Research on the Mental Health of Older Adults with Serious Mental Illness (R01 Clinical Trial Required)

Research on the Mental Health of Older Adults with Serious Mental Illness (R01 Clinical Trial Required) is sponsored by National Institute of Mental Health (NIMH). This NOFO will solicit applications for research focused on the optimization, delivery, sustainability, and effectiveness of empirically-supported interventions for addressing the mental health needs of older adults with serious mental illness (SMI).

Expired PA-06-422: Clinical Research on Mental Illnesses in Older Adults (R01) This notice has expired. Check the NIH Guide for active opportunities and notices. Part I Overview Information of Health and Human Services Participating Organizations National Institutes of Health (NIH) ( http://www.

nih. gov ) Components of Participating Organizations National Institute of Mental Health (NIMH) ( http://www. nimh.

nih. gov ) Title: Clinical Research on Mental Illnesses in Older Adults (R01) This is a reissue of PA-03-014 , which was previously issued on October 22, 2002. Update: The following update relating to this announcement has been issued: December 13, 2006 - The R01 portion of this funding opportunity has been replaced by PA-07-163 , which now uses the electronic SF424 (R&R) application for February 5, 2007 submission dates and beyond.

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government, during FY 2006 the NIH will gradually transition each research grant mechanism to electronic submission through Grants. gov and the use of the SF 424 Research and Related (R&R) forms.

Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications electronically using Grants. gov. For more information and an initial timeline, see http://era. nih.

gov/ElectronicReceipt/ . NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts ( http://grants. nih.

gov/grants/guide/index. html ). Specific funding opportunity announcements will also clearly indicate if Grants.

gov submission and the use of the SF424 (R&R) is required. Investigators should consult the NIH Forms and Applications Web site ( http://grants. nih.

gov/grants/forms. htm ) for the most current information when preparing a grant Announcement (PA) Number: PA-06-422 Catalog of Federal Domestic Assistance Number(s) Date(s): Standard dates apply, please see http://grants1. nih.

gov/grants/funding/submissionschedule. htm for details. AIDS Application Receipt Dates(s): Not applicable.

Peer Review Date(s):See http://grants1. nih. gov/grants/funding/submissionschedule.

htm#reviewandaward . Date(s):See http://grants1. nih.

gov/grants/funding/submissionschedule. htm#reviewandaward . Start Date(s): See http://grants1.

nih. gov/grants/funding/submissionschedule. htm#reviewandaward .

To Be Available Date (Url Activation Date): Not applicable. Expiration Date for R01 Non-AIDS Applications : November 2, 2006 Expiration Date for R01 AIDS and AIDS-Related Applications : January 3, 2007 purpose of this Funding Opportunity Announcement is to invite grant applications for clinical research that will reduce the burden of mental illnesses on older adults.

NIMH has a long-standing commitment to studying mental illnesses in older individuals.

The intent of this Funding Opportunity Announcement is to intensify investigator-initiated research in this area, to attract new investigators to the field, and to enhance interdisciplinary FOA will use the NIH Research Project Grant (R01) but grant applications under the NIH Exploratory/Developmental Grant Program (R21); the NIH Small Research Grant Program (R03) and the NIMH’s Clinical Exploratory Research Grant Program (R34) are also solicited.

Applicants for the R21, R03, and R34 mechanisms must submit their applications electronically and should respond to the NIH Parent FOA for Exploratory/Developmental Grants (R21- PA-06-181 ); for Small Research Grants (R03- PA-06-180 ); or the NIMH Clinical Exploratory Grant (R34- PA-06-248 ), while mentioning this specific FOA in their abstract.

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 organizations include: For profit organizations; Non-profit organizations; Public or private institutions, such as universities, colleges, hospitals and laboratories; Units of State government; Units of local government; Eligible institutions of the Federal government; Domestic institutions; Foreign institutions; Faith-based or community-based organizations; ; Indian/Native American Tribal Government (Federally Recognized); Indian/Native American Tribal Government (Other than Federally Recognized); and Indian/Native American Tribally Designated Organization.

project directors/principal investigators (PD/PIs) include any individual with the skills, knowledge and resources necessary to carry out the proposed research is invited to work with their institution 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.

may submit more than one application, provided they are scientifically Section IV. 1 for application materials. for the hearing impaired is available at: TTY 301-451-5936.

