BIOBEHAVIORAL RESEARCH FOR EFFECTIVE SLEEP
Release Date: January 19, 2000
PA NUMBER: PA-00-046
National Institute of Nursing Research
National Heart, Lung, and Blood Institute
National Institute on Aging
National Institute on Alcohol Abuse and Alcoholism
National Institute of Child Health and Human Development
National Institute on Drug Abuse
National Institute of Mental Health
National Cancer Institute
THIS PA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED
WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA.
PURPOSE
The National Institute of Nursing Research (NINR), National Heart, Lung, and
Blood Institute (NHLBI), National Institute on Aging (NIA), National Institute
on Alcohol Abuse and Alcoholism (NIAAA), National Institute of Child Health
and Human Development (NICHD), National Institute on Drug Abuse (NIDA),
National Institute of Mental Health (NIMH), and the National Cancer Institute
(NCI) invite applications to investigate sleep deprivation in health and
illness. The goal of this program announcement is to stimulate clinical and
applied research on behavioral, psychosocial and physiological consequences of
acute and chronic partial sleep deprivation in either chronically ill or
healthy individuals and to develop environmental, clinical management, and
other interventions with the potential to reduce sleep disturbances and
significantly improve the health of large numbers of people. Although sleep
disorders are a cause of sleep loss in affected individuals, the questions to
be addressed under this solicitation should focus on causes and consequences
of sleep deprivation, apart from any sleep pathology.
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 PA, Biobehavioral Research for
Effective Sleep, is related to the priority areas of health promotion and
disease prevention. Potential applicants may obtain a copy of "Healthy People
2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000.
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 and 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.
MECHANISM OF SUPPORT
This PA will use the National Institutes of Health (NIH) research project
grant (R01) award mechanism. Responsibility for the planning, direction, and
execution of the proposed project will be solely that of the applicant. The
total project period for an application submitted in response to this PA may
not exceed five years.
Specific application instructions have been modified to reflect "MODULAR
GRANT" and "JUST-IN-TIME" streamlining efforts being utilized by the NIH.
Complete and detailed instructions and information on Modular Grant
applications can be found at:
http://grants.nih.gov/grants/funding/modular/modular.htm
RESEARCH OBJECTIVES
Background
Inadequate sleep or nonrestorative sleep has major implications for public
health, safety, productivity, and well-being. It has been estimated that more
than 60 million Americans, or approximately one in three adults, experience
inadequate sleep that can interfere with daily activities. In fact, the
report of the National Commission on Sleep Disorders Research concluded that
inadequate sleep is such a pervasive problem that it appears to be accepted as
a normal part of life. Excessive sleepiness has been associated with
accidents at work or at home, and at least three percent of serious automobile
accidents and fatalities are due to a fatigued driver. Accidents occurring as
a result of sleep deprivation have major implications for public health and
safety. In addition, partial and chronic sleep deprivation adversely affects
individual job performance and quality of life. The NIH National Sleep
Disorders Research Plan identified research needed in basic, clinical and
applied areas. The basic and clinical areas of research have been the focus
of other initiatives.
The current program announcement focuses on the applied research areas, the
sleep-related problems found in healthy and chronically ill individuals who
have acute and chronic partial sleep deprivation. Partial chronic sleep
deprivation in healthy individuals is primarily due to external demands as
found in shift workers, medical students, nurses and working parents. In
addition, sleep deprivation may be due to lifestyle choices as made by teens
and young adults. Little is known about the consequences of sleep deprivation
on quality of life and measures of behavioral, cognitive and psychosocial
function.
There are many chronic health conditions that interfere with sleep. Sleep
disturbances are associated with Alzheimer’s Disease and other dementias,
rheumatoid arthritis, fibromyalgia, AIDS, cancer, neurodegenerative disorders,
chronic obstructive pulmonary disease, asthma, cardiovascular disease, urinary
incontinence, drug abuse (as well as withdrawal from drug abuse) and chronic
alcoholism. Sleep deprivation can be exacerbated by pain and by environmental
conditions associated with hospitalization and home care that are not
conducive to restorative sleep. Sleep deprivation can also increase the risk
of depression in chronically ill individuals. Research is needed on sleep
deprivation associated with medical disorders, and their link to other mental
disorders, symptoms, and related disabilities.
