road, Room 3000 Atlanta, GA 30341–

4146, telephone (770)-488–2757, E-mail:

coc9@cdc.gov.

For program technical assistance,

contact: Deborah Jones, Division of

Nutrition and Physical Activity,

National Center for Chronic Disease

Prevention and Health Promotion,

Centers for Disease Control and

Prevention, 4770 Buford Highway,

Atlanta, GA 30341–3724, telephone

(770) 488–5593, E-mail address:

DAJones@cdc.gov.

Dated: May 11, 2000.

John L. Williams,

Director, Procurement and Grants Office,

Center for Disease Control and Prevention

(CDC).

[FR Doc. 00–12342 Filed 5–16–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

Notice of Appeal

AGENCY: Administration for Children

and Families (ACF), DHHS.

ACTION: Notice of appeal.

SUMMARY: By designation of the

Administration for Children and

Families, a member of the Departmental

Appeals Board will be the presiding

officer for appeals concerning ACF’s

imposition of Adoption and Foster Care

Analysis and Reporting System

penalties for the States of California,

Florida, Iowa, Kansas, Maryland,

Minnesota, New York North Carolina,