Full Text AI-95-007

NATIONAL COOPERATIVE INNER-CITY ASTHMA STUDY

NIH GUIDE, Volume 24, Number 4, February 3, 1995

RFA:  AI-95-007

P.T. 04

Keywords: 
  Asthma 
  Biomedical Research, Multidiscipl 
  Environmental Effects 


National Institute of Allergy and Infectious Diseases
National Institute of Environmental Health Science

Letter of Intent Receipt Date:  April 15, 1995
Application Receipt Date:  June 15, 1995

PURPOSE

The National Institute of Allergy and Infectious Diseases (NIAID) and
the National Institute of Environmental Health Sciences (NIEHS) of
the National Institutes of Health (NIH) invite applications from
institutions wishing to serve as Asthma Study Centers for the
National Cooperative Inner-City Asthma Study (NCICAS), as well as the
central Data Coordinating Center for all participating Asthma Study
Centers.  This cooperative, multi-center study seeks to reduce the
disproportionate burden of asthma morbidity among underserved, inner-
city children and adolescents from 4 to 12 years of age.
Underserved, inner-city populations are defined as those having low
socioeconomic status and residing in urban areas.  The goal of this
study is to design and evaluate an asthma intervention, based in
health care delivery settings, aimed at reducing asthma morbidity in
a cost-effective manner.  Health care delivery settings are defined
as medical clinics, hospital clinics, or emergency room clinics.

Because of the multifaceted nature of asthma, a broad-based approach
to the intervention is required.  The intervention will involve all
of the following elements:  improving asthma treatment by physicians,
increasing asthma self-management by asthmatics and their families,
and environmental interventions.  The specific components should be
derived from the experience and findings generated by the initial
NIAID-sponsored NCICAS, 1991-1996, existing asthma knowledge, pre-
existing asthma interventions or programs, and/or new innovative
approaches to this problem.

HEALTHY PEOPLE 2000

The Public Health Service 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 Request
for Applications (RFA), the National Cooperative Inner-City Asthma
Study, is related to the priority areas of environmental health,
diabetes and chronic disabling diseases, and age-related objectives
pertaining to children.  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 government, and
eligible agencies of the Federal government.  Foreign organizations
are not eligible to apply.  Domestic applications may not include
international components.  Racial/ethnic minority individuals, women,
and persons with disabilities are encouraged to apply as Principal
Investigators.

All applicants must apply to participate as an Asthma Study Center.
Applicants may also apply to participate as both an Asthma Study
Center and the central Data Coordinating Center.  Two separate
applications will be required from institutions applying for both an
Asthma Study Center and the central Data Coordinating Center,
including a specific plan for how the independent operation of each
unit will be maintained as required.

MECHANISM OF SUPPORT

The administrative and funding mechanism to be used to undertake this
program will be the Cooperative Agreement (U01), an "assistance"
mechanism, rather than an "acquisition" mechanism, in which
substantial NIH scientific and/or programmatic involvement with the
awardee is anticipated during the performance of the activity.  Under
the cooperative agreement, the NIH purpose is to support and/or
stimulate the recipient's activity by involvement in and otherwise
working jointly with the award recipient in a partner role, but it is
not to assume direction, prime responsibility, or a dominant role in
the activity.  Details of the responsibilities, relationships and
governance of a study funded under cooperative agreement(s) are
discussed under the section "Terms and Conditions of Award."

The total project period for applications submitted in response to
this RFA may not exceed five years.  At this time, the NIAID and the
NIEHS have not determined whether and how this solicitation will be
continued beyond the present RFA.