Little is known about sleep deprivation in children. A vast majority of
children complain about feeling tired during the day and 15 percent of
children have reported falling asleep during school at least once. Acute and
chronic partial sleep deprivation in children has been associated with
decreased cognitive functioning and school performance. Sleep deprivation may
also be a risk factor for poor behavioral adjustment and behavioral problems
such as attention deficit disorder. The potential consequences of sleep
deprivation on behavior and growth across the different stages of development
has not been well characterized.
It has been estimated that over half of the 33 million adults over 65 years of
age have some chronic sleep complaint which contributes to personal discomfort
and illness, to caregiver burden, and to overall health care costs. Elderly
individuals without sleep disorders may experience sleep disruption due to
factors associated with the institutional care environment and/or poor sleep
hygiene practices.
The etiology of sleep deprivation (i.e., shift work, environmental conditions,
lifestyle, chronic illness, medical treatment related effects) needs to be
determined and specific at-risk populations with adverse health consequences
need to be identified, apart from sleep disorders. Research is also needed to
identify interventions (e.g., light therapy, behavioral interventions) to
improve the quality of sleep in healthy and chronically ill individuals.
Treatment approaches using sleep deprivation or phase shifting as an
intervention for mental disorders in patients of any age is also an area of
interest.
Listed below are examples of studies that would be responsive to this program
announcement. However, these are only illustrative examples and applicants
are encouraged to propose other topics consistent with the goals of this
program. Not all areas are required in a single application.
o Identify specific chronically ill populations at increased risk (e.g.,
Alzheimer’s disease, rheumatoid arthritis, cardiopulmonary disease, cancer
survivors, patients with alcohol problems) of chronic partial sleep
deprivation and identify the etiology of excessive daytime sleepiness, apart
from sleep disorders within these populations
o Identify factors contributing to sleep deprivation (e.g., shift work,
occupational demands, environmental conditions, alcohol and drug use,
lifestyle choices, stress, medical treatment sequelae) and whether age,
gender, and ethnicity may play a role
o Determine the physiological, cognitive, behavioral, and psychosocial risks
associated with varying lengths of sleep deprivation for both acute and
chronic partial sleep deprivation in children, adolescents and adults
o Elucidate the role of evening or bedtime alcohol use in sleep deprivation,
and investigate the contribution of sleep deprivation to risk-taking behaviors
such as drug and alcohol consumption
o Identify effective recovery patterns following chronic partial sleep loss
and whether rates of recovery vary by age and/or for physiological, behavioral
and cognitive processes
o Determine the restorative function of sleep in maintenance of health
o Determine the relationship between menopause (natural or medically induced)
and sleep disturbances
o Develop interventions to improve the quality of sleep and to prevent sleep
deprivation from occurring in healthy and chronically ill individuals across
the lifespan including neonates, children, adolescents, adults, and older
persons
o Identify strategies to help children and adults adapt to the sleep
disturbance associated with hospitals, critical care settings, and nursing
homes
o Develop and use improved approaches to assess acute and chronic sleep
deprivation
o Determine whether measurements of sleep quality can predict response to
treatment of alcoholism and mental disorders across the life cycle
o Determine how sleep patterns are affected by alcohol and psychoactive drug
use and how the withdrawal from alcohol and drug use affects sleep patterns
o Identify the relationship between partial sleep deprivation in children and
adolescents and the relationship to possible effects on learning and behavior
problems
o Determine whether different stages of development alter the consequences of
sleep deprivation in children and/or whether sleep is required for adequate
growth and development
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 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) and in the NIH Guide for Grants and Contracts, Vol. 23,
No. 11, March 18, 1994 available on the web at the following URL address:
http://grants.nih.gov/grants/guide/notice-files/not94-100.html
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of 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: http://grants.nih.gov/grants/guide/notice-files/not98-024.html
NOTE FOR APPLICATIONS FOCUSED ON AGING RESEARCH
Some applications received in response to this program announcement are
expected to focus on scientific issues related to aging and to aging-related
aspects of disease. In this regard applicants may use Justification 1, the
research topic to be studied is irrelevant to children, from the policy
announcement.
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.
APPLICATION PROCEDURES
Applications are to be submitted on the grant application form PHS 398 (rev.
4/98) and will be accepted at the standard application deadlines as indicated
in the application kit. Application kits are available at most institutional
offices of sponsored research and 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: GrantsInfo@nih.gov.
