Announcement Type
This is a reissue of PA-05-046,
which was previously released February 9, 2005.
NOTICE: Applications submitted in response to this Funding Opportunity
Announcement (FOA) for Federal assistance must be submitted electronically
through Grants.gov (http://www.grants.gov) using the SF424 Research
and Related (R&R) forms and the SF424 (R&R) Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application
guidelines included with this announcement in Grants.gov/Apply
for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission
and applicants are highly encouraged to start the process at least four weeks
prior to the grant submission date. See Section IV.
Program Announcement (PA) Number: PA-07-140
Catalog of Federal Domestic Assistance Number(s) .93.866, 93.273, 93.846, 93.864, 93.279, 93.233,
93.242, 93.853, 93.361, 93.213, 93.865
Purpose. This Funding Opportunity Announcement (FOA) solicits
grant applications proposing research to advance biomedical
knowledge related to sleep or sleep disorders, improve understanding of
the neurobiology or functions of sleep over the life-span, enhance timely
diagnosis and effective treatment for individuals affected by sleep-related
disorders, or implement and evaluate innovative community-based public health
education and intervention programs.
Mechanism of Support.
This FOA will utilize the NIH Research Project Grant (R01)award mechanismand runs in parallel with an FOA of identical scientific
scope, PA-06-238, that solicits applications under the Exploratory/Developmental (R21) grant mechanism.
Funds Available and Anticipated Number of Awards. Because the nature
and scope of the proposed research will vary from application to application,
it is anticipated that the size and duration of each award will also vary.
The total amount awarded and the number of awards will depend upon the mechanism
numbers, quality, duration, and costs of the applications received.
Eligible Institutions/Organizations. Public/State Controlled Institution of Higher Education; Private Institution
of Higher Education; Nonprofit with 501(c)(3) IRS Status (Other than Institution
of Higher Education); Nonprofit without 501(c)(3) IRS Status (Other than
Institution of Higher Education); Small Business; For-Profit Organization
(Other than Small Business); State Government; Non-domestic (non-U.S.) Entity
(Foreign Organization); Other(s): Eligible agencies of the Federal government;
Faith-based or community based organizations.
Eligible Project Directors/Principal Investigators
(PDs/PIs): Individuals with the skills, knowledge, and resources necessary to carry
out the proposed research are invited to work with their institution/organization
to develop an application for support. Individuals from underrepresented
racial and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.
Number of Applications. Applicants may submit
more than one application, provided each application is scientifically distinct.
Renewals and Resubmissions. Applications can be renewed by competing for additional project periods.
Applicants may submit a resubmission application, but
such application must include an Introduction addressing the previous
peer review critique (Summary Statement).
Number of PDs/PIS. More than one PD/PI, or multiple
PDs/PIs, may be designated on the application.
Application Materials. See Section IV.1 for application materials.
General Information. For general information
on SF424 (R&R) Application and Electronic Submission, see these Web
sites:
Section III. Eligibility Information 1. Eligible Applicants A. Eligible Institutions B. Eligible Individuals 2. Cost Sharing or Matching 3. Other-Special Eligibility Criteria
Section IV. Application and Submission Information 1. Request Application Information 2. Content and Form of Application Submission 3. Submission Dates and Times A. Submission, Review, and Anticipated
Start Dates
1. Letter of Intent B. Submitting an Application Electronically
to the NIH C. Application Processing 4. Intergovernmental Review 5. Funding Restrictions 6. Other Submission Requirements
Section V. Application Review Information 1. Criteria 2. Review and Selection Process A. Additional Review Criteria B. Additional Review Considerations
C. Sharing Research Data D. Sharing Research Resources 3. Anticipated Announcement and Award Dates
The three broad categories of sleep-related disorders
include:
Sleep Restriction: Many children, adolescents,
and adults regularly fail to get sufficient sleep to function effectively
during waking hours as a result of imposed or self-imposed lifestyles and
work schedules.
Primary Sleep Disorders: More than 70 types of sleep disorders chronically
affect people of all ages and their prevalence increases with aging. More
than 50% of patients remain undiagnosed and therefore untreated.
Secondary Sleep Disorders: People having a chronic disease, or an
alcohol or substance abuse disorder, often experience poor sleep quality and
excessive daytime sleepiness. Alterations in circadian rhythmicity and the
greater incidence of co-morbid conditions, as well as lifestyle changes, make
the aging population at greater risk for sleep disorders.
An estimated 70 million people in the United States
suffer from sleep problems, and more than 50% of them have a chronic sleep
disorder. About 30 million American adults have frequent or chronic insomnia.
Approximately 18 million have sleep apnea (sleep disordered breathing), but
it is estimated that fewer than 50% are presently being diagnosed. An estimated
250,000 people have narcolepsy, and 10 to 15% of adults are affected by restless
legs syndrome. According to the National Highway Traffic and Safety Administration
(NHTSA), 100,000 accidents and 1,500 traffic fatalities per year are related
to drowsy driving. More than 50% of Americans over age 65 have sleep difficulties,
and prevalence of sleep problems will therefore increase as the over-65 population
increases. Each year, sleep disorders, sleep deprivation, and excessive daytime
sleepiness add approximately $16 billion annually to the cost of health care
in the U.S., and result in $50 billion annually in lost productivity. In addition
to conventional therapies to treat sleep disorders, many individuals use complementary
and alternative therapies (CAM). According to the 2002 National Health Interview
Survey, approximately 1.6 million adults use CAM specifically for sleep disorders.
Sleep problems and disorders have major societal impacts, but have not received
sufficient attention in basic and clinical research.
The 2003 National Sleep Disorders Research Plan (http://www.nhlbi.nih.gov/health/prof/sleep/res_plan/index.html)
summarizes current knowledge regarding the neurobiology of sleep and sleep
disorders, and concludes with a prioritized listing of recommendations for
future research.
We are now beginning to understand the impact of chronic
sleep loss or sleeping at adverse circadian times on the ability to function
optimally and on physical and mental health. How sleep loss, sleep displacement
(e.g., shift work), and a wide range of sleep disorders affect one's ability
to maintain health and healthy functioning in a 24/7 world, however, are relatively
poorly understood. In addition, with the enhanced lifespan, the growing aging
population carries a risk for sleep disturbances caused by greater physical
and psychological changes. Thus, despite substantial scientific progress in
both clinical and basic science related to sleep and its disorders, there
remains the challenge and the need to better understand the functions of sleep,
to better understand and treat disorders affecting sleep, and to explain the
nature of human physiology during wakefulness and the individual stages of
sleep. Without progress in these areas, millions will continue to suffer the
consequences of dysfunction and abuse of this most basic regulatory process.
