[Federal Register Volume 63, Number 121 (Wednesday, June 24, 1998)]
[Notices]
[Pages 34426-34433]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-16766]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Program Announcement 98085]
Young People in Alternative Education Settings: Preventing HIV
and Other Sexually Transmitted Diseases Notice of Availability of
Fiscal Year 1998 Funds
Introduction
The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 1998 funds for cooperative agreements
for the prevention of human immunodeficiency virus (HIV), and other
sexually transmitted diseases (STDs) among young people in alternative
educational
[[Page 34427]]
settings. Applied research programs that implement and evaluate
promising, multicomponent interventions to reduce unprotected sexual
intercourse among young people in alternative educational settings will
be supported under this cooperative agreement.
Young people in high-risk situations for HIV and other STDs are
served in alternative educational settings, which include: alternative
schools, and school-based or school-linked dropout prevention programs,
and dropout recovery programs. Alternative schools, dropout prevention
programs, and dropout recovery programs serve students primarily who
are at high risk of not progressing in regular high schools (or who
have previously stopped attending school), and as a result, not
graduating, as well as students who have already gotten into
disciplinary trouble, usually related to illegal drug use or violence.
Of particular interest are alternative educational settings targeting
adjudicated young people (that is, young people in contact with the
juvenile justice system), although interventions may target other young
people in high risk situations served within alternative educational
settings. (See Attachment 1 for the CDC's definition of young people in
high risk situations.)
The CDC is committed to achieving the health promotion and disease
prevention objectives of ``Healthy People 2000,'' a national activity
to reduce morbidity and death and improve the quality of life. This
announcement is related to priority areas of Family Planning, HIV
Infection, and Sexually Transmitted Diseases. (To order a copy of
``Healthy People 2000,'' see the section ``Where To Obtain Additional
Information.'')
Authority
This program is authorized under sections 301(a) and 317(k)(2) [42
U.S.C. 241(a) and 247b(k)(2)] of the Public Health Service Act, as
amended. Regulations are set forth in 42 CFR Part 51b.
Smoke-free Workplace
CDC strongly encourages all grant recipients to provide a smoke-
free workplace and to promote the nonuse of all tobacco products, and
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities that receive Federal funds in which educational,
library, day care, health care, and early childhood development
services are provided to children.
Eligible Applicants
Eligible applicants are the official educational, juvenile
corrections, public health, family planning, and substance abuse
agencies of the State; the District of Columbia and Puerto Rico, as
well as local governments, nonprofit organizations, academic
institutions, and other nonprofit health, family planning, substance
abuse, or social service providers. All applicants must provide
evidence that demonstrates a successful history of working in
partnership with interdisciplinary groups of health researchers and
local racial and ethnic minority communities on applied social and
behavioral science projects.
Residential programs in which participants receive interventions
while institutionalized both weekdays and weekends are not eligible to
avoid duplication of current CDC initiatives targeting incarcerated
young people.
Note: Effective January 1, 1996, Public Law 104-65 states that
an organization described in section 501(c)(4) of the Internal
Revenue Code of 1986 which engages in lobbying activities will not
be eligible for the receipt of Federal funds constituting an award,
grant, cooperative agreement, contract, loan, or any other form.
Availability of Funds
Approximately $600,000 is available in FY 1998 to fund up to two
awards. It is expected that awards will begin on or about September 30,
1998, and will be made for a 12-month budget period within a project
period of up to 4 years. Funding estimates may vary and are subject to
change.
Continuation awards within the project period will be made on the
basis of satisfactory performance and the availability of funds.
Use of Funds
Restrictions on Lobbying
Applicants should be aware of restrictions on the use of HHS funds
for lobbying of Federal or State legislative bodies. Under the
provisions of 31 U.S.C. Section 1352 (which has been in effect since
December 23, 1989), recipients (and their subtier contractors) are
prohibited from using appropriated Federal funds (other than profits
from a Federal contract) for lobbying congress or any Federal agency in
connection with the award of a particular contract, grant, cooperative
agreement, or loan. This includes grants/cooperative agreements that,
in whole or in part, involve conferences for which Federal funds cannot
be used directly or indirectly to encourage participants to lobby or to
instruct participants on how to lobby.