Part II Full Text of Announcement Section I. Funding Opportunity Section II. Award Information 2.

Cost Sharing or Matching 3. Other - Special Eligibility Criteria Section IV. Application and 1.

Request Application Information 2. Content and Form of Application Submission 3. Submission Dates and Times A.

Submission, Review and B. Sending an Application to the NIH C. Application Processing 4.

Intergovernmental Review 6. Other Submission Requirements Section V. Application Review 2.

Review and Selection Process A. Additional Review Criteria B. Additional Review Considerations D.

Sharing Research Resources 3. Anticipated Announcement and Award Dates Section VI. Award Administration 2.

Administrative and National Policy Section VII. Agency Contact(s) 1. Scientific/Research Contact(s) 2.

Peer Review Contact(s) 3. Financial/ Grants Management Contact(s) Section VIII. Other Information - Required Federal Citations - Full Text of Announcement Section I.

Funding Opportunity Description National Institute of Mental Health (NIMH) invites grant applications for clinical research that will reduce the burden of mental illnesses on older adults. NIMH has a long-standing commitment to geriatric mental health research, which is supported by several components of the Institute.

The greatest concentration of clinical studies of mental illnesses in older individuals, which is the focus of this announcement, is based programmatically in the Geriatrics Research Branch. With a review of the Branch’s late-life research portfolio, NIMH has identified opportunities for enhancing and strengthening its investment in late-life research.

The intent of this Funding Opportunity Announcement is to intensify investigator-initiated research in this area, to attract new investigators to the field, and to enhance interdisciplinary approaches to research. The United States has a larger number of older adults than at any other time in its history, and this number is rapidly increasing. As of July 2003, U.S. Census estimates project that 35.

9 million Americans are 65 years of age or older, comprising 12. 3 percent of the population. By 2030, the number of older adults will have increased to over 71.

5 million doubling the current size of this age group and making older adults roughly 20 percent of the U.S. population. This rapid increase in our aging adult cohort creates an increased need to understand and reduce the public health burden of mental illnesses on older Americans.

Through its Geriatrics Research Branch, NIMH supports a broad portfolio of clinical research relating to major mental disorders in late life , which includes studies of the phenotypic characterization and risk factors for these disorders; studies to elucidate their etiology, psychopathology, and pathophysiology; and development and evaluation of both assessment methods and psychosocial, psychopharmacologic, and somatic interventions to treat or prevent disorders.

Disorders of interest include: mood, anxiety, and personality disorders; psychotic disorders and schizophrenia; Alzheimer’s disease and related dementias; suicide; neuroregulatory disorders and homeostatic disorders including sleep disorders, eating disorders, and disorders associated with the menstrual cycle. .

Although old age or later life are conventionally identified with persons 65 years or older, studies involving participants outside that exclusive age range may be classified as geriatric research on other bases, as well.

Thus, the Geriatrics Research Branch supports clinical studies with mixed or comparative age samples in which there is a preponderance of geriatric participants or a central emphasis on questions relating to aging or developmental processes in late life, as well as research that has other special relevance to mental disorders among older adults (including animal studies that attempt to model specific clinical features of these disorders).

Based on a recent review of this Branch’s portfolio, NIMH has identified opportunities for enhancing and strengthening its support for late-life clinical research. As noted below, additional types of aging-related research, including geriatric mental health services research, are supported by other NIMH programs and Divisions and in other Institutes and Centers.

Within the Geriatrics Research Branch programs, NIMH has particular interest in expanding translational research aimed at understanding the etiology and pathophysiology of mental illness in late life, identifying risk and protective factors and their relationship to the development of various disorders, and hastening the translation of behavioral science and neuroscience advances into innovations in clinical care.