Sleep Neurobiology: The discovery of hypocretin/orexin and its role in the development of
narcolepsy in animal models and in humans revolutionized our understanding
of this debilitating disorder and promises important advances in the diagnosis
and therapy of human narcolepsy. However, we need to better understand the
neuromodulatory role of hypocretin/orexin and improve our understanding of
the basic neurobiological processes that control sleep and wakefulness. New
anatomical and physiological approaches have led to advances in our understanding
of the location and interconnections between hypothalamic and brainstem circuits
controlling REM, nonREM, and wake states. Factors regulating the activity
of these sleep-controlling neurons have been identified. Circuitry and neurotransmitter
mechanisms controlling muscle tone across the sleep cycle, of relevance to
numerous sleep pathologies, have also been identified.
Circadian Biology: A growing number of "clock genes" have been identified that
play a critical role in mammalian circadian timing. In addition, there is
clear evidence that non-suprachiasmatic nucleus (SCN) tissues have clock genes
and can demonstrate circadian rhythms. Thus, circadian modulation occurs both
centrally and peripherally, further emphasizing the importance of circadian
chronobiology in the timing of sleep and waking as well as a wide variety
of physiologic functions. These studies of clock genes also apply to humans,
in particular patients with advanced sleep phase syndrome, especially prominent
in the elderly population. The role of endogenous melatonin in the sleep/wake
cycle has been better defined and the clinical studies on the role of exogenous
melatonin to treat sleep disorders are ongoing.
Sleep Deprivation: Previous studies have demonstrated many of the ill effects of total sleep
deprivation, but the impact of chronic partial sleep deprivation (restriction)
has not been extensively investigated even though it is much more common.
Recent studies indicate that 4 to 6 hours of sleep per night yields a progressive,
cumulative deterioration in neurobehavioral function including vigilance,
neurocognitive performance, and mood. This reduction in performance is also
associated with changes in cerebral activation during cognitive tasks. Physiologic
changes also appear to occur, e.g., insulin resistance, increased sympathetic
activation, decreased immune system function, lower core body temperature,
and decreased release of growth hormone. Both the neurocognitive and physiologic
effects of chronic sleep loss suggest there is optimal sleep duration and
a cost for failing to achieve it. However, the exact duration of sleep required
at different periods of life remains poorly understood, as do the mechanisms
driving these neural and metabolic processes.
Sleep-Disordered Breathing (SDB): The consequences of SDB (obstructive sleep apnea) have become increasingly
defined over the last few years. In adults, the contribution of SDB to the
development of systemic hypertension is becoming more evident and data are
accumulating that other adverse cardiovascular outcomes (stroke, congestive
heart failure, myocardial infarction) may result from this disorder. Co-existing
obesity can result in structural impairments impacting airway patency, creating
additional cardiovascular problems. In children, there is increasing evidence
that sleep apnea may contribute to behavioral problems as well as learning
and cognitive deficits.
Insomnia: The high prevalence, risk factors, and consequences of insomnia are being
increasingly defined. Insomnia has been identified as a risk factor for the
onset of subsequent depression, anxiety, and substance use disorders. In addition,
the efficacy and durability of behavioral therapies for insomnia have been
demonstrated in controlled clinical trials.
Sleep in Psychiatric, Alcohol, and Substance Use
Disorders: Most psychiatric and substance use disorders are associated with sleep
disruption. Alcohol dependence and use of other psychoactive substances lead
to complaints of insomnia and sleep disruption that can persist for months
into recovery. These sleep disturbances may result in continued alcohol and/or
drug use to alleviate symptoms, and thereby precipitate relapse. Psychiatric
disorders can also be associated with daytime sleepiness, fatigue, abnormal
circadian sleep patterns, disturbing dreams and nightmares. Conversely, increasing
evidence suggests that primary insomnia (without concurrent psychiatric disorder)
is a risk factor for later developing psychiatric disorders, particularly
depression, anxiety, and substance use disorders.
Most progress has been related to associations between
psychiatric disorders and various sleep symptoms (e.g., insomnia and nightmares),
sleep EEG patterns (e.g., delta EEG activity), and sleep disorders. Less progress
has been made in identifying fundamental pathophysiological mechanisms linking
psychiatric disorders and sleep. Sensitive and specific sleep biomarkers of
psychiatric disorders, for example, have not been validated. Similarly, endogenous
circadian rhythm disturbances have not been identified in most patients with
depression or other psychiatric disorders. Little is known about characteristics
or consequences of sleep disturbances in most childhood psychiatric disorders,
in children of alcohol or substance abusing mothers, or in children at high
risk for developing psychiatric and alcohol/substance abuse disorders. The
application of sleep and circadian rhythm therapies to psychiatric disorders
has been limited, and their efficacy not consistently demonstrated.
Clinical neuroscience studies are needed to investigate
the common mechanisms and consequences of disordered sleep (e.g., immune dysfunction)
in psychiatric and alcohol/substance dependent populations. Insomnia and sleep
disturbances are risk factors for psychiatric disorders including alcohol
dependence, but long-term follow-up studies have not yet been done to determine
whether intervention can reduce these risks and the progression of these disorders.
Pediatrics: Recent research regarding the physiologic, psychological and developmental
aspects of sleep in infants, children, and adolescents has contributed to
an increased understanding of the unique aspects of sleep and development.
The study of pediatric disorders such as Congenital Central Hypoventilation
Syndrome and Rett Syndrome has led to a better basic understanding of autonomic
regulation and respiratory control. Recent findings regarding the complex
relationship between sleep patterns and hormonal changes in adolescence have
broadened our understanding of pubertal influences on sleep and circadian
biology. The extent of sleep restriction and sleep disturbances among children
and adolescents is much greater than previously believed, and the consequent
impact on mood, neurobehavioral and academic functioning, safety, and health
is considerable. Recognition of the link between sleep disturbances and neurobehavioral
disorders in childhood, such as attention deficit hyperactivity disorder (ADHD),
has major public health implications for both the treatment and prevention
of psychiatric co-morbidity.
Sleep Education: A variety of recently implemented educational activities have substantial
potential impact on sleep literacy and public health. We need to consolidate
and extend the research progress made to date, and to translate new knowledge
into effective therapies and community-based dissemination and implementation
programs in order to apply what is known to improve public health and quality
of life.
Complementary and Alternative Medical Therapies
for Sleep Disorders: Many individuals use complementary and alternative medical (CAM) therapies
for sleep disorders. These therapies are often already in the public domain,
but have only recently been subjected to rigorous basic and clinical research
to determine efficacy, effectiveness, and mechanisms of action. Ongoing research
is determining efficacy of natural products such as valerian and melatonin
for specific sleep disorders. Other CAM approaches such as meditation, yoga,
and light therapy are also being investigated for their role in improving
sleep. Programs to educate health practitioners about the potential role of
evidenced-base CAM therapies for treating sleep disorders will in turn aid
in educating the public about both the benefits and risks of CAM therapies.
