From: kristoff@NET.BIO.NET (Dave Kristofferson)
Newsgroups: bionet.sci-resources
Subject: NIH Guide, vol. 21, no. 35, pt. 3, 2 October 1992
Date: 9 Oct 92 02:00:31 GMT
Distribution: bionet


$$XID RFA HD9308 HD-93-08 P1O1 *****************************************

FAMILY AND CHILD WELLBEING RESEARCH NETWORK

NIH GUIDE, Volume 21, Number 35, October 2, 1992

RFA:  HD-93-08

P.T. 34, AA; K.W. 0730010, 0730005

National Institute of Child Health and Human Development

Application Receipt Date:  December 18, 1992

PURPOSE

The Demographic and Behavioral Sciences Branch of the Center for
Population Research at the National Institute of Child Health and Human
Development (NICHD) invites applications for cooperative agreements
(U01) to develop a research network to investigate the relationship of
family factors to child wellbeing.  The research network will conduct
a systematic analysis of existing data to determine what can be learned
about the relationship of family factors to child wellbeing using
extant data.  The research network will also examine the public policy
implications of its work and systematically pursue research leads that
show promise for informing public policy.

Each investigator in the network will be expected to have demonstrated
expertise and access to at least one data set relevant to the topic.
Also, applicants must demonstrate that they have both the substantive
and statistical expertise to function as part of an interdisciplinary
research network.  Each investigator will be given support to pursue
his or her individual research agenda, but a large part of the
available resources will be held in reserve to address cooperative
research questions agreed upon by the network.  Each investigator will
propose both an individual research plan and a cooperative research
plan in which they identify areas of research that they would be
willing to cooperate in implementing.

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,
Family and Child Wellbeing Research Network, is related to the priority
areas of family planning, educational and community-based programs, and
maternal and infant health. 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

Applications may be submitted by domestic for-profit and non-profit
organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State and local governments, and
eligible agencies of the Federal government.  Applications from
minority individuals and women are encouraged.

Institutions may submit applications on behalf of more than one
Principal Investigator (PI), but each PI must submit a separate
application.

MECHANISM OF SUPPORT

The funding mechanism to be used to support the research network will
be the cooperative agreement (U01).  Cooperative agreements are
assistance mechanisms but differ from research project grants in that
there will be substantial programmatic involvement of the NICHD Project
Coordinator above and beyond the levels required for traditional
program management of grants.  Specifically, the Project Coordinator
will cooperate with the PI as a partner in the research network.  All
parties agree to accept the participatory and cooperative nature of the
group process.

This RFA is intended as a one time solicitation.  The total project
period for the research network is five years and applications
submitted in response to the present RFA should not exceed five years.
Should there be a sufficient continuing program need, the NICHD may
reissue this RFA.  The anticipated award date is July 1, 1993.

FUNDS AVAILABLE

It is anticipated that up to seven awards will be made.  One million
dollars of direct cost support have been set aside to support the
network and this amount will increase by an inflation factor in
subsequent years of the network.  Approximately one half of the
resources allocated for the network will be devoted to support
cooperative research.  Resources available for cooperative research
will be very small in the first year of the network, but will increase
progressively in the subsequent years of the network.  The percentage
of funding for cooperative research will increase according to the
following schedule:  20 percent in FY 93, 35 percent in FY 94, 50
percent in FY 95, 65 percent in FY 96 and 80 percent in FY 97.  The
level of support is dependent on the receipt of a sufficient number of
applications of high scientific merit.  Although this program will be
provided for in the financial plan of the NICHD, the award of grants
pursuant to this RFA is also contingent on the availability of funds
for this purpose.

RESEARCH OBJECTIVES

There is a heightened awareness in both public policy and research
communities that the wellbeing of children is deteriorating and that
family factors are important explanations of this phenomenon.  Within
public policy circles there is a growing frustration that basic
information about family and child wellbeing is filled with gaps and is
analyzed in an uneven manner.  Within the research community there is
a fundamental problem that family and child research is spread among a
large number of disciplines, and these disciplines are so diverse in
their research approaches that communication across fields is
difficult.  It is timely to create a systematic effort to both
understand the relationship of family and child wellbeing from a
multi-disciplinary point of view and address public policy concerns in
a comprehensive and responsive manner. The NICHD wishes to assist the
scientific community to mount a systematic attack using all sources of
existing information.

