[Federal Register Volume 66, Number 93 (Monday, May 14, 2001)]
[Notices]
[Pages 24376-24380]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-11998]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 01095]


Building Quality Parent Components for School-Based Health 
Programs in Elementary and Middle Schools; Notice of Availability of 
Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2001 funds for a cooperative agreement 
program for Building Quality Parent Components for School-Based Health 
Programs in Elementary and Middle Schools. This program addresses the 
``Healthy People 2010'' focus areas of Family Planning, HIV, Nutrition 
and Over weight, Physical Activity and Fitness, Sexually Transmitted 
Disease, and Tobacco Use. A goal of this program is to eliminate health 
disparities among different segments of the population.
    The purpose of this cooperative agreement is to develop and 
evaluate parent-focused intervention components to be used as a 
supplement for school-based sexual risk reduction and chronic disease 
risk factor prevention programs in elementary and middle schools. These 
intervention components would be designed to assist parents in reducing 
the risk behaviors of their children. The risk factors among young 
people being targeted by this program are sexual risk behaviors and 
chronic disease risk factors which include tobacco use, physical 
inactivity, poor nutrition, and being overweight or at risk of becoming 
overweight. Interventions will target parents (i.e., primary 
caregivers) of elementary or middle school students.
    For the purposes of this announcement, parents are defined as 
primary caregivers who are biological parents or legal guardians (e.g., 
adoptive parent, stepparent, grandparent) of elementary and middle 
school students. Primary caregivers are individuals who take primary 
responsibility for providing care for their children. Parents (i.e., 
primary care-givers) are eligible for the study if their elementary or 
middle school children currently reside with them and if they have 
lived in the same residence with their elementary or middle school 
children for at least one year prior to the study.
    Sexual risk reduction interventions are programs that show promise 
of success or have demonstrated evidence of efficacy in delaying 
initiation of sexual activity among young people, increasing condom or 
contraceptive use among sexually active young people, or decreasing 
frequency of intercourse or number of sexual partners among sexually 
active young people. Chronic disease risk factor prevention 
interventions are programs that show promise of success or have 
demonstrated evidence of efficacy in preventing initiation or promoting 
a decrease of tobacco use among young people, increasing physical 
activity, increasing healthy eating, or decreasing the number of 
children who are overweight or at risk of becoming overweight. Youth 
tobacco use prevention programs are included in this announcement, 
however, youth tobacco cessation programs are not within the scope of 
this announcement.
    Please reference to Appendix 1 for background information relevant 
to this program announcement.

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, territorial, and local 
governments or their bona fide agents, and federally recognized Indian 
tribal governments, Indian tribes, or Indian tribal organizations.
    Successful applicants shall demonstrate a history of conducting 
evaluation research in partnership with interdisciplinary groups of 
health researchers and local racial and ethnic minority communities on 
applied social and behavioral science projects.

    Note: Title 2 of the United States Code, Chapter 26, Section 
1611 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.


[[Page 24377]]



A. Availability of Funds

    Approximately $300,000 is available in FY 2001 to fund one award. 
It is expected that the award will begin on or about August 31, 2001, 
and will be made for a 12-month budget period within a project period 
of up to five years. First year funding will be approximately $300,000 
because the first year of the project is expected to be a planning 
year.
    Subsequent funding years are expected to be funded at approximately 
$700,000. Funding estimates may vary and are subject to 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.

