NOCTURNAL ASTHMA, CHRONOBIOLOGY AND SLEEP

Release Date:  January 20, 1999

RFA:  HL-99-011

P.T.

National Heart, Lung, and Blood Institute

Letter of Intent Receipt Date:  April 12, 1999
Application Receipt Date:  June 16, 1999

THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  THIS RFA INCLUDES
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE FOLLOWED
WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA.

PURPOSE

The National Heart, Lung, and Blood Institute (NHLBI) invites research grant
applications to conduct studies on the pathogenesis of nocturnal asthma and the
role of circadian rhythm and/or sleep/sleep disturbances in this disease process.
The overall goal of this program is to establish the cellular and molecular
mechanisms which underlie the chronobiology of nocturnal exacerbations of asthma
and airway inflammation, as well as the role played by sleep/sleep disturbances. 
Toward this goal, this initiative strongly encourages scientific collaborations
among investigators with interest in asthma, chronobiology, sleep medicine,
immunology, physiology, and neurophysiology.

Among the disciplines and expertise that are appropriate for this research
program are molecular biology, cell biology, immunology, biochemistry, allergy,
asthma, chronobiology, sleep medicine, neurophysiology, genetics, pulmonary
medicine, and pulmonary physiology.

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 Request for Applications (RFA),
Nocturnal Asthma, Chronobiology and Sleep, is related to one or more of the
priority areas.  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 202-512-1800) or at
http://www.crisny.org/health/us/health7.html.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign, for-profit and non-profit
organizations, public and private, such as universities, colleges, hospitals,
laboratories, units of State or local governments, and eligible agencies of the
Federal government.  Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as Principal Investigators.

All current policies and requirements that govern the research grant programs of
the National Institutes of Health (NIH) will apply to grants awarded under this
RFA.  Awards under this RFA to foreign institutions will be made only for
research of very unusual merit, need, and promise, and in accordance with PHS
policy governing such awards.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) research project grant
(R01) award mechanism.  However, specific application instructions have been
modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being
examined by the NIH.  The modular grant concept establishes specific modules in
which direct costs may be requested as well as a maximum level for requested
budgets.  Only limited budgetary information is required under this approach. 
The just-in-time concept allows applicants to submit certain information only
when there is a possibility for an award.  It is anticipated that these changes
will reduce the administrative burden for the applicants, reviewers and Institute
staff.

For this RFA, funds must be requested in $25,000 direct cost modules and a
maximum of 9 modules ($225,000 direct costs) per year may be requested.  A
feature of the modular grant concept is that no escalation is provided for future
years, and all anticipated expenses for all years of the project must be included
within the number of modules being requested.  Only limited budget information
will be required and any budget adjustments made by the Initial Review Group will
be in modules of $25,000.  Instructions for completing the Biographical Sketch
have also been modified.  In addition, Other Support information and the
application Checklist page are not required as part of the initial application. 
If there is a possibility for an award, necessary budget, Other Support and
Checklist information will be requested by NHLBI staff following the initial
review.  The APPLICATION PROCEDURES section of this RFA provides specific details
of modifications to standard PHS 398 application kit instructions. 
Responsibility for the planning, direction, and execution of the proposed project
will be solely that of the applicant.  Administrative adjustments in project
period and/or amount may be required at the time of the award.

This RFA is a one-time solicitation.  Future unsolicited competing continuation
applications will compete with all investigator-initiated applications and be
reviewed according to the customary peer review procedures.  The anticipated
award date is April 1, 2000.

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 either from the GCRC program director or principal investigator should
be included with the application.

FUNDS AVAILABLE

The NHLBI intends to commit approximately $2,100,000 total costs in fiscal year
2000 for the first year of support of this initiative.  Award of grants pursuant
to this RFA is contingent upon receipt of such funds for this purpose.  It is
anticipated that approximately 5 to 6 new grants will be awarded under this
program.  Applicants may request up to 4 years of support.  The specific number
to be funded will, however, depend on the merit and scope of the application
received and on the availability of funds.  Direct costs will be awarded in
modules of  $25,000, less any overlap or other necessary administrative
adjustments.  Facilities and administrative (indirect) costs will be awarded
based on the negotiated rates.

Although not co-sponsoring this RFA, other Institutes have an interest in the
research area discussed in this RFA.  Applications submitted to and not selected
for funding by the NHLBI in response to this RFA may be considered for funding
by the National Institute of Nursing Research, according to referral guidelines.

