[Federal Register Volume 62, Number 126 (Tuesday, July 1, 1997)]
[Notices]
[Pages 35506-35513]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-17123]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Program Announcement 774]
Young Women at Risk: Prevention of Unplanned Pregnancies, HIV,
and Other Sexually Transmitted Diseases
Introduction
The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 1997 funds for cooperative agreements
for the prevention of unplanned pregnancies, human immunodeficiency
virus (HIV), and other sexually transmitted diseases (STDs) among young
women aged 15-25 years, in the United States (U.S.). Applied research
programs that design, implement, and evaluate interventions to reduce
unprotected sexual intercourse among young women and their male
partners will be supported under this cooperative agreement.
Applications are sought that focus on the dynamics of heterosexual
relationships and the factors that may contribute to successful risk
reduction. Research should assess factors that affect sexual decision-
making, disease and pregnancy prevention behavior, such as the nature
and the effect of implicit or explicit communication between
heterosexual partners about sex and protective behavior; the importance
of gender roles, relationship stage, concordance of couples'
reproductive desires, the balance of power in the relationship; and the
influence of other network, family, and sociocultural factors.
The CDC is committed to achieving the health promotion and disease
prevention objectives of Healthy People 2000, a national activity to
reduce morbidity and mortality 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 the Public Health Services Act,
Section
[[Page 35507]]
301(a) [42 U.S.C. 241(a)], Section 317(k)(2) [42 U.S.C. 247b(k)(2)],
and Section 318(b)(3) [42 U.S.C. 247c(b)(3)], as amended.
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 education,
library, day care, health care, and early childhood development
services are provided to children.
Eligible Applicants
Eligible applicants are the official public health, family
planning, and substance abuse agencies of the States, 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.
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 $1.2 million is available in FY 1997 to fund
approximately three awards. It is expected that the average award will
be $450,000, ranging from $300,000 to $650,000. It is expected that
awards will begin on or about September 30, 1997, and will be made for
a 12-month budget period within a project period of up to 5 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 Department
of Health and Human Services (HHS) funds for lobbying of Federal or
State legislative bodies. Under the provisions of 31 U.S.C. 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 1997 Departments of Labor, HHS, and Education,
and Related Agencies Appropriations Act, which became effective October
1, 1996, expressly prohibits the use of 1997 appropriated funds for
indirect or ``grass roots'' lobbying efforts that are designed to
support or defeat legislation pending before State legislatures.
Section 503 of this new law, as enacted by the Omnibus Consolidated
Appropriations Act, 1997, Division A, Title I, Section 101(e), Public
Law No. 104-208 (September 30, 1996), provides as follows:
Section 503(a) No part of any appropriation contained in this
Act shall be used, other than for normal and recognized executive-
legislative relationships, 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, * * *
except in presentation to the Congress or any State legislative body
itself.
Section 503(b) 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
Adolescent and young women in racial and ethnic communities are at
increased risk for a range of preventable health threats such as
unplanned pregnancy, human immunodeficiency virus (HIV) infection, and
other sexually transmitted diseases (STDs). Although CDC promotes
abstinence as the most effective strategy for prevention of these
public health problems, many women will choose to become sexually
active during adolescence and young adulthood. An estimated one million
adolescents become pregnant every year, and teenagers undergo one-third
of the 1.5 million abortions performed in the U.S. each year. There are
adverse consequences of having a baby during early adolescence for both
the mother and the infant. These include increased risk of low birth
weight and developmental problems for the child, as well as detrimental
effects on the lifelong physical, educational, and financial well-being
of the young mother. These problems are compounded for young women who
are living in communities characterized by high rates of violence,
illegal drug use, and poverty.