Sleep in Chronic Pain and Rheumatologic Disorders: Sleep and changes in sleep are related to various cellular, hormonal,
and immunological functions. Pain and other components of disease may influence
the sleep process and alter these parameters, thereby interacting with the
disease process. Correspondingly, many of the daytime symptoms in patients
with rheumatic diseases pain, stiffness, fatigue, and cognitive dysfunction
may be linked to non-restorative sleep patterns associated with these diseases.
Research is needed on the role of sleep, and the bi-directional interactions
between sleep and disease processes, in rheumatic diseases in humans and animal
models. Studies on effects of sleep and sleep dysfunction on relevant physiological
processes, and on disease progression, symptoms, and daily functioning are
needed. Effects of disease treatment (e.g., TNF alpha) on sleep should be
investigated. In addition, changes in disease-relevant parameters following
intervention studies targeting sleep or experimental manipulation of sleep
should be investigated, as should the relationship between sleep and pain,
especially in fibromyalgia.
Topics for research that would be responsive to
this Funding Opportunity Announcement (FOA) include, but are not limited to:
Neurobiology and functions of sleep and neurochemistry
of sleep/wake generating systems from fetal life across the full age spectrum,
including molecular, biochemical, anatomic and physiologic investigations.
Exploration of the physiologic basis for the restorative
function of sleep in maintenance of health.
Basic research on hypocretins to better define the
exact role of this system in the regulation of normal sleep and other behaviors.
Neurobiological mechanisms of the effects of sleep,
circadian regulation, sleep homeostasis, and sleep disorders on the aging
process and the diseases associated with late age.
Methods to measure sleep, circadian physiology, and
sleepiness across the age spectrum, including methods used in the home.
Psychological, behavioral , neurobiological, and physiological
consequences and underlying mechanisms of long-term partial sleep deprivation
from childhood through old age.
Recovery patterns following chronic partial sleep loss
and whether rates of recovery vary by age and/or for physiological, behavioral
and cognitive processes; identification of factors that facilitate recovery
and minimize long-term adverse consequences.
Epidemiologic, behavioral, physiologic or neurobiological
studies addressing relationships between the processes of sleep and the development
and progression of both neural and non-neural diseases.
Studies of the mechanisms by which sleep disturbances
affect adherence to treatments for chronic disease and ways that improving
sleep may improve treatment outcomes.
Improved understanding of the processes that lead to
specific sleep disorders in infants, children, and adults, including the aged
population.
Interventions to help children and adults adapt to
the sleep disturbance associated with homes, hospitals, critical care settings,
and nursing homes
Studies of sleep disturbance in children and adolescents
as a risk factor for the early onset of drinking, and the development of alcohol
abuse and dependence.
Studies of insomnia and hypersomnia as modifiable risk
factors for poor outcomes in mood, anxiety, and psychotic disorders, alcoholism,
and substance abuse disorders, including whether interventions can prevent
progression of these disorders and reduce risk for relapse in the alcohol
and substance abuse disorders.
Impact of sleep-disordered breathing (SDB) and its
treatment on functional status, psychiatric disorders, neurocognitive function
and behavior, and other disease processes.
Studies of disorders leading to hypersomnolence or
neural mechanisms leading to hypersomnolence in conditions such as narcolepsy
or primary central nervous system hypersomnolence, and how these mechanisms
may differ from or resemble the effects of sleep loss.
Studies of normal human sleep phenotypes and the normal
range of variation in children, adults and the aged (including racial and
ethnic disparities), and quantitative assessment of sleep variables such as
duration, sleep stage distribution and sleep quality.
Studies of sleep problems and disorders in children
related to chronic maternal use of alcohol, cigarette smoking, and narcotic
drugs.
Interrelationships between sleep and neuroendocrine
systems, including aging male and female populations.
Studies of the role of cytokines in sleep regulation
in psychiatric populations also at risk for infectious or inflammatory disorders,
and studies of cytokine antagonists in sleep-disturbed alcohol using populations
with evidence of immune activation.
New treatments for sleep disorders, including methods
to adapt these therapies to individual patients using approaches such as pharmacogenetics.
Basic and clinical research on complementary and alternative
medicine (CAM) therapies for sleep disorders. These could include, but are
not limited to mind/body therapies such as yoga and meditation; biological
based therapies such as herbal medicine; manipulative therapies such as chiropractic
manipulation; energy medicine such as Reiki and Qi gong; and therapies based
on traditional medical systems such as Traditional Chinese Medicine or naturopathic
medicine.
Assessment of outcomes of sleep disorder therapies,
including CAM therapies, at all levels including efficacy, adherence, effectiveness,
morbidity, quality of life, health care costs, safety, and performance/productivity.
Impact of sleep educational programs related to healthy
sleep habits and sleep literacy or to improved rates of diagnosis and treatment
of sleep disorders.
Assessment of physician and other health care provider
knowledge of sleep disorders and current treatment options, both CAM and conventional.
Applications of informatics to clinical, neurophysiologic,
imaging, and genetic studies as they apply to sleep and its disorders.
Neurophysiology of sleep regulation affecting risk
for and mechanisms of sleep disorders in women in relation to menarche, pregnancy,
or menopause.
Neurophysiological and neuroanatomical correlates and
gene-environment interactions contributing to racial and ethnic disparities
in prevalence and severity of individual sleep disorders, and strategies to
better inform racial and ethnic minority populations about sleep-related conditions
through public health education programs.
Sleep in neurodegenerative disorders including but
not restricted to Parkinson's disease.
Specifically, if you are a U.S. organization and
are submitting an application with direct costs in each year of $250,000 or
less (excluding consortium Facilities and Administrative [F&A]
costs), use the PHS398 Modular Budget component provided in the SF424 (R&R)
Application Package and SF424 (R&R) Application Guide (see specifically
Section 5.4, Modular Budget Component, of the Application Guide).
U.S. applicants requesting more than $250,000 in annual direct costs
and all foreign applicants must complete and submit budget requests using
the Research & Related Budget component found in the application package
for this FOA. See NOT-OD-06-096,
August 23, 2006.
2. Funds Available
Because the nature and scope of the proposed research will vary from application
to application, it is anticipated that the size and duration of each award
will also vary. Although the financial plans of the Institutes and Centers
(ICs) provide support for this program, awards pursuant to this funding opportunity
are contingent upon the availability of funds and the submission of a sufficient
number of meritorious applications.
NIH grants policies as described in the NIH Grants Policy
Statement will apply to the applications submitted and awards made
in response to this FOA.