RESEARCH OBJECTIVES

Background

Asthma is characterized by increased bronchial responsiveness, airway
inflammation and episodic airway obstruction.  Nocturnal asthma  is a variable
exacerbation of the asthmatic condition occurring at night.  Nocturnal asthma is
associated with increases in symptoms, worsening of lung function, and a greater
need for medication.  The onset of nocturnal asthmatic attacks are less common
in the first part of the night, eighty per cent of asthmatic ventilatory arrests
occur between midnight and 8 a.m., and deaths from asthma are more common during
these hours.  In one study of asthma mortality, 79 percent of the patients who
died had a sleep disturbance (arousal) prior to the terminal event.  Also,
circadian (day-night) variation in the intensity and frequency of late asthmatic
responses to antigen have been observed, suggesting an enhancement in those
events which regulate airway inflammation at night.  The changes in asthma
severity are believed to relate to sleep and/or circadian events that regulate
airway inflammation..

The  regulation of sleep involves complex cascades of biochemical events within
the brain which are, in part, analogous to events involved in immune cell
regulation. Evidence is accumulating that sleep regulation may share some of the
inflammatory and immune events seen in asthma that are under circadian
regulation.  The consequences of circadian regulation have been shown to
exaggerate other diseases and are likely to play a role in the pathogenesis of 
asthma. However, the roles of circadian rhythm and sleep regulation in asthma are
unclear.  Studies have not been conducted using paradigms such as "constant
routine" or "forced desynchrony" to allow characterization of the relative role
of circadian versus sleep factors in asthma.  Other limited data suggests that
both systems may play a role in these processes.

This RFA seeks to encourage research designed to elucidate the cellular and
molecular mechanisms underlying nocturnal asthma and its relationship with sleep
and circadian events.

Some research topics and issues that will be responsive to this program are
listed below.  These are only examples; applicants are encouraged to propose
other topics that address the overall goals of this initiative.

o  Genetic regulation of nocturnal asthma is poorly understood.  Not all
individuals experience nighttime episodes of asthma.  Who is susceptible for
developing nocturnal asthma?  Does it represent a more severe degree of "usual"
asthma, or does it represent a distinct entity?

o  Inflammatory and immune events are now recognized as critical factors in the
pathophysiology of asthma.  What roles do inflammatory and immune events play in
nocturnal asthma?  Are the factors which produce, amplify, control and resolve
inflammation regulated differently in nocturnal asthma?  Are there differences
in the cellular components (i.e., eosinophils, neutrophils, lymphocytes,
macrophages, basophils), or their locations (i.e., airspace, bronchial mucosa,
pulmonary tissue, or blood), which differentiate nocturnal asthma from other
variants?  Is nocturnal asthma a unique manifestation of inflammation, either in
timing or character?  Which inflammatory cells and mediators are most important
in nocturnal asthma, and how can they be blocked most effectively?  What are the
specific biochemical markers which best reflect the inflammatory process in
nocturnal asthma?  What causes the increased allergen-related airway
responsiveness at night?  What are the mechanisms by which changes in
inflammatory and immune function lead to airway hyperresponsiveness and
obstruction in nocturnal asthma?

o  The level of airway inflammation as well as immune function vary with clock
time.  How are the immune and inflammatory processes turned on and off over the
24hr cycle?  Are these changes in the inflammatory-immune system controlled by
circadian events and/or the sleep/wake cycle?  Studies are needed to separate the
effect of circadian rhythm from sleep homeostasis on the immunology of the lung
and lung function.

o  The "clock" gene which regulates chronobiologic phenomena has recently been
identified.  What are the mechanisms by which the central biologic "clock" and
other possible genes interface with and control the  immune-inflammatory cascade
in nocturnal asthma?  What are the circadian patterns of inflammatory regulatory
cytokines, the source of these cytokines (brain or other areas), and the targets
of these events?  Is target susceptibility affected by the time of day versus
sleep?

o  Are the circadian rhythms of proinflammatory cytokines in the brain affected
by the occurrence of nocturnal asthma?  Do central levels of proinflammatory
cytokines alter lung physiology and pathology?  Proinflammatory cytokines, such
as interleukin-1 and tumor necrosis factor alpha, are involved in the physiologic
regulation of  non-rapid eye movement sleep.  They also play a role in asthma. 
Do sleep pathologies result in altered central proinflammatory cytokine
production and/or affect the severity of asthma?  What other physiologic changes
directly attributable to sleep/sleep pathologies promote the worsening of
nocturnal asthma?  What are the mechanisms involved?