HIV infection and STDs are a significant threat to young people--
one out of every eight adolescents contracts an STD, and 20 percent of
the acquired immunodeficiency syndrome (AIDS) cases reported are among
persons younger than 29 years of age. Because the median time between
infection with HIV and the onset of AIDS symptoms is 8 to 10 years,
most of these young people were probably infected during their teenage
years. Further, the pattern of HIV infection in the U.S. has made a
significant shift toward women. The overall slowing in the growth rate
of the AIDS epidemic in the U.S. has not been seen among women--the
proportion of AIDS cases among women has risen from 11 percent of cases
reported in 1989, to 20 percent of cases reported in 1996. AIDS is now
the third leading cause of death among U.S. women aged 25-44 years.
Heterosexual transmission accounts for at least 40 percent of current
AIDS cases among women, and in 1992, surpassed injecting drug use as
the most common mode of HIV transmission to U.S. women. The increase in
rates of AIDS has especially affected racial and ethnic minority
women--78 percent of all women and 85 percent of children diagnosed
with AIDS are Black or Hispanic.
Eighty percent of women with AIDS are of childbearing age and 90
percent of AIDS cases reported among children are believed to have been
transmitted from the mother. With the recent finding that zidovudine
(AZT) given to HIV-positive pregnant women can significantly reduce the
risk of perinatal transmission, there is hope of significantly reducing
this mode of HIV transmission to children. Still, as of the end of
1996, 7,629 pediatric AIDS cases had been reported. Preventing primary
HIV infection among women and helping women who are already infected
with HIV to avoid unintended pregnancies will help reduce HIV infection
among infants.
In 1991, in response to the growing threat of HIV to women and
infants, and in recognition of the need to integrate pregnancy and
disease prevention strategies for women at risk, CDC funded cooperative
agreements for the prevention of HIV among women and infants
(Announcement Number 124).
[[Page 35508]]
This project, known as Project CARES (Comprehensive AIDS and
Reproductive Health Education Study), provided reproductive health
services in nontraditional settings and enhanced counseling services
offered by peer para-professionals to women aged 15-44 years. Women at
risk for unplanned pregnancy, HIV, and other STDs, as well as women
living with HIV infection, participated in a counseling intervention
tailored to each woman's readiness to change her sexual risk behavior.
Findings from Project CARES suggest that the male sex partner's
influence on condom and other contraceptive use among young women at
risk is an important area for further research and intervention. The
partner's reproductive desires, length of the relationship, the
partner's support for using contraceptives, and communication with
one's partner about condom use, are associated with condom and other
contraceptive use. Very little research has been done that focuses on
the influence of sex partners on each other and the effect of other
social and normative factors on the sexual dyad.
Thus, this announcement seeks research that expands the conceptual
framework for understanding the sexual behavior of young women at high
risk for unplanned pregnancy, HIV, and other STDs, by taking into
consideration individual-level, relationship-level, and social-level
factors, and to using this foundation to design interventions to reduce
sexual risk behavior.
Purpose
These awards will support advancing efforts to prevent unplanned
pregnancy, HIV, and other STDs among young women in the U.S. by
focusing on sexual behavior as a social or dyadic phenomenon best
understood by considering the joint influence of sex partners on
behavior. To reach this goal, the program will support applied research
that meets the following criteria:
1. Extends or enhances existing social and psychological models
of sexual behavior change, and develops and tests new hypotheses and
measures to examine the dynamics of heterosexual relationships,
taking into consideration the influence of sex partners on each
other. Individual-level variables (e.g., perception of partners'
attitude toward condom use, etc.), relationship-level variables
(e.g., length of relationship, concordance of partners' attitudes
toward risk reduction, etc.), and social and cultural-level
variables (e.g., culturally prescribed sexual behavior norms for
young men and women, etc.) should be assessed.
2. Designs, conducts, and evaluates new intervention strategies,
or extensions of existing strategies, to promote safer sexual
behavior, including condom and other contraceptive use, among young
women (who have chosen not to abstain) and their male sex partners.
All proposed projects must be grounded in social and behavioral
science theory and past research, and applicants must provide
theoretical, scientific, and programmatic justification for the
activities proposed.