F&A costs requested by consortium participants
are not included in the direct cost limitation. See NOT-OD-05-004,
November 2, 2004.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit an application(s) if your institution/organization
has any of the following characteristics:
Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher
Education)
Small Business; For-Profit Organization (Other than Small Business)
Other(s): Eligible agencies of the Federal government; Faith-based or community
based organizations
1.B. Eligible Individuals
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the PD/PI is invited to work
with his/her organization to develop an application for support. Individuals
from underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH support.
More than one PD/PI, or multiple
PDs/PIs, may be designated on the application for projects that require a
team science approach that clearly does not fit the single-PD/PI model. Additional
information on the implementation plans and policies and procedures to formally
allow more than one PD/PI on individual research projects is available athttp://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior
to the submission of the application (seehttp://era.nih.gov/ElectronicReceipt/preparing.htmfor instructions).
The decision of whether to apply for a single PD/PI or multiple
PD/PI grant is the responsibility of the investigators and applicant organizations
and should be determined by the scientific goals of the project. Applications
for multiple PD/PI grants will require additional information, as outlined
in the instructions below. The NIH review criteria for approach, investigators,
and environment have been modified to accommodate applications involving either
a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please
be aware that the structure and governance of the PD/PI leadership team as
well as the knowledge, skills and experience of the individual PD/PIs will
be factored into the assessment of the overall scientific merit of the application.
Multiple PDs/PIs on a project share the authority and responsibility for leading
and directing the project, intellectually and logistically. Each PD/PI
is responsible and accountable to the grantee organization, or, as appropriate,
to a collaborating organization, for the proper conduct of the project or
program, including the submission of required reports. For further information
on multiple PDs/PIs, please seehttp://grants.nih.gov/grants/multi_pi.
3. Other-Special Eligibility Criteria Applicants may submit more than one application,
provided each application is scientifically distinct.
Section
IV. Application and Submission Information
To download a SF424 (R&R) Application Package and
SF424 (R&R) Application Guide for completing the SF424 (R&R) forms
for this FOA, link to http://www.grants.gov/applicants/apply_for_grants.jsp
and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
If your organization does not have a Taxpayer Identification Number (TIN)
or Employer Identification Number (EIN), allow for extra time. A valid TIN
or EIN is necessary for CCR registration.
The CCR also validates the EIN against Internal Revenue Service records,
a step that will take an additional one to two business days.
Direct questions regarding Grants.gov registration to: Grants.gov Customer
Support
Contact Center Phone: 800-518-4726
Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
Email [email protected]
Direct questions regarding the Commons registration to:
eRA Commons Help Desk
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
Email [email protected]
The individual(s) designated as PDs/PIs on the
application must also be registered in the NIH eRA Commons. In the
case of multiple PDs/PIs, all PDs/PIs must be registered and be assigned
the PI role in the eRA Commons prior to the submission of the application.
Each PD/PI must hold a PD/PI account in the Commons. Applicants should not
share a Commons account for both an Authorized Organization Representative/
Signing Official (AOR/SO) role and a PD/PI role; however, if they have both
a PD/PI role and an Internet Assisted Review (IAR) role, both roles should
exist under one Commons account.
When multiple PDs/PIs are proposed, all PDs/PIs at the applicant organization
must be affiliated with that organization. PDs/PIs located at another
institution need not be affiliated with the applicant organization, but must
be affiliated with their own organization to be able to access the Commons.
This registration/affiliation must be done by the AOR/SO or their designee
who is already registered in the Commons.
Both the PD/PI(s) and AOR/SO need separate accounts
in the NIH eRA Commons, since both are authorized to view the application
image.
Note that if a PD/PI is also an NIH peer-reviewer with
an Individual DUNS and CCR registration, that particular DUNS number and CCR
registration are for the individual reviewer only. These are different than
any DUNS number and CCR registration used by an applicant organization. Individual
DUNS and CCR registration should be used only for the purposes of personal
reimbursement and should not be used on any grant applications submitted to
the Federal Government.
Several of the steps of the registration process could
take four weeks or more. Therefore, applicants should immediately check with
their business official to determine whether their organization/institution
is already registered in both Grants.gov and the Commons. The NIH will accept electronic
applications only from organizations that have completed all necessary registrations.
1. Request
Application Information
Applicants must download the SF424 (R&R) application
forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
Note: Only the forms package
directly attached to a specific FOA can be used. You will not be able to use
any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA),
although some of the "Attachment" files may be useable for more
than one FOA.
For further assistance, contact GrantsInfo: Telephone
301-710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Prepare all applications using the SF424 (R&R)
application forms and in accordance with the SF424
(R&R) Application Guide for this FOA through Grants.gov/Apply.
The SF424 (R&R) Application Guide is critical to
submitting a complete and accurate application to NIH. There are fields within
the SF424 (R&R) application components that, although not marked as mandatory,
are required by NIH (e.g., the Credential log-in field of the Research
& Related Senior/Key Person Profile component must contain the PD/PI’s
assigned eRA Commons User ID). Agency-specific instructions for such fields
are clearly identified in the Application Guide. For additional information,
see Frequently Asked Questions Application Guide, Electronic Submission
of Grant Applications.
The SF424 (R&R) application has several components.
Some components are required, others are optional. The forms package associated
with this FOA in Grants.gov/APPLYincludes all applicable components, required and optional. A completed
application in response to this FOA includes the data in the following components:
Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget or Research & Related Budget,
as appropriate
(See Section IV.6., Special Instructions, regarding appropriate required budget component.)
Research & Related Budget (required for foreign
applications)
Optional Components:
PHS398 Cover Letter File Research & Related Subaward Budget Attachment(s)
Form
Prepare detailed budgets for all applications (that
is, complete the Research & Related Budget component of the SF424
not the PHS398 Modular Budget component). SeeNOT-OD-06-096
Charge back of customs and import fees is not allowed.
Format: Every effort should be made to comply with the
format specifications, which are based upon a standard U.S. paper size of
8.5 x 11 within each PDF.
Funds for up to 8% administrative costs (excluding equipment)
may be requested. See NOT-OD-01-028,
March 29, 2001.
Organizations must comply with Federal/NIH policies
on human subjects, animals, and biohazards.
Organizations must comply with Federal/NIH biosafety
and biosecurity regulations. See Section VI.2., Administrative and National Policy
Requirements.
Proposed research should provide special opportunities
for furthering research programs through the use of unusual talent, resources,
populations, or environmental conditions in other countries that are not readily
available in the United States or that augment existing U.S. resources.
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one
PD/PI to be designated as the "Contact PI, who will be responsible for
all communication between the PDs/PIs and the NIH, for assembling the application
materials outlined below, and for coordinating progress reports for the project.