B. 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 the activities 
listed under 2. (CDC Activities).

1. Recipient Activities

    a. Establish and maintain appropriate staff positions allocated to 
specific responsibilities including a Research Director and a Project 
Director with research and training experience and allocated time 
sufficient to achieve the objectives of this program announcement.
    b. Lead an expert panel of individuals with demonstrated experience 
in conducting research on parental influences on adolescent risk 
behaviors or who have developed and implemented parent-based 
interventions. The purpose of the panel should be to refine and further 
develop the parent intervention components. Develop final version of 
the parent components.
    c. Develop a quasi-experimental or experimental evaluation design 
in which sites or individual participants (or some other justified 
unit) will be randomized to the control or comparison condition or the 
experimental condition. An evaluation plan should be developed to 
include both process and outcome evaluation components. Refine research 
questions, conceptual frameworks, measurement and analysis strategies, 
and intervention protocols to meet program goals. Develop strategies to 
maintain an adequate response rate through the follow-up period.
    d. Collaborate and coordinate efforts with appropriate school, 
parent, and community organizations to identify schools to participate 
in the study and obtain approvals. Efforts should be made to include 
members of the targeted population in developing and revising the 
research and intervention activities whenever appropriate and feasible. 
Plans to collaborate with schools to sustain successful interventions 
beyond the duration of the project should be made.
    e. Develop a research protocol for local and CDC Institutional 
Review Board review.
    f. Recruit participants into the study. Conduct intervention 
components designed to assist parents in reducing sexual risk behavior 
and preventing chronic disease risk factors among young people in 
elementary or middle school.
    g. Collect data from participants at baseline (i.e., prior to the 
delivery of the intervention), immediately following the completion of 
the intervention, and 12 months following the completion of the 
intervention.
    h. Analyze data according to planned strategies in order to measure 
the success of interventions with targeted populations in comparison to 
a control/comparison group, which should consist of the existing sexual 
risk reduction and chronic disease risk factor prevention programs 
without the parent component supplements. Behavioral outcomes (e.g., 
increasing condom use, preventing tobacco initiation, increasing 
healthy eating) should be measured, on both parents and children. 
Knowledge and attitude assessment may be included, in additional to 
behavioral outcomes. Parental outcomes (e.g., measures of parental 
monitoring, communication, parental modeling) should be measured with 
both parents and children.
    i. Develop a plan for disseminating results of the research to 
members of the scientific, programmatic, and targeted communities 
through scientific publications, presentations and other appropriate 
methods.

2. CDC Activities

    a. Assist in selection of the student interventions. Participate in 
an expert panel to refine and further develop the parent intervention 
components. Assist with the development of the final version of the 
parent components.
    b. Assist in the development of research and evaluation protocols 
for the study and for IRB review by all cooperating institutions 
participating in the research project. The CDC IRB will review the 
protocol initially and on at least an annual basis until the research 
project is completed.
    c. Assist with the scientific and technical coordination of the 
general operation of the research project, including data management 
support.
    d. Assist in the analysis of data gathered from program activities 
and the reporting of results.
    e. Collaborate in the dissemination of evaluation findings through 
scientific publications and presentations.

E. Application Content

    Use the information in the Program Requirements, Other 
Requirements, and Evaluation Criteria sections and the instructions and 
format provided below 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 30 double-spaced pages, printed on one side, 
with one inch margins, and unreduced font.
    The application should include an abstract and general 
introduction, followed by one narrative subsection per application 
content element (1-7) in the order in which the elements appear below. 
Each narrative subsection should be labeled with the element title and 
contain all of the information needed to evaluate that element of the 
application (except for curriculum vitae, references, intervention 
descriptions and materials, and letters of support). The referenced 
exception materials should be placed in the appendices section of the 
application.

1. Specific Aims, Background and Significance

    a. List the broad, long-term objectives and what the specific 
research proposed in this application is intended to accomplish. State 
the hypotheses to be tested.
    b. Provide a review of the relevant literature to specify a 
theoretical and empirical justification for the proposed research, and 
clearly describe how the proposed intervention will advance efforts to 
reduce sexual risk behaviors and prevent chronic disease risk factors 
among young people in elementary or middle school by intervening with 
parents (i.e., primary caregivers) of elementary or middle school young 
people. Specifically, the application should include explicit models 
(with schematic drawings) that illustrate factors to be modified 
through the intervention and that explain the mechanisms by which 
outcome effects are produced.

2. Intervention Plan

    a. Describe, in detail, the school-based sexual risk reduction and 
chronic

[[Page 24378]]

disease risk factor prevention curricula to which a parent component 
will be added. Provide evidence that the selected programs have been 
found to be efficacious or promising with elementary or middle school 
students. Describe the proposed potential parent components to be added 
to these curricula and how these will fit into the proposed 
interventions for young people. Provide evidence justifying inclusion 
of the proposed parent components as promising strategies to reduce 
risk behaviors.
    b. Discuss why the planned parent intervention components are 
promising. Intervention descriptions should be provided if possible. 
Discuss feasibility and acceptability of the intervention in a school 
setting and among parents and why it is expected that the planned 
intervention components will avoid the problems of parent recruitment 
and retention encountered by other parent programs.