In addition, the FY 1998 Department of Labor, Health and Human
Services, and Education, and Related Agencies Appropriations Act
(Public Law 105-78) states in Section 503 (a) and (b) that no part of
any appropriation contained in this Act shall be used, other than for
normal and recognized executive-legislative relations, for publicity or
propaganda purposes, for the preparation, distribution, or use of any
kit, pamphlet, booklet, publication, radio, television, or video
presentation designed to support or defeat legislation pending before
the Congress or any State legislature, except in presentation to the
Congress or any State legislature itself. No part of any appropriation
contained in this Act shall be used to pay the salary or expenses of
any grant or contract recipient, or agent acting for such recipient,
related to any activity designed to influence legislation or
appropriations pending before the Congress or any State legislature.
Background
CDC has prioritized programs reducing sexual risk behavior among
young people in high risk situations, particularly among young men
having sex with men, injection drug using young people, and adjudicated
young people. High rates of HIV, STDs, and unintended pregnancies among
young people point to a need for interventions that effectively address
adolescent sexual and drug use behavior. Several ``Healthy People
2000'' objectives call for effective interventions in these areas. The
1992 National Health Interview Survey Youth Risk Behavior supplement
revealed that sexual risk and drug-use behaviors among out-of-school
young people are more common than among their in-school counterparts.
Programs designed to reach students at risk for school dropout are an
important strategy to provide health education and activities to
prevent behavior that may put them at risk for HIV and STDs. Evaluating
the effectiveness of prevention programs within these settings is
important and has been rarely undertaken.
Alternative schools are one important avenue for reaching young
people who have dropped out or who are at risk of dropping out of
regular school programs. Within the United States there are over 1300
free-standing alternative schools that serve 280,000 young peoples in
grades 8 or higher. The number of students enrolled in such programs is
even greater when alternative school programs within regular schools,
and after-school diploma and GED programs are included. Such
educational services are
[[Page 34428]]
needed given the number of young people dropping out of schools: in
1994, 11.4 percent of young people aged 16-24 dropped out of school
without obtaining a high school diploma or GED.
Studies of alternative school students in Texas, Montana,
Minnesota, and Florida demonstrate high rates of sexual risk behaviors
strongly correlated with HIV, STDs, and unintended pregnancy. Young
people in drop-out prevention programs and alternative schools exhibit
higher rates of sexual risk behavior than their counterparts in regular
schools including higher prevalence of sexual activity (between 83
percent and 97 percent), lower prevalence of condom use at last
intercourse (between 40 percent and 60 percent), and higher prevalence
of sex with multiple partners (between 31 percent and 43 percent).
Young people in drop-out prevention programs and alternative school
settings are also more likely to report a prior pregnancy (between 25
percent and 40 percent) than their regular school counterparts.
Further, alternative school students report a high prevalence of drug
use, including alcohol, marijuana, and cocaine.
Low academic and occupational expectations, academic failure, and
school dropout are strongly and persistently associated with contact
with the juvenile justice system. Federal Bureau of Investigation
arrest statistics reveal that criminal offenses for males and females
increase in early adolescence, peak in late adolescence, and decrease
thereafter, bringing a higher proportion of young people into contact
with the justice system than other age groups. Alternative school and
dropout prevention programs that serve adjudicated young people, are
detailed in ``Reaching Out to Youth Out of the Education Mainstream.''
(To order a copy of ``Reaching Out to Youth Out of the Education
Mainstream,'' see the section ``Where To Obtain Additional
Information.'') Community-based follow-up programs for young people
that reinforce risk reduction behaviors have been shown to be promising
strategies, and could be implemented in alternative educational
settings. Such programs vary in the timing with which they intervene as
young people progress through the juvenile justice system. Some
alternative educational programs are preventive and implemented at the
time of first offense, some provide model school experiences for
incarcerated young people, and some are implemented after juveniles are
released from incarceration to reintegrate them with the mainstream
educational system.
Although there is a clear need for interventions to reduce sexual
risk behaviors among young people at risk for school dropout, little
research has been conducted to determine intervention efficacy for this
population. While alternative and dropout prevention program students
have been exposed to mainstream school HIV and STD prevention programs
at relatively high rates, these programs may not adequately meet the
needs of young people at high risk. One study of students in a dropout
recovery program in Illinois found that a lack of tailored
interventions has resulted in low basic knowledge regarding sexual
risk, as well as high levels of risk behavior.