The contact PD/PI must meet all eligibility requirements for PD/PI status
in the same way as other PDs/PIs, but has no other special roles or responsibilities
within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered
in item 15 of the SF424 (R&R) Cover component. All other PDs/PIs
should be listed in the Research & Related Senior/Key Person component
and assigned the project role of PD/PI. Please remember that all PDs/PIs
must be registered in the eRA Commons prior to application submission. The
Commons ID of each PD/PI must be included in the Credential field of the
Research & Related Senior/Key Person component. Failure to include
this data field will cause the application to be rejected.
All projects proposing Multiple PDs/PIs will be required to include a new
section describing the leadership of the project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section
of the research plan, entitled Multiple PD/PI Leadership Plan (section 14
of the Research Plan Component in the SF424 (R&R) or Section I of the
Research Plan in the PHS 398), must be included. A rationale for choosing
a multiple PD/PI approach should be described. The governance and organizational
structure of the leadership team and the research project should be described,
including communication plans, process for making decisions on scientific
direction, and procedures for resolving conflicts. The roles and administrative,
technical, and scientific responsibilities for the project or program should
be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution
of resources to specific components of the project or the individual PDs/PIs
should be delineated in the Leadership Plan. In the event of an award, the
requested allocations may be reflected in a footnote on the Notice of Award.
Applications Involving a Single Institution
When all PDs/PIs are within a single institution, follow
the instructions contained in the SF424 (R&R) Application Guide.
Applications Involving Multiple Institutions
When multiple institutions are involved, one institution
must be designated as the prime institution and funding for the other institution(s)
must be requested via a subcontract to be administered by the prime institution.
When submitting a detailed budget, the prime institution should submit its
budget using the Research & Related Budget component. All other institutions
should have their individual budgets attached separately to the Research &
Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424
(R&R) Application Guide for further instruction regarding the use of the
subaward budget form.
When submitting a modular budget, the prime institution
completes the PHS398 Modular Budget component only. Information concerning
the consortium/subcontract budget is provided in the budget justification.
Separate budgets for each consortium/subcontract grantee are not required
when using the Modular budget format. See Section 5.4 of the Application Guide
for further instruction regarding the use of the PHS398 Modular Budget component.
A letter of intent is not required for the funding opportunity.
3.B. Submitting an Application
Electronically to the NIH
To submit an application in response to this FOA, applicants should access
this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp
and follow steps 1-4. Note: Applications must only be submitted electronically.
PAPER APPLICATIONS WILL NOT BE ACCEPTED.
3.C. Application Processing
Applications may be submitted on or after
the opening date and must be successfully received by Grants.gov no
later than 5:00 p.m. local time (of the applicant
institution/organization) on the application
submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application
is not submitted by the receipt date(s) and time, the application may be delayed
in the review process or not reviewed.
Once an application package has been successfully submitted
through Grants.gov, any errors have been addressed, and the assembled application
has been created in the eRA Commons, the PD/PI and the Authorized Organization
Representative/Signing Official (AOR/SO) have two business days to view the
application image.
If everything is acceptable, no further action is
necessary. The application will automatically move forward for processing
by the Division of Receipt and Referral, Center for Scientific Review, NIH,
after two business days.
Prior to the submission deadline, the AOR/SO can
Reject the assembled application and submit a changed/corrected application
within the two-day viewing window. This option should be used if the AOR/SO
determines that warnings should be addressed or if information was lost or
compromised during transmission. Reminder: warnings do not stop further application
processing. If an application submission results in warnings (but no errors),
it will automatically move forward after two business days if no action is
taken. Please remember that some warnings may not be applicable or may need
to be addressed after application submission.
If the two-day window falls after the submission
deadline, the AOR/SO will have the option to Reject the application if,
due to an eRA Commons or Grants.gov system issue, the application does not
correctly reflect the submitted application package (e.g., some part of the
application was lost or didn t transfer correctly during the submission process).
The AOR/SO should first contact the eRA
Commons Helpdesk to confirm the system error, document the issue, and
determine the best course of action. NIH will not penalize the applicant for
an eRA Commons or Grants.gov system issue.
If the AOR/SO chooses to Reject the image after
the submission deadline for a reason other than an eRA Commons or Grants.gov
system failure, a changed/corrected application still can be submitted, but
it will be subject to the NIH
late policy guidelines and may not be accepted. The reason for this delay
should be explained in the cover letter attachment.
Both the AOR/SO and PD/PI will receive e-mail notifications
when the application is rejected or the application automatically moves forward
in the process after two days.
Upon receipt, applications
will be evaluated for completeness by the Center for Scientific Review, NIH.
Incomplete applications will not be reviewed.
There will be an acknowledgement of receipt of
applications from Grants.gov and the Commons. The submitting AOR receives
the Grants.gov acknowledgments. The AOR and the PI receive Commons acknowledgments.
Information related to the assignment of an application to a Scientific Review
Group is also in the Commons.
Note: Since email can be unreliable, it is the responsibility
of the applicant to check periodically on their application status in the
Commons.
The NIH will not accept any application in response to
this FOA that is essentially the same as one currently pending initial merit
review unless the applicant withdraws the pending application. The NIH will
not accept any application that is essentially the same as one already reviewed.
This does not preclude the submission of an application already reviewed with
substantial changes, but such application must include an Introduction addressing
the previous critique. Note such an application is considered a "resubmission"
for the SF424 (R&R).
All NIH awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH
Grants Policy Statement.
Pre-award costs are allowable.
A grantee may, at its own risk and without NIH prior approval, incur obligations
and expenditures to cover costs up to 90 days before the beginning date of
the initial budget period of a new or competing renewal (formerly competing
continuation ) award if such costs: are necessary to conduct the project,
and would be allowable under the grant, if awarded, without NIH prior approval.
If specific expenditures would otherwise require prior approval, the grantee
must obtain NIH approval before incurring the cost. NIH prior approval is
required for any costs to be incurred more than 90 days before the beginning
date of the initial budget period of a new or competing renewal award.
The incurrence of pre-award costs in anticipation
of a competing or non-competing award imposes no obligation on NIH either
to make the award or to increase the amount of the approved budget if an award
is made for less than the amount anticipated and is inadequate to cover the
pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award
costs result in borrowing against future support and that such borrowing must
not impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.
See the NIH Grants
Policy Statement.
6. Other Submission Requirements
PD/PI Credential (e.g., Agency Login)
The NIH requires the PD/PI(s) to fill in his/her Commons
User ID in the PROFILE Project Director/Principal Investigator section,
Credential log-in field of the Research & Related Senior/Key Person
Profile component.
Organizational DUNS
The applicant organization
must include its DUNS number in its Organization Profile in the eRA Commons.