Opportunities exist to develop novel models of late-life mental disorders and to develop and validate endophenotypes and biomarkers for various aspects of these conditions, In particular, a significant number of opportunities are available to integrate findings and newly developed techniques from neuroimaging studies and genetics research into late-life clinical research.

NIMH encourages intervention research across the spectrum from new treatment development efforts to effectiveness outcome studies examining optimal utilization of existing mental health interventions to benefit older adults with mental disorders. Such intervention research may include both psychosocial and pharmacological approaches and their combinations, and prevention as well as treatment studies.

Significant opportunities exist to identify predictors of older adults response to varying interventions, including vulnerability to side effects, and to develop markers that will aid understanding of treatment mechanisms and processes of change in this age group.

To these ends, NIMH encourages applications proposing multidisciplinary research programs involving both clinical investigators and collaborators from molecular neuroscience, cognitive sciences, and social and behavioral sciences so as to facilitate the translation of basic science and preclinical research to clinical research.

Such studies may examine basic findings from various sciences for their relevance in understanding late-life mental disorders and/or in developing new and improved assessments and treatments for these disorders, utilizing such techniques as brain imaging, pharmacogenetics and genomics, and the methods of molecular biology, cognitive neuroscience, neuropsychology, and the behavioral and social sciences.

Virtually every area studied by NIMH-funded researchers has opportunities for expansion. The following section describes some of these areas that are of particular interest, but is not meant to be all-inclusive.

of Late-life Mood and Anxiety Disorders to Cognitive Impairment, Central Nervous System Pathology, and Mortality Cognitive impairment is often observed in depressed older adults, and a growing body of evidence suggests that late-life depression is associated with increased risks of cognitive decline and/or progression to frank dementia over time.

Likewise, many depressed older adults suffer from other coexisting medical illnesses, and numerous studies have linked depression with poorer outcomes of treatments for these illnesses and with increased mortality risks.

The biological and/or behavioral processes and mechanisms underlying these patterns have not been well studied and are poorly understood, Whereas some studies suggest that chronic experience of depression may lead to developing particular forms of neuropathology, others suggest that depressive syndromes in older adults may often occur simply as a prodromal phase or manifestation in the gradual progression of degenerative dementias, such as Alzheimer’s disease or cerebrovascular forms of dementia.

Symptoms of depressed mood and anxiety frequently coexist in older adults, and the admixture is predictive of attenuated response to treatments for depression. However, relationships between anxiety disorders and cognitive impairments and mortality have not been extensively studied.

Advances in neuroimaging and cognitive neuroscience have created new opportunities to utilize basic science methods to better delineate the cognitive dysfunction that frequently accompanies late life depression, and that appears to moderate and predict response to antidepressant treatments, and to identify the associated patterns of neuropathology or other mechanisms linking late-life affective disturbance with increased cognitive and mortality risks.

Examples of studies that might be proposed to examine pertinent questions in this general area include: Studies aimed at establishing biological (e.g., genetic, neuroimaging, neuroendocrine) markers linking both the etiology and progression of depression and cognitive decline in older adults Research that characterizes how late-life mood and/or anxiety disorder may interact with neuropsychological and neurobiological risk factors in predicting the development of dementia, such as how depression may modify the risk of progressing from mild cognitive impairment to dementia Studies of biological and behavioral mechanisms that may help explain observed relationships among depression, cognitive impairment, functional disability, and mortality in late life Research examining the role that vascular disease, and/or neuroinflammatory, neuroendocrine or neuroimmunological processes may play in linking depression with cognitive decline or increased mortality in older adults Studies examining how co-occurring physical illnesses alter the natural history or course of cognitive and affective symptoms in late-life mood and anxiety disorders Studies using cognitive neuroscience methods to better characterize specific forms of cognitive impairment linked with late-life depression Studies examining genetic and neuropathological subtypes of mild cognitive impairment in older adults, and the association of depression and anxiety with these subtypes Research to clarify the impact of cognitive impairments or associated neurobiological disruptions on treatment outcomes in geriatric mood and anxiety disorders the impact of pharmacological cognitive enhancer agents on the progression of depressive disorders and associated cognitive impairments over time, or on response to antidepressant treatments b.