o  It has been demonstrated that sleep promotes nocturnal increases in upper
airway resistance similar to those in patients with nocturnal asthma.  Sleep also
leads to reductions in the volume of hyperinflated lungs in such patients.  Are
these effects mediated through a sleep-associated reduction in inspiratory muscle
tone, a decrease in pulmonary compliance, a combination of both, or an alteration
in events regulating airway inflammation?  Also, how do sleep, time of day, or
the synergism between these two parameters contribute to the development of
airway inflammation and asthma?

o  Nitric oxide seems to be involved in the central somnogenic actions of
cytokines, growth factor releasing hormone, and adenosine.  Nitric oxide may also
be involved in asthma.  Are the molecular events involved in these phenomena
similar?  For example, is the production of inducible nitric oxide synthetase
necessary for sleep and/or nocturnal asthma?

o  It is important to understand how the circadian rhythm of endogenous
catecholamines and cortisol differ in persons with and without nocturnal asthma. 
What roles do endogenous and exogenous glucocorticoids, other hormones and
neurohumoral mechanisms play in nocturnal asthma, and how do sleep disruptions
due to asthma and/or asthma treatment affect the circadian rhythm of endogenous
hormones?

o  Understanding rhythm dependency of medications (chronopharmacology) and
knowing how to synchronize medications is essential for rational management of
nocturnal asthma.  This has already been shown with several asthma medications
such as theophylline and corticosteroids. As newer drugs (such as leukotriene
active drugs and others) for the treatment of asthma emerge, there is a need to
explore their effectiveness in the treatment of nocturnal asthma.  Do these
medications improve nighttime symptoms, lung function, and decrease inflammation? 
What are the mechanisms of action of these drugs in relation to circadian
patterns or sleep?  Do they work by modifying the normal circadian rhythms of
endogenous hormones, inflammatory cells and mediators, or through some other
mechanism?

THESE ARE EXAMPLES ONLY.  INVESTIGATORS SHOULD NOT FEEL LIMITED TO THE SUBJECTS
MENTIONED ABOVE AND ARE ENCOURAGED TO SUBMIT OTHER TOPICS PERTINENT TO THE
OBJECTIVES OF THE RFA.

SPECIAL REQUIREMENTS

Applications that propose descriptive studies and do not contain hypothesis
driven studies directed at understanding the mechanisms associated with nocturnal
asthma and its relationship with sleep and/or circadian rhythms will not be
responsive to the RFA.  The principal focus of  applications should be on human
studies.  Applicants who propose to test hypotheses in animal or in vitro models
must demonstrate relevance to nocturnal asthma and its relationship with sleep
and/or circadian rhythms in humans.  Studies directed solely at sleep-related
and/or circadian events, without relevance to nocturnal asthma, will not be
responsive to this initiative.  Multidisciplinary investigations bringing
together investigators with expertise in asthma, immunology, sleep, and
chronobiology are strongly encouraged.  Large clinical studies or epidemiologic
studies are not within the scope of this RFA.

Upon initiation of the program, the NHLBI will sponsor periodic meetings to
encourage exchange of information among investigators who participate in this
program.  Travel funds for a one day meeting each year, most likely to be held
in Bethesda, Maryland, should be included in the modules.  Applicants should also
include a statement in their application indicating their willingness to
participate in these meetings.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

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
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public
Law 103-43).

All investigators proposing research involving human subjects should follow the
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research", which have been published in the Federal Register of March 28, 1994
(FR 59 14508-14513), and in the NIH GUIDE FOR GRANTS AND CONTRACTS, Volume 23,
Number 11, March 18, 1994, available on the web at:
https://grants.nih.gov/grants/guide/notice-files/not94-105.html.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there are scientific and ethical reasons not to include them.  This
policy applies to all initial (Type 1) applications submitted for receipt dates
after October 1, 1998.

All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects" that was published in the NIH Guide for Grants
and Contracts, March 6, 1998, and is available at the following URL address:
https://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators also may obtain copies of these policies from the program staff
listed under INQUIRIES.  Program staff may also provide additional relevant
information concerning the policy.

LETTER OF INTENT

Prospective applicants are asked to submit 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 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 allows NHLBI 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 the program staff listed under INQUIRIES
by the letter of intent receipt date listed in the heading of this RFA.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used in applying
for these grants, with the modifications noted below.  These forms are available
at most institutional offices of sponsored research and from the Division of
Extramural Outreach and Information Resources, National Institutes of Health,
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267,
email: GrantsInfo@nih.gov and on the Internet at https://grants.nih.gov/grants/forms.htm.  
Sample budgets and justification page will be provided upon request or following 
the submission of a letter of intent.