There are a large number of social problems that impinge on the
wellbeing of children.  Among them, poverty and the emergence of an
underclass population with a growing dependence on public transfer
programs are highly visible areas of concern.  Moreover, family factors
such as marital instability, out-of-wedlock childbearing, and changes
in the demographic and economic structure of the family seem to be
inextricably related to these and other problems affecting child
wellbeing.  It is important to describe fully these interconnections
and to formulate and test models of the causes and consequences of
these relationships.  It is also important to elucidate the mechanisms
of action by which family factors affect child wellbeing so that
possible avenues of social intervention can be ascertained or existing
interventions, such as child support enforcement or child care
subsidies, can be evaluated.

The American family has undergone considerable change in modern times.
These changes are associated with changes in the way children are
raised and with changes in familial support structures that sustain
children and develop them into productive adults.  It is the intent of
this RFA to assist in measuring both family factors and child wellbeing
very broadly to develop as comprehensive a picture as possible about
the relationship between these considerations.  It is also important to
understand how family factors and socio-economic conditions combine to
nurture children and help them develop into productive adults from both
an individual and societal perspective.  It is important to understand
how the intergenerational structure of the family marshals resources to
care for dependent children and how intergenerational family processes
relate to public intervention to sustain and develop children.

The research network is expected to confine its activity to secondary
data analysis.  This will enable the research community to exploit
fully many of the sources of data that have been specially created for
the research community by the NICHD and other agencies.  These data
sources include:  The National Survey of Families and Households, The
National Longitudinal Survey Youth Cohort and related Child
Supplements, The June 1990 Marriage and Fertility Supplement of the
Current Population Survey, The National Survey of Family Growth and
others.  In addition, there are many data resources of sub-national
populations that should be fully analyzed.  It is the intent of this
RFA to utilize data containing a fair representation of women and
minorities.  In exceptional circumstances data confined to specialized
populations may be used to enhance our understanding of selected
dimensions of the research problem.

The network will be assembled to achieve the broadest possible coverage
in terms of research perspective, analytical technique, and sources of
data.  The focus of the network is the United States, but the use of
foreign data may be justified if it provides an insight into the
American condition.  Investigators must demonstrate that they have a
long-term research agenda that is addressing important questions
relevant to the research goals of this RFA.  In addition, they must
describe the sources of data to which they have access and plan to use
in their research plan.  It is important to describe the extent to
which the investigator has experience using these data.  It is also
important to outline the analytic plan of attack and to describe the
statistical techniques that will be employed in each phase of the
research plan.

The PI must propose an individual research plan to accomplish his or
her personal research agenda.  The plan must have the same degree of
specificity as an individual research grant (R01).  A PI may request
support for any type of research activity commonly available through
research assistance mechanisms offered by the NICHD except the cost of
collecting new data. It is anticipated that such support will be higher
in the first year of the initial agreement than in subsequent years and
will diminish progressively throughout the five years in which the
network is in operation.

The PI must also propose a cooperative research plan that will describe
the proposed cooperative research effort that transcends his/her
individual research programs.  The cooperative research plan should
propose questions of substantive and/or public policy significance that
should be examined cooperatively and should indicate how their
disciplinary and methodological perspectives could contribute to a
cooperative research effort.  Also, investigators should indicate which
sources of data, with which they have familiarity and access, should be
used in the cooperative research plan.

