Release Date: December 18, 1998

RFA:  HL-99-001


National Heart, Lung, and Blood Institute
National Institute of Mental Health
National Institute on Aging
National Institute of Neurological Disorders and Stroke

Letter of Intent Receipt Date:  January 26, 1999
Application Receipt Date:  February 26, 1999



The primary goal of this initiative is to advance our understanding of sleep and
wakefulness by developing improved molecular, cellular, and systems approaches
to investigate sleep and circadian phenotypes in mice.  Better and more
extensively-characterized mouse models will help determine the genetic
underpinnings of sleep and wakefulness, elucidate the physiological role of
sleep, and develop new directions for the treatment of sleep disorders. 
Establishing inbred mice strains as a platform for sleep studies will advance our
understanding of normal sleep phenotypes; facilitate the use of targeted and
transgenic gene modification approaches; and lead to a refinement in the
definition of sleep state in molecular and genomic terms.


The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of Health People 2000, a PHS-led national
activity for setting priority areas.  This RFA, Phenotypic Characterization of
Sleep in Mice, is related to the priority areas of heart disease and stroke,
chronic disabling conditions, mental health and disorders, maternal and infant
health, immunization and infectious diseases, and clinical prevention services. 
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).


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 institutions may not apply.  However, foreign
components that are critical to the proposed research may be included as
subcontracts.  Ethnic minority individuals, women, and persons with disabilities
are especially encouraged to apply as principal investigators.

Multiple applications from the same institution will not be considered unless
each application is submitted by a different principal investigator, and is
self-contained and independent of others from that institution.  Overlap in the
scientific scope of applications from the same institution will not be accepted. 
This does not preclude cooperation among participants after awards are made.  If
more than one application is envisioned from an institution, the investigators
are encouraged to discuss their plans with the program administrator listed under
INQUIRIES.  Applications submitted in response to this RFA will only be
considered as new applications.


This RFA will use the National Institutes of Health (NIH) individual research
project grant (R01) mechanism of support.  Awards will be made and managed by the
sponsoring Institutes of this RFA.  All current policies and requirements that
govern the research grant programs of the NIH will apply to grants awarded under
this RFA.  However, specific application instructions have been modified to
reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts currently 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 in the application 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,
applicant institutions, reviewers, and Institute staff.

Funds must be requested in $25,000 direct cost modules and a maximum of  nine
modules ($225,000 direct costs) per year may be requested for four years.  The
cost of equipment is included in the budget limitation.  Any necessary escalation
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 staff of the
awarding Institute following the initial review.  The APPLICATION PROCEDURES
section of this RFA provides specific details of  modifications to standard PHS
398 application kit instructions.

This RFA is a one time solicitation.  Applications for continuation beyond this
initial award period will compete with all investigator-initiated applications
in the regular grant program and according to customary peer review procedures.


It is anticipated that for fiscal year 1999, total costs of $3,500,000 will be
available for this initiative.  Award of grants pursuant to this RFA is
contingent upon receipt of such funds for this purpose.  Approximately eight to
eleven new grants requesting direct costs of up to $225,000 per year for four
years are expected to be awarded under this program.  The specific number of
grants to be funded, however, depend on the merit and scope of the applications
received and on the availability of funds.  Direct costs will be awarded in
modules of $25,000, less any overlap and other administrative adjustments.  The
earliest anticipated award date for successful grant applications is September
30, 1999.



Sleep is a fundamental and essential biological process.  An estimated 40 million
individuals in the United States experience chronic or intermittent sleep-related
problems and disorders, such as sleep apnea, behavioral and cognitive
dysfunction, narcolepsy, insomnia, restless legs syndrome, fibromyalgia, and
Sudden Infant Death Syndrome.  Sleep disorders are associated with increased
morbidity and mortality, as well as the loss of life due to accidents caused by
excessive sleepiness.  Sleep disorders can alter the severity of cardiovascular,
behavioral, and immunological diseases.  Defining the basic role of sleep in
health and disease represents a significant unmet biomedical challenge yet it
remains a relatively understudied area of research.  Little is known about the
molecular and genetic basis of sleep control, the relationships between sleep and
the function of major physiological systems, and changes in the sleep process
during development, growth, and aging.

