Exploratory/Developmental (R21) Grant Applications on Women's Mental Health in relation to Pregnancy and the Postpartum Period

Exploratory/Developmental (R21) Grant Applications on Women's Mental Health in relation to Pregnancy and the Postpartum Period is sponsored by National Institutes of Health (NIH). This opportunity supports mission-aligned projects and measurable outcomes.

Expired PA-06-377: Womens Mental Health in Pregnancy and the Postpartum Period (R21) This notice has expired. Check the NIH Guide for active opportunities and notices. Part I Overview Information Department of Health and Human Services Participating Organizations National Institutes of Health (NIH), ( http://www.

nih. gov ) Agency for Healthcare Research and Quality (AHRQ), ( http://www. ahrq.

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

gov ) National Institute of Child Health and Human Development (NICHD), ( http://www. nichd. nih.

gov/ ) National Institute of Drug Abuse (NIDA), ( http://www. nida. nih.

gov/ ) Center for Primary Care, Prevention, and Clinical Partnerships (CP3), ( http://ahrq. gov/about/CP3 ) Title: Women’s Mental Health in Pregnancy and the Postpartum This is a reissue of PA-03-135 , which was previously released on June 6, 2003. Update: The following update relating to this announcement has been issued: April 24, 2009 - This PA has been reissued as (PA-09-175).

April 29, 2008 - See Notice (NOT-MH-08-010) Change of Program Contact from Catherine Roca to Kathleen O'Leary. September 17, 2007 - Expiration Date adjusted to accommodate recent changes to standing submission deadlines, per NOT-OD-07-093. submitted in response to this 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 SF424 (R&R) This FOA must be read in conjunction with the application guidelines provided 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 4 weeks prior to the grant submission date.

See Section IV . Program Announcement (PA) Number: PA-06-377 Domestic Assistance Number(s) Release/Posted Date: April 28, Opening Date: May 2, 2006 (Earliest date an application may be submitted On time submission requires that applications be successfully submitted to Grants. gov no later than 5:00 p.

m. local time (of applicant institution/organization). Application Submission Date(s): Standard dates apply, please see http://grants1.

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

AIDS Application Receipt Date(s): See http://grants1. nih. gov/grants/funding/submissionschedule.

htm#AIDS . Peer Review Date(s): S ee http://grants1. nih.

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

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

Earliest Anticipated Start Date(s): S ee http://grants1. nih. gov/grants/funding/submissionschedule.

htm#reviewandaward . Additional Information To Be Available Date (Url Activation Date): Not applicable. Expiration Date: March 2, 2009 (now May 8, 2009 per NOT-OD-07-093 ) Additional Overview Content This funding opportunity announcement (FOA) solicits Exploratory/Developmental (R21) grant applications on the topic of women's mental health in relation to pregnancy and the postpartum period.

The FOA encourages research on perinatal mood and other mental disorders in four areas: (1) clinical course, epidemiology and risk factors; (2) basic and clinical neuroscience; (3) interventions; and (4) services. Research is encouraged both on perinatal non-psychotic mood disorders and on psychotic disorders.

Studies exploring the effects of current or lifetime drug abuse, including treatment status and comorbid conditions, on onset and course of mental disorders during the perinatal period are also will utilize the Exploratory/Developmental (R21) grant mechanism and runs in parallel with an FOA of identical scientific scope, PA-06-376 , that solicits applications using the R01 research grant mechanism.

total amount awarded and the number of awards will depend upon the mechanism numbers, quality, duration, and costs of the applications received. total project period for an application submitted in response to this funding opportunity may not exceed two years.

Direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in organizations: 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): 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 each application is See Section IV. 1 for application materials. The SF424 (R&R) Application Guide for this FOA is located at these Web sites: http://grants1.

nih. gov/grants/funding/424/SF424_RR_Guide_General_Ver2. doc http://grants1.

nih. gov/grants/funding/424/SF424_RR_Guide_General_Ver2. pdf (PDF) For general information on SF424 (R&R) Application and Electronic Submission, see these the following SF424 (R&R) Application and Electronic Submission Information: http://grants.

nih. gov/grants/funding/424/index. htm Electronic Submission of Grant Applications: http://era.

nih. gov/ElectronicReceipt/ Telecommunications for the hearing impaired is available at: TTY 301-451-5936. Part I Overview Information 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 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 Requirements 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 II - Full Text of Announcement Section I.