SPECIAL REQUIREMENTS

Terms and Conditions

Awardee Responsibilities

Each PI will have primary responsibility to define objectives and
approaches and to plan, conduct, analyze, and publish results,
interpretations, and conclusions of his/her studies.  Awardees will
retain custody of, and primary rights to, their data developed under
these award, subject to Government rights of access, consistent with
current HHS, PHS, and NIH policies.  A budget supporting the individual
research programs will be negotiated with the NICHD based on the
corresponding budget presented in the application.  Each investigator
will have the right to publish based on the work of their individual
research programs.  Each PI will also propose a cooperative research
plan in which they will identify research questions, protocols, and
data sets that they propose to work on cooperatively.  The Steering
Committee will formulate a research plan for cooperative research that
will distill the several individual cooperative research plans into a
coherent plan and will involve allocating resources among the
participating cooperative agreements to implement it.  The cooperative
research plan will be agreed upon by majority vote of the Steering
Committee, but each PI will have the right of approval for any aspect
of the cooperative research plan involving them.  Due publication
credit will be given to all work done cooperatively.

Steering Committee Responsibilities

Planning and implementation of the cooperative aspects of the study
will be done by a Steering Committee consisting of the PI from each
participating awardee institution and the NICHD Project Coordinator.
If necessary, the Steering Committee may invite outside, non-voting
expert consultants to their meetings for advice as common protocols are
developed.

o  Plan the design and implementation of the cooperative research
protocols

o  Participate in decision-making regarding allocation of funds for
cooperative research protocols

o  Publish results, conclusions and interpretations of the cooperative
protocols

o  Formulate publication policy and appoint a Publication Subcommittee,
as judged necessary by the Steering Committee

o  Agree to accept the coordinating role of the committee and the
cooperative nature of the group process

NICHD Responsibilities

The NICHD Project Coordinator will be the Family Demography Coordinator
of the Demographic and Behavioral Sciences Branch, NICHD.  He will:

o  Assist in all functions of the Steering Committee

o  Assist with the development of common protocols

o  Assist the steering committee in reviewing and commenting on each
stage of the program before subsequent stages are started

o  Assist the steering committee in exercising the options of adding,
modifying, or terminating aspects of the program

o  Assist in the analysis, interpretation and reporting of findings in
the scientific literature and other media to the community at large

o  Have the option to withhold support to a participating institution,
if technical performance requirements such as compliance with the
protocol are not met

o  Continuous review of all activities to ensure objectives are being
met

The above responsibilities are in addition to, not in lieu of, the
levels of involvement normally required for program stewardship of
grants.

Arbitration Procedures

When agreement between an awardee and NICHD staff cannot be reached on
programmatic and scientific-technical issues that may arise after the
award, an arbitration panel will be formed.  The panel will consist of
one person selected by the PIs, one person selected by the NICHD staff,
and a third person selected by these two members.  The decision of the
arbitration panel, by majority vote, will be binding.  These special
arbitration procedures in no way affect the awardee's right to appeal
an adverse action in accordance with PHS regulations at 42 CFR Part 50,
Subpart D, and HHS regulations at 45 CFR Part 16.

Cooperative agreements are assistance mechanisms and are subject to the
same administrative requirements as grants.  The above Terms of Award
are in addition to, and not in lieu of, otherwise applicable OMB
administrative guidelines, HHS grant administration regulation at 45
CFR Part 74, and other HHS, PHS, and NIH grant administration policies
and procedures.

Meetings

Each investigator must budget for four meetings a year in the
Washington, DC area.  Each meeting will be approximately two days in
length.  During these meetings, the Steering Committee will decide upon
the operating policies of the network, discuss ongoing research,
formulate the collaborative research plan, and discuss the implications
of their research with interested parties outside of the network who
may be invited by the Steering Committee as the occasion warrants.  If
more meetings are necessary, as may be the case especially in the first
year of the network, or if project personnel other than the PI are
invited to the meetings, individual awards will be supplemented with
appropriate funds.  These meetings will be coordinated by the Project
Coordinator.

Communications

There will be a much greater level of communication among network
members than is normal for individual research project grants.
Individual PIs must budget appropriately for greater telephone usage,
more copies of research papers, and greater mailing costs than in a
research grant (R01).  The use of BITNET will also be encouraged.