The research program is intended to benefit populations of young
women (aged 15-25 years) who are currently having sex with men (or who
are likely to do so in the future), and who live in communities in
which there are elevated rates of social and health problems among the
adolescent and young adult population, and who have had, or are at risk
for unintended pregnancy, STDs, using crack cocaine or other illegal
drugs, trading sex for money, drugs, or other things, sex with partners
who have known risks for HIV infection, running away from home,
dropping out of school, becoming involved with the juvenile justice
system.
Interventions may target young women as described above, and may
also include (1) their male sexual partner(s), (2) other young men in
the community who are not necessarily current sex partners, or (3)
other important peer, family, or social network members. Research and
measurement activities may extend beyond those who directly participate
in the intervention. For example, applicants who intervene with young
women only may propose to limit research questions and outcome
evaluation to the individual-level (e.g., perception of partners'
attitude, perceived social norms regarding gender-appropriate behavior,
etc.), or they may include assessment of male partners or other peer,
family, or social network members not directly targeted by the
intervention to examine diffusion effects of the intervention and to
further understand contextual factors that affect the sexual risk
behavior of young women and their male partners.
Program Requirements
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).
Recipient Activities
1. Develop a theory-based, and empirically supported, conceptual
model of heterosexual risk behavior for young women at risk for
unplanned pregnancies, HIV and other STDs that focuses on the dynamics
of heterosexual relationships and the factors that may contribute to
successful risk reduction including comprehensive measures of key
intrapersonal, interpersonal, and sociocultural factors that affect
sexual relationships.
2. Validate the conceptual model through the development and
testing of measures of key interpersonal, intrapersonal, and/or
sociocultural influences, and through the answering of specific
research questions, such as, but not limited to, the following:
(a) How do women come to understand and interpret partner attitudes
toward family planning, contraception, and STD and HIV prevention?
(b) How are reproductive and disease prevention values communicated
between young women and their sex partners, and within their social
networks?
(c) How is a couple's sexual behavior affected by their agreement
or disagreement on goals for childbearing, contraception, and HIV and
other STD prevention?
(d) How do changes in a couple's relationship over time affect
their sexual behavior, family planning, contraceptive use, and HIV and
other STD prevention behavior?
(e) What are the positive and negative influences of a partner's
attitude and behavior on sexual risk behavior? How important are
partner influences relative to other personal, family, network, or
cultural influences?
(f) How can male partners and other social and family network
members support young women in achieving proximal pregnancy and disease
prevention goals, and more long-term reproductive health preservation
goals?
3. Develop and conduct an intervention based on theory and data
that will influence specific intrapersonal, interpersonal and
sociocultural factors to reduce unprotected sexual intercourse among
young women and their male partners. Examples include, but are not
limited to, the following:
(a) Providing theory-based training to help young women negotiate
sexual risk reduction.
(b) Identifying and enlisting family, peer, and social networks to
support and reinforce sexual risk reduction.
(c) Creating and mobilizing new networks of communication,
influence, and support concerning sexual risk reduction.
(d) Providing opportunities for acquisition and practice of
[[Page 35509]]
communication skills and risk reduction strategies.
4. Measure the success of interventions with targeted populations
in comparison to a control/comparison group (or community) with outcome
measures of interpersonal, intrapersonal, and sociocultural changes
such as, but not limited to, self-reports, observations, and other
measures of:
(a) Cognitive, emotional, and behavioral change among individuals,
(b) Interpersonal changes such as changes in distribution of power
in sexual relationships, changes in network characteristics or
functioning, and
(c) Cultural and normative changes such as changes in content of
media messages on reproductive health, changes in distribution of
reproductive health services funds, changes in community attitudes,
etc.
5. Work with other cooperative agreement recipients and CDC to
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 unplanned pregnancy, HIV, and other STDs among young women
at risk. 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.
6. Collaborate and coordinate efforts with appropriate health,
substance abuse, youth-service, 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.
7. Develop a plan for disseminating results of the research to
members of the scientific, programmatic, and targeted communities.
CDC Activities
1. Host meetings each year to plan the research program and to
promote progress toward national objectives.
2. Provide scientific and technical assistance in the design and
development of the research, intervention, and evaluation protocols,
selection of measures and instruments, operational plans and
objectives, and data analysis strategies.