Objectives and Scope

Descriptive approaches have demonstrated for many years that sleep can be
objectively defined and its properties measured.  Much has been learned about
specific humoral factors, neural pathways, and the physiology of sleep and
circadian rhythms using traditional behavioral and systems techniques.  An
essential step is to build on what has been learned in other mammals by analyzing
the component molecular and cellular events of sleep using models in which the
contribution of specific genes and their encoded proteins can be identified and
well-characterized.  In order to accomplish this goal, it is necessary to
establish and validate properties of sleep and wakefulness in the mouse including
sleep staging, regulation of sleep onset and arousal from sleep, seasonal and
daily patterns of sleep, and biological substrates of sleep such as
electrophysiological, neurochemical, and neuroanatomical correlates.

With the expected elucidation of the mouse genome and the availability of
techniques to alter the expression and composition of genes in this species, the
mouse offers an excellent model for investigations into the biochemical basis of
sleep.  However, research is greatly hampered by the lack of detailed
investigations into the normal and abnormal sleep of this species.  Existing
approaches to studying sleep in cats, rats, and other mammalian species need to
be extended to the mouse through studies which test and validate well-established
properties and methods in other species.  New protocols that simplify the
investigation of sleep parameters such as total sleep time, sleep stage
distribution and sleep latency are needed to facilitate the characterization of
sleep phenotypes.  Inbred and genomically well-characterized mouse strains can
be used as benchmarks against which novel sleep mutants and variants can be
compared.  Carefully controlled descriptions of traditional and novel sleep
phenotypes, as well as differences in sleep phenotypes between strains and
responses to sleep-relevant pharmaceuticals, should facilitate future research
efforts to define the responsible genes and their roles in sleep mechanisms.

There are a number of research directions that could be pursued using the mouse
as a model  for the investigation of sleep and circadian rhythms.  Molecular and
genetic approaches combined with neurophysiological, behavioral, neuroanatomical,
or pharmacological techniques are encouraged.  The following are examples of
studies using mouse models that would be responsive to this program:

o  Development of new technologies for phenotype characterization and the
physiological and behavioral analysis of sleep and wakefulness in the mouse;

o  Validation in the mouse of known electrophysiological, neuropharmacological,
and neuroanatomical indicators of sleep;

o  Elucidation of mechanisms that regulate sleep such as somnogenic factors;

o  Identification of molecular and cellular mechanisms responsible for the
altered properties of neural networks contributing to cardiorespiratory
regulation, sensory perception, and cognition during the sleep state;

o  Relationship of circadian rhythms to the basic developmental and restorative
functions of sleep including how circadian rhythm and sleep/wake cycles are
established, and how sleep and sleepiness affect behavioral performance and the
function of  the brain, heart, lung, and blood;

o  Characterization of normal and disordered changes in sleep and circadian
rhythms during development or aging of the biological clock and the investigation
of interventions that may enhance the function of clock components or somnogenic

o  Tissue-specific maps of gene expression influencing the sleep characteristics
of inbred or transgenic mice.

o  Elucidation of mechanisms linking sleep to diurnal variations in
cardiopulmonary function, endocrine function, immunological responses, and other
physiological functions.

These topics serve as examples and are not a comprehensive or exclusive list of
the areas that could be considered under this announcement.  Not all areas are
required in an application.  Applicants are encouraged to propose other topics
consistent with the goals of this program.


In order to be considered responsive to this announcement, applications must
propose hypothesis-driven studies that focus on developing the mouse as a
platform for sleep research.  Studies that are needed to overcome technical
barriers such as the scaling of methods for use in the mouse should be integrated
into the proposed research program.  However, applications focused solely on the
transfer of established methods to the mouse will not be accepted.  In addition
to traditional research programs, applications may propose necessary
developmental approaches to test innovative and conceptually creative hypotheses
forming the basis of future sleep research project applications using mouse

Applications should propose strategies that combine molecular and genetic
approaches with physiological, behavioral, neuroanatomical, or pharmacological
techniques.  Collaborations and consortia promoting interdisciplinary approaches
between scientists studying sleep, circadian biology, and mouse genetics are
strongly encouraged.  In such cases, each participant's contribution should be
identified and well-integrated into the overall experimental design.

