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From: Dot Baker <UNCDOT@UNC.BITNET>
Subject: NIH GUIDE - RFA OD-92-01 - V20(46) 12/13/91
To: pjones@UNCVX1.BITNET
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Hi Paul,
   Please post to the NIH Listserver as:
    RFAOD-92-01.911213
 ---------------------------- Text of forwarded message -----------------------
 
$$XID RFA OD9201 OD-92-01 P1O1 *****************************************
 
MINORITY YOUTH HEALTH BEHAVIOR RESEARCH:  THE DEVELOPMENT AND
EVALUATION OF INTERVENTIONS
 
RFA:  OD-92-01
 
P.T. 34, FF; K.W. 0404000, 0715027, 0404023, 0745027
 
National Institutes of Health
 
Letter of Intent Receipt Date:  February 1, 1992
Application Receipt Date:  May 15, 1992
 
PURPOSE
 
The National Institutes of Health (NIH) invites applications for
cooperative agreements to develop, implement and evaluate a
coordinated program of community based health behavior interventions
to lower the unacceptably high rates of morbidity and mortality among
minority youth.  Although this is an NIH-wide initiative, the
National Institute for Child Health and Human Development (NICHD), in
close cooperation with the Office of Minority Programs at NIH, will
be the lead Institute.  One NIH/NICHD staff person will participate
as the Project Coordinator and will facilitate grantee access to
expertise in other NIH components whenever appropriate.
 
Applications responsive to this Request for Applications (RFA) must
include, but are not limited to, strategies for decreasing
violence-related injuries and deaths, sexually transmitted diseases
(STDs), and unwanted or unintended pregnancies in minority youth ages
10-24.  Interventions in other health-related areas that have
particular impact on minority youth are also encouraged (e.g.,
obesity and nutrition, asthma control, management of diabetes,
alcohol and drug use, the impact of communication disorders).
 
Respondents must document knowledge of the major theoretical
approaches underlying interventions in the areas of violence,
pregnancy, and STDs prevention, as well as other prevention
strategies included in the application. Demonstrated competence in
the design and evaluation of interventions is a prerequisite.  The
application also must demonstrate a solid ongoing partnership among
the community-based and research components and must be willing and
able to participate in a cooperative program of evaluation design
with other successful applicants.
 
The NIH also invites applications for a cooperative agreement with a
Data Center for these sites.  This center will manage data from the
surveys and interventions at the sites.  This center will be
functionally independent of all research sites, although it could be
physically located at one of them.
 
HEALTHY PEOPLE 2000
 
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This RFA,
Minority Youth Health Behavior Research:  The Development and
Evaluation of Interventions, is related to the priority areas of the
prevention of violent and abusive behaviors, education and community
based programs, family planning and the prevention of HIV infection
and STDs.  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) through the
Superintendent of Documents, Government Printing Office, Washington,
DC 20402-9325 (telephone 202-783-3238).
 
ELIGIBILITY REQUIREMENTS
 
Any domestic institution, public or private, profit or non-profit,
may apply.  For-profit organizations must note that no profit or fees
may be requested under financial assistance awards.  In addition,
since there are no cost principles applicable to for-profit
organizations receiving financial assistance awards, those set forth
in Federal Acquisition Regulations in 48 CFR Part 31.2 will generally
be used.
 
Each institution may submit an application singly or in partnership
with two or more groups.  Both community and research capabilities
must be represented regardless of the organization submitting as the
applicant organization.
 
MECHANISM OF SUPPORT
 
The funding mechanism to be used to assist the community in
undertaking this coordinated program of community-based health
behavior intervention research will be a cooperative agreement (U01)
between each participating site and NIH/NICHD.  The major difference
between a cooperative agreement and a research project grant is that
there will be substantial programmatic involvement of the NIH/NICHD
Project Coordinator above and beyond the levels required for
traditional program management of grants.  Specifically, an NIH/NICHD
staff member will cooperate with the Principal Investigators as an
equal partner in the funded projects and serve as the Project
Coordinator.  All parties will agree to accept the participatory and
cooperative nature of the group process.
 
The primary rights and responsibilities of the awardees are as
follows:
 
o  Development of interventions and evaluation strategies
o  Development of research protocols
o  Implementation of the interventions
o  Data collection (including quality control), analysis and
interpretation
o  Presentation of plans and results to the Steering Committee
o  Publication and dissemination of results
o  Collaboration with other awardees
o  Retention of custody of, and rights to, the data developed under
these awards subject only to Government rights of access consistent
with current HHS, PHS, and NIH policies.
 