3. Provide scientific and technical coordination of the general
operation of the research project, including data management support.
4. Participate in the analysis of data gathered from program
activities and the reporting of results.
5. Conduct site visits to assess program progress.
Technical Reporting Requirements
Semiannual progress reports are required and must be submitted no
later than 30 days after each semiannual reporting period. The
semiannual progress reports of activities conducted and accomplishments
during the previous period should include:
1. A brief program description.
2. A comparison of actual accomplishments to goals and objectives
established for the 6-month period.
3. Explanations for all goals or objectives either delayed or not
accomplished and a plan of corrective action.
4. Documentation of the applicant's ability to conduct the research
and intervention activities, including implementation of the
intervention and evaluation protocol activities within the required
timelines, recruitment and follow-up of required number of
participants, recruitment and maintenance of appropriate personnel, and
efficient use of funds.
5. Data on participation in intervention and research activities,
including numbers of completed baseline and follow-up (if appropriate)
interviews, and recruitment and retention rates, should be presented in
tabular form for the 6-month period and cumulatively.
6. Activities planned for the next six months to accomplish the
goals and objectives, including the following (as appropriate to the
design):
a. Procedures and strategies for tracking and contacting the target
population for follow-up interviews within the required time period.
b. Projected numbers of baseline and follow-up interviews to be
completed.
c. Intervention activities, and projected numbers of participant
contacts.
d. Monitoring/quality assurance.
e. Training (if any).
f. Process evaluation (data collection and entry).
g. Outcome evaluation (interview data collection and entry).
h. Plans for data transfer to data management contractor.
i. Qualitative and quantitative data analysis plans (both process
and outcome), including amount of staff resources designated for site
specific and cross-site data analysis and paper/presentation
preparation.
Report for the first 6-month period should detail progress in
accomplishing program objectives. The second report should detail
progress in the preceding 6 months and summarize the entire year's
accomplishments. The final progress report is required no later than 90
days after the end of the project period. All manuscripts published as
a result of the work supported in part or whole by the cooperative
agreement will be submitted with the progress reports.
An annual financial status report (FSR) must be submitted no later
than 90 days after the end of each budget period. The final financial
status report is due no later than 90 days after the end of the project
period.
An original and two copies of all reports should be submitted to
the Grants Management Officer, Grants Management Branch, 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. How the applicant will assess predictors of sexual risk
behavior, including the specific research questions that will be
addressed and conceptual models used.
2. The design and evaluation of an intervention to reduce
unprotected sexual intercourse between young women and their male sex
partners.
3. A feasible and timely strategy for disseminating findings from
this research to scientific, public health, and community partners.
The application should include a general introduction, followed by
one narrative subsection per application content element 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 vita, references, and letters of support, that are
appropriate for the appendixes).
A. Significance, Impact, and Theoretical Basis of the Proposed Research
The applicant should clearly describe how the proposed research
will advance efforts to prevent unplanned pregnancy, HIV, and other
STDs among young women in the U.S. Specifically, the application should
describe how existing social and psychological models of sexual
behavior change will be expanded or extended to take into consideration
the influence of both members of a couple on each other, and
[[Page 35510]]
should include explicit models (with schematic drawings) that
illustrate factors to be modified through intervention and to explain
the mechanisms by which outcome effects are believed to arise.
Applicants should discuss how the research and intervention is
innovative and represents a new approach to the integration and
extension of known theoretical models and intervention strategies to
reduce unprotected sexual intercourse among young women and their male
sex partners.
Applicants should describe what results are expected from the
research; the potential limitations of the results given the complexity
of the research focus, the target 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 women at risk for unplanned
pregnancy, HIV, and other STDs.
B. Research and Intervention Plan
The applicant should describe in detail the proposed research and
intervention plan, including:
1. A review of the relevant literature to provide a theoretical,
empirical, and programmatic justification for the proposed research.
2. 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.