3. Research Plan

    a. Describe all aspects of the study design and methods, including 
the evaluation design (both process and outcome), and how threats to 
validity will be handled; a detailed description of the targeted 
population, including but not limited to age, grade, sex, race, 
socioeconomic status, and how the population will be accessed; 
instrumentation; the sampling strategy (including a justification for 
the sampling unit, sample size, power analysis justifying the sample 
size, an indication of expected effect sizes, and the randomization 
strategy); and training plans for individuals collecting data, and data 
collection plans, including but not limited to, linking participants' 
responses between measurement periods.
    b. Describe plans for recruitment and retention of both parents and 
children into the study, including expected sample attrition during 
both intervention and measurement phases. Describe how study 
participants will be tracked and what strategies will be used to 
increase retention.
    c. Describe how the intervention implementation process will be 
measured and how the findings will be used to monitor implementation 
and provide feedback to staff, and to explicate other findings. Include 
plans to maintain detailed records of the costs involved in 
implementation such that cost-effectiveness and cost-benefit analyses 
can be performed.
    d. Describe the plans and quality assurance monitoring for data 
management, plans for data analysis, and interpretation.
    e. Describe the potential limitations of the results given the 
complexity of the research focus, the targeted population, and the 
applied nature of the evaluation; to whom the findings will be 
generalizeable; and how they can be used to develop national 
recommendations for including parents in efforts to reduce sexual risk 
behaviors and prevent chronic disease risk factors among children in 
elementary and middle schools.
    f. Discuss how the proposed study will meet 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. Research and Intervention Capacity

    a. Demonstrate the feasibility of the proposed research by 
providing a detailed time-line, with specific products, specifying 
which staff person will be responsible for which task.
    b. Describe the research team and show that the proposed research 
staff for the project represents an interdisciplinary team of 
behavioral and social scientists with the scientific training and the 
previous scientific and practical experience needed to conduct and 
complete high quality research within the specified time-line, as 
evidenced by the successful completion of past research in the areas 
proposed in this application. Describe previous service or research 
conducted with this population.
    c. Demonstrate the adequacy of the proposed staff, through 
curriculum vitae and position descriptions that detail 
responsibilities, to carry out all proposed activities (i.e., 
sufficient in number, percentage of time commitments, behavioral or 
social scientists in key project positions, and qualifications).
    d. Describe the facilities, data processing and analysis capacity, 
and systems for management of data security and participant 
confidentiality.

5. Collaboration, Sustainability, and Dissemination

    a. Describe how academic, program, and community partners will 
participate in developing, conducting, and evaluating the proposed 
research. Specifically, describe the involvement of appropriate key 
organizations and members of the targeted population and discuss 
previous work of the proposed collaborators. Include letters of support 
from proposed collaborating organizations indicating willingness to 
participate in the proposed research, including but not limited to, 
evidence of past successful collaboration, willingness to be randomized 
to a control/comparison or experimental condition, and the number and 
demographic characteristics of young people served.
    b. Define the responsibilities of collaborating partners and 
identify a primary contact within collaborating organizations.
    c. Discuss efforts to be made throughout the project period to 
ensure that the intervention will be sustained once Federal funding 
ends.
    d. Provide a clear dissemination plan to include, but not limited 
to, the timely sharing of findings with local partners; and include a 
plan to work with other sites to ensure that analysis and production of 
scientific papers and reports give priority to findings that can be 
used to develop national prevention recommendations for inclusion of 
parents in efforts to reduce sexual risk behavior and prevent chronic 
disease risk factors among young people in elementary or middle school. 
Describe key dissemination products including peer-reviewed 
publications and presentations that can be used by program planners, 
policy makers, and other interested parties.

6. Budget with Justification

    Provide a detailed budget with a line-item justification that is 
consistent with the proposed activities.

7. Human Subjects

    Does the applicant adequately address the requirements of Title 45 
CFR Part 46 for the protection of human subjects?

F. Submission and Deadline

Application

    Submit the original and five copies of PHS 398 (OMB Number 0925-
0001). Forms are available at the following Internet address: http://forms.psc.gov, or in the application kit.
    On or before June 22, 2001, submit the application to the Grants 
Management Specialist identified in the ``Where to

[[Page 24379]]

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 (Total 100 Points)

    Each application will be evaluated individually against the 
following criteria by an independent review group appointed by CDC:

1. Specific Aims, Background, and Significance (10 points)

    a. The extent to which the specific aims and objectives of the 
proposed research are clearly stated and justified and the stated 
hypotheses are testable.
    b. The extent to which a comprehensive review of the relevant 
literature and specification of a theoretical and empirical 
justification for the proposed research is provided.

2. Intervention Plan (25 points)

    a. The extent to which the applicant adequately describes the 
school-based sexual risk reduction and chronic disease risk factor 
prevention intervention curricula to which a parent component will be 
added and describes the proposed parent components. The extent to which 
evidence is provided that the selected programs have been found to be 
efficacious or promising with elementary or middle school students.
    b. The extent to which the applicant addresses the issues of 
feasibility and acceptability of the intervention in a school setting 
and among parents. The extent to which the planned intervention 
components can be expected to avoid the problems of parent recruitment 
and retention encountered by other parent programs.