The RFA label found in the PHS 398 (rev. 4/98) application form 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 (Nocturnal
Asthma, Chronobiology and Sleep) and number (HL-99-011) must be typed on line 2
of the face page of the application form and the YES box must be marked.

BUDGET INSTRUCTIONS

The total direct costs must be requested in accordance with the program
guidelines and the modifications made to the standard PHS 398 application
instructions described below:

o  FACE PAGE
As a reminder, Items 7 should be completed to indicated Modular Direct Costs
requested and Items 8 should reflect Total Costs (Modular Direct plus F&A costs).

o  DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD
Do not complete Form Page 4-DD of the PHS 398 (rev 4/98).  It is not required nor
will it be accepted at the time of application.

o  BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT
Do not complete the categorical budget tables on page 5-EE of the PHS 398 (rev.
4/98) Form.  Only the requested total direct costs line for each year should be
completed based on the number of $25,000 modules being requested.  Applicants may
not request a change in the amount of each module.  A maximum of 9 modules
($225,000 direct cost) per year may be requested for each R01 application. 
Applicants may request for up to four years of support for this RFA.  Direct cost
budgets will remain constant throughout the life of the project (i.e., the same
number of modules requested for all budget periods).  Any necessary escalation
should be considered when determining the number of modules to be requested. 
However, in the event that the number of modules requested must change in any
future year due to the nature of the research proposed, appropriate justification 
must be provided.  Total Direct Costs for the Entire Proposed Project Period
should be shown in the box provided.

o  BUDGET JUSTIFICATION

- Budget justifications should be provided under "Justifications" on Form Page
5-EE of the PHS 398.
- List the names, role on the project and proposed percent effort for all project
personnel (salaried or unsalaried)and provide a narrative justification for each
person based on his/her role on the project.
- Identify all consultants by name and organizational affiliation and describe
the services to be performed.
- Provide a general narrative justification for individual categories (equipment,
supplies, etc.) required to complete the work proposed.  More detailed
justifications should be provided for high cost items.  Any large one-time
purchases, such as large equipment requests, must be accommodated within these
limits.  No specific costs for items or categories should be shown.

o  CONSORTIUM/CONTRACTUAL COSTS

If collaborations or subcontracts are involved that require transfer of funds
from the grantee to other institutions, it is necessary to establish formal
subcontract agreements with each collaborating institution.  A letter of intent
from each collaborating institution should be submitted with the application. 
Only the percentage of the consortium/contractual TOTAL COSTS (direct and
facilities and administrative costs) relative to the total DIRECT COSTS of the
overall project needs to be stated at this time.  The following example should
be used to indicate the percentage cost of the consortium, "The consortium
agreement represents 27% of overall direct costs requested in the first year." 
A budget justification for the consortium should be provided as described in the
"Budget Justification" section above (no Form Page 5 required for the
consortium).  Please indicate whether the consortium will be in place for the
entire project period and identify any future year changes in the percentage
relative to the parent grant.

If there is a possibility of an award, the applicant will be requested to
identify actual direct and facilities and administrative costs (indirect costs)
for all years of the consortium.  Please note that total subcontract costs need
not be calculated in $25,000 modules. However, when subcontract funds are added
to the parent grant budget, the total direct cost amount must be included in the
number of $25,000 modules requested.

o  BIOGRAPHICAL SKETCH

A biographical sketch is required for all key personnel, following the modified
instructions below.  Do not exceed the two-page limit for each person.
- Complete the educational block at the top of the form page;
- List current position(s) and those previous positions directly relevant to the
application;
- List selected peer-reviewed publications directly relevant to the proposed
project, with full citation;
- The applicant has the option to provide information on research projects
completed and/or research grants participated in during the last five years that
are relevant to the proposed project.

o  OTHER SUPPORT

Do not complete the "Other Support" pages (Form Page 7).  Selected other support
information relevant to the proposed research may be included in the Biographical
Sketch as indicated above.  Complete Other Support information will be requested
by NHLBI staff if there is a possibility for an award.

o  CHECKLIST

No "Checklist" page is required as part of the initial application.  A completed
Checklist will be requested by NHLBI staff if there is a possibility for an
award.

The applicant should provide the name and phone number of the individual to
contact concerning fiscal and administrative issues if additional information is
necessary following the initial review.

Applications not conforming to these guidelines will be considered unresponsive
to this RFA and will be returned without further review.

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

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

At the time of submission, two additional copies of the application must be sent
to Dr. C. James Scheirer, at the address listed under INQUIRIES.

