[Federal Register Volume 65, Number 96 (Wednesday, May 17, 2000)]
[Notices]
[Pages 31332-31335]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-12342]


-----------------------------------------------------------------------

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.

[[Page 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

[[Page 31334]]

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

[[Page 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: [email protected].
    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: [email protected].

    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