FUNDS AVAILABLE

The estimated total funds (direct and indirect) available for the
first year of support for awards under this RFA will be $2,250,000:
$1,500,000 from the NIAID and $750,000 from the NIEHS.  In Fiscal
Year 1996, the NIAID and the NIEHS plan to fund up to 7 new and/or
recompeting Asthma Study Centers, one of which will serve as the
central Data Coordinating Center.  Applications from institutions
wishing to participate as Asthma Study Centers should not request
first-year budgets in excess of $280,000 in total (direct and
indirect) costs.  Applications from institutions wishing to
participate as both an Asthma Study Center and the central Data
Coordinating Center should not request first-year budgets in excess
of $300,000 in total (direct and indirect) costs to support the
central Data Coordinating Center functions.  The NIH is currently
limiting annual inflationary increases to no more than four percent
for future years of awards.  The usual PHS policies governing grants
administration and management will apply.  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 plans of the NIAID and the NIEHS, awards pursuant to this
RFA are contingent upon the availability of funds for this purpose.
Funding beyond the first and subsequent years of the grant will be
contingent upon satisfactory progress during the preceding years and
availability of funds.

RESEARCH OBJECTIVES

Background

Asthma is one of the most common chronic diseases of childhood.  Data
from the 1990 U.S. National Health Interview Survey indicate that
nearly 3.7 million children, ages 17 years and less, suffer from
asthma -- 5.8 percent of the U.S. population.  Asthma morbidity and
mortality have increased in recent years.  Asthma prevalence
increased by 40 percent among children less than 18 years of age
during the 1980s, with African-American children having higher levels
of asthma than white children.  African-American children also
experienced almost double the rate of increase in asthma
hospitalization rates compared to white children during this time
period.  Little information on Latino children is available, but
recent studies have found that Latino children in New York have very
high levels of asthma prevalence and hospitalization.  Although
asthma deaths are still infrequent, mortality rates increased 6.2
percent per annum during the 1980s for 5 to 34 year olds; non-whites
are two to three times more likely than whites to die from asthma.

The economic costs of asthma are enormous despite its low mortality.
In 1990, the cost of asthma in the United States was estimated to be
$6.2 billion.  Despite the widespread assumption that asthma is a
mild illness, 43 percent of the cost was due to emergency room use,
hospitalization and death.

Most of the advances in asthma care during the 1960s and 1970s can be
attributed to the development of better drugs to treat this disease.
Despite the availability of these improved drugs, asthma is
undertreated in the United States.

Environmental factors play an important role in asthma.  Air
pollutants, such as nitrogen dioxide, ozone, sulfur dioxide, and
particulates from diesel exhaust have been associated with worsening
of asthma and higher levels of sensitization to allergens.  The
indoor environment has been the focus of interest, especially as
individuals spend the majority of their life indoors.  A wide variety
of elements in the indoor environment have been associated with
asthma, such as house dust mites, cockroach, cat, tobacco smoke and
nitrogen dioxide.

Many recent attempts at reducing asthma morbidity have focused on
educational strategies.  However, because of the multifaceted nature
of this disease, particularly among underserved children and
adolescents, a broad-based approach to intervention involving the
provider, the patient, and the environment will be required to
achieve a meaningful impact on disease burden.  In 1991, the NIAID
established the National Cooperative Inner-City Asthma Study, a two-
part, five-year study undertaken at eight sites in seven sites
nationwide.  The objective of NCICAS Phase I (1991-1994) was to
identify factors amenable to intervention that determine asthma
severity and morbidity among inner-city children, ages 4 to 9 years.
Preliminary results indicate that asthma morbidity is affected by
lack of access to medical care, poor self-management skills, and
environmental exposures.  NCICAS Phase II (1994-1996) involves an
intervention trial using an asthma counselor with a social work
background to modify these factors in order to reduce asthma
morbidity in these populations.  The protocols for NCICAS, 1991-1996,
Phases I and II will be available upon request from the NIAID program
contact listed under INQUIRIES.

Research Objectives and Scope

Study Design

This RFA solicits applications for a cooperative intervention study
for underserved urban asthmatic children and adolescents, ages 4 to
12 years.  Underserved urban populations are defined as those having
low socioeconomic status and residing in urban areas.