Purpose
These awards will support evaluation of promising interventions to
decrease sexual risk behaviors among young people in alternative
educational settings. This cooperative agreement will support applied
research that meets the following criteria:
1. Identifies a promising group-level intervention based on a sound
theoretical foundation. Promising programs are those with demonstrated
effectiveness based on preliminary evaluation data, expert appraisal,
or favorable response by participants. A rationale should be provided
that justifies use of the intervention in the current population and
setting. Programs may be revised, improved, or updated for purposes of
the current research.
2. Implements and evaluates intervention strategies among young
people in alternative educational settings to reduce sexual risk
behavior.
3. Collaborates with academic, program, and community partners in
conducting, and evaluating the proposed intervention, and proposes to
work with partners throughout the project period to sustain successful
interventions beyond the project's duration.
Program Requirements
Studies will be quasi-experimental or experimental in design and
should measure knowledge, attitudes, and behavior related to HIV and
other STDs. Measures of behavior should include, but are not limited
to, abstinence, correct and consistent condom use among sexually active
young people, past sexual experience including victimization, measures
of number of partners, and frequency of sexual intercourse. While the
major focus of the cooperative agreement is to decrease HIV and STD
related risk behaviors, interventions may include as a secondary focus
reducing the prevalence of alcohol and drug use, or sexual behaviors
related to unintended pregnancy, including increasing effective
contraceptive use among sexually active young people.
Studies should include at least two sites in which the intervention
will be implemented, and sites or individual participants (or some
other justified sampling unit) should be randomized to the control or
comparison condition or the experimental condition. Studies should be
designed to follow-up participants at least 12 months after the end of
the intervention. Extensive strategies to maintain an adequate response
rate throughout the follow-up will be of critical importance. The
overall evaluation of these programs will include both process and
outcome evaluation components.
In conducting activities to achieve the purpose of this program,
the recipient will be responsible for the activities under A.
(Recipient Activities), and CDC will be responsible for conducting
activities under B. (CDC Activities).
A. Recipient Activities
1. Establish and maintain staff positions allocated to specific
responsibilities, with at least a 50 percent time research director and
a 100 percent time project director with training, experience, and
authority sufficient to achieve the objectives of this program
announcement.
2. Identify and implement a promising intervention designed to
reduce sexual risk behavior among young people in alternative
educational settings. Examples include, but are not limited to, the
following:
(a) Increasing knowledge about HIV and other STDs, and promoting
attitudes and behavioral intentions that support reductions in sexual
risk behavior.
(b) Providing skill-based training that increases, through modeling
and practice, decision-making and communication skills that support
reduction of sexual risk behaviors.
(c) Identifying, creating, or mobilizing school, family, peer, and
other social networks to support and reinforce sexual risk reduction
through activities including, but not limited to, mentoring, peer-
influence, familial involvement, increased communication with sexual
partners, community involvement, or social diffusion.
(d) Promoting resiliency, social skills, and youth assets through a
youth development approach.
(e) If alcohol and drug-related behavior is a secondary focus, then
promoting knowledge, attitudes,
[[Page 34429]]
behavioral intentions, and behavior to reduce alcohol and illegal drug
use, or to reduce harm associated with use.
(f) If pregnancy prevention is a secondary focus, then increasing
knowledge, attitudes, and behavioral intentions and behavior to
increase effective contraceptive use (which may include multiple
methods of contraception) to prevent HIV, STD, and unintended pregnancy
among sexually active young people.
3. Measure the success of interventions with targeted populations
in comparison to a control/comparison group. Self-reported outcome
measures may include, but are not limited to:
(a) Past sexual experience, including sexual victimization;
(b) Sexual initiation;
(c) Correct and consistent condom use among sexually active young
people;
(d) Knowledge, attitudes, and behavioral intentions to reduce
sexual risk behavior;
(e) Number of sexual partners and frequency of sexual intercourse;
(f) Number of STDs diagnosed;
(g) HIV testing reported by participants;
(h) Social assets, communication skills, perception of peer norms,
increased integration in familial and community networks;
(i) If alcohol and drug-related behavior is a secondary focus, then
knowledge, attitudes, behavioral intentions, and alcohol and drug use
behavior, and the impact of alcohol and drug-use on sexual risk
behaviors; and
(j) If pregnancy prevention is a secondary focus, then knowledge,
attitudes, behavioral intentions, and behavior. Measures may include,
but are not limited to, number of pregnancies in the sample, and
effective contraception use (including multiple methods) among sexually
active young people.