The programmatic assistance by the NIH/NICHD Project Coordinator
includes:
 
o  The Project Coordinator will participation in the development of
optimal approaches and design of interventions and adjustments of
approaches and designs as needed.  The Project Coordinator will
assist and facilitate the process rather than direct.
 
o  The Project Coordinator, in concert with the members of the
Steering Committee, will seek the advice and consultation of other
NIH Institutes when needed for optimal implementation of the
intervention designs.
 
o  Assistance with, and review of, all phases of interventions to
assure consistency and compliance with agreed-upon designs, to
improve and strengthen cooperation between the sites, and to help
redirect efforts, if necessary
 
o  Participation in data analyses, interpretation and publication of
study results; and
 
o  Identification, jointly with awardees, of the need for additional
sites or to phase out a site when performance requirements are not
met.
 
Specific terms, conditions, and details of arbitration procedures
pertaining to the scope and nature of the interaction between
NIH/NICHD and participating sites will be incorporated into the
Notice of Grant Award.  These procedures will be in addition to the
customary programmatic and financial negotiations that occur in the
administration of grants.  Arbitration procedures will be invoked
only when agreement cannot be reached on programmatic issues that may
arise between an awardee(s) and the Project Coordinator after the
award has been made.  In that event, an arbitration panel will be
formed consisting of one person selected by the Principal
Investigators, one person selected by the Project Coordinator, and a
third person selected by those two members.  The decision of the
arbitration panel, by majority vote, will be binding.
 
The above Terms of Award are in addition to, and not in lieu of,
otherwise applicable OMB administrative guidelines, HHS grant
administration regulations at 45 CFR Part 74, and other HHS, PHS, and
NIH grant administration policies.  The special arbitration
procedures described above in no way affect the right of the
recipient of a cooperative agreement assistance grant to appeal an
adverse determination in accordance with PHS regulations at 42 CFR
Part 50, Subpart D, and HHS regulations at 45 CFR Part 16 and 75.
Business management aspects of these awards will be administered by
the NICHD Grants Management Office in accordance with HHS, PHS, and
NIH grants administration requirements.
 
This RFA is intended as a one-time solicitation.  The total project
period for applications submitted in response to this RFA may not
exceed five years.  However, if it is determined that there is a
sufficient continuing program need, the NIH may reissue this RFA.
The anticipated award date will be November 1, 1992.
 
FUNDS AVAILABLE
 
It is anticipated that up to eight awards will be made under this RFA
for a total of approximately $5 million (including direct and
indirect costs) during the first program year.  Levels of support may
increase in out years of the agreement.  This level of support is
dependent on the receipt of a sufficient number of applications of
high scientific merit.  Although this program is provided for in the
financial plan of the NIH, the award of grants pursuant to this RFA
is also contingent on the availability of funds for this purpose.
 
RESEARCH OBJECTIVES
 
Although adolescence is generally considered a period of good health,
racial and ethnic variations do exist.  Much of the racial and ethnic
disparity in health is a function of social class and economics, but
a significant proportion of this disparity reflects the unique risks
faced by minority youth.  There is growing indication that prevention
education must be specifically targeted for its audience, and that
"generic" interventions may be less successful in changing deeply
entrenched behaviors.  Interventions that are successful in changing
behavior may not succeed in assisting individuals to maintain the new
behavior.  Strategies that take into account the unique problems of
minority populations may improve the efficacy of any intervention.
 
Many issues related to minority health reflect the social context in
which these young people live--the family, peer group, neighborhood,
and community.  The family is the primary socializing agent for
children and the context in which most people obtain health care and
learn health habits.  Childbearing outside of marriage and high rates
of marital dissolution mean that many children are raised in single-
parent families.  Single-parent families often are faced with
increased economic stress.  In addition, economic and other chronic
stressors common to minority communities may exacerbate strain within
families. Many youth may enter adolescence without the necessary
grounding in decision-making, social skills, or role models of
healthy adult lifestyles.
 
Thus, the health behavior of minority youth can neither be understood
nor improved without attending to the social, economic and behavioral
contexts.  Of specific concern in this application are the
identification, implementation, and evaluation of behavioral
interventions to decrease the generally higher levels of violence,
some diseases, early sexual activity leading to exposure to STDs, and
association with drug use.  Examples of such problems include, but
are not limited to, the following:
 
Homicide is the leading cause of death for black men ages 15-24, with
rates for black men six times that of white, and those for black
women 3.5 times higher.  Rates for other non-white groups are also
higher than for white youth.
 