3. Research Plan (30 points; a-e, 25 pts.; f, 5 pts.)

    a. The extent to which the study and evaluation design (both 
process and outcome) and methods are scientifically sound. Demonstrated 
ability to access the target population. The adequacy of the proposed 
instrumentation; the sampling strategy; training plans for individuals 
collecting data, and data collection plans.
    b. The adequacy with which study participants will be tracked, and 
the extent to which strategies presented are likely to produce adequate 
recruitment and retention of participants (includes expected 
attrition).
    c. The extent to which the intervention implementation process can 
be measured and findings used to monitor implementation and provide 
feedback to staff as well as to replicate the intervention in other 
settings, including the ability to perform cost-effectiveness and cost-
benefit analyses.
    d. The extent to which the plans for data management, data 
analysis, and interpretation are clear, appropriate and are monitored 
adequately for quality.
    e. The extent to which the evaluation will provide results that are 
scientifically sound, generalizeable, and useful for developing 
national recommendations for the inclusion of parent components in 
school programs.
    f. The extent to which the applicant has met the CDC Policy 
requirements regarding the inclusion of women and ethnic and racial 
groups in the proposed research.

4. Research and Intervention Capacity (20 points)

    a. The feasibility of the proposed research plan and the adequacy 
of the time-line with specific products, specifying which staff person 
will be responsible for which task.
    b. The extent to which the proposed research staff represents an 
interdisciplinary team of behavioral and social scientists with the 
scientific training and the previous experience needed to conduct high 
quality research within the specified time-line.
    c. The adequacy of the proposed staff, as evidenced by curriculum 
vitae and position descriptions that detail responsibilities, to 
conduct all proposed activities (i.e., sufficient in number, percentage 
of time commitments, behavioral scientists in key project positions, 
and qualifications).
    d. The adequacy of facilities, data processing and analysis 
capacity, and systems for management of data security and participant 
confidentiality.

5. Collaboration, Sustainability, and Dissemination (15 points)

    a. The extent to which the applicant includes academic and 
community partners in developing, conducting, and evaluating the 
proposed research, and includes the involvement of appropriate key 
organizations and members of the targeted population. Degree to which 
applicant includes letters of support from proposed collaborating 
organizations. The extent to which the responsibilities of 
collaborating partners are defined.
    b. The adequacy of efforts to be made throughout the project period 
to ensure that the intervention will be sustained once Federal funding 
ends.
    c. The extent to which the dissemination plan is clearly 
articulated and includes the timely sharing of findings with local 
partners.

6. Budget (Not Scored)

    Extent to which the budget is reasonable, itemized, clearly 
justified, and consistent with the intended use of the funds.

7. Human Subjects (Not Scored)

    Does the application adequately address 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. Progress reports (annual, semiannual, or quarterly);
    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.
    For a description of the following Other Requirements, 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-4  HIV/AIDS Confidentiality Provisions
AR-5  HIV Program Review Panel Requirements
AR-8  Public Health System Reporting Requirements
AR-9  Paperwork Reduction Act 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

[[Page 24380]]

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under Sections 301(a), 311(b) and (c) 
and 317(k)(2)[42 U.S.C. section 241(a), 243(b) and (c), and 
247b(k)(2)], of the Public Health Service Act, as amended. The Catalog 
of Federal Domestic Assistance number is 93.938.

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.''
    For more information on effective programs, visit the Department of 
Justice website, http://www.usdoj.gov, the Department of Education 
website, http://www.ed.gov and CDC's ``Programs That Work'' website, 
http://www.cdc.gov/nccdphp/dash/rtc/index.htm.
    Should you have questions after reviewing the contents of all the 
documents, business management technical assistance may be obtained 
from: Cynthia Collins, Grants Management Specialist, Grants Management 
Branch, Procurement and Grants Office, Centers for Disease Control and 
Prevention, Announcement 01095, 2920 Brandywine Road, Room 3000, 
Atlanta, GA 30341-4146, Telephone number: 770-488-2757, E-mail address: 
[email protected].
    For program technical assistance, contact: Patricia Dittus, Ph.D., 
Division of Adolescent and School Health, Centers for Disease Control 
and Prevention, 4770 Buford Highway NE, MS K-33, Atlanta, GA 30341, 
Telephone number: 770-488-6196, E-Mail address: [email protected].

    Dated: May 08, 2001.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 01-11998 Filed 5-11-01; 8:45 am]
BILLING CODE 4163-18-P