Expectation of Cooperation

There will be high expectations of the members of the research network
to interact with other members of the network, share research insights,
cooperate in the design and implementation of a cooperative research
plan, be responsive to needs of the cooperative work of the network,
and be sensitive to the public policy significance of it all.
Applicants must indicate their willingness to participate in these
stated aspects of the network.  The statement of willingness to
cooperate should be included under Consortium/Collaborators, section
C-8 of the Research Plan in the PHS 398 application.

APPLICATION PROCEDURES

The grant application form PHS 398 (rev. 9/91) is to be used in
applying for this grant. The RFA label available in the form PHS 398
must be affixed to the bottom of the face page.  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 the review.  In
addition, the RFA title and number must be typed on line 2a of the face
page of the application form and the YES box must be marked.  The PHS
398 is available from most business offices or grants/contracts offices
at most institutions and can also be obtained from the Office of Grants
Inquiries, Division of Research Grants, National Institutes of Health,
5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301)
496-7441.

The research plan section of the application must conform to the
guidelines of form PHS 398.  The individual research plan should be
presented first and should follow steps 1-4, i.e., Specific Aims,
Background and Significance, Progress Report/Preliminary Studies, and
Research Design and Methods, of the standard research plan section.
The budget for the application must be predicated on the requirements
of the individual research plan and on the cooperative research plan
that the investigator is proposing to work on cooperatively. Since
these applications will in fact be proposing two research plans, the
individual and the collaborative, the standard 25-page limitation will
not apply.  However, applicants are encouraged not to exceed 40 pages.
The budget instructions provided in the application form PHS 398 must
be followed, and budget presentations must include budgets for the
collaborative group efforts suggested in the application.  Indirect
costs will be provided.  Budgets will be reviewed on the basis of
appropriateness for the work proposed.  Allowable costs and policies
governing the research grant program of the NIH will prevail. In
preparing the budget section of the application, each applicant must
submit detailed budgets for his/her own research plans only.
Applicants are encouraged to be mindful of the declining allocation of
funds for individual protocols in future years.  Budgets must be
proposed accordingly.

Submit a signed typewritten original of the application, including the
Checklist, and three signed photocopies in one package 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:

Laurance S. Johnston, Ph.D.
Acting Deputy Director
Division of Scientific Review
National Institute of Child Health and Human Development
Executive Plaza North, Room 520
Bethesda, MD  20892

Applications must be received at the Division of Research Grants by
December 18, 1992.  If an application is received after that date, it
will be returned to the applicant.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed by DRG staff for
completeness and NICHD staff for responsiveness.  Incomplete
applications will be returned to the applicant without further
consideration.  If the application is not responsive to the RFA, NICHD
staff will return the application to the applicant.

Applications may be triaged by an NICHD peer review group on the basis
of relative competitiveness.  The NICHD will withdraw from further
competition those applications judged to be non-competitive for award
and notify the applicant PI and institutional official.  Those
applications judged to be competitive will undergo further scientific
merit review.

Those applications that are complete, responsive, and competitive will
be evaluated in accordance with the criteria stated below for
scientific/technical merit by a special review committee convened by
the NICHD.  The second level of review will be provided by the National
Child Health and Human Development Advisory Council.

The review criteria for the individual research plans of the network
are:

o  Scientific and technical significance and originality of proposed
research;

o  Appropriateness and adequacy of the research approach and
methodology proposed to carry out the research;

o  Qualifications and research experience of the PI and staff,
particularly, but not exclusively, in the area of the proposed
research;

o  Availability of resources necessary to perform the research;

o  Appropriateness of the proposed budget and duration in relation to
the proposed research;

o  Access to and experience with sources of existing data suitable for
the purposes of the research network.

AWARD CRITERIA

The anticipated date of award is July 1, 1993.  An attempt will be made
to balance the network so that it will have a multi-disciplinary
composition, a diversity of research issues and broad coverage of
extant data sources.  Awards will be made on the basis of the
scientific merit of the research application and the need to create a
balanced network.

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.