Applicants planning to submit an investigator-initiated new (type 1),
competing continuation (type 2), competing supplement, or any amended/revised
version of the preceding grant application types requesting $500,000 or more
in direct costs for any year are advised that he or she must contact the
Institute or Center (IC) program staff before submitting the application,
i.e., as plans for the study are being developed. Furthermore, the application
must obtain agreement from the IC staff that the IC will accept the
application for consideration for award. Finally, the applicant must identify,
in a cover letter sent with the application, the staff member and Institute or
Center who agreed to accept assignment of the application.
This policy requires an applicant to obtain agreement for acceptance of both
any such application and any such subsequent amendment. Refer to the NIH Guide
for Grants and Contracts, March 20, 1998 at
http://grants.nih.gov/grants/guide/notice-files/not98-030.html
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. The research grant application form PHS 398 (rev. 4/98) is to be used
in applying for these grants, with the modifications noted below.
BUDGET INSTRUCTIONS
Modular Grant applications will request direct costs in $25,000 modules, up
to a total direct cost request of $250,000 per year. (Applications that
request more than $250,000 direct costs in any year must follow the
traditional PHS 398 application 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:
PHS 398
o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in
$25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total
Direct plus Facilities and Administrative (F&A) costs] for the initial budget
period. Items 8a and 8b should be completed indicating the Direct and Total
Costs for the entire proposed period of support.
o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4
of the PHS 398. It is not required and will not be accepted with the
application.
o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the
categorical budget table on Form Page 5 of the PHS 398. It is not required and
will not be accepted with the application.
o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative
page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample
pages.) At the top of the page, enter the total direct costs requested for
each year. (This is not a Form page).
o Under Personnel, list key project personnel, including their names, percent
of effort, and roles on the project. No individual salary information should
be provided. However, the applicant should use the NIH appropriation language
salary cap and the NIH policy for graduate student compensation in developing
the budget request.
For Consortium/Contractual costs, provide an estimate of total costs (direct
plus facilities and administrative) for each year, each rounded to the nearest
$1,000. List the individuals/organizations with whom consortium or contractual
arrangements have been made, the percent effort of key personnel, and the role
on the project. Indicate whether the collaborating institution is foreign or
domestic. The total cost for a consortium/contractual arrangement is included
in the overall requested modular direct cost amount. Include the Letter of
Intent to establish a consortium.
Provide an additional narrative budget justification for any variation in the
number of modules requested.
o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by
reviewers in the assessment of each individual"s qualifications for a specific
role in the proposed project, as well as to evaluate the overall
qualifications of the research team. A biographical sketch is required for all
key personnel, following the instructions below. No more than three pages may
be used for each person. A sample biographical sketch may be viewed at:
http://grants.nih.gov/grants/funding/modular/modular.htm
- Complete the educational block at the top of the form page,
- List position(s) and any honors,
- Provide information, including overall goals and responsibilities, on
research projects ongoing or completed during the last three years.
- List selected peer-reviewed publications, with full citations,
o CHECKLIST - This page should be completed and submitted with the
application. If the F&A rate agreement has been established, indicate the type
of agreement and the date. It is important to identify all exclusions that
were used in the calculation of the F&A costs for the initial budget period
and all future budget years.
The title and number of the program announcement must be typed on line 2 of
the face page of the application form and the YES box must be marked.
Submit a signed, typewritten original of the application, including the
Checklist, and five 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)
REVIEW CONSIDERATIONS
Applications will be assigned on the basis of established PHS referral
guidelines. Applications will be evaluated for scientific and technical merit
by an appropriate scientific review group convened in accordance with the
standard NIH peer review procedures. 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 appropriate national
advisory council or board.
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 assigning the overall score,
weighting them as appropriate for each application. Note that the application
does not need to be strong in all categories to be judged likely 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.
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?
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?
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?
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)?
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 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 they may be adversely affected by the project
proposed in the application.
AWARD CRITERIA
Applications will compete for available funds with all other recommended
applications. The following will be considered in making funding decisions:
Quality of the proposed project as determined by peer review, availability of
funds, and program priority.
INQUIRIES
Inquiries are encouraged. The opportunity to clarify any issues or questions
from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
Karin F. Helmers, PhD
National Institute of Nursing Research
Building 45, Room 3AN-12
Bethesda, MD 20892
Tel: (301) 594-2177
Fax: (301) 480-8260
Email: karin_helmers@nih.gov
Michael Twery, Ph.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
Rockledge 2, Suite 10018
Bethesda, MD 20892-7952
Tel: (301) 435-0202
Fax: (301) 480-3557
Email: TweryM@nhlbi.nih.gov
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
Tel: (301) 496-9350
Fax: (301) 496-1494
Email: am39m@nih.gov
Ellen Witt, Ph.D.