Sixty-one percent of homicides among young black men occur during an
argument or other non-felony activity--an indication that violence
may be disproportionately used as a means of resolving conflicts.
 
Rates of morbidity resulting from violence are high, and, once
released from the hospital, youth do not adhere to rehabilitation or
medication programs such as rehabilitation after violence-related
head injuries.
 
There is some indication that psychological referrals are not made
for youth who have been hospitalized as a result of violence, even if
they have expressed a plan for vengeance against the perpetrator of
the violence.
 
Compared with white or Hispanic youth, twice as many black youth
start having sex at ages younger than 15, which predisposes them to
greater risk of STDs and unintended pregnancy.  Gonorrhea rates are
40 times higher for black than white men, 10 times higher for black
than Hispanic men.  Gonorrhea rates peak in the ages 15-24.
 
Asthma mortality is three times higher in black children than in
white.  Asthma is also more prevalent among black children than among
white children of the same age.  The effects of asthma may be
mediated by access to health care.  Yet it is also a disease for
which compliance with care is an issue.
 
It has been suggested that language disorders and language- based
learning disorders are disproportionally prevalent in youth who are
first offenders.  An understanding of the complex interrelationship
between communication disorders and behavioral disorders is very
important for the development of appropriate intervention strategies.
 
Death rates from diabetes are twice as high for blacks, Hispanics and
Native Americans as for whites.  Education in appropriate self-care
improves compliance with treatments, and may improve self-management
in other areas of life.
 
Obesity, which is of concern in some minority groups, is a major risk
factor for diabetes and is also implicated in coronary heart disease
in adulthood.
 
Minority adolescents have higher rates of oral diseases, in part
because they do not have the access to professional care, knowledge,
skills or oral hygiene agents necessary to maintain oral health.  In
addition, minority youth may suffer disproportionately from orofacial
trauma due to their higher rates of violence.
 
In-school black youth are considerably less likely to smoke than are
white youth.  Analysis of the determinants of that difference might
have use in designing prevention programs for other health behavior
topics.  However, subgroups of minority youth, for example, young
pregnant women, may be appropriate targets for smoking cessation
interventions.
 
Stress disorders are not uncommon.  Stress may be a mechanism by
which social and/or economic dislocation leads to adverse health
outcomes.  Racism can be viewed as a psychosocial stressor, and as
such may have specific physiologic effects.  The extent to which
individuals experience or perceive racism and the resources they have
to cope with this may influence their levels of stress.
 
Problems related to alcohol abuse, while evident in all populations,
are disproportionally present in Native American youth.  This leads
to a rate of death from alcohol almost four times higher than in
other U.S. populations.
 
Interest in the adolescent has at times been polarized into those who
view problems as deriving from individual shortcomings or poor
behavior versus those who view problems as deriving from the fact
that minority youth often live in disadvantaged circumstances.
Applicants for this RFA should construct a behavioral intervention
that acknowledges the complexity of adolescents' lives while focusing
on the major risks to health within their communities.
 
The key component of this research will be a program of
community-based health behavior interventions.  The specific
locations--homes, schools, social service agencies, churches, or
elsewhere--the precise ages of the participants, and the outcomes of
interest beyond the reduction of morbidity and mortality due to the
adverse outcomes of violence and sexual risk-taking, may vary across
successful applications.  The broad age range (10-24) being
contemplated is especially challenging since the problems to be
addressed and the opportunities for intervention (e.g., school,
church, workplace, and out of school settings) also differ by age.
Since early prevention of adverse health behaviors may have the
greatest impact on lifetime health, the younger end of the age
spectrum is of particular interest.
 
Although the health problems of minority adolescents are entangled
with their economic futures, it is unrealistic to expect a health
intervention to change the economic structure of a community or even
to provide jobs or job training.  However, there are employment
demonstration projects in many areas that could, for example, serve
as backdrops for an application.  Alternatively, there might be an
ongoing intervention in one community that could be included in the
application as one component, although already funded through other
sources.  In such cases, the application might assess the added value
of these programs to the health initiative.
 
The outcome variables of interest include the major causes of
morbidity and mortality:  violence, (especially homicide),
drug/alcohol use, very early sexual activity and sexually transmitted
diseases, including HIV/AIDS.  Other important behaviors include
proper oral health, cessation of, or never starting with, cigarette
smoking, and weight control strategies.  NIH acknowledges the
deleterious effects of drugs, smoking, and alcohol on adolescent
health and recognizes that these factors impact on all youth, not
only minority youth.  However, this research initiative is focused on
the health behaviors and needs of minority youth.
 