Direct inquiries regarding programmatic issues to:

V. Jeffery Evans, Ph.D., J.D.
Family Demography Coordinator
Demographic and Behavioral Sciences Branch
Center for Population Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B13
Bethesda, MD  20892
Telephone:  (301) 496-1174
FAX:  (301) 496-0962
BITNET:  EVANSJ@NIHHD01.BITNET

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 Building, 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.  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.


$$XID RFA HL9302P HL-93-02-P P1O1 **************************************

IMPROVING HYPERTENSIVE CARE FOR INNER CITY MINORITIES

NIH GUIDE, Volume 21, Number 35, October 2, 1992

RFA:  HL-93-02-P

P.T. 34; K.W. 0715115, 0414014, 0413001, 0403004, 0502017

National Heart, Lung, and Blood Institute

Letter of Intent Receipt Date:  November 30, 1992
Application Receipt Date:  February 16, 1993

PURPOSE

The Division of Epidemiology and Clinical Applications (DECA) invites
applications for demonstration and education projects aimed at
improvements in hypertensive care among inner city minority
populations.  The awards will be for a funding period of four years.
The program will focus on community-based health education and/or other
approaches for enhancing compliance and improving blood pressure
control in urban minority populations.  The intervention models should
be widely applicable and economical.  While hypertension is the focus
of the program, a multiple risk factor approach may be used to assess
changes in other cardiovascular risk factors.

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,
Improving Hypertensive Care for Inner City Minorities, is related to
the priority area of heart disease and stroke.  Potential applicants
may obtain a copy of "Healthy People 2000" (Full Report:  Stock No.
017-001-00474-0 or 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

Applications may be submitted by domestic, for-profit and non-profit
organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State and local governments, and
eligible agencies of the Federal government.  Foreign organizations are
not eligible to apply and domestic applications may not include
international components.  Applications from minority individuals,
particularly African Americans, Hispanics, and women are encouraged.

MECHANISM OF SUPPORT

The support mechanism for this RFA will be the National Institutes of
Health (NIH) demonstration and education (D&E) research grant (R18).
Responsibility for the planning, direction, and execution of the
proposed project will be solely that of the applicant.  The total
project period for applications submitted in response to this RFA may
not exceed four years.  The anticipated award date is September 30,
1993.

FUNDS AVAILABLE

It is anticipated that three to five Centers will be supported over the
four year period of this program.  An estimated total cost (direct and
indirect) of $2,500,000 will be available for the first year of funding
for the entire program, with an estimated four year total cost of
$10,600,000.  This level of support is dependent upon the receipt of a
sufficient number of applications of high scientific merit.  Although
this program is provided for in the financial plans of the National
Heart, Lung, and Blood Institute (NHLBI), awards pursuant to this RFA
are contingent upon the availability of funds for this purpose.

RESEARCH OBJECTIVES

Background

Hypertension is a major independent risk factor for the development of
cardiovascular disease, the leading cause of death in the U.S.  Despite
improvements in the treatment and control of hypertension in recent
years, African Americans continue to experience higher morbidity and
mortality from hypertension than the white population.  Hypertension is
more likely to appear earlier in life in African Americans.  Adequate
treatment is often hampered by socioeconomic factors.

Complications of uncontrolled hypertension, including stroke and
end-stage renal disease, occur earlier and more frequently in African
Americans than in whites.  In 1986, the age-adjusted stroke mortality
rate was 83 percent higher in African Americans than in whites.  While
age-adjusted mortality rates for stroke are declining for both African
Americans and whites, both for males and females, the rate of decline
is lower for African Americans.  The African American to white ratio of
age-adjusted stroke mortality increased from 1.85 in 1980 to 1.93 in
1988 for males and from 1.75 to 1.83 over the same time for females
(1,2).