Safety Issues in Antipsychotic Treatment of Older Adults A growing body of evidence indicates that treatment with antipsychotic medications may place older adults at an increased risk of developing strokes, metabolic syndromes, or other adverse physiological effects, including falls and fractures.

Increased mortality rates appear to apply to older adults treated with conventional neuroleptic as well as the newer atypical antipsychotic medications. The existing findings led the Food and Drug Administration to issue a warning in 2005 about the risks of treating older adults with dementia with the atypical antipsychotics.

In the current context, both clinicians and older individuals themselves and their families lack adequate information to make well reasoned decisions about treatment options for such clinical problems as agitation and psychosis in older adults with dementia, and maintenance treatment of older adults with chronic schizophrenia.

A broad range of studies is urgently needed to identify the mechanisms underlying the long-term adverse effects of antipsychotic treatments in older adults, the particular neurobiological or clinical characteristics predictive of vulnerability to these effects, and relative benefits and risks of various antipsychotic treatment options.

Examples of studies that might be usefully pursued include: Studies to clarify the mechanisms and particular conditions under which antipsychotic medications may lead to development of particular adverse physiological outcomes in older adults (e.g., metabolic syndrome, strokes) Research aimed at improved understanding of clinical factors and vulnerabilities that increase or buffer the risks for older adults to experience serious adverse events with psychotropic medications Studies examining the relative safety of alternate pharmacotherapies in particular subgroups of older adults (e.g. those with chronic mental illness, those with significant comorbid medical disorders, those with dementia and behavioral problems or psychosis) Studies of adjunctive treatments that may reduce or counteract the potential of antipsychotic medications to produce adverse side effects in elderly patients Research aimed at developing and testing alternative nonpharmacological interventions for the clinical problems in older adults that often prompt use of antipsychotic medications (e.g., agitation or other behavioral problems in older adults with dementia) Studies of appropriate education and consent procedures to assist older adults, family members, and clinical providers in evaluating the risks and benefits associated with various treatment options for mental disorders in late life c.

Accuracy and Efficiency of Assessment and Diagnostic Methods for Late-life Mental Disorder Older adults with symptoms of mental disorder often do not fit the typical profiles or standard categories specified by diagnostic nomenclatures. They may have the same symptoms at lower severity or different duration than stated in diagnostic criteria, or their symptom pattern may be different.

It may be difficult to ascertain or interpret their symptoms because they may have other co-occurring physical or mental illnesses. Ultimately, to reduce the burden of mental illnesses on these individuals, it is necessary to have valid conceptualizations of those illnesses that are in fact typical in late life, as well as assessment methods known to be valid for use with older adults .

Examples of studies that might usefully address such research questions include: Studies of the prevalence and clinical characteristics of older individuals with significant psychopathology who fail to meet standard diagnostic criteria for particular mental disorders (e.g., late-life worry and anxiety, suicidal ideation, subsyndromal depression, depression without sadness), including the impact of their symptoms on everyday functioning and needs for care Studies of alternative approaches to evaluating older adults in whom comorbid conditions complicate the diagnosis of late-life mental disorders (including whether diagnostic criteria should be modified in these contexts) Translational studies that test recent advances in the behavioral sciences or neurosciences for their applicability to improving the assessment of mental disorder in older adults Research on the utility of biological and biobehavioral tests and indices in diagnosing mental disorders in older adults, or in providing surrogate markers for treatment effects Studies that bridge clinical neuropsychology and the cognitive and affective neurosciences to develop new, theory-based approaches to assessing the presence of mental disorders, as well as disease severity and progression in older adults Research to develop and validate new or improved scales , or to tailor and refine standard assessment methods for optimal reliability, validity, sensitivity and efficiency when used in evaluating older adults with mental disorders or in assessing outcomes in clinical trials with older adults Research to improve and refine methods of evaluating decision-making capacity and the adequacy of informed consent procedures in older adults with possible cognitive or other impairments d.