Production of inbred or transgenic mice is not a requirement.  Transgenic mice
already produced in other studies may be used to address the research goals of
this RFA.  However, studies directed solely at either the production or screening
of mutant mice unaccompanied by studies of sleep mechanisms will not be accepted. 
Applications proposing to include data collection from species other than the
mouse or from human subjects must provide a strong rationale that is clearly
relevant to the goal of developing the mouse as a platform for sleep research. 
Studies in mice must be the principal focus of the application.  Applicants are
encouraged to contact the program officials listed under INQUIRIES for further

Upon initiation of the program, the sponsoring Institutes will sponsor periodic
meetings to encourage exchange of information among investigators who participate
in this program.  Travel funds for a two day meeting each year, most likely to
be held in Bethesda, Maryland, must be included in the module calculation. 
Applicants must include a statement indicating their willingness to participate
in these meetings.


The primary objective of this RFA is to derive mouse models for sleep and
circadian research.  There may be instances in which applicants must collect or
use pathology specimens derived from human subjects, or clinical or
epidemiological data from projects involving human subjects, to design  models
or to derive the standards that validate them as models of human sleep or
circadian rhythm disorders.  In those instances, the NIH policies described below
apply and must be addressed in the application.


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 research.  This policy
results from the NIH Revitalization Act of 1993 (Section 492B of Public Law

All investigators proposing research involving human subjects should read 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), in the NIH Guide for Grants and Contracts of March 18, 1994,
and is available at the following URL address:


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 specific 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:


Prospective applicants are asked to submit, by January 26, 1999, 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
a subsequent application, the information that it contains allows staff to
estimate the potential review workload and to avoid conflict of interest in the
review.  The letter of intent is to be mailed, or faxed, to Dr. C. James Scheirer
at the address listed under INQUIRIES.


Applications are to be submitted on the research grant application form PHS 398
(rev. 4/98).  Application kits are available at most institutional offices of
sponsored research or may be obtained 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:


Sample budgets and justification page for the for modular grants can be obtained
by contacting Mr. Raymond Zimmerman listed under INQUIRIES.

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

Item 7 should be completed to indicate Modular Direct Costs requested and Item
8 should reflect Total Costs (Modular Direct plus facilities and administrative

Do not complete Form Page 4 of the PHS 398 (rev 4/98).  It is not required nor
will it be accepted at the time of application.

Do not complete the categorical budget tables on Form page 5 of the PHS 398 (rev.
4/98).  Only the requested total direct costs line for each year must 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 nine modules
($225,000 direct costs) per year may be requested and each applicant may request
up to four years of support for this program.  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.

Budget justifications should be provided under "Justifications" on Form Page 5
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 their 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.

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 plus 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 $175,000 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). 
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

If there is a possibility for an award, the applicant will be requested to
identify actual direct and facilities and administrative costs for all years of
the consortium.  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.  If clarification of the policy is needed, contact Mr. Raymond
Zimmerman at the address listed under INQUIRIES.


- 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

- 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.

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 the staff of NHLBI or collaborating Institutes
if there is a possibility for an award.


- No "Checklist" page is required as part of the initial application. A completed
Checklist including a breakdown of facilities and administrative cost
calculations (rate, base, and base exclusions) will be requested by the staff of
NHLBI or collaborating Institutes 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.

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.

The RFA label available 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 and
number must be typed on line 2 of the face page of the application
form and the YES box must be marked.

Send or deliver the completed application and three signed, exact photocopies of
it to the following, making sure that the original application with the RFA label
attached is on top:

6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

Send an additional two copies of the application to Dr. Scheirer at the address
listed under INQUIRIES.  It is important to send these two copies at the same
time as the original and three copies are sent to the Center for Scientific
Review (CSR).  Otherwise the sponsoring Institutes cannot guarantee that the
application will be reviewed in competition for this RFA.

Applications must be received by February 26, 1999.  If an application is
received after that date, it will be returned to the applicant without review. 
The 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 also 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.