Funding Opportunity National Institute of Mental Health (NIMH), the National Institute of Drug Abuse (NIDA), the National Institute of Child Health and Human Development (NICHD), and the Agency for Healthcare Research and Quality (AHRQ) encourage research on women's mental health in relation to pregnancy and the postpartum period.

As illustrated by a few highly publicized cases, the consequences of severe untreated postpartum depression and psychosis can be devastating for individuals, families, and communities. In July 2002, NIMH held a major interdisciplinary conference to identify research needs in the areas of pregnancy-onset and postpartum depression and postpartum psychosis (hereafter referred to collectively as perinatal mood disorders).

In February 2003,’s 450 and HR 846 were introduced in the 108th Congress. The bills call for the Secretary of Health and Human Services, working through the Director of NIMH to provide for basic, epidemiological, diagnostic, clinical, and intervention research on postpartum depression and psychosis.

Perinatal mood disorders are potentially devastating conditions that affect many women during pregnancy (often referred to as gestational or antepartum) and after pregnancy (often referred to as postpartum, puerperium or postnatal). Perinatal mood disorders are broadly termed maternal depression.

Perinatal mood disorders are classified into three groups: the (postpartum) blues, which is a common and less severe form of postpartum depression; clinical mood and anxiety disorders, which can occur during pregnancy and following childbirth, usually within six months to a year later (depending on the definition used) and often necessitating treatment; and postpartum psychosis, which is the most extreme form of perinatal mental illness, usually occurring within a few weeks of childbirth and constituting a medical emergency.

The causes of these conditions are complex and most likely heterogeneous, with putative distinct and shared risk factors. Biologically oriented explanations are likely to consider changes in levels of estrogen and progesterone following delivery, genetic vulnerability factors sensitive to hormonal changes, and hypothyroidism as possible triggering events.

Environmental factors associated with perinatal mood disorders include difficult delivery, marital stress, and lack of social support. A personal or family history of mood disorders, particularly bipolar disorder or prior postpartum psychosis, is also a major risk factor for a perinatal mood disorder.

A subset of women with perinatal mood disorders may also manifest mood disorders particularly in relation to other reproductive transitions such as those that occur during the premenstrual period. It is estimated that 8-15 percent of women having children suffer from a clinically significant postpartum mood disorder; of these women, many experienced depressive symptoms as well during pregnancy. An estimated .

5 to 1 percent of women will experience a postpartum psychosis. There are limited epidemiological data on postpartum psychosis because of the low incidence. Perinatal mood disorders are under-diagnosed and under-treated.

It is estimated that health care providers identify only 20-30 percent of these conditions. Maternal depression, anxiety, and stress during pregnancy are associated with a variety of poor physical and emotional outcomes in offspring. Untreated perinatal mood disorders can have a range of poor maternal functional outcomes, from substance abuse, loss of employment, and divorce to suicidal behavior or death by suicide.

Untreated perinatal depression also impacts society through its effect on a mother's ability to promote the infant's cognitive and emotional development. Maternal depression has been associated with poorer pregnancy outcomes as well as impaired child cognitive and psychological development.

In extreme cases, such as postpartum psychosis, it has been associated with poorer neonatal outcomes, even In addition to the mood disorders, many women enter the perinatal period with active and/or relapsing/recurring drug or alcohol use disorders as well as mental illness (anxiety disorders, eating disorders, schizophrenia) and with medical conditions related to substance abuse such as infectious disease (HIV, HBV, HCV).

These conditions and other co-occurring conditions of higher prevalence in women such as autoimmune disorders must be explored at the level of basic, epidemiological, diagnostic, clinical, and intervention research in relation to maternal perinatal health.

This FOA encourages research on perinatal mood and other mental disorders in four areas: (1) clinical course, epidemiology and risk factors; (2) basic and clinical neuroscience; and (3) interventions; and (4) services. Research is encouraged both on perinatal non-psychotic mood disorders and on psychotic disorders.

Clinical Course, Epidemiological and Risk Factors Current national epidemiology studies have paid surprisingly little attention to the postpartum period and even less attention to pregnancy in terms of risk