Mental Health Diagnosis and Treatment of Racial/Ethnic Minority Elders A major goal of NIMH research efforts with respect to late-life mental disorders is to expand the knowledge base about interventions that effectively reduce the burden that mental illnesses have on older Americans, their families, and society at large.

As minority individuals have not been adequately represented in much past research, currently insufficient information is available about the accuracy and sensitivity of many mental health assessment methods for older adults from ethnic and racial minority groups, and about the relative efficacy and effectiveness of standard treatment approaches in various groups of minority elders.

Studies dedicated to redressing these shortages of clinically relevant diagnostic and treatment data are needed.

Examples of studies that might usefully be pursued in this area include: Studies examining how ethnic, racial and gender differences (and associated risk factor patterns, such as social and environmental contexts) influence vulnerability to mental disorder in old age Research to develop or adapt assessment techniques for cultural sensitivity, reliability, validity, and cultural fairness across ethnic/racial differences among older adults Comparative outcome studies examining whether treatment outcomes in older adults differ, based on such factors as ethnicity, race, gender, and socioeconomic status, and whether more fundamental bases for the observed variations in treatment response can be identified (e.g., potential metabolic or genetic differences in responding to psychopharmacological agents) Research to develop culturally appropriate adaptations of effective interventions so as to make them more acceptable and accessible to minority elders, and to enhance treatment engagement and adherence Development of validated methods that reduce barriers to participation for underrepresented racial/ethnic minority elders in clinical trials and other clinical research e.

Mental Health Intervention Packages/Algorithms Tailored to Diverse Geriatric Care Settings and Needs A major goal of NIMH geriatric intervention research is to build knowledge about how mental health interventions with established efficacy can be effectively implemented and made accessible to a larger number of older adults who need them.

This includes the development of treatment variants that can be efficiently employed in care settings where large numbers of older adults with mental disorders are typically seen, as well as algorithms for utilizing particular interventions appropriately in the various care contexts and at different steps or stages within the overall treatment process.

Such research efforts may lead to development of more cost-effective ways of intervening that will enable delivery of treatment to more of those in need.

Examples of studies that might usefully be pursued in this area include: Research to develop or adapt screening, assessment and intervention techniques for reliable, valid and efficient use in varying care contexts in which older adults with mental disorders are frequently seen (primary care clinics, nursing homes, assisted living facilities, in-home care agencies, social service organizations, prisons, other community settings) Studies of the timing, dosing, duration, and sequencing of therapies for mental disorders in older adults, including what criteria should determine the optimal length of treatment Studies of rational approaches to combining or sequencing multiple treatments (e.g., pharmacologic, psychotherapeutic, somatic), including examination of the degree to which combination therapy affects overall treatment adherence or quickens the speed of evoking a treatment response Research testing adjunctive or second-line intervention methods designed to reduce residual symptoms and improve overall functioning in older adults who respond unsatisfactorily or only partially to standard treatment approaches Studies examining the utility of genetic, neural, or other biological predictors of treatment response among older adults seen for psychiatric care in various clinical settings Research examining the role and optimal utilization of the family in treatment of mental illnesses in late life Research to develop prevention methods that can reduce the onset, duration or severity of late-life mental illnesses, including studies on when treatment should be given prophylactically to older adults, whether to prevent the occurrence of disorder or to reduce the risk of relapse or recurrence research addressing the mental health service needs of older adults is supported within all programs of the NIMH Services Research and Clinical Epidemiology Branch (see http://www.

nimh. nih. gov/dsir/82-se.

cfm). National Institute on Aging The National Institute on Aging (NIA) also supports late-life research, including studies of the aging process, age-related diseases (including neuro-degenerative diseases), and special problems of the aging population (including disability). This Funding Opportunity in particular is targeted to mental illness research in late life and not the above-mentioned areas.