Division of Basic Research
National Institute on Alcohol Abuse and Alcoholism
Willco Bldg, Suite 402
6000 Executive Blvd, MSC 7003
Bethesda, MD 20892-7003
Tel: (301) 443-6545
Fax: (301) 594-0673
email: ewitt@willco.niaaa.nih.gov
Lynne Haverkos, MD, MPH
Director, Behavioral Pediatrics and
Health Promotion Research program
National Institute on Child Health and Development
6100 Executive Blvd. Rm. 4B05B MSC 7510
Bethesda, MD 20892-7510
Tel: (301)435-6881
Fax : (301) 480-7773
email: haverkol@mail.nih.gov
Harold W. Gordon, Ph.D.
Clinical Neurobiology Unit
Division of Treatment Research and Development
National Institute on Drug Abuse
Neuroscience Building
Room 4234, MSC 9559
6001 Executive Boulevard
Bethesda, MD 20892-9559
Tel: (301) 443-4877
Fax: (301) 443-6814
Email: hg23r@nih.gov
Israel I. Lederhendler, Ph.D.
Coordinator for Sleep Research
National Institute of Mental Health
National Institutes of Health
6001 Executive Boulevard, Room 7-170, MSC 9637
Bethesda, MD 20892-9637
Tel: 301/443-1576
Fax: 301/443-4822
e-mail: ilu@helix.nih.gov
Noreen Aziz, MD, PhD, MPH
Office of Cancer Survivorship
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Blvd, MSC 7339
EPN Suite 539
Bethesda, MD 20892-7339
Tel: (301) 496-0598
Fax: (301) 496-8675
Email: na45f@nih.gov
Direct inquiries regarding fiscal matters to:
Cindy McDermott
Office of Grants and Contract Management
National Institute of Nursing Research
Building 45, Room 3AN-12
6300 Center Drive MSC 6301
Bethesda, MD 20892-6301
Telephone: (301) 594-5979
Fax: (301) 480-8260
E-mail: cindy_mcdermott@nih.gov
Raymond Zimmerman
Grants Operations Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7154, MSC 7926
Bethesda, Maryland 20892_7926
Telephone: 301 435_0171
Fax: 301 480_3310
Email: ZimmermR@nih.gov
Joe Ellis
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2N212, MSC 9205
Bethesda, MD 20892-9205
Telephone: (301) 496-1472
Fax: (301) 402-3672
E-mail: ellisj@exmur.nia.nih.gov
Judy Simons
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 504
6000 Executive Blvd, MSC 7003
Bethesda, MD 20892-7003
Phone: (301) 443-2324
Fax: (301) 443-3891
E-mail: jsimons@willco.niaaa.nih.gov
Edgar D. Shawver
Grants Management Branch
National Institute of Child Health and Human Development
Bldg. 6100, Rm. 8A17
9000 Rockville Pike MSC 7510
Bethesda, Md. 20892-7510
Tel: 301 435-6999
Fax: 301 402-0915
Email: ds117g@nih.gov
Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse
The Neuroscience Center
6001 Executive Boulevard, Room 3119
Bethesda, MD 20892
Tel: 301-443-6710
Fax: 301-594-6849
e-mail: gf6s@nih.gov
Diana S. Trunnell
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, MSC 9605
Bethesda, MD 20892-9605
Tel: 301-443-2805
Fax: 301-443-6885
e-mail: Diana_Trunnell@nih.gov
Bill Wells
Executive Plaza South 243
Grants Administration Branch
National Cancer Institute
Bethesda, MD, 20892
Tel: 301-496-8796
Fax: 301-496-8601
e-mail: ww14j@nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
93.361 (NINR), No. 93.837 (NHLBI), No. 93.866 (NIA), No. 93.273 (NIAAA), No.
93.865 (NICHD), No. 93.279 (NIDA), No. 93.242 (NIMH), and No. 93.399 (NCI).
Awards are made under authorization of the Public Health Service Act, Title
IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and
285) and administered under NIH grants policies and Federal Regulations 42 CFR
52 and 45 CFR Parts 74 and 92. This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards will be administered under NIH grants policy as
stated in the NIH Grants Policy Statement (10-98).
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, and 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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