In each of these areas there is some evidence of successful
interventions, although packaging them to make a meaningful impact on
the prospects for minority youth is a major challenge.  The Appendix
is a selected listing of previously evaluated interventions as
examples.  It is, however, neither a comprehensive nor an exhaustive
listing of such resources.
 
A focus on primary prevention is strongly encouraged. However,
secondary prevention is also important.  Primary prevention will be
directed at the youngest ages and seek to promote compliance with
healthful behaviors, prevent the initiation of health compromising
behaviors, and instill positive skills for conflict resolution and
for avoiding adverse outcomes of sexual activity such as unwanted
pregnancy, STDs, and HIV.  Primary prevention efforts may also be
appropriate for older youth to assist them in maintaining healthy
behaviors.  Secondary prevention may be aimed at older adolescents
and young adults who have already experienced some of these problems.
 
While primary prevention may be broadly based in the community,
secondary prevention may better target specific groups, such as
incarcerated or homeless youth.  For example, there is some concern
that youth who have spent time hospitalized as a result of head
injuries--often resulting from violence--may be lost to follow-up
care after their release.
 
Applications must provide information concerning the appropriateness
of the match among intervention(s), target population, outcome
measures, and evaluation plan.  The application must also provide
information about:
 
o  The feasibility of implementing the intervention at the selected
site.
 
o  The mechanisms for assessing compliance with the implementation
and intervention.
 
o  An outline of the specific behaviors to be measured.
 
o  The specific articulations and responsibilities among the
institutions, agencies or other entities who will be participating in
the proposed project.
 
This is an RFA for research.  The NIH cannot fund interventions for
indefinite periods of time.  Thus, applicants may wish to consider
developing plans to secure continuing funding after the NIH support
ends.  The NIH will work with successful applicants on this aspect of
their programs.  Mechanisms for dissemination of findings and
assistance to other communities in replication of successful programs
are also possible components of an application.
 
SPECIAL REQUIREMENTS
 
Study Phases
 
The first phase will be the study design.  Meetings of the Steering
Committee, which will include the Principal Investigators of
successful applications, and the NIH/NICHD Project Coordinator, will
be held during this phase.  The two primary tasks will be to design
the data collection instruments:  the study elements that all centers
must standardize and share in order to assure that each has common
elements; and to finalize each site's interventions, with suitable
commonality across sites.  Because each awardee will be collecting
data and implementing interventions in at least two common areas,
violence and sexually-related diseases and conditions, certain
components of the various awardees' research will overlap, and common
data collection instruments will facilitate cross-awardee
comparisons.
 
Phase two, implementation, will involve baseline data collection
conducted across sites with the core protocol. This will provide not
only information about adolescents but of the family context in which
they live and the structure of their social life.  While a common,
structured instrument among all funded projects offers many
advantages, sites may have site-specific studies that will enrich the
view of the health behaviors and problems in their community.  Having
gathered baseline data, each site will implement its planned
interventions.  The interventions must either be grounded in
scientifically evaluated successful program or based on solid, and
stated, theory.  Applicants must indicate their understanding of the
likely effects of selection bias into programs on outcome measures.
 
The end points for assessing the effect of the intervention will vary
with the age group and the specific behavior.  The feasibility of
longitudinal data collection or several cross-sectional data
collection efforts must be addressed in the application.  The
designation of appropriate control groups must also be considered.
In addition to data collected on the interventions, at least one
final community-based data collection will be required to document
intervention impact.
 
Although ongoing analyses will be conducted within sites, a data
center will offer analytical support for sites and comparative
analyses.  In addition, NIH wishes to ensure that research data will
be available for others to analyze after a suitable period,
determined by the steering committee, during which the Principal
Investigators may have exclusive rights to the data, although this is
subject to Government rights of access.  This data center will create
public use data sets to broaden access to the research data and
facilitate cross-site comparative evaluation.
 
Phase three will include close-out or transfer to other funding
activities, data analysis and final report and manuscript
preparation.
 
Organizational Components:
 
Sites:
 
The institutions or agencies that receive the awards for conducting
the intervention studies under this RFA are referred to as "sites."
The Principal Investigator at each site is encouraged to form a
multidisciplinary team, including program and evaluation research
experts.  There must be evidence of strong support from all
participating agencies and institutions and a stated willingness to
follow shared aspects of the design and measures as developed by the
steering committee.
 