Upon receipt, applications will be reviewed for completeness by the CSR and for
responsiveness to this RFA by the collaborating Institutes.  Incomplete and/or
non-responsive applications will be returned to the applicant without further
consideration.  Applications that are complete and responsive to the RFA will
receive primary assignment to NHLBI and secondary assignment to NIMH, NIA, and/or
NINDS.  Applications will be evaluated for scientific and technical merit by an
appropriate peer review group convened by the Division of Extramural Affairs,
NHLBI.  Final Institute primary assignments will be determined by the
collaborating Institutes.

As part of the initial merit review, all applications will 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 applications under
review, will be discussed, assigned a priority score, and receive a second level
review by the National Advisory Councils of the sponsoring Institutes.

Review Criteria

The following criteria will be considered when assessing the scientific and
technical merit of a research grant application:

(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

(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 key personnel?

(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?

Additional Considerations

(1) Potential of the proposed study to extend existing knowledge about mammalian
sleep and circadian rhythms to either the initial development of new interesting
models in mice or the improved characterization of sleep phenotypes using inbred
or transgenic mouse strains.

(2) Experience of the key personnel in conducting sleep and circadian biology
research using mice or other animal models.

The personnel category will be reviewed for appropriate staffing based on the
requested percent effort.  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.


Funding decisions will be made on the basis of scientific and technical merit as
determined by peer review, relevance to the scientific programs of the
participating Institutes, overall programmatic balance, and the availability of
funds.  Designated funding levels are subject to change at any time prior to
award, due to unforeseen budgetary, administrative and/or scientific
developments.  Subject to the availability of necessary funds and consonant with
the priorities of this RFA, the sponsoring Institutes of this RFA will provide
funds for a project period up to four years.

The anticipated date of award is September 30, 1999.


Inquiries concerning this RFA are encouraged.  The opportunity to clarify any
issues or questions from potential applicants is welcome.

Inquiries regarding programmatic issues may be directed to:

Michael J. Twery, Ph.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Suite 7024, MSC-7952
Bethesda, MD  20892-7952
Telephone:  (301) 435-0202
FAX:  (301) 480-3557

Israel I. Lederhendler, Ph.D.
Coordinator for Sleep Research
National Institute of Mental Health
5600 Fishers Lane, Room 11C-16
Rockville, MD  20857
Telephone:  (301) 443-1576
FAX:  (301) 443-4822

Andrew A. Monjan, Ph.D., M.P.H.
Neuroscience and Neuropsychology of Aging Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 3C307 - MSC 9205
Bethesda, MD  20892-9205
Telephone:  (301) 496-9350
FAX:  (301) 496-1494

Charlotte McCutchen, M.D.
National Institute of Neurological Disorders and Stroke
7550 Wisconsin Avenue, Room 516, MSC 9020
Bethesda, MD  20892-9020
Telephone:  (301) 496-1917
FAX:  (301) 496-9916

Direct inquiries regarding the receipt and review of applications to:

C. James Scheirer, 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

Direct inquiries regarding fiscal matters to:

Raymond L. Zimmerman
Grants Operations Branch
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7154
Bethesda, MD  20892-7926
Telephone:  (301) 435-0171
FAX:  (301) 480-3310

Diana Trunnell
Grants Management Branch
National Institute of Mental Health
5600 Fishers Lane, Room 7C-08
Rockville, MD  20857
Telephone:  (301) 443-3065

Joseph Ellis
Grants Management Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2C212, MSC 9205
Bethesda, MD  20892-9205
Telephone:  (301) 496-1472

Maurice Johnson
Grants Management Branch
National Institute of Neurological Disorders and Stroke
7550 Wisconsin Avenue, Room 1004
Bethesda, MD  20892-9190
Telephone:  (301) 496-9231


This program is described in the Catalog of Federal Domestic Assistance Nos.
93.839 and 93.848.  Awards will be made under the authority of the Public Health
Service Act, Section 301 (42 USC 241) and administered under PHS grant policies
and Federal regulations, most specifically 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.

The PHS strongly encourages all grant and contract 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

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