APPLICATIONS MUST BE RECEIVED BY JUNE 16, 1999.  IF AN APPLICATION IS RECEIVED
AFTER THAT DATE, IT WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW.

The Center for Scientific Review (CSR) 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.  The CSR
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 CSR and
responsiveness by NHLBI.  Incomplete and/or unresponsive 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 NHLBI in accordance
with the review criteria stated below.  As part of the initial merit review, a
process will be used by the initial review group in which applications receive
a written critique and undergo a process in which only those applications deemed
to have the highest scientific merit, generally the top half of the applications
under review, will be discussed, assigned a priority score, and receive a second
level review by the National Heart, Lung, and Blood Advisory Council (NHLBAC).

Review Criteria

The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.  In the
written comments, reviewers will be asked to discuss the following aspects of the
application in order to judge the likelihood that the proposed research will have
a substantial impact on the pursuit of these goals.  Each of these criteria will
be addressed and considered in the assigning the overall score, weighing them as
appropriate for each application.  Note that the application does not need to be
strong in all categories to be judged to have major scientific impact and thus
deserve a high priority score.  For example, an investigator may propose to carry
out important work that by its nature is not innovative but is essential to move
a field forward..

1) Significance.  Does this study address an important problem?  If the aims of
the application are achieved, how will scientific knowledge be advanced?  What
will be the effect of these studies on the concepts or methods that drive this
field?

2) Approach.  Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the aims of the
project?  Does the applicant acknowledge potential problem areas and consider
alternative tactics?

3) Innovation.  Does the project employ novel concepts, approaches or method? 
Are the aims original and innovative?  Does the project challenge existing
paradigms or develop new methodologies or technologies?

4) Investigator.  Is the investigator appropriately trained and well suited to
carry out this work?  Is the work proposed appropriate to the experience level
of the principal investigator and other researchers (if any)?

5) Environment.  Does the scientific environment in which the work will be done
contribute to the probability of success?  Do the proposed experiments take
advantage of unique features of the scientific environment or employ useful
collaborative arrangements?  Is there evidence of institutional support?

In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:

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

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

o The adequacy of the proposed protection for humans, animals or the environment,
to the extent that may be adversely affected by the project proposed in the
application.

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

The personnel category will be reviewed for appropriate staffing based on the
requested percent effort and justification provided.  The direct costs budget
request will be reviewed for consistency with the proposed methods and specific
aims.  Any budgetary adjustments recommended by the reviewers will be in $25,000
modules.  The duration of support will be reviewed to determine if it is
appropriate to ensure successful completion of the requested scope of the
project.

Schedule

Letter of Intent Receipt Date:    April 12, 1999
Application Receipt Date:         June 16, 1999
Date of Initial Review:           September/October 1999
Review by NHLB Advisory Council:  February 10, 2000
Anticipated Award Date:           April 1, 2000

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o  Scientific merit (as determined by peer review)
o  Total costs of the proposed project and availability of funds
o  Programmatic priorities and program balance

INQUIRIES

Inquiries concerning this RFA are encouraged.  Potential applicants may request
sample budget pages as previously stated.  The opportunity to clarify any issues
or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Susan Banks-Schlegel, Ph.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 10018, MSC 7952
Bethesda, MD  20892-7952
Telephone:  (301) 435-0202
FAX:  (301) 480-3557
Email: SchlegeS@gwgate.nhlbi.nih.gov

James Kiley, Ph.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 10018, MSC 7952
Bethesda, MD  20892-7952
Telephone:  (301) 435-0202
FAX:  (301) 480-3557
Email:  KileyJ@gwgate.nhlbi.nih.gov

Direct inquiries regarding review matters to:

C. James Schreirer, Ph.D.
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7220, MSC 7924
Bethesda, MD  20892-7924
Telephone: (301) 435-0266
FAX: (301) 480-3541
Email: JS110J@nih.gov

Direct inquiries regarding fiscal matters to:

Raymond L. Zimmerman
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7154, MSC 7926
Bethesda, MD  20892-7926
Telephone:  (301) 435-0171
FAX:  (301) 480-3310
Email:  ZimmermR@gwgate.nhlbi.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance, No.
93.838.  Awards are made under authorization of the Public Health Service Act,
Title IV, Part A (Public Law 78-410, 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 program is not subject to the intergovernmental
review requirements of Executive Order 12372 or a Health Systems Agency Review.

The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and promote the non-use of all tobacco products.  In addition, Public
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities (or in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care or early childhood development
services are provided to children.  This is consistent with the PHS mission to
protect and advance the physical and mental health of the American people.

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