Steering Committee:
 
Although the studies funded through this RFA will differ with respect
to particular interventions, it is expected that certain aspects of
the studies will be shared (e.g., baseline and final survey data
needs, training and quality control, data management and intervention
issues).  To facilitate comparability with respect to common aspects,
a Steering Committee will be formed with overall responsibility for
decision-making regarding these shared aspects.  The committee will
be comprised of the Principal Investigator of each study and the
NIH/NICHD Project Coordinator.  Each Principal Investigator will have
one vote, and the NIH/NICHD Project Coordinator will have one vote.
The Principal Investigator of the Data Center will also have one vote
on the Steering Committee.
 
During the first year of the program, the Steering Committee will
meet a minimum of four times and participate in telephone conferences
to (1) develop and finalize the core protocol for the studies, and
(2) review and coordinate the specific intervention strategies being
used.
 
Subsequent face-to-face meetings will be held at least yearly and
will include more detailed discussions of data management and study
progress.  The committee will also deal with publication concerns
during the life of the project, including issues of data access, and
may act as an adjudicative body whenever appropriate.  The Steering
Committee may decide to devolve into subcommittees to address
particular issues.  In that case, each site shall be represented on
each subcommittee that shall exist at the discretion of the Steering
Committee.  Meetings may also be attended by selected key staff from
each project.
 
Data Center:
 
This entity will serve as a centralized information management system
for collecting, editing, storing and analyzing data.  The center will
be responsible for the management and analysis of the data from all
sites.  It will be responsible for ensuring data integrity, accuracy,
and accessibility to remote sites.  It will offer analytical support
for remote sites, thus providing various comparative analyses.  It
will be responsible for the timely production and dissemination of an
operations manual detailing the shared aspects of the study.  It will
maintain strict independence of the cooperating sites and will
compile, for the Steering Committee, progress reports prepared by the
sites and updates on data at six-month intervals.
 
Examples of additional functions of the Data Coordinating Center are
to:
 
o  design and develop a mechanism for standardizing data collection
from remote sites
 
o  perform data entry
 
o  coordinate, with the Steering Committee, baseline and outcome
measures for all sites
 
o  develop appropriate statistical analyses in consultation with
remote sites
 
o  provide cross-site comparative statistical analyses
 
o  create public use data sets as a mechanism to broaden the access
to the research data
 
o  manage data quality control in a timely manner
 
o  produce detailed reports for Steering Committee meetings and
provide the data for tracking study progress.
 
Any applicant wishing to apply for consideration as the Data Center
must submit a separate application describing their qualifications to
serve as such a center.  A complete description of the computing
facilities and allied resources must be provided.  Two completely
separate applications from different applicant-investigators must be
filed if an institution seeks selection as both a Site and as the
Data Coordinating Center.  Regardless of whether or not the Data
Center is located at one of the cooperating sites, it will maintain
strict independence.
 
Access to National Information Sources:
 
All applicants responding to this announcement are encouraged to
consider ensuring that their organizations have access to national
information sources such as the National Library of Medicine (NLM)
MEDLINE database.  As applicants prepare to submit applications, NLM
is willing to connect them to such national information sources.
There are many approaches, ranging from on-site training classes in
the use of computer and telecommunication technologies to affiliation
with regional health science libraries.  NLM will also work with
successful awardees to introduce such technologies and to facilitate
their use.  NLM representatives will participate in the technical
assistance workshop to be held a month after this RFA is issued, to
introduce their services to potential applicants.
 
STUDY POPULATIONS
 
NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical
research grants and cooperative agreements will be required to
include minorities and women in study populations so that research
findings can be of benefit to all persons at risk of the disease,
disorder or condition under study; special emphasis should be placed
on the need for inclusion of minorities and women in studies of
diseases, disorders and conditions which disproportionately affect
them.  This policy is intended to apply to males and females of all
ages.  If women or minorities are excluded or inadequately
represented in clinical research, particularly in proposed
population-based studies, a clear compelling rationale should be
provided.
 