The objective of this cooperative study is to develop, implement, and
evaluate a culturally-appropriate, comprehensive, and cost-effective
intervention program aimed at reducing asthma morbidity by modifying
those potentially reversible factors shown to contribute to asthma
morbidity.  The final study design will consist of a consensus core
protocol with site-specific additions/modifications to address local
issues.  The core protocol will include all of the following
elements:  medical treatment for asthma delivered in a health care
facility, self-management by asthmatics and their families, and
indoor environmental interventions including studies to measure,
monitor and improve the indoor environment.  Although the major
environmental focus of this cooperative study is the indoor
environment, proposed protocols for innovative approaches may include
major outdoor environmental factors.  The core protocol may be
modified by the individual Asthma Study Centers to tailor the core
intervention to local populations, communities, or health care
facilities.

NOTE:  Although the actual protocol to be conducted will be designed
by the Steering Committee, applications must include a proposed
protocol that meets the objectives and scope of this RFA.

SPECIAL REQUIREMENTS

A.  Study Organization

1.  Steering Committee

A Steering Committee will be established to serve as the main
governing body of the study.  The Steering Committee will be composed
of the Principal Investigator (or his/her designee) from each Asthma
Study Center, one NIAID representative from the Office of
Epidemiology and Clinical Trials, Division of Allergy, Immunology and
Transplantation, hereafter designated the NIAID Study Coordinator,
and one NIEHS representative, hereafter designated as the NIEHS Study
Coordinator.  Principal Instigators must be physicians with
substantial experience in (1) asthma treatment, (2) asthma research,
and (3) the design, implementation and evaluation of asthma
intervention trials.  All major scientific decisions will be
determined by majority vote of the Steering Committee, with each
Principal Investigator, the NIAID Study Coordinator, and the NIEHS
Study Coordinator having one vote.  The Chairperson will be selected
by the Steering Committee from among the non-Federal members during
the first meeting of the Committee, to be convened by the NIAID and
the NIEHS Study Coordinators.  The Director of the central Data
Coordinating Center shall serve as a non-voting member of the
Steering Committee and shall participate in all Committee activities
in an advisory capacity.  The Steering Committee will meet at least
two times during the first 12 months of the study and at least
annually thereafter.  The Steering Committee will have primary
responsibility for:  developing the consensus core protocol;
approving site-specific modifications to the core protocol as
necessary to tailor the core intervention to local populations,
communities, or health care facilities; facilitating the conduct and
monitoring of the study; determining analyses to be performed using
the collective data base; interpreting study data; and reporting
study results.  The study will proceed into the implementation stage
only with the concurrence of the awardees, the NIAID Study
Coordinator, and the NIEHS Study Coordinator.  Each Principal
Investigator (or his/her designee) will be expected to participate in
all other Steering Committee activities, e.g., conference calls,
special subcommittees as may be necessary, etc.

Subcommittees of the Steering Committee may be established as
necessary.

2.  Data and Safety Monitoring Board

An independent Data and Safety Monitoring Board, to be appointed by
the NIAID and the NIEHS Study Coordinators with approval of the
Steering Committee, will review progress at least annually and report
to the NIAID and the NIEHS Study Coordinators.  Protocols will be
subject to review by the Data and Safety Monitoring Board in an
advisory capacity.

3.  Data Coordination, Management and Analysis

Each Asthma Study Center will be responsible for:  collecting all
site-specific data for the consensus core protocol; submitting all
such data to the Data Coordinating Center; and adhering to the
policies and procedures established by the Steering Committee with
respect to standardized data collection, data management, and
protocol implementation and compliance.  Applications for Asthma
Study Centers should include in their budget requests support for all
of these functions.

The Data Coordinating Center will have primary responsibility for:
the acquisition or creation of forms and/or materials for protocol
implementation; quality control; uniformity of data collection;
overseeing implementation of and adherence to the consensus core
protocol; and storing, managing and analyzing data generated from the
consensus core protocol.  Specific analyses of the collective data
base to be carried out by the Data Coordinating Center will be
approved by the Steering Committee and the results of those analyses
will be delivered to the Steering Committee as the group responsible
for reviewing and approving the use and dissemination of study
findings.  The Data Coordinating Center will also be responsible for
providing reports, at least annually, to the Steering Committee and,
when appropriate, to the Data and Safety Monitory Board, concerning
any and all of the above responsibilities, and for the planning and
logistical arrangements of meetings of the Steering Committee and its
subcommittees.  Applications for the central Data Coordinating Center
should include in their budget requests support for all of these
functions.