This DUNS number must match the DUNS number provided at CCR registration with
Grants.gov. For additional information, see Frequently Asked Questions
Application Guide, Electronic Submission
of Grant Applications.
PHS398 Research Plan Component Sections
Items 2-5 of the PHS398 Research Plan component are limited
to 25 pages. While each section of the Research Plan component needs to be
uploaded separately as a PDF attachment, applicants are encouraged to construct
the Research Plan component as a single document, separating sections into
distinct PDF attachments just before uploading the files. This approach will
enable applicants to better monitor formatting requirements such as page limits.
All attachments must be provided to NIH in PDF format, filenames must be included
with no spaces or special characters, and a .pdf extension must be used.
All application instructions outlined in the SF424 (R&R)
Application Guide are to be followed, incorporating "Just-in-Time"
information concepts, and with the following additional requirements:
R01 applications from U.S.
institutions/organizations requesting up to $250,000 per year in direct costs
(excluding consortium F&A costs) must be submitted in a modular budget
format. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm. When
submitting a modular budget, the applicant organization will include only
the PHS398 Modular Budget component. See Section 5.4 of the SF424
(R&R) Application Guide for further instructions regarding the use of
the PHS398 Modular Budget component.
Foreign organizations may not submit modular budgets.
See NOT-OD-06-096.
Special Instructions
for Applications Requesting $500,000 (direct costs) or More Per Year
Applicants requesting $500,000
or more in direct costs for any year (excluding consortium F&A costs)
must carry out the following steps:
1) Contact the IC program staff at least 6 weeks
before submitting the application, i.e., as you are developing plans for the
study;.
2) Obtain agreement from the IC
staff that the IC will accept your application for consideration for award;
and,.
3) Include the PHS398 Cover Letter component with the application to identify
the staff member and IC who agreed to accept assignment of the application.
This policy applies to all new applications, competing
renewal (formerly competing continuation ) applications, resubmission (formerly
revised/amended ) applications, and revision (formerly competing supplemental )
applications. See NOT-OD-02-004,
October 16, 2001.
APPENDIX MATERIALS
IMPORTANT NOTE: NIH
has published new limitations on grant application appendix materials to encourage
applications to be as concise as possible while containing the information
needed for expert scientific review.
Do not use the Appendix to circumvent the page limitations
of the Research Plan component. An application that does not observe the required
page limitations may be delayed in the review process.
Note: While each section of the PHS398 Research Plan component
needs to be uploaded separately as a PDF attachment, applicants are encouraged
to construct the Research Plan component as a single document, separating
sections into distinct PDF attachments just before uploading the files. This
approach will enable applicants to monitor better formatting requirements
such as page limits. All attachments must be provided to NIH in PDF format,
filenames must be included with no spaces or special characters, and a .pdf
extension must be used.
Indicate how the proposed project has specific relevance
to the mission and objectives of the IC and has the potential for significantly
advancing the health sciences in the United States.
Plan for Sharing Research Data
The precise content of the
data-sharing plan will vary, depending on the data being collected and how
the investigator is planning to share the data. Applicants who are planning
to share data may wish to describe briefly the expected schedule for data
sharing, the format of the final dataset, the documentation to be provided,
whether or not any analytic tools also will be provided, whether or not a
data-sharing agreement will be required and, if so, a brief description of
such an agreement (including the criteria for deciding who can receive the
data and whether or not any conditions will be placed on their use), and the
mode of data sharing (e.g., under their own auspices by mailing a disk or
posting data on their institutional or personal Web site, through a data archive
or enclave). Investigators choosing to share under their own auspices may
wish to enter into a data-sharing agreement. References to data sharing may
also be appropriate in other sections of the application.
Applicants requesting more than $500,000 in direct
costs in any year of the proposed research must include a plan for sharing
research data in their application. The funding organization will be responsible
for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).
The reasonableness of the data sharing plan or the
rationale for not sharing research data may be assessed by the reviewers.
However, reviewers will not factor the proposed data sharing plan into the
determination of scientific merit or the priority score.
Sharing Research Resources
NIH policy expects that grant
recipients make unique research resources readily available for research purposes
to qualified individuals within the scientific community after publication
(See the NIH Grants Policy Statementhttp://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The effectiveness
of the resource sharing will be evaluated as part of the administrative review
of each Non-Competing Grant
Progress Report (PHS 2590). See Section VI.3., Reporting.
Section V.
Application Review Information
1. Criteria
Only the review criteria described below will be considered
in the review process.
2. Review and Selection Process
Applications submitted for this funding opportunity
will be assigned to the ICs on the basis of established PHS referral guidelines.
Appropriate scientific review groups convened in accordance
with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm)
will evaluate applications for scientific and technical merit.
As part of the initial merit review, all applications will:
Undergo a selection process in which only those applications
deemed to have the highest scientific merit, generally the top half of applications
under review, will be discussed and assigned a priority score.
Receive a written critique.
Receive a second level of review by the appropriate national advisory council or board.
Applications submitted in response
to this funding opportunity will compete for available funds with all other
recommended applications. The following will be considered in making funding
decisions:
Scientific merit of the proposed project as determined
by peer review.
Availability of funds.
Relevance of program priorities.
The goals of NIH supported research are to advance our
understanding of biological systems, to improve the control of disease, and
to enhance health. In their written critiques, reviewers will be asked to
comment on each of the following criteria 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.
Significance
Approach
Innovation
Investigator
Environment
Note that an 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 scientific health problem?
If the aims of the application are achieved, how will scientific knowledge
or clinical practice be advanced? What will be the effect of these studies
on the concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?
Approach: Are the conceptual or clinical framework, design, methods,
and analyses adequately developed, well-integrated, well-reasoned, and appropriate
to the aims of the project? Does the applicant acknowledge potential problem
areas and consider alternative tactics? For applications designating multiple PDs/PIs, is the leadership
approach, including the designated roles and responsibilities, governance,
and organizational structure, consistent with and justified by the aims of
the project and the expertise of each of the PDs/PIs?
Innovation: Is the project original and innovative? For example: Does the
project challenge existing paradigms or clinical practice; address an innovative
hypothesis or critical barrier to progress in the field? Does the project
develop or employ novel concepts, approaches, methodologies, tools, or technologies
for this area?
Investigators:
Are the PD/PI(s) and other key personnel appropriately
trained and well suited to carry out this work? Is the work proposed appropriate
to the experience level of the PD/PI(s) and other researchers? Do the PD/PI(s)
and investigative team bring complementary and integrated
expertise to the project (if applicable)?
Environment: Do(es) the scientific environment(s) in which the work will
be done contribute to the probability of success? Do the proposed studies
benefit from unique features of the scientific environment, or subject populations,
or employ useful collaborative arrangements? Is there evidence of institutional
support?