4. Develop and refine research questions and methods, conceptual
frameworks, measurement and analysis strategies, and intervention
protocols so that findings can be used to facilitate national efforts
to prevent HIV and STDs among young people in alternative educational
settings. This may require modifying conceptual frameworks, sampling
plans, data collection instruments, intervention activities, and other
elements of the applicant's proposal to meet the program goals.
5. Develop, revise, and submit a written justification package and
other documentation necessary for obtaining Office of Management and
Budget (OMB) clearance.
6. Collaborate and coordinate efforts with appropriate educational,
corrections, health, substance abuse, youth-serving, community-based,
and minority organizations who deliver services or interventions to the
targeted populations. Include members of the targeted population in
planning, developing, and revising the research and intervention
activities whenever appropriate and feasible. Collaborate with service
providers to sustain successful interventions beyond the duration of
the project.
7. Develop a plan for disseminating results of the research to
members of the scientific, programmatic, and targeted communities.
8. Disseminates evaluation findings through peer-reviewed
publications and presentations.
B. CDC Activities:
1. Provide scientific and technical assistance in the design and
development of the research, and evaluation protocols, selection of
measures and instruments, operational plans and objectives, and data
analysis strategies.
2. Provide scientific and technical coordination of the general
operation of the research project, including data management support.
3. Participate in the analysis of data gathered from program
activities and the reporting of results.
4. Conduct site visits to assess program progress.
5. 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.
Technical Reporting Requirements
An original and two copies of the progress report and financial
status report must be submitted on an annual basis and are due 90 days
after the end of the budget period. The progress report must include
the following for each program, function, or activity involved: (1) a
brief program description; (2) a comparison of actual accomplishments
to goals and objectives established for the 12-month period; (3)
explanations for all goals or objectives either delayed or not
accomplished and a plan of corrective action; (4) data on participation
in intervention and research activities, including numbers of completed
baseline and follow-up interviews, and recruitment and retention rates
(5) other pertinent information including, when appropriate, analysis
and explanation of unexpectedly high costs for performance. All
manuscripts supported in part or whole by the cooperative agreement
will be required to go through CDC clearance before submission for
publication.
A final financial report is required no later than 90 days after
the end of the project period. All reports are submitted to the Grants
Management Office, CDC.
Application Content
Applications must be developed in accordance with PHS Form 5161-1
(OMB Number 0937-0189), information contained in the program
announcement, and the instructions and format provided below.
Applications should describe:
1. The identification of a promising program to reduce sexual risk
behavior among young people in alternative educational settings,
including a theoretical basis, rationale, and explanation of previous
use.
2. Implementation and evaluation of an intervention to reduce
unprotected sexual intercourse among young people in alternative
educational settings, including the evaluation design, sampling plan,
and analysis strategy.
3. A feasible and timely strategy for disseminating findings from
this research to scientific, public health, and community partners, and
efforts to be made throughout the project to ensure that the
intervention will be sustained once Federal funding ends.
The application should include a general introduction, followed by
one narrative subsection per application content element (A-H) 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 that are appropriate for the
appendixes).
A. Intervention Plan
1. Provide a review of the relevant literature to provide a
theoretical, empirical, and programmatic justification for the proposed
research, and clearly describe how the proposed intervention will
advance efforts to prevent HIV and STDs among young people in
alternative educational settings.
Specifically, the application should include explicit models (with
schematic drawings) that illustrate factors to be modified through the
intervention and to explain the mechanisms by which outcome effects are
produced.
2. Discuss why the intervention is promising, to include a
discussion of
[[Page 34430]]
the settings and populations in which the intervention was previously
implemented. Intervention descriptions and materials should be provided
if possible. Discuss feasibility and acceptability of the intervention
in the selected setting.
B. Research Plan
1. Specify a set of clear and testable research questions and
hypotheses that are responsive to the intended purposes of the research
sought under this cooperative agreement.
2. 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, HIV and STD risk factors, and how the population
will be accessed; instrumentation; the sampling strategy (including a
justification for the sampling unit), sample size, and power analysis
justifying the sample size and including an indication of expected
effect sizes, the randomization strategy; training plans for
individuals collecting data, and data collection plans, including but
not limited to, linking participants' responses between measurement
periods.
3. Describe expected sample attrition. Describe how study
participants will be tracked and what strategies will be used to
increase retention.
4. 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 estimates can be derived.
5. Describe the plans and quality assurance monitoring for data
management, analysis, and interpretation.
6. Describe key dissemination products including peer-reviewed
publications and presentations that can be used by program planners,
policy makers, and other interested parties.
7. 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
generalizable; and how they can be used to develop national
recommendations for reducing unprotected sexual intercourse among young
people in alternative educational settings.
8. As appropriate and necessary, provide for the inclusion of women
and racial and ethnic minority groups as required by CDC/ATSDR policy,
or, where inclusion is inappropriate or not feasible, provide an
explanation for the exclusion of women and racial and ethnic minority
groups from the research design. (See ``Other Requirements'' section of
this announcement for details.)
C. Research and Intervention Capacity
1. Demonstrate the feasibility of the proposed research by
providing a detailed timeline, with specific products, specifying which
staff person will be responsible for which task.
2. Describe the research team and show that the proposed research
staff for the project represent 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 timeline, 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.
3. 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).
4. Describe the facilities, data processing and analysis capacity,
and systems for management of data security and participant
confidentiality.
D. Collaboration and Sustainability
1. 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 containing
information on the number and demographic characteristics of young
people served.
2. Define the responsibilities of collaborating partners.
3. Discuss efforts to be made throughout the project period to
ensure that the intervention will be sustained once Federal funding
ends.
E. Dissemination
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 CDC and other sites to ensure that analysis and production
of peer-reviewed papers, and reports give priority to findings that can
be used to develop national prevention recommendations for young people
in alternative educational settings to prevent HIV and STDs.
F. Budget with Justification
Provide a detailed budget request and complete line-item
justification that is consistent with the proposed activities.
G. Human Subjects
Describe any risks to human subjects and the procedures that will
be used to protect human subjects both through local institutional
review boards. Involvement by the CDC in the design, analysis, and
dissemination of research involving human subjects also requires the
study to be cleared through the CDC human subjects review process. The
applicant will be responsible for providing assurance in accordance
with the appropriate guidelines and form provided in the application
kit.
Typing and Mailing
Applicants are required to submit an original and two copies of the
application. The application may not exceed 60 single-spaced pages in
length, excluding appendixes. Provide a one-page abstract of the
proposal. Number all pages clearly and sequentially and include a
complete Table of Contents to the application and its appendixes. The
original and each copy of the application must be submitted unstapled
and unbound. Print all material, single-spaced, in a 12-point or larger
font on 8.5'' by 11'' paper, with at least 1'' margins and printed on
one side only.
Evaluation Criteria (Total 100 Points)
Objective Review panels evaluate the scientific and technical merit
of applications and their responsiveness to the information requested
in the ``Application Content'' section above. Applications will be
reviewed and evaluated according to the following criteria:
A. Intervention Plan (20 Points)
1. The extent to which the research proposed will advance efforts
to reduce the risk of HIV and other STDs among
[[Page 34431]]
young people in alternative educational settings. The extent to which
the intervention represents a careful application of a theoretically,
empirically, and programmatically justified prevention approach; can be
expected to produce the intended effect; and can be evaluated by using
a scientifically rigorous evaluation design and methods.
2. The extent to which the intervention is promising, and has the
potential for use with young people in alternative educational settings
or with populations served in alternative educational settings (such as
interventions designed for adjudicated young people).
B. Research Plan (30 Points)
1. The clarity and testability of the research questions and
hypotheses, and the extent to which the questions are responsive to the
intended purposes of the research sought under this cooperative
agreement.
2. The extent to which the study and evaluation design and methods
are scientifically sound and capable of producing the intended results,
and will result in the adequate recruitment of participants.
3. The adequacy with which study participants will be tracked, and
the extent to which strategies presented are likely to produce adequate
retention of participants.
4. The extent to which the intervention implementation process can
be measured and findings used to replicate the intervention in other
settings, including cost-benefit estimates.
5. The extent to which the plans for data management, analysis, and
interpretation are clear, appropriate and are adequately monitored for
quality.
6. The extent to which dissemination products will result in the
generation of peer-reviewed papers and presentations.
7. The extent to which the evaluation will provide results that are
scientifically sound, generalizable, and useful for developing national
recommendations for reducing unprotected sexual intercourse among young
people in alternative educational settings.
8. 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. This includes:
(a) The proposed plan for the inclusion of both sexes and racial
and ethnic minority populations for appropriate representation.
(b) The proposed 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.
(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
will be documented.
C. Research and Intervention Capacity (25 Points)
1. The feasibility of the proposed research plan and the adequacy
of the timeline with specific products.
2. The extent to which the proposed research staff for the project
represent 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 timeline, as evidenced by the successful completion of
past research in the areas proposed in this application. The extent of
the applicant's familiarity with, access to, and good working
relationships with young people in this setting, as evidenced by
previous service or research with proposed population.
3. The adequacy of the proposed staff to conduct all proposed
activities (i.e., sufficient in number, percentage of time commitments,
behavioral scientists in key project positions, and qualifications).
4. The adequacy of facilities, data processing and analysis
capacity, and systems for management of data security and participant
confidentiality.
D. Collaboration and Sustainability (15 Points)
The extent to which the applicant includes academic, program, and
community partners in developing, conducting, and evaluating the
proposed research, and to sustain the intervention after completion of
the research as evidenced by inclusion of appropriate key
organizations, members of the targeted population, and selected
collaborators; defined responsibilities for organizations and
individuals; and planned efforts to ensure that the intervention will
be sustained once Federal funding ends.
E. Dissemination (10 Points)
The extent to which the dissemination plan is clearly articulated
and includes the timely sharing of findings with local partners and a
plan to work with appropriate others to ensure production of papers and
presentations.
F. Budget (Not Weighted)
Extent to which the budget is reasonable, itemized, clearly
justified, and consistent with the intended use of the funds.
G. Human Subjects (Not Weighted)
Whether or not exempt from the Department of Health and Human
Services regulations, procedures must be adequate for the protection of
human subjects. Recommendations on the adequacy of protections include:
(1) protections appear adequate and there are no comments to make or
concerns to raise, or (2) protections appear adequate, but there are
comments regarding the protocol, or (3) protections appear inadequate
and the Objective Review Group (ORG) has concerns related to human
subjects, or (4) disapproval of the application is recommended because
the research risks are sufficiently serious and protection against the
risks are inadequate as to make the entire application unacceptable.
Content of Noncompeting Continuation Applications
In compliance with 45 CFR 74.51(b)(d), 45 CFR 92.10(b)(4) and
92.40(b), annual noncompeting continuation applications submitted
within the project period need only include:
A. A brief progress report that describes the accomplishments of
the previous budget period.
B. Any new or significantly revised items or information
(objectives, scope of activities, operational methods, evaluation,
etc.) not included in the year 01 application.
C. An annual budget and justification. Existing budget items that
are unchanged from the previous budget period do not need
rejustification. Simply list the items in the budget and indicate that
they are continuation items. Supporting justification should be
provided where appropriate.
Executive Order 12372 Review
Applications are subject to Intergovernmental Review of Federal
Programs as governed by Executive Order (E.O.) 12372, which sets up a
system for State and local government review of proposed Federal
assistance applications. Applicants should contact their State Single
Point of Contact (SPOC) as early as possible to alert them to the
prospective applications and receive any necessary instructions on the
State process. For proposed projects serving more than one State, the
applicant is advised to contact the SPOC for each affected State. A
current list of
[[Page 34432]]
SPOCs is included in the application kit. If SPOCs have any State
process recommendations on applications submitted to CDC, they should
send them to Sharon P. Orum, Grants Management Officer, Grants
Management Branch, Procurement and Grants Office, Centers for Disease
Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Atlanta,
GA 30305, no later than 30 days after the application deadline date.
The Program Announcement Number and Program Title should be referenced
on the document. The granting agency does not guarantee to
``accommodate or explain'' State process recommendations it receives
after that date.
Public Health System Reporting Requirements
This program is subject to the Public Health System Reporting
Requirements. Under these requirements, all community-based
nongovernmental applicants must prepare and submit the items identified
below to the head of the appropriate State and/or local health
agency(s) in the program area(s) that may be impacted by the proposed
project no later than the receipt date of the Federal application. The
appropriate State and/or local health agency is determined by the
applicant. The following information must be provided:
a. A copy of the face page of the application (SF 424).
b. A summary of the project that should be titled ``Public Health
System Impact Statement'' (PHSIS), not to exceed one page, and include
the following:
(1) A description of the population to be served;
(2) A summary of the services to be provided; and,
(3) A description of the coordination plans with the appropriate
State and/or local health agencies.
If the State and/or local health official should desire a copy of
the entire application, it may be obtained from the State Single Point
of Contact (SPOC) or directly from the applicant.
Catalog of Federal Domestic Assistance Number
The Catalog of Federal Domestic Assistance number is 93.938.
Other Requirements
Paperwork Reduction Act
Projects that involve the collection of information from 10 or more
individuals and funded by cooperative agreement will be subject to
review by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act.
Human Subjects
If the proposed project involves research on human subjects, the
applicant must comply with the Department of Health and Human Services
Regulations, 45 CFR Part 46, regarding the protection of human
subjects. Assurance must be provided to demonstrate that the project
will be subject to initial and continuing review by an appropriate
institutional review committee. The applicant will be responsible for
providing assurance in accordance with the appropriate guidelines and
form provided in the application kit.
Women and Racial and Ethnic Minority Groups
It is the policy of the CDC and the Agency for Toxic Substances and
Disease Registry (ATSDR) to ensure that individuals of both sexes and
the various racial and ethnic groups will be included in CDC/ATSDR-
supported research projects involving human subjects, whenever feasible
and appropriate. Racial and ethnic groups are those defined in OMB
Directive No. 15 and include American Indian or Alaska Native, Asian,
Black or African American, Native Hawaiian or Pacific Islander, and
White. There will be two categories for data on ethnicity: ``Hispanic
or Latino'' and ``Not Hispanic or Latino.'' Applicants shall ensure
that women, racial and ethnic minority populations are appropriately
represented in applications for research involving human subjects.
Where clear and compelling rationale exist that inclusion is
inappropriate or not feasible, this situation must be explained as part
of the application. In conducting review for scientific merit, review
groups will evaluate proposed plans for inclusion of minorities and
both sexes as part of the scientific assessment of scoring.
This policy does not apply to research studies when the
investigator cannot control the race, ethnicity and/or sex of subjects.
Further guidance to this policy is contained in the Federal Register,
Vol. 60, No. 179, pages 47947-47951, dated Friday, September 15, 1995.
HIV/AIDS Requirements
Recipients must comply with the document entitled Content of AIDS-
Related Written Materials, Pictorials, Audiovisuals, Questionnaires,
Survey Instruments, and Educational Sessions (June 1992) (a copy is in
the application kit). To meet the requirements for a program review
panel, recipients are encouraged to use an existing program review
panel, such as the one created by the State health department's HIV/
AIDS prevention program. If the recipient forms its own program review
panel, at least one member must be an employee (or designated
representative) of a State or local health department. The names of the
review panel members must be listed on the Assurance of Compliance for
CDC 0.1113, which is also included in the application kit. The
recipient must submit the program review panel's report that indicates
all materials have been reviewed and approved.
Application Submission and Deadline
An original and two copies of the application PHS Form 5161-1
(Revised 5/96, OMB Number 0937-0189) must be submitted to Sharron P.
Orum, Grants Management Officer, Grants Management Branch, Procurement
and Grants Office, Centers for Disease Control and Prevention (CDC),
255 East Paces Ferry Road, NE., Room 300, Mail Stop E-18, Atlanta, GA
30305, on or before August 3, 1998.
1. 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 objective review group. (Applicants must request a
legibly dated U.S. Postal Service postmark or obtain a legibly dated
receipt from a commercial carrier or the U.S. Postal Service. Private
metered postmarks shall not be acceptable as proof of timely mailing.)
2. Late Applications: Applications which do not meet the criteria
in 1.(a) or 1.(b) above are considered late applications. Late
applications will not be considered in the current competition and will
be returned to the applicant.
Where To Obtain Additional Information
To receive additional written information and to request an
application kit, call 1-888-GRANTS4 (1-888-472-6874). You will be asked
to leave your name and address and will be instructed to identify the
Announcement Number of interest. You will receive a complete program
description and information on application procedures and application
forms. If you have questions after reviewing the contents of all the
documents, business management technical assistance may be obtained
from Glynnis Taylor, Grants Management Specialist, Grants Management
Branch, Procurement and Grants Office, Centers for Disease Control and
Prevention (CDC), 255 East
[[Page 34433]]
Paces Ferry Road, NE., Room 300, Mail Stop E-18, Atlanta, GA 30305,
telephone (404) 842-6593, by fax (404) 842-6513, or by the Internet
address: gld1@cdc.gov.
Programmatic technical assistance and information about studies
cited in this announcement may be obtained from Leah Robin, Ph.D.,
Division of Adolescent and School Health, National Center for Chronic
Disease Prevention and Health Promotion, Centers for Disease Control
and Prevention (CDC), 4700 Buford Highway, NE., Mail Stop K-33,
Atlanta, GA 30341-3717; telephone (770) 488-3210, or by the Internet
address: ler7@cdc.gov.
You may obtain this announcement, and other CDC announcements, from
one of two Internet sites on the actual publication date: CDC's
homepage at http://www.cdc.gov or at the Government Printing Office
homepage (including free on-line access to the Federal Register at
http://www.access.gpo.gov).
Please refer to Announcement Number 98085 when requesting
information and submitting an application.
Potential applicants may obtain a copy of:
1. ``Healthy People 2000'' (Full Report, Stock No. 017-001-00474-
0), or ``Healthy People 2000'' (Summary Report, Stock No. 017-001-
00473-1), referenced in the ``Introduction'' through the Superintendent
of Documents, Government Printing Office, Washington, DC 20402-9325,
telephone (202) 512-1800.
2. ``Reaching Out to Youth Out of the Education Mainstream'' (NCJ
163920), referenced in the section entitled ``Background,'' through the
Office of Juvenile Justice and Delinquency Prevention's Juvenile
Justice Clearinghouse, P.O. Box 6000, Rockville, MD 20849-6000;
telephone (800) 638-8736; E-mail: aksncirs@ncirs.org.
Dated: June 18, 1998.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control
and Prevention (CDC).
Attachment 1
Youth in High-Risk Situations
The following is the Centers for Disease Control and
Prevention's definition of youth in high-risk situations. (From CDC,
``Report of the Fourth Meeting of the CDC Advisory Committee on the
Prevention of HIV Infection,'' November 7-8, 1990.)
Young people between the ages of 10 and 24 who fit at least one
of the following categories are considered at high risk for HIV
infection:
1. Homeless youth
2. Runaway youth
3. Youth not in school and unemployed
4. Youth requiring drug or alcohol rehabilitation
5. Youth who interface with the juvenile corrections system
6. Medically indigent youth
7. Youth requiring mental health services
8. Youth in foster homes
9. Migrant farm worker youth
10. Gay or lesbian youth
11. Youth with STDs, especially genital ulcer disease
12. Sexually abused youth
13. Sexually active youth
14. Pregnant youth
15. Youth seeking counseling and testing for HIV infection
16. Youth with signs and symptoms of HIV infection or AIDS without
alternative diagnosis
17. Youth who barter or sell sex
18. Youth who use illegal injected drugs (including crack cocaine)
Some characteristics of youth who fit the definition of youth at
high risk for HIV infection pose barriers to effective intervention.
Those characteristics include:
1. feeling invulnerable to disease;
2. having little adult supervision, whether at home, having run away
from home, or having been asked to leave home;
3. a history of emotional, sexual, and/or physical abuse;
4. distrust of adults;
5. serious emotional and personal problems;
6. disenfranchised from institutions that normally provide structure
and support; and
7. difficulty filling basic human needs for food, shelter, money,
and safety--consequently placing prevention of HIV infection a low
priority.
[FR Doc. 98-16766 Filed 6-23-98; 8:45 am]
BILLING CODE 4163-18-P