B.  Terms and Conditions of Award

The following terms and conditions will be incorporated into the
award statement and provided to the Principal Investigator as well as
the institutional official at the time of award.

These special 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 92, and other HHS,
PHS, and NIH Grant Administration policy statements.

The administrative and funding instrument used for this program is
the cooperative agreement (U01), an "assistance" mechanism (rather
than an "acquisition" mechanism), in which substantial NIH scientific
and/or programmatic involvement with the awardee is anticipated
during the performance of the activity.  Under the cooperative
agreement, the NIH purpose is to support and/or stimulate the
recipient's activity by involvement in and otherwise working jointly
with the award recipient in a partner role, but it is not to assume
direction, prime responsibility, or a dominant role in the activity.
Consistent with this concept, the dominant role and prime
responsibility for the activity resides with the awardees for the
project as a whole, although specific tasks and activities in
carrying out the study will be shared among the awardees, the NIAID
Study Coordinator, and the NIEHS Study Coordinator.

1.  Awardee Rights and Responsibilities

Awardees will have primary responsibility for defining the details
for the project within the guidelines of the RFA and for performing
the scientific activity, and agree to accept close coordination,
cooperation, and participation of the NIAID and the NIEHS Study
Coordinators in all aspects of the scientific and technical
management of the project.  Specifically, awardees have primary
responsibilities as described below.

Steering Committee Membership and Meeting Attendance

Each Principal Investigator (or his/her designee) will serve as a
voting member of the Steering Committee and will participate in all
scientific decisions.  Each Principal Investigator (or his/her
designee) will be responsible for attending all Steering Committee
meetings, including not less than two meetings during the first 12
months of the study and one per year thereafter.  The Steering
Committee shall be responsible for determining the frequency of
meetings and scheduling the time and location.  Each Principal
Investigator (or his/her designee) will be expected to participate in
all other Steering Committee activities, e.g., conference calls,
special subcommittees as may be necessary, etc.

Subcommittees of the Steering Committee may be established as
necessary.

The Director of the Data Coordinating Center shall serve as a non-
voting member of the Steering Committee and shall participate in all
Steering Committee activities in an advisory capacity.

Protocol Development and Conduct

The Steering Committee will define the core protocol objectives and
approaches within the areas of health care delivery, asthma self-
management, and environmental controls.  The Steering Committee will
design the consensus core protocol and approve the site-specific
additions to address local issues.  With Steering Committee approval,
the core protocol may be modified by the individual sites as
necessary to tailor the core intervention to local populations,
communities, or health care facilities.  Each awardee will follow the
procedures required by the Steering Committee regarding study conduct
and monitoring, patient management, data collection, quality control,
data analysis, and data presentation and publication.

Data Coordination, Management and Analysis

Each awardee will be responsible for:  collecting all primary, site-
specific study data; providing all such data to the Data Coordinating
Center; and adhering to the policies and procedures established by
the Steering Committee with respect to standardized data collection,
quality and analysis, and protocol implementation and adherence.  All
data will be available to all awardees.  The awardees will retain
custody of and have primary rights to all data developed under these
awards, subject to Government rights of access consistent with HHS,
PHS, and NIH policies.

Publication and Presentation of Study Findings

Early publication of major findings is encouraged.  Publications and
oral presentations of work performed under this agreement will
require appropriate acknowledgement of the Asthma Study Centers,
NIAID and NIEHS support.  Analyses to be performed using the
collective data from all Asthma Study Centers will be directed and
coordinated by the Steering Committee.  Asthma Study Centers
performing analyses of local data will be subject to Steering
Committee review and approval in order to avoid duplication.  Review
and approval by the Steering Committee will be required for all
analyses prior to publication or presentation according to criteria
that will be developed by the Steering Committee.

Monitoring Study Progress

The Steering Committee will establish mechanisms for assessing
performance of the Asthma Study Centers, with particular attention to
accrual of adequate numbers of eligible patients, timely submission
and quality of required data, and conscientious observance of
protocol requirements.