Although based on single blood pressure measurements, data regarding
the prevalence, awareness, treatment, and control of hypertension in
the U.S. are available from the 1976-80 National Health and Nutrition
Examination Survey (NHANES II) (3).  African Americans collectively
have a higher prevalence of hypertension, based upon a 140/90 mm Hg
cutpoint or taking antihypertensive medication, than whites (38 vs. 29
percent).  Severe hypertension is four times as prevalent among African
American males relative to white males.  The following data on
awareness, treatment, and control are for blood pressure cutpoints of
140/90 mm Hg; similar trends exist for the higher cutpoints of 160/95
mm Hg.  Of those with hypertension, African Americans were shown to be
slightly more aware of their hypertension (65.6 vs. 52.3 percent) than
whites, and slightly more received pharmacologic therapy (38.5 vs. 32.6
percent).  Nonpharmacologic therapy was not included in this analysis.
While control rates for African Americans collectively were slightly
better than for whites (13.3 vs. 10.9 percent), the hypertension of
African American males was slightly less controlled than that of white
males (5.8 vs. 6.1 percent).  It is also noteworthy that these control
rates were very low for all race-sex groups.

An inverse relationship between socioeconomic status and health exists
for a number of disease entities, findings that come primarily from
studies of non-minority populations.  Although data are somewhat
limited for comparison between differing levels of socioeconomic status
among African-Americans, a number of studies reveal that African
Americans of lower socioeconomic status have a higher level of
hypertension-related disease burden than more advantaged African
Americans (6).  The Hypertension Detection and Follow-Up Program
(HDFP), which screened over 40,000 African Americans and entered over
4800 African Americans into the study, showed an inverse relationship
between level of education, used as a measure for socioeconomic status,
and severity of hypertension for both African Americans and whites.
This inverse relationship between education and hypertension was more
pronounced within the highest stratum of blood pressure.  The gradient
was essentially eliminated by stepped care antihypertensive drug
therapy (7).

Hispanics represent the second largest minority population in the U.S.,
and this group is rapidly growing.  The Hispanic population is
heterogenous. The Hispanic Health and Nutrition Examination Survey
(HHANES) was conducted among three Hispanic subgroups (of Mexican,
Cuban, and Puerto Rican origins) in the U.S. from 1982 to 1984 (8).
Data from this survey reveal that Hispanics have lower prevalence of
hypertension, higher awareness, higher treatment rates, and higher
control rates compared to the rates for both whites and African
Americans in NHANES II.  It should be noted that the HHANES data are
more recent than NHANES II.

The San Antonio Heart Study provides additional data regarding
hypertension among Mexican Americans.  Data presented for four
different definitions of hypertension (isolated and combined elevations
using 160/95 and 140/90 mm Hg cutpoints) show a lower prevalence among
Mexican Americans relative to non-Hispanic whites, although only two of
the eight pairwise comparisons (four hypertensive definitions by
gender) were statistically significant.  After adjustment for age, body
mass index, and non-insulin-dependent diabetes mellitus, Mexican
Americans were shown to have a statistically significant lower
prevalence of hypertension (9).

Certainly these data indicate substantial room for improvement in the
awareness, treatment, and control of hypertension for all Americans.
African Americans, with both an increased burden of disease and
problems with access to care, require special attention.  While the
data for Hispanics populations do not indicate excess disease burden,
socioeconomic factors are likely to put many Hispanics at a
disadvantage for optimal hypertension detection and management.

Several investigators have shown improvement in the care for inner-city
minority hypertensives.  As an example, Levine and colleagues designed
a long term program using a population-based intervention, administered
under the direction of a task force of community leaders and
organizations and the Johns Hopkins Medical Institutions.  Five-year
results demonstrate significant improvements in both behavioral
objectives and blood pressure control.

In summary, excess disease burden from hypertension in African
Americans, combined with numerous socio-economic barriers to optimal
care for many inner city individuals, provides a setting in which
substantial improvements are both urgently needed and likely
achievable.

Objectives and Scope

The primary objective of this four year demonstration and education
research program is to develop, and to evaluate for feasibility,
acceptability, and effectiveness, methods to maintain therapy and
control of hypertension, for both newly and previously diagnosed
individuals, in inner city, primarily minority populations.  The focus
will be on community-based health education and other approaches for
enhancing compliance and improving blood pressure control among inner
city minority populations.  The delivery of and adherence to the
interventions is the main objective, rather than clinical algorithms
used to treat hypertension.  While the improvement of hypertensive care
is the focus of this program, other cardiovascular disease risk factors
may be included in the interventions, and changes in these factors
should be assessed.  The role of non-pharmacologic approaches to
reducing blood pressure, including drug and alcohol avoidance, should
be addressed.