2.A. Additional Review Criteria
Resubmission Applications (formerly revised/amended
applications): Are the responses to comments from the previous scientific
review group adequate? Are the improvements in the resubmission application
appropriate?
Protection of Human Subjects from Research Risk:
The involvement of human subjects and protections from research risk relating
to their participation in the proposed research will be assessed. See the
Human Subjects Sections of the PHS398 Research Plan component of the SF424
(R&R).
Inclusion of Women, Minorities and Children in Research: The adequacy
of plans to include subjects from both genders, all racial and ethnic groups
(and subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated. See the Human Subjects Sections of the PHS398 Research
Plan component of the SF424 (R&R).
Care and Use of Vertebrate Animals in Research: If vertebrate animals
are to be used in the project, the adequacy of the plans for their care and
use will be assessed. See the Other Research Plan Sections of the PHS398
Research Plan component of the SF424 (R&R).
Biohazards: If materials or procedures are proposed that are potentially
hazardous to research personnel and/or the environment, determine if the proposed
protection is adequate.
2.B. Additional Review Considerations
Budget and Period of Support:. The reasonableness of the proposed budget and the appropriateness
of the requested period of support in relation to the proposed research may
be assessed by the reviewers. The priority score should not be affected by
the evaluation of the budget.
Applications from Foreign Organizations: Whether
the project presents special opportunities for furthering research programs
through the use of unusual talent, resources, populations, or environmental
conditions in other countries that are not readily available in the United
States or that augment existing U.S. resources will be assessed.
2.C. Sharing Research Data
Data Sharing Plan: The reasonableness of the data sharing plan or the rationale
for not sharing research data may be assessed by the reviewers. However, reviewers
will not factor the proposed data sharing plan into the determination of scientific
merit or the priority score. The funding organization will be responsible
for monitoring the data sharing policy http://grants.nih.gov/grants/policy/data_sharing.
2.D. Sharing Research Resources
NIH policy expects that grant recipients make unique
research resources readily available for research purposes to qualified individuals
within the scientific community after publication (See the NIH Grants Policy
Statementhttp://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
Program staff will be responsible for the administrative review of the plan
for sharing research resources.
The adequacy of the resources sharing
plan and any related data sharing plans will be considered by Program staff
of the funding organization when making recommendations about funding applications.
The effectiveness of the resource sharing will be evaluated as part of the
administrative review of each Non-Competing Grant
Progress Report (PHS 2590), See Section VI.3.,
Reporting.
Model Organism Sharing Plan: Reviewersare
asked to assess the sharing plan in an administrative note. The sharing plan
itself should be discussed after the application is scored. Whether a sharing
plan is reasonable can be determined by the reviewers on a case-by-case basis,
taking into consideration the organism, the timeline, the applicant's decision
to distribute the resource or deposit it in a repository, and other relevant
considerations.
3. Anticipated Announcement and Award Dates
Not Applicable
Section
VI. Award Administration Information
1. Award Notices
After the peer review of the application is completed, the PD/PI will be able
to access his or her Summary Statement (written critique) via the NIH eRA
Commons.
A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via
email notification from the awarding component to the grantee business official.
Selection of an application for award is not an authorization
to begin performance. Any costs incurred before receipt of the NoA are at
the recipient's risk. These costs may be reimbursed only to the extent considered
allowable pre-award costs. See Section IV.5., Funding Restrictions.
2. Administrative and National
Policy Requirements
We encourage your inquiries
concerning this funding opportunity and welcome the opportunity to answer
questions from potential applicants. Inquiries may fall into three areas:
scientific/research, peer review, and financial or grants management issues:
1. Scientific/Research Contact(s):
Michael Twery, Ph.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 10116
Bethesda, MD 20892-7952
Telephone: (301) 435-0202
Email: [email protected]
Andrew A. Monjan, Ph.D., M.P.H.
Neuroscience and Neuropsychology of Aging Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 350
Bethesda, MD 20892-9205
Telephone: (301) 496-9350
Email: [email protected]
Ellen D. Witt, Ph.D.
Division of Neuroscience and Behavior
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2063
Bethesda, MD 20892-9304
Telephone: (301) 443-6545
Email: [email protected]
Ann O'Mara, Ph.D., R.N.
Program Director, Symptom Management/End of Life
Community Clinical Oncology Program (CCOP)
National Cancer Institute
6130 Executive Blvd., EPN 2010
Bethesda, MD 20892-7340
Telephone: (301) 496-8541
Email: [email protected]
Lynne M. Haverkos, M.D., M.P.H.
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
6100 Executive Blvd., Room 4B05
Bethesda, MD. 20892-7510
Telephone: (301) 435-6881
Email: [email protected]
Nancy Pearson, Ph.D.
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd., Room 401
Bethesda, MD 20892-5475
Telephone: (301) 594-0519
Email: [email protected]
Harold Gordon, Ph.D.
Division of Clinical Neuroscience and Behavioral Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3168, MSC 9593
Bethesda, MD 20892-9593
Telephone: (301) 443-4877
Email: [email protected]
William T. Riley, Ph.D.
Behavior Change Program Chief
National Institute of Mental Health
6001 Executive Blvd., Room 6226
Bethesda, MD 20892-9615
Telephone: (301) 435-0301
Email: [email protected]
Merrill M. Mitler, Ph.D.
Division of Extramural Research
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd, Room 2116
Bethesda, MD 20892-9521
Telephone: (301) 496-9964
Email: [email protected]
Kathy Mann Koepke, Ph.D.
Division of Extramural Activities
National Institute of Nursing Research
6701 Democracy Blvd, Ste. 710
Bethesda, MD 20892-4870
Telephone: (301) 496-9623
Email: [email protected]
Eleanor Z. Hanna, Ph.D.