Federally Mandated Regulatory Requirements

Each Asthma Study Center is required to meet the DHHS/PHS regulations
for the protection of human subjects and FDA requirements for the
conduct of research using investigational agents.  At a minimum,
these include:

o  methods for assuring that each institution at which Asthma Study
Center investigators are conducting clinical studies has a current,
approved assurance on file with the Office of Protection from
Research Risks (OPRR); that study protocols are reviewed and approved
by the responsible Institutional Review Board (IRB) prior to patient
entry; that active protocols are reviewed at least annually by the
IRB; and that amendments are approved by the IRB.

o  methods for assuring or documenting that each patient, or
patient's parent/legal guardian, gives fully informed consent to
participation in a research protocol prior to the initiation of the
experimental intervention.

2.  NIAID and NIEHS Staff Responsibilities

The NIAID and the NIEHS Study Coordinators will have substantial
scientific/programmatic involvement during the conduct of this
activity through technical assistance, advice and coordination above
and beyond normal program stewardship for grants, as described below.

Steering Committee Membership and Meeting Attendance

The NIAID and the NIEHS Study Coordinators will serve as voting
members of the Steering Committee, will attend all Steering Committee
meetings, and will participate in other Committee activities, e.g.,
conference calls, special subcommittees.

Protocol Development

As members of the Steering Committee, the NIAID and the NIEHS Study
Coordinators will serve as resources with respect to the design of
the protocol and will assist the Steering Committee in protocol
development.  The NIAID Study Coordinator will provide all protocols
and available data from NCICAS, 1991-1996, for development of the
core consensus protocol.

Study Materials

The individual Asthma Study Centers will be responsible for the
acquisition of study materials required by the protocol.  The NIAID
and the NIEHS Study Coordinators will arrange for the appropriate
approvals (when necessary) from the Food and Drug Administration
(FDA) and the Bureau of Biologics (BOB) with respect to the use of
investigational drugs.

Monitoring Study Performance

The NIAID and the NIEHS Study Coordinators will provide assistance to
the Steering Committee in the development of mechanisms and
procedures for monitoring study performance.  This includes
participation in periodic on-site monitoring with respect to
compliance with protocol specifications, quality control and accuracy
of data recording, and patient accrual.

Data Coordination and Management

Under the direction of the Steering Committee, the NIAID and the
NIEHS Study Coordinators will provide technical guidance on data
management to the Asthma Study Centers with respect to quality
control, uniformity of data collection, management of the collective
data base, and data analysis.

The Government, via the NIAID and the NIEHS Study Coordinators, will
have access to data generated under this Cooperative Agreement and
may periodically review the data and progress reports.  Information
obtained from the data may be used by the NIAID and the NIEHS Study
Coordinators for the preparation of internal reports on the
activities of the study.  However, awardees will retain custody of
and have primary rights to all data developed under these awards.

Publication and Presentation of Study Findings

The NIAID and the NIEHS Study Coordinators may contribute, through
review, comment, analyses, and/or co-authorship, to reporting results
of the study to the investigator community and other interested
scientific and lay organizations.  Co-authorship by the NIAID and the
NIEHS Study Coordinators will be subject to approval in accordance
with NIH policies regarding staff authorship of publications
resulting from extramural awards.

Organizational Changes

Certain organizational changes require the prior written approval of
the NIAID and the NIEHS Study Coordinators.  These changes include
the addition/deletion of a physician, scientific investigator,
affiliate, component, or research base that is associated with this
study.  A change in the Principal Investigator, or in any key
personnel identified on the Notice of Award, must have the prior
written approval of the NIAID and NIEHS Grants Management Specialists
in consultation with the NIAID and the NIEHS Study Coordinators.

Program Review

The NIAID and the NIEHS Study Coordinators will review the progress
of each Asthma Study Center through consideration of annual reports,
site visits, patient logs, etc.  This review may include, but is not
limited to, compliance with the study protocol, meeting patient
enrollment targets, adherence to uniform data collection procedures,
and the timeliness and quality of data reporting.