Primary outcome measures to assess the interventions may include:
percentages aware of hypertension, screened for hypertension, treated
for hypertension, responding to treatment, and controlled to normal
levels of blood pressure; clinic attendance; and compliance with
therapy.  Secondary outcomes include the assessment of:  effects on
other CVD risk factors, e.g., cigarette smoking, overweight, lipid
profile, and diabetes; health quality of life measures; and cost
effectiveness of the interventions.

The experimental design is not restricted by this RFA.  Applicants
should develop their own independent design, and provide justification
for the proposed design.  The designs should focus on an integrated
approach including various management factors that have previously been
shown to be effective.  Health education and other approaches for
enhancing compliance and improving blood pressure control must be
adequately described.  A randomized design, comparing special
interventions against usual care would be one appropriate study design
to test intervention models.  If justified by the nature of the
proposed intervention, i.e., delivery of an intervention to a social
group (e.g., neighborhood or employee group), other designs will be
considered responsive.

Annual meetings, to be held in Bethesda, MD, are planned for the
exchange of information among investigators.  Applicants must budget
the travel costs associated with these meetings in their applications.

STUDY POPULATIONS

Because of their excess burden of hypertension, African Americans
should comprise a large proportion of the study population.  Although
there is no compelling evidence of excess burden from hypertension
among Hispanics compared to the population at large, socioeconomic
factors for inner-city members of this group may result in less than
optimal hypertension detection and treatment.  Therefore the inclusion
of Hispanics, which may be best accomplished by the inclusion of
Hispanics as the majority of the sample at one of the study sites, may
be proposed.  Investigators should also consider other minority groups,
as well as low socioeconomic whites, for inclusion.  The inclusion of
low socioeconomic status (SES) whites may provide some means to
separate the effects of SES and ethnicity.  As the lowest hypertension
control rates are seen in young African Americans, investigators should
address the advantages and disadvantages of oversampling this younger
segment of the population.

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS

NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical
research grants and cooperative agreements are 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 must 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 must be provided.

The composition of the proposed study population must be described in
terms of approximate percentages by gender and racial/ethnic group.  In
addition, gender and racial/ethnic issues must be addressed in
developing a research design and sample size appropriate for the
scientific objectives of the study.  This information must be included
in the form PHS 398 (rev. 9/91) in Sections 1-4 of the Research Plan
AND summarized in Section 5, Human Subjects.  Applicants are urged to
assess carefully the feasibility of including the broadest possible
representation of minority groups.  However, the NIH recognizes that it
may not be feasible or appropriate in all research projects 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 population groups should
be provided.

For the purpose of this policy, clinical research is defined as human
biomedical studies of etiology, epidemiology, prevention (and
preventive strategies), diagnosis, or treatment of diseases, disorders
or conditions, including, but not limited, to clinical trials.

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 apply the results of the
study broadly, and this should be addressed by applicants.

If the required information is not contained in 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 reflected in assigning
the priority score to the application.

All applications for clinical research submitted to the NIH are
required to address these policies.  NIH funding components will not
award grants or cooperative agreements that do not comply with these
policies.

LETTER OF INTENT

Prospective applicants are asked to submit, by November 30, 1992, a
letter of intent that includes a descriptive title of the proposed
research; the name, address, and telephone number of the PI; the
identities of other key personnel and participating institutions; and
the number and title of the RFA in response to which the application
may be 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 NHLBI staff to estimate the potential workload and to avoid
conflict of interest in the review.

The letter of intent is to be sent to:

C. James Scheirer, Ph.D.
Review Branch, Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Westwood Building, Room 548
Bethesda, MD  20892
Telephone:  (301) 496-7363
FAX:  (301) 402-1660

APPLICATION PROCEDURES

The research grant application form 398 (rev. 9/91) is to be used in
applying for this award.  These forms are available at most
institutional business offices; from the Office of Grants Inquiries,
Division of Research Grants, National Institutes of Health, 5333
Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301)
496-7441; and from the NHLBI Program Administrator named below.