The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues should be addressed in developing a research
design and sample size appropriate for the scientific objectives of
the study. This information should be included in the form PHS 398 in
Section 2, A-D of the Research Plan, AND summarized in Section 2, E,
Human Subjects.  Applicants are urged to assess carefully the
feasibility of including the broadest possible representation of
minority groups.  However, NIH recognizes that it may not be feasible
or appropriate to include representation of the full array of United
States racial/ethnic minority populations (i.e., Native Americans
(including American Indians or Alaskan Natives), Asian/Pacific
Islanders, Blacks, Hispanics).  The rationale for studies on single
minority populations should be provided.  For the purpose of this
policy, clinical research includes human biomedical and behavioral
studies of etiology, epidemiology, prevention (and preventive
strategies), diagnosis, or treatment of diseases, disorders or
conditions, including but not limited to clinical trials. If the
required information is not contained within the application, the
application will be returned.
 
Peer reviewers will address specifically whether the research plan in
the application conforms to these policies. If the representation of
women or minorities in a study design is inadequate to answer the
scientific question(s) addressed AND the justification for the
selected study population is inadequate, it will be considered a
scientific weakness or deficiency in the study design and will be
reflected in assigning the priority score to the application.
 
All applications for clinical research submitted to NIH are required
to address these policies.  NIH funding components will not award
grants or cooperative agreements that do not comply with these
policies.
 
The usual NIH policies concerning research on human subjects also
apply.  Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded.  However,
every effort should be made to include human tissues from women and
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by applicants.
 
REVIEW CONSIDERATIONS
 
All applicants will be judged on the basis of the scientific merit of
the proposed study and documented ability to complete the components
as outlined under the Scientific Plan section of this RFA.  It is the
intention of the NIH to support one or more minority institutions
that submit applications rated meritorious by the initial review
group.
 
Review Method
 
Applications will be received by the NIH Division of Research Grants.
Upon receipt, applications will be reviewed by NIH/NICHD program
staff for responsiveness to the objectives of this RFA.  Any
application judged to be nonresponsive will be returned to the
applicant without review.
 
Responsive applications will be reviewed within six months of
receipt.  They may be subjected to triage by a peer review group
convened by NICHD to determine scientific merit relative to the other
applications received in response to this RFA.  NIH will remove from
further competition those applications judged to be noncompetitive
and notify the applicant and institutional business official.  Those
application judged to be competitive will be further evaluated for
scientific merit by a review panel convened solely for this purpose
by the Division of Scientific Review, NICHD.
 
Following review by the Initial Review Group, applications will be
evaluated by the NICHD Advisory Council for program relevance and
policy issues before awards for meritorious applications are made.
 
Applications will be judged primarily on:
 
1.   Overall scientific quality
 
2.  Cooperation evidenced among all organizations participating in
the application, as demonstrated both in written form from the
organization directors and in the body of the application.
 
3.  The qualifications and experience of the investigative team, as
demonstrated by:
 
o  the theoretical premises, hypotheses, and preliminary data
supporting the proposed interventions;
 
o  the scientific and administrative abilities of the Principal
Investigator and team;
 
o  the knowledge and experience pertaining to the site- specific
component of the study and the targeted population(s);
 
o  the capacity to carry out longitudinal research, following
individuals over time;
 
o  the ability to evaluate interventions in a natural setting; and
 
o  the ability of key personnel to devote the time required to carry
out the project.
 
4.  The responsiveness of the application to the objectives of the
study.
 
5.  The definition of and access to an appropriate population,
including the adequacy of fulfilling criteria for the inclusion of
minorities and women.
 
6.  The quality of the proposed site-specific research.
 
7.  The generalizability of the proposed interventions.
 
8.  The appropriateness of the budget for the work proposed.
 
9.  The willingness of the team to collaborate with other study sites
and to work with the assistance of the Project Coordinator.
 
Applications for the Data Center will be judged primarily on:
 
1.  The infrastructure to provide the scientific computing and the
reporting activities necessary.
 
2.  The overall scientific and technical qualifications of the
Principal Investigator and staff (including key personnel).
 
3.  Demonstrated experience of the Principal Investigator and team to
support such an effort that is evidenced by:
 
o  the scientific, technical and administrative abilities of the
Principal Investigator and team;
 
o  the ability of key personnel to devote the time required to manage
and complete the project; and
 
o  the ability to control and coordinate the update, access and
analysis of similar database(s) in a manner that ensures data
consistency and reliability.
 
4.  The appropriateness of the budget for the work proposed.
 
5.  The willingness of the team to cooperate with all study sites and
with the assistance of the Project Coordinator.
 
APPLICATION PROCEDURES
 
In order to allow institutions to develop the community, research,
evaluation, and program linkages that this RFA demands, the
applications will be due at NIH by May 15, 1992.
 