3. A description of all aspects of the study design and methods,
including a detailed description of the targeted population and
comparison group and how they will be accessed; the sampling strategy,
and if applicable, the randomization strategy; the evaluation design
(both process and outcome) and how threats to validity will be handled;
the plans for instrument development, pilot-testing, interviewer
training, data collection, analysis, interpretation, and quality
assurance.
4. A description of the intervention including how theory and past
research will be operationalized; and a justification for how and why
the intervention can be expected to produce the intended effect.
Discuss feasibility of the intervention in the selected setting and
acceptability and potential sustainability of the intervention for the
targeted population.
5. A description of 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. Discuss how findings could be used to sustain the
intervention or replicate it in other settings.
6. Describe the quality assurance monitoring plan for all research
and intervention activities.
7. Describe the plans for data management, analysis, and
interpretation; highlight how they are innovative (for example,
integrate qualitative and quantitative data); and present a realistic
and detailed timeline for the generation of papers, reports, and other
products that can be used by program planners and policy makers.
C. Research and Intervention Capacity
1. Demonstrate the feasibility of the proposed research and
intervention plan by providing a detailed timeline, with specific
products, specifying which staff person will be responsible for which
task.
2. Demonstrate the capacity to obtain the participation of, and
retain for follow-up if appropriate, adequate numbers of the targeted
population for assessment by providing detailed information about the
targeted population (characteristics, risk factors, numbers available
for intervention in specific settings, etc.), and describe how they
will be accessed and previous service or research conducted involving
this population (include letters from organizations, journal articles,
etc.).
3. 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.
4. Demonstrate the adequacy of the proposed staff 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), and the adequacy of the staff time allocated for
specific responsibilities, with at least a 50 percent time Ph.D.-level
research director and a 100 percent time project director, through
curriculum vita and position descriptions that detail responsibilities.
Include a list of all grants and other sources of support (include
percent of time on project) for all investigators.
5. Describe the facilities, data processing and analysis capacity,
and systems for management of data security and participant
confidentiality.
6. Provide assurances that the applicant and all members of the
applicant's research and intervention team are willing to work closely
with other funded sites and CDC, and are willing to modify research
questions, sampling plans, instruments, and protocols. The applicant
must assure that no organizational or institutional barriers will
impede this process or the successful completion of the research and
intervention project. Applicant must also state a commitment to
participate with other sites and CDC on data analysis, presentation,
and publication of research findings.
D. Collaboration
Describe how academic, program, and community partners will
participate in developing, conducting, and evaluating the proposed
research. Specifically:
1. Describe the involvement of appropriate key organizations, and
members of the targeted population (as evidenced by letters of support
describing their role in the proposed scope of work, etc.).
2. Define the responsibilities of these other organizations and
individuals.
3. Discuss previous work of the proposed collaborators and request
evidence of past successful collaboration and commitment to
participation in the proposed project.
E. Dissemination and Sustainability
Provide a clear dissemination plan that includes a plan for the
timely sharing of findings with local partners; describes efforts that
will be made to secure separate funding to continue prevention
activities that are proven to be effective in reducing sexual risk
behavior; and includes a plan to work with CDC and other sites to
ensure that analysis and production of papers, presentations, and
reports give priority to findings that can be used to develop national
prevention recommendations for young women at risk for unplanned
pregnancy, HIV, and other 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. The applicant will be responsible
for providing assurance in accordance with the appropriate guidelines
and form provided in the application kit.
[[Page 35511]]
H. Women, Racial, and Ethnic Minorities
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.
Typing and Mailing
Applicants are required to submit an original and two copies of the
application. The application may not exceed 30 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 index 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
\1/2\'' by 11'' paper, with at least 1'' margins and printed on one
side only.
Evaluation Criteria
Applications will be reviewed and evaluated according to the
following criteria:
A. Significance and Impact of the Proposed Research (20 Points)
The extent to which the research proposed will advance efforts to
prevent unplanned pregnancy, HIV, and other STDs among young women in
the U.S. Specifically, the extent to which:
1. The research proposed will extend or enhance existing social and
psychological models of sexual behavior change that take into
consideration the influence of both members of a couple on each other.