Applicants should consider contacting program staff at NIMH or NIA for assistance in determining the Institute most appropriate for See Section VIII , Other Information - Required Federal Citations, for policies related to this announcement. This FOA will use the NIH Research Project Grant (R01) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

The total project period for an R01 application submitted in response to this FOA may not exceed This funding opportunity uses just-in-time 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 submitting an application with direct costs in each year of $250,000 or less, use the modular budget format described in the PHS 398 application instructions.

Otherwise follow the instructions for non-modular research grant 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 IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of meritorious Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004 . III. Eligibility Information 1.

A.

Eligible Institutions application(s) if your organization has any of the following characteristics: Public or private institutions, such as universities, colleges, hospitals, and laboratories Units of State government Units of local government Eligible agencies of the Federal Faith-based or community-based Indian/Native American Tribal Government (Federally Recognized) American Tribal Government (Other than Federally Recognized) American Tribally Designated Organization 1.

B. Eligible Individuals Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution 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.

2. Cost Sharing or Matching Cost sharing is not required. The most current Grants Policy Statement can be found at: http://grants.

nih. gov/grants/policy/nihgps_2003/nihgps_Part2. htm#matching_or_cost_sharing .

Other-Special Eligibility Criteria Section IV. Application and Submission Information 1. Address to Request Application Information instructions are available at http://grants.

nih. gov/grants/funding/phs398/phs398. html in an interactive format.

Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected] . the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements.

The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www. dnb. com/us/ .

The D&B number should be entered on line 11 of the face page of the PHS 398 The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box Several special provisions apply to applications submitted by foreign organizations: 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. administrative costs (excluding equipment) can now be requested.

( http://grants. nih. gov/grants/guide/notice-files/NOT-OD-01-028.

html ). 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 .

Additional information regarding foreign grants is available in the NIH Grants Policy Statement ( http://grants. nih. gov/grants/policy/nihgps_2003/NIHGPS_Part12.

htm#_Toc54600260 ) 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. Submission Dates and Times Submission, Review and Anticipated Start Dates Application Submission Date(s): Standard dates apply.

See http://grants. nih. gov/grants/funding/submissionschedule.

htm . Peer Review Date(s): See http://grants. nih.

gov/grants/funding/submissionschedule. htm . Council Review Date(s): See http://grants.

nih. gov/grants/funding/submissionschedule. htm Earliest Anticipated Start Date(s): See http://grants.

nih. gov/grants/funding/submissionschedule. htm .

A letter of intent is not required for this funding Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application.

Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 (U.S. Postal Service Express Bethesda, MD 20817 (for express/courier service; applications are no longer permitted (see http://grants. nih. gov/grants/guide/notice-files/NOT-OD-03-040.

html ). Applications must be submitted on or before the application receipt dates described above ( Section IV. 3.

A. ) and at http://grants. nih.

gov/grants/dates. htm . Upon receipt, applications will be evaluated for completeness by CSR.

Incomplete applications will not be reviewed. The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial 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 a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons. era.

nih. gov/commons/ . not subject to intergovernmental subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement ( http://grants.

nih. gov/grants/policy/policy. htm ).

Pre-Award Costs are allowable. A grantee may, at his/her 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 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 continuation award.

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 NIH Grants Policy Statement http://grants. nih.

gov/grants/policy/nihgps_2003/NIHGPS_Part6. htm . 6.

Other Submission Requirements Specific Instructions for Modular Grant applications. Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail.

Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 at http://grants. nih.

gov/grants/funding/phs398/phs398. html includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398.

Additional information on modular budgets is available at http://grants. nih. gov/grants/funding/modular/modular.

htm .

Instructions for Applications Requesting $500,000 (direct costs) or More per $500,000 or more in direct costs for any year must carry out the following 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 a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types.

Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants. nih. gov/grants/guide/notice-files/NOT-OD-02-004.

html . 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