The RFA label available in the PHS 398 (rev. 9/91) application must be
affixed to the bottom of the face page of the 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.  In
addition, the RFA title and number must be typed on line 2a of the face
page of the application form and the YES box must be marked.

Submit the signed, typewritten original of the application, and three
signed photocopies in one package to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At the time of submission, two additional copies must also be sent to:

C. James Scheirer, Ph.D.
Review Branch, Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Westwood Building, Room 548
Bethesda, MD  20892

It is important to send these two copies at the same time as the
original and three copies are sent to the Division of Research Grants.
Otherwise, the NHLBI cannot guarantee that the application will be
reviewed in competition for this RFA.

Applications must be received by February 16, 1993.  If an application
is received after that date, it will be returned to the applicant
without review.  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.  The DRG will not 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.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by DRG and
for responsiveness by the NHLBI.  Incomplete applications will be
returned to the applicant without further consideration.  If the
application is not responsive to the RFA, NHLBI staff will contact the
applicant to determine whether to return the application to the
applicant or submit it for review in competition with unsolicited
applications at the next review cycle.

Applications that are found to be responsive will be reviewed for
scientific and technical merit by an initial review group, convened by
the Division of Extramural Affairs, NHLBI solely to review these
applications.  The initial review will include an evaluation to
determine scientific merit relative to other applications received in
response to this RFA (triage).  The NIH will withdraw from further
competition those applications judged non-competitive for award and
notify the applicant PI and the official signing for the applicant
organization.  Those applications judged to be competitive will be
further evaluated for scientific/technical merit by the usual peer
review procedures, including, if deemed appropriate, a reverse site
visit at the applicant's expense.  Secondary review of applications
will be conducted by the National Heart, Lung, and Blood Advisory
Council.

Review Criteria

The review group will assess the scientific merit of the study,
including:

o  The documentation of the need for improving hypertensive care in
this segment of the population, and the soundness of the rationale for
the selection of the intervention methods.

o  Appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research, including appropriate
determination and discussion of the required sample size and adequate
recruitment plans in accordance with sample size estimate.

o  Qualifications and research experience of the PI and staff,
including:  administrative abilities of the PI and co-PIs; experience
of the key investigators in the area of the proposed research,
including experience in adequate recruitment of participants into
research projects; ability of investigators and other key personnel to
devote adequate time for proper conduct of the study, over the duration
of the study; representation of minority individuals among
investigators and staff.

o  Appropriateness of the proposed budget and duration in relation to
the proposed research.

Applicants must describe in their application the potential for
involvement with one or more community service organizations and the
potential for the transfer of ownership of the interventional program
to these organizations.  It is hoped that longevity of the program
beyond the funded period can be achieved in this manner.  Although the
actual transfer of ownership to these organizations is not a
requirement of the study, the potential for transfer will be carefully
addressed in the review of applications, and those applications without
such a description will be considered to be non-responsive to this RFA.

AWARD CRITERIA

Applications recommended by the National Heart, Lung, and Blood
Advisory Council will be considered for award based upon scientific and
technical merit (priority scores), programmatic priorities, and the
availability of funds.  The anticipated date of award is September 30,
1993.

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.

Direct inquiries regarding programmatic issues to:

P. Scott Allender, M.D.
Prevention and Demonstration Research Branch
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
Federal Building, Room 604
7550 Wisconsin Avenue
Bethesda, MD  20892
Telephone:  (301) 496-2465

Direct inquiries regarding fiscal matters to:

William W. Darby
Section Chief, Grants Operations Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Westwood Building, Room 4A11
Bethesda, MD  20892
Telephone:  (301) 496-7536

AUTHORITY AND REGULATIONS

This project is described in the Catalog of Federal Domestic Assistance
No. 93.837.  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 52 and 45 CFR Part 74.  This
project is not subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency review.