The NIAID and the NIEHS Study Coordinators reserve the right to
terminate or curtail the study (or any individual award) in the event
of (a) substantial shortfall in participant recruitment, follow-up,
data reporting, quality control, or other major breech of the
protocol, (b) substantive changes in the agreed-upon protocol to
which the NIAID and the NIEHS Study Coordinators do not agree, (c)
reaching a major study endpoint substantially before schedule with
persuasive statistical significance, or (d) human subject ethical
issues that may dictate a premature termination.

3.  Collaborative Responsibilities

A Steering Committee, composed of the Principal Investigators, the
NIAID Study Coordinator, and the NIEHS Study Coordinator will be the
main governing body of the study and will have primary responsibility
for all scientific decisions, including:  developing the consensus
core protocol; approving site-specific modifications to the core
protocol as necessary to tailor the core intervention to local
populations, communities, or health care facilities; coordination of
the site-specific protocol additions; facilitating the conduct and
monitoring of the study; coordination and oversight of the
development of data collection, management and quality control
procedures; establishing procedures for assessing performance with
respect to accrual, quality of data, and conscientious observance of
protocol requirements; and coordinating and overseeing the analysis,
interpretation, and publication of study data.  Each member of the
Steering Committee will have one vote.  The Chairperson will be
selected by the Steering Committee from among the non-Federal
members.  Subcommittees will be established by the Steering Committee
as it deems appropriate.

An independent Data and Safety Monitoring Board, to be appointed by
the NIAID and the NIEHS Study Coordinators with Steering Committee
approval, will review progress at least annually and report to the
NIAID and the NIEHS Study Coordinators.  The protocol will be subject
to review by this Board in an advisory capacity.

Awardees will be required to accept and implement the consensus core
protocol and procedures approved by the Steering Committee.  The
study will proceed into the implementation stage only with the
concurrence of the awardees, the NIAID Study Coordinator, and the
NIEHS Study Coordinator.

4.  Arbitration

Any disagreement that may arise on scientific/programmatic matters
(within the scope of the award) between award recipients, the NIAID
Study Coordinator, and the NIEHS Study Coordinator may be brought to
arbitration.  An arbitration panel will be composed of three members
-- one selected by the Steering Committee (with the NIAID and the
NIEHS Study Coordinators not voting) or by the individual awardee in
the event of an individual disagreement, a second member selected by
the NIAID and the NIEHS Study Coordinators, and the third member
selected by the two prior members.  This special arbitration
procedure in no way affects the awardee's rights to appeal an adverse
action that is otherwise appealable in accordance with the PHS
regulations at 42 CFR part 50, subpart D and HHS regulation at 45 CFR
part 16.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS

The study population for this RFA is limited to underserved, inner-
city children from 4 to 12 years of age.  Within this population, NIH
requirements for inclusion of women and minorities in study
populations apply.

It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH-supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations) which
have been in effect since 1990.  The new policy contains some new
provisions that are substantially different from the 1990 policies.

All investigators proposing research involving human subjects should
read the "NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research," which has been published in the
Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted
in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume
23, Number 11.

Investigators may obtain copies from these sources or from the
program staff or contact person listed below.  Program staff may also
provide additional relevant information concerning the policy.

LETTER OF INTENT

Prospective applicants are asked to submit by, April 15, 1995, a
letter of intent that includes a descriptive title of the overall
proposed research, the name, address and telephone number of the
Principal Investigator, the number and title of this RFA, and a list
of the key investigators and their institution(s).  Although the
letter of intent is not required, is not binding, does not commit the
sender to submit an application, and does not enter into the review
of subsequent applications, the information that it contains allows
the NIAID and the NIEHS staff to estimate the potential review
workload and to avoid conflict of interest in the review.  The letter
of intent is to be sent to Dr. Paula Strickland at the address listed
under INQUIRIES.

APPLICATION PROCEDURES

Applications are to be submitted on the standard research grant
application form PHS 398 (rev. 9/91).  These application forms may be
obtained from the institution's office of sponsored research or its
equivalent  and from the Office of Grants Information, Division of
Research Grants, National Institutes of Health, 5333 Westbard Avenue,
Room 449, Bethesda, MD 20892, telephone (301) 435-0714.  For purposes
of identification and processing, item 2a on the face page of the
application must be marked "YES" and the RFA number and the words
"NATIONAL COOPERATIVE INNER CITY ASTHMA STUDY" must be typed in.

