Part I Overview Information


Department of Health and Human Services

Participating Organizations
 National Institutes of Health (NIH), (http://www.nih.gov)  

Components of Participating Organizations     
National Heart, Lung, and Blood Institute (NHLBI), ( http://www.nhlbi.nih.gov/)
National Center on Sleep Disorders Research (NCSDR), (http://www.nhlbi.nih.gov/sleep)
National Institute on Aging (NIA), (http://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov/)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), (http://www.niams.nih.gov/)
National Cancer Institute (NCI), (http://www.nci.nih.gov/)
National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov/)
National Center for Complementary and Alternative Medicine (NCCAM), (http://www.nccam.nih.gov/)
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov/)
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov/)
National Institute of Nursing Research (NINR), (http://www.ninr.nih.gov/)
Office of Research on Women's Health (ORWH), (http://www4.od.nih.gov/orwh/)

Title:  Research on Sleep and Sleep Disorders (R01)

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  

Key Dates
Release/Posted Date: December 12, 1006
Opening Date: January 5, 2007 (Earliest date an application may be submitted to Grants.gov) Letters of Intent Receipt Date(s): Not Applicable. 
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). 
Application Submission/Receipt Date(s):  Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm  
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward 
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: July 6, 2008

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives


Section II. Award Information
1. Mechanism of Support
2. Funds Available

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

Section VI. Award Administration Information
1. Award Notices

2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contacts
1. Scientific/Research Contact(s)

2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

The three broad categories of sleep-related disorders include:

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.

Sleep in neuropathic pain conditions.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This FOA will use the NIH Research Project Grant (R01) award mechanism.   

The applicant will be solely responsible for planning, directing, and executing the proposed project.  

This FOA uses “Just-in-Time” information concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm).

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 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:

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 at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for 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 see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

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:

PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1)  Organizational/Institutional Registration in Grants.gov/Get Registered

2)  Organizational/Institutional Registration in the eRA Commons

3)  Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

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 301-435-0714, Email: GrantsInfo@nih.gov.

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/APPLY includes 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

Foreign Organizations (Non-domestic (non-U.S.) Entity)

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600260.

Applications from foreign organizations must:

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.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates

Opening Date: January 5, 2007 (Earliest date an application may be submitted to Grants.gov)

Application Submission/Receipt Date(s):  Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward  

3.A.1. Letter of Intent

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.

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).

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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:

Special Instructions for Modular Grant applications

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

Stop Sign 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.

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

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.

Foreign Applications (Non-domestic (non-U.S.) Entity)

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 Statement  http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.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:

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:

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.

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 Statement  http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.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: Reviewers are 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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

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

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts


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: 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 350
Bethesda, MD 20892-9205
Telephone: (301) 496-9350
Email: monjana@nia.nih.gov

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: ewitt@mail.nih.gov

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: ao45s@nih.gov

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: haverkol@mail.nih.gov

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: pearsonn@mail.nih.gov

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: hg23r@nih.gov

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: wiriley@mail.nih.gov

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: mitlerm@ninds.nih.gov

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: KoepkeK@mail.nih.gov

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: hannae@od.nih.gov

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: piker@nhlbi.nih.gov

Deborah Stauffer
Lead Grants Management Specialist
National Institute on Aging
7201 Wisconsin Ave. Suite 2N212
Bethesda, MD 20892-9205
Telephone: (301) 496-1472
Email: stauffed@mail.nih.gov

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: jfox@mail.nih.gov

Penny Jones
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, EPS Suite 243
Bethesda, MD 20892-7150
Telephone: (301) 496-3197
Email: jonespen@mail.nih.gov

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:  tatestua@mail.nih.gov

George Tucker
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd, Suite 401
Bethesda, MD 20892-5475
Telephone: (301) 594-0519
Email: tuckerg@mail.nih.gov

Pamela Fleming
Grants Management Branch
National Institute on Drug Abuse
6101 Executive Boulevard, Suite 270  
Bethesda, MD 20892-8403
Telephone: (301) 435-1369
Email: pfleming@nida.nih.gov

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: rc253d@nih.gov

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: jesseed@ninds.nih.gov

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: HALLERL@mail.nih.gov

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: kendrixt@od.nih.gov

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

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/.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.