A special technical assistance workshop will be offered to assist
potential applicants who have limited experience with the NIH
application process.  Representatives from each NIH institute will
participate in this workshop to provide potential applicants with
information on areas of particular interests.  This workshop will be
held in the Washington, DC metropolitan area on February 24, 1992.
The NIH cannot support individuals who wish to attend the conference,
but the conference will be open to any individual or organization who
wishes to attend.  An agenda may be obtained by contacting Dr. Bob
Eisinger, Office of AIDS Research (telephone 301-496-0357) or Dr.
Susan Newcomer (telephone 301/496-1174).  For those who are unable to
attent the workshop, a summary will be available upon request to Dr.
Newcomer.
 
This technical assistance workshop will also be teleconferenced on
the Black College Teleconference Network. Contact Ogden Lacey at
telephone (301) 496-1584 for further details on participation in the
teleconference.
 
Applications must be submitted on form PHS 398 (rev. 10/88, reprinted
10/89) that is available in most institutional business offices and
from the Division of Research Grants, NIH (telephone 301-496-7441).
Applications must be identified by checking the "yes" box in Item No.
2 on the face page of the application and by typing in the title and
number of this RFA.  The RFA label available in form PHS 398 must be
affixed to the bottom of the face page of the original application.
Failure to use this label could result in delayed processing of the
application such that it may not reach the review committee in time
for review.  The signed original (topmost) and four copies of the
application must be received by May 15, 1992.  Applications must be
sent or delivered to:
 
DIVISION OF RESEARCH GRANTS
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
 
At the time of submission, two additional copies of the application
must also be sent to:
 
Dr. A.T. Gregoire
Scientific Review Coordinator
National Institute of Child Health and Human Development
Executive Plaza North, Room 520
Bethesda, MD  20892
 
Applications must be received by May 15, 1992.  If an application is
received after that date, it will be returned to the applicant.
Also, the Division of Research Grants (DRG) will not accept any
application in response to this announcement that is essentially the
same as one currently pending initial review, unless the applicant
withdraws the pending application.  Nor will the DRG accept any
application that is essentially the same as one already reviewed.
This does not preclude the submission of substantial revisions of
applications already reviewed, but such applications must include an
introduction addressing the previous critique.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit by February 1, 1992, a
letter of intent that includes a descriptive title of the proposed
research, the name, address and telephone number of the Principal
Investigator, the identities of other key personnel and participating
institutions, and the number and title of the RFA in response to
which the application is being submitted.
 
Although a letter of intent is not required, is not binding, and does
not enter into the review of subsequent applications, the information
that it contains is helpful in planning for the review of
applications.  It allows staff to estimate the potential review
workload and to avoid possible conflict of interest in the review.
 
The letter of intent is to be sent to:
 
Susan Newcomer, Ph.D.
OMP Project Coordinator
National Institute of Child Health and Human Development
Executive Plaza North, Room 611
Bethesda, MD  20892
Telephone:  (301) 496-1174
FAX:  (301) 496-0962
 
INQUIRIES
 
Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.  Direct inquires regarding programmatic issues
or the technical assistance workshop to Dr. Susan Newcomer (Address
as above).
 
Dr. Newcomer will also facilitate consultations with health
scientists in other NIH Institutes, Centers, and Divisions who may
better answer queries on specific subject areas.
 
Direct inquiries regarding fiscal matters to:
 
Ms. Melinda Nelson
Office of Grants and Contracts
National Institute of Child Health and Human Development
Executive Plaza North, Room 505
Bethesda, MD  20892
Telephone:  (301) 496-5481
FAX:  (301) 402-0915
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.864 (Population Research).  Awards are made under
authorization of the Public Health Service Act, Title IV, Part A
(Public Law 78-410, as amended by Public Law 99- 158, 42 USC 241 and
285) and administered under PHS grants policies and Federal
Regulations, 42 CFR Part 52 and 45 CFR Part 74.  This program is not
subject to the intergovernmental review requirements of Executive
Order 12372 or to Health Systems Agency review.
 
Appendix
 
Selected Resources on Interventions and Evaluations
 
Aledort, Louis, H. Weiss, C. Parker, J. Levi and R. Simon. 1990.
"Life-Style Interventions in the Young." in: Shumaker, Sally A., E.B.
Schron and J.K. Ockene, editors. 1990.  The Handbook of Health
Behavior Change.  New York: Springer.
 