Office of Research on Women's Health
Office of the Director
6120 Executive Boulevard, Room 150A
Bethesda, MD 20892-7116
Telephone: (301) 435-1573
Email: [email protected]
2. Peer Review Contact(s):
Not Applicable
3. Financial/Grants Management Contact(s):
Bob Pike
Lung Team Section Chief
Grants Operations Branch
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7152
Bethesda, MD 20892-7926
Telephone (301) 435-0182
Email: [email protected]
Deborah Stauffer
Lead Grants Management Specialist
National Institute on Aging
7201 Wisconsin Ave. Suite 2N212
Bethesda, MD 20892-9205
Telephone: (301) 496-1472
Email: [email protected]
Judy Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3023
Bethesda, MD 20892-9304
Telephone: (301) 443-4704
Email: [email protected]
Penny Jones
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, EPS Suite 243
Bethesda, MD 20892-7150
Telephone: (301) 496-3197
Email: [email protected]
Stuart Tate
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17
Bethesda, MD 20892-7510
Telephone: (301) 435-6999
Email: [email protected]
George Tucker
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd, Suite 401
Bethesda, MD 20892-5475
Telephone: (301) 594-0519
Email: [email protected]
Pamela Fleming
Grants Management Branch
National Institute on Drug Abuse
6101 Executive Boulevard, Suite 270
Bethesda, MD 20892-8403
Telephone: (301) 435-1369
Email: [email protected]
Rebecca D. Claycamp, CRA
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6122
Bethesda, MD 20892-9605
Telephone: (301) 443-2811
Email: [email protected]
Dianna Jessee
Grants Management Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd., Room 3290
Bethesda, MD 20892-9531
Telephone: (301) 496-9231
Email: [email protected]
Lawrence Haller
Office of Grants/Contract Management
National Institute of Nursing Research, NIH
6701 Democracy Blvd, Room 710
Bethesda, MD 20892-4870
Telephone: (301) 402-1878
Email: [email protected]
Terri Kendrix
Office of Research on Women's Health
Office of the Director
6120 Executive Boulevard, Room 150A
Bethesda, MD 20892-7116
Telephone: (301) 435-6724
Email: [email protected]
Human Subjects Protection: Federal regulations (45 CFR 46) require that applications
and proposals involving human subjects must be evaluated with reference to
the risks to the subjects, the adequacy of protection against these risks,
the potential benefits of the research to the subjects and others, and the
importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan: Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative
trials (Phase III). Monitoring should be commensurate with risk. The establishment
of data and safety monitoring boards (DSMBs) is required for multi-site clinical
trials involving interventions that entail potential risks to the participants
( NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and
Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data: Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include
a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their institutions,
on issues related to institutional policies and local IRB rules, as well as
local, State and Federal laws and regulations, including the Privacy Rule.
Reviewers will consider the data sharing plan but will not factor the plan
into the determination of the scientific merit or the priority score.
Access to Research Data through
the Freedom of Information Act: The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are (1) first
produced in a project that is supported in whole or in part with Federal funds
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity
in a public archive, which can provide protections for the data and manage
the distribution for an indefinite period of time. If so, the application
should include a description of the archiving plan in the study design and
include information about this in the budget justification section of the
application. In addition, applicants should think about how to structure informed
consent statements and other human subjects procedures given the potential
for wider use of data collected under this award.
Sharing of Model Organisms: NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model organisms
for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors
to elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH
Grants Policy Statement. Beginning October 1, 2004, all investigators
submitting an NIH application or contract proposal are expected to include
in the application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to
a cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.
Inclusion of Women And Minorities in Clinical Research: It is the policy of the NIH that women and members
of minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating 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 clinical research should read the "NIH Guidelines for Inclusion
of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new
OMB standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the SF424 (R&R) application; and updated roles
and responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: (a)
all applications or proposals and/or protocols must provide a description
of plans to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and (b) investigators
must report annual accrual and progress in conducting analyses, as appropriate,
by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical
Research: The NIH maintains a policy that children (i.e., individuals
under the age of 21) must be included in all clinical research, conducted
or supported by the NIH, unless there are scientific and ethical reasons not
to include them.
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 (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject
Participants: NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key personnel.
The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC): Criteria for federal funding of research on hESCs
can be found at http://stemcells.nih.gov/index.asp
and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research. Applications that do not provide this
information will be returned without review.
NIH Public Access Policy: NIH-funded investigators are requested to submit to
the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov/)
at PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole
or in part with direct costs from NIH. The author's final manuscript is defined
as the final version accepted for journal publication, and includes all modifications
from the publishing peer review process.
NIH is requesting that authors submit manuscripts
resulting from 1) currently funded NIH research projects or 2) previously
supported NIH research projects if they are accepted for publication on or
after May 2, 2005. The NIH Public Access Policy applies to all research grant
and career development award mechanisms, cooperative agreements, contracts,
Institutional and Individual Ruth L. Kirschstein National Research Service
Awards, as well as NIH intramural research studies. The Policy applies to
peer-reviewed, original research publications that have been supported in
whole or in part with direct costs from NIH, but it does not apply to book
chapters, editorials, reviews, or conference proceedings. Publications resulting
from non-NIH-supported research projects should not be submitted.
For more information about the Policy or the submission
process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov//
and view the Policy or other Resources and Tools, including the Authors' Manual.
Standards for Privacy of Individually Identifiable
Health Information: The Department of Health and Human Services (HHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information", the "Privacy Rule", on August
14, 2002. The Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection
of individually identifiable health information, and is administered and enforced
by the HHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/) provides
information on the Privacy Rule, including a complete Regulation Text and
a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and research
contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be
self-contained within specified page limitations. For publications listed
in the appendix and/or Progress report, Internet addresses (URLs) or PubMed
Central (PMC) submission identification numbers must be used for publicly
accessible on-line journal articles. Publicly accessible on-line journal
articles or PMC articles/manuscripts accepted for publication that are directly
relevant to the project may be included only as URLs or PMC
submission identification numbers accompanying the full reference in either
the Bibliography & References Cited section, the Progress Report Publication
List section, or the Biographical Sketch section of the NIH grant application.
A URL or PMC submission identification number citation may be repeated in
each of these sections as appropriate. There is no limit to the number of
URLs or PMC submission identification numbers that can be cited.
Healthy People 2010: The Public Health Service (PHS) is committed to achieving
the health promotion and disease prevention objectives of "Healthy People
2010," a PHS-led national activity for setting priority areas. This PA
is related to one or more of the priority areas. Potential applicants may
obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations: This program is described in the Catalog of
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements
of Executive Order 12372 or Health Systems Agency review. Awards are made
under the authorization of Sections 301 and 405 of the Public Health Service
Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part
52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions,
cost principles, and other considerations described in the NIH Grants
Policy Statement.
The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the 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.
Loan Repayment Programs: NIH encourages applications for educational loan repayment
from qualified health professionals who have made a commitment to pursue a
research career involving clinical, pediatric, contraception, infertility,
and health disparities related areas. The LRP is an important component of
NIH's efforts to recruit and retain the next generation of researchers by
providing the means for developing a research career unfettered by the burden
of student loan debt. Note that an NIH grant is not required for eligibility
and concurrent career award and LRP applications are encouraged. The periods
of career award and LRP award may overlap providing the LRP recipient with
the required commitment of time and effort, as LRP awardees must commit at
least 50% of their time (at least 20 hours per week based on a 40 hour week)
for two years to the research. For further information, please see: http://www.lrp.nih.gov/.
IMPORTANT NOTE: NIH
has published new limitations on grant application appendix materials to encourage
applications to be as concise as possible while containing the information
needed for expert scientific review.