Applications must address the requirements below.

For Asthma Study Centers:

1.  Applications should include a proposed protocol that meets the
objectives and scope of this RFA, as well as a discussion of the
rationale for the patient population, the study design and the
intervention strategy selected for study, timeline for completion of
the study, and an assessment of how anticipated study results can be
expected to contribute to improvements in asthma morbidity among
underserved urban children and adolescents with asthma.

2.  The applicant institution must document its experience and
capacity to recruit and retain study participants, provide a
description of the population currently available for the proposed
protocol, and describe proposed mechanisms for monitoring accrual
performance and criteria for continued participation.

3.  Applications must name a single Principal Investigator (PI) who
will have scientific responsibility for the application as a whole
including all Asthma Study Center-related research activities
included under it.  The PI must be a physician with substantial
experience in (1) asthma treatment; (2) asthma research; and (3) the
design, implementation and evaluation of asthma intervention trials.

4.  Applications must name a Project Coordinator who is an individual
with substantial technical/administrative experience in managing
patient enrollment, patient follow-up, and multi-source data
collection for intervention trials.

5.  Applications must provide:  a clear, concise plan in narrative
and diagrammatic form that depicts the interrelationships among the
members of the Asthma Study Center, their relevant
experience/expertise, and the contribution of each to fulfillment of
the objectives of this RFA; an organizational chart of the Asthma
Study Center showing the name, organization, and scientific
discipline of the PI and of all key scientific, technical and
administrative personnel; and a mechanism for selecting and replacing
key professional or technical personnel.

6.  Applications must provide a plan to assure the maintenance of
close cooperation and effective communication among members of the
Asthma Study Center.

7.  Applications should discuss the capability of the applicant
organization to participate and interact effectively in a
cooperative, multi-center asthma intervention trial.

8.  Applications must include a written commitment to accept the
participation and assistance of the NIAID and NIEHS Study
Coordinators in accordance with the guidelines outlined under "Terms
and Conditions of Award:  NIAID and NIEHS Staff Responsibilities."
The application must also include a written commitment to the
cooperative organization and willingness to serve on the Steering
Committee and adhere to the decisions reached by that Committee,
including following the consensus core protocol.

9.  All costs required for the proposed protocol must be included in
the application and must be fully justified.  These include the
additional costs of clinical research associated with the proposed
protocol, costs for patient recruitment and follow-up, laboratory
studies, materials or forms required by the protocol, data collection
and management, and participation in on-site quality assurance
audits.  Requested budgets should also include: (1) travel to the
Washington, DC area for two 2-day Steering Committee meetings during
the first 12 months of the study and annual Steering Committee
meetings thereafter for the Principal Investigator.

For the Data Coordinating Center:

1.  Applications must provide documentation of the specific
competence and previous experience of professional, technical and
administrative staff pertinent to the operation of a Data
Coordinating Center for a multi-center, cooperative clinical
intervention, including prior experience in similar or related
studies with respect to the collection, management and analysis of
data from multiple sites and experience in monitoring the quality and
timeliness of such data.

2.  Applications must include a proposed plan for data management,
quality assurance and analysis, as well as proposed methods for
monitoring protocol implementation and adherence in similar and/or
related projects.

3.  Applications must describe the adequacy of the proposed facility,
technical hardware, and space.

4.  Applications must provide evidence of the degree of commitment
and support of the institution for the proposed program, including
the relative position of the proposed project staff within the
applicant organization's structure.

It is highly recommended that the Director of the Office of
Epidemiology and Clinical Trials, NIAID Division of Allergy,
Immunology and Transplantation or the Program Administrator, Organs
and Systems Toxicology Branch, NIEHS Division of Extramural Research
and Training, be contacted in the early stages of preparation of the
application.  (See program contacts listed under INQUIRIES.)

Applications must be received by June 15, 1995.