Bowen-Spencer, Michele. 1987.  Working with the church:  A guide to
establishing church-based health promotion activities.  The
Church-Community Teen-Link.  Durham NC: Lincoln Community Health
Center.
 
Brindis, Claire D. 1991.  Adolescent pregnancy prevention: A
guidebook for communities.  Palo Alto CA:  Health Promotion Resource
Center, Stanford Center for Research in Disease Prevention.
 
Carnegie Council on Adolescent Development.  1989.  Turning Points:
Preparing American youth for the 21st century.  New York:  Carnegie
Corporation.
 
Evans, David, N. Clark, C. Feldman, Y. Wasilewski, J. Levison, B.
Zimmerman, B. Levin and R. Mellins. 1990. "School-based Health
Education for Children with Asthma: Some Issues for Adherence
Research." in: Shumaker, Sally A., E.B. Schron and J.K. Ockene,
editors. 1990.  The Handbook of Health Behavior Change.  New
York:Springer.
 
Gans, Janet, Dale Blyth, Arthur Elster and Lena Gaveras. 1990.
America's Adolescents: How healthy are they?  Chicago IL:  American
Medical Association, Department of Adolescent Health.
 
Hardy, Janet and Laurie Schwab Zabin. 1991. Adolescent Pregnancy in
an Urban Environment:  Issues, Programs and Evaluation.  Washington
DC: The Urban Institute.
 
Horowitz, Alice M.  Preventing tooth decay:  A guide for implementing
self-applied fluorides in school settings. U.S.DHHS, PHS.  NIH
publication 82-1197, revised December 1981.
 
Lewis, C.E., Rachelefsky, G. et.al.  1984.  "A Randomized trial of
A.C.T. (asthma care training) for kids." Pediatrics.  74:478-486.
 
Miller, Brent C., Josefina J. Card, James L. Peterson and Roberta L.
Paikoff (editors). 1991.  Preventing adolescent pregnancy:  model
programs and evaluations.  San Francisco; Sage.
 
National Committee for Injury Prevention and Control.  1989. Injury
Prevention:  Meeting the Challenge.  NY: Oxford University Press,
published as a special issue of the American Journal of Prevention
Medicine, Volume 5, Number 3.
 
Palumbo, Dennis J.  1987.  The Politics of Program Evaluation.
Newbury Park:Sage.
 
Parker, Sydney R. and John M. Wolle.  1987.  Asthma Self- Management:
A Second Generation of Research Programs. Special edition of the
Health Education Quarterly vol. 14(3).
 
Prothrow-Stith, Deborah. 1991.  "Needed:  A New Pathway to the
Prevention of Violence."  Public Health Reports May-June vol.
106(3):263-265.
 
Prothrow-Stith, Deborah.  1991.  Deadly Consequences:  How Violence
is Destroying our Teenage Population.  New York:Harper Collins.
 
Shumaker, Sally A., E.B. Schron and J.K. Ockene, editors. 1990.  The
Handbook of Health Behavior Change.  New York:Springer.
 
U. S. Congress. Office of Technology Assessment.  1991. Adolescent
health-- Volume I:  Summary and policy options, Volume III:
Crosscutting issues in the Delivery of health and related services.
OTA-H-468 and OTA-H-467. Superintendent of Documents, Government
Printing Office, Washington DC 20402-9325 (Telephone 202/783-3238).
 
U.S.DHHS, Healthy People 2000 (Full Report: Stock No. 017-
001-00474-0; Summary Report: Stock No. 017-001-00473-1)
Superintendent of Documents, Government Printing Office, Washington
DC 20402-9325 (Telephone 202/783-3238).
 
U.S.DHHS, PHS.  Office of Disease Prevention and Health Promotion.
1986. Integration of risk factor interventions: Two reports to the
Office of Disease Prevention and Health Promotion.  Available from
ODPHP Health Information Center, Box 1133, Washington DC 20013-1133.
1-800-336-4797.
 
U.S.DHHS, PHS.  Health Resources and Services Administration, Bureau
of Health Professions, Division of Disadvantaged Assistance.  1991.
Health Status of Minorities and Low Income Groups:  Third Edition.
Washington DC:  U.S. Government Printing Office.
 
U.S.DHHS, PHS.  National Institutes of Health, National Institute of
Neurological Disorders and Stroke.  1989. Interagency Head Injury
Task Force Report
 
U.S. Department of Justice, Office of Justice Programs, Bureau of
Justice Statistics.  1990.  Criminal Victimization in the United
States, 1988.