2. The research and intervention is innovative and represents a new
approach to the integration and extension of known theoretical models
and intervention strategies to reduce unprotected sexual intercourse
among young women and their male sex partners.
3. The research and intervention evaluation will provide results
that are scientifically sound, generalizable, and useful for developing
national recommendations for reducing unprotected sexual intercourse
among young women at risk for unplanned pregnancy, HIV, and other STDs.
B. Research and Intervention Plan (30 Points)
The quality of the proposed research and intervention plan,
including:
1. The theoretical, empirical, and programmatic justification for
the proposed research.
2. 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.
3. The extent to which the study design and methods, the plans for
instrument development, data collection, and analysis are
scientifically sound and capable of producing the intended results.
4. 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.
5. The extent to which the intervention implementation process can
be measured and findings used to replicate the intervention in other
settings;
6. The extent and rigor of the quality assurance monitoring plan
for both research activities and intervention activities.
7. The extent to which the plans for data management, analysis, and
interpretation are clear and innovative (for example, integrate
qualitative and quantitative data) and will result in the timely
generation of papers, reports and other products that can be used by
program planners and other interested parties.
8. The degree to which the applicant has met the CDC Policy
requirements regarding the inclusion of women, ethnic, and racial
groups in the proposed research. This includes: (a) The proposed plan
for the inclusion of both sexes and racial and ethnic minority
populations for appropriate representation, (b) The proposed
justification when representation is limited or absent, (c) A statement
as to whether the design of the study is adequate to measure
differences when warranted, and (d) A statement as to whether the plans
for recruitment and outreach for study participants include the process
of establishing partnerships with community(ies) and recognition of
mutual benefits.
C. Research and Intervention Capacity (25 Points)
1. The feasibility of the proposed research and intervention plan
and the adequacy of the timeline with specific products.
2. The applicant's demonstrated capacity to obtain the
participation of, and retain for follow-up, adequate numbers of the
targeted population for assessment; and the extent of the applicant's
familiarity with, access to, and good working relations with, young
women at risk (and young men, if applicable), as evidenced by previous
service or research involving this population.
3. 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.
4. 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),
and the adequacy of the staff time allocated for specific
responsibilities, with at least a 50 percent time Ph.D.-level research
director and a 100 percent time project director, as evidenced by their
curriculum vita and position descriptions.
5. The adequacy of facilities, data processing and analysis
capacity, and systems for management of data security and participant
confidentiality.
6. The extent to which the applicant is willing to work with other
funded sites and CDC to modify research questions, sampling plans,
instruments, and protocols, and is committed to working with other
sites and CDC on data analysis, presentation, and publication of
research findings.
D. Collaboration (15 Points)
The extent to which the applicant includes both academic, program,
and community partners in developing, conducting, and evaluating the
proposed research. Specifically, the extent to which the applicant has:
1. Involved other appropriate key organizations, and members of the
targeted population (as evidenced by letters of support, etc.).
2. Clearly defined the responsibilities of these other
organizations and individuals.
3. Previously worked with the proposed collaborators and provided
evidence of past successful collaboration and commitment to
participation in the proposed project.
[[Page 35512]]
E. Dissemination and Sustainability (10 Points)
The extent to which the dissemination plan is clearly articulated
and includes the timely sharing of findings with local partners,
reasonable efforts to secure separate funding for continuation of
effective interventions, and a plan to work with other sites and CDC to
ensure that analysis and production of papers, presentations, and
reports give priority to findings that can be used to develop national
prevention recommendations for young women at risk for unplanned
pregnancy, HIV, and other STDs.
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)
The extent to which the applicant adequately describes the
procedures that will be used to protect human subjects, and provides
assurance to demonstrate that the project will be subject to initial
and continuing review by appropriate institutional review committees.
Content of Noncompeting Continuation Applications
In compliance with 45 CFR 74.51(b)(d), 45 CFR 92.10(b)(4) and
92.40(b), 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. E.O. 12372 sets
up a system for State and local governments 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 SPOCs is included in the application kit. If SPOCs have
any State process recommendations on applications submitted to CDC,
they should send them 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 305, Mail Stop E-18, Atlanta, GA 30305, no later than 30 days
after the application deadline date (the appropriation for this
financial assistance program was received late in the fiscal year and
would not allow for an application receipt date that would accommodate
the 60-day State recommendation process period). 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
department(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 or local health department 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 should
include the following:
1. A description of the population to be served.
2. A summary of the services to be provided.
3. A description of the coordination plans with the appropriate
State and local health departments.
If the State or local health official should desire a copy of the
entire application, it may be obtained from the Single Point of Contact
(SPOC) or directly from the applicant.
Catalog of Federal Domestic Assistance Number
The Catalog of Federal Domestic Assistance number is 93.283.
Other Requirements
Paperwork Reduction Act
Projects that involve the collection of information from 10
individuals 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 committees. The applicant will be responsible for
providing assurance in accordance with the appropriate guidelines and
form provided in the application kit.
Racial and Ethnic Minorities
The policy of the Centers for Disease Control and Prevention (CDC)
and the Agency for Toxic Substances and Disease Registry (ATSDR) is to
ensure that individuals of 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 Alaskan Native, Asian or Pacific Islander, Black, and Hispanic.
Applicants shall ensure that 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. This policy does not apply to research studies when
the investigator cannot control the race, ethnicity, or sex of
participants. 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
[[Page 35513]]
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 Deadlines
Preapplication Letter of Intent
A nonbinding letter of intent-to-apply is required from potential
applicants. An original and two copies of the letter should be
submitted to the Grants Management Officer, Grants Management Branch,
CDC (see Applications for the address). It should be postmarked no
later than July 15, 1997. The letter should identify the announcement
number, name of principal investigator, and specify the activity(ies)
to be addressed by the proposed project. The letter of intent does not
influence review or funding decisions, but it will enable CDC to plan
the review more efficiently, and will ensure that each applicant
receives timely and relevant information before the application is
submitted. Notification may be provided by facsimile or postal mail to
Sharron P. Orum, Grants Management Officer, Grants Management Branch,
Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry
Road, NE., Room 305, Mailstop E-18, Atlanta, GA 30305, facsimile (404)
842-6513.
Application
An original and two copies of the application PHS Form 5161-1 (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 305, Mail Stop E-18, Atlanta, GA 30305, on
or before August 15, 1997.
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 that do not meet the criteria in
1.(a) or 1.(b) above are considered late applications. Late
applications will not be considered and will be returned to the
applicant.
Where To Obtain Additional Information
To receive additional written information, call (404) 332-4561. You
will be asked to leave your name, address, and telephone number. Please
refer to Announcement #774. You will receive a complete program
description, 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 Gladys T. Gissentanna, Grants Management Specialist, Grants
Management Branch, Procurement and Grants Office, Centers for Disease
Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Room 314,
Mail Stop E-18, Atlanta, GA 30305, telephone (404) 842-6801.
Programmatic technical assistance may be obtained from Christine
Galavotti, Ph.D., Division of Reproductive Health, National Center for
Chronic Disease Prevention and Health Promotion, Centers for Disease
Control and Prevention (CDC), 4700 Buford Highway, NE., Mail Stop K-34,
Atlanta, GA 30341-3724, telephone (770) 488-5245. The announcement will
also be available on one of two Internet sites on the publication date:
CDC's homepage at http://www.cdc.gov>, or at the Government Printing
Office homepage (including free access to the Federal Register) at
http://www.access.gpo.gov>. Other CDC Announcements are also listed on
the Internet on the CDC homepage.
Please refer to Announcement Number 774 when requesting information
and submitting an application.
Potential applicants may obtain a copy of 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.
Dated: June 25, 1997.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for
Disease Control and Prevention (CDC).
[FR Doc. 97-17123 Filed 6-30-97; 8:45 am]
BILLING CODE 4163-18-P