Applications that do not conform to the instructions contained in PHS
398 (rev. 9/91) application kit will be judged nonresponsive and will
be returned to the applicant.

The RFA label available in the 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 review.

Applications received after the receipt date will be returned without
review.  The Division of Research Grants (DRG) will not accept any
application in response to this RFA that is essentially the same as
one currently pending initial review, unless the applicant withdraws
the pending application.  This does not exclude the submission of
substantial revisions of an application already reviewed.  These
applications must, however, include an introduction addressing the
previous critique.

Submit a signed, typewritten original of the application, including
the checklist, and three signed, exact, single-spaced 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 exact copies of the grant
application and all five sets of appendix material must also be sent
to Dr. Paula Strickland at the address listed under INQUIRIES.

Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research
Resources may wish to identify the GCRC as a resource for conducting
the proposed research.  If so, a letter of agreement from either the
GCRC program director or principal investigator could be included
with the application.

REVIEW CONSIDERATIONS

Review Procedures

Upon receipt, applications will be reviewed for completeness by the
DRG and for responsiveness by NIAID and NIEHS staff.  Incomplete and
non-responsive applications will be returned to the applicant without
further consideration.

Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by the NIAID in accordance with the review
criteria stated below.  As part of the initial merit review, a
process (triage) may be used by the initial review group in which
applications will be determined to be competitive or non- competitive
based on their scientific merit relative to other applications
received in response to the RFA.  Applications judged to be
competitive will be discussed and be assigned a priority score.
Applications determined to be non-competitive will be withdrawn from
further consideration and the principal investigator and the official
signing for the applicant organization will be promptly notified.
The second level of review will be provided by the NIAID and NIEHS
Advisory Councils.

Review Criteria

Applicants are expected to address the requirements identified under
APPLICATION PROCEDURES.  The review criteria for applications in
response to this RFA are:

o  scientific, technical, or medical significance and originality of
proposed research;

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

o  qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the
area of the proposed research;

o  availability of the resources necessary to perform the research;

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

o  adequacy of plans to include both genders and minorities and their
subgroups as appropriate for the scientific goals of the research.
Plans for the recruitment and retention of subjects will also be
evaluated.

The initial review group will also examine the provisions for the
protection of human and animal subjects and the safety of the
research environment.

AWARD CRITERIA

Funding decisions will be made on the basis of scientific and
technical merit as determined by peer review, program needs and
balance, and the availability of funds.

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:

Peter J. Gergen, M.D.,M.P.H.
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4A29
6003 Executive Boulevard - MSC 7640
Bethesda, MD  20892-7640
Telephone:  (301) 496-0982
FAX:  (301) 402-2571
Email:  pg17q@nih.gov

George S. Malindzak, Jr., Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
104 T. W. Alexander Drive
Research Triangle Park, NC  27709
Telephone:  (919) 541-3289
FAX:  (919) 541-2843
Email:  gm26f@nih.gov

Direct inquiries regarding review issues, address the letter of
intent to, and mail two copies of the application and all five sets
of appendices to:

Paula Strickland, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4C02
6003 Executive Boulevard - MSC 7610
Bethesda, MD  20892-7610
Telephone:  (301) 402-0643
FAX:  (301) 402-2638
Email:  ps30f@nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Linda M. Shaw
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4C23
6003 Executive Boulevard - MSC 7610
Bethesda, MD  20892-7610
Telephone:  (301) 496-7075
FAX:  (301) 480-3780
Email:  ls15k@nih.gov

Schedule

Letter of Intent Receipt Date:  April 15, 1995
Application Receipt Date:       June 15, 1995
Scientific Review Date:         October 1995
Advisory Council Date:          January 1996
Earliest Award Date:            April 1996

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance N0. 93.855, 93.113 and 93.115.  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, 43 USC 241 and
285) and administered under PHS grant policies and Federal
Regulations 42 CFR 52 and 45 CFR Part 74.  This program is not
subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant recipients to provide a smoke-
free work place and promote the nonuse of all tobacco products.  This
is consistent with the PHS mission to protect and advance the
physical and mental health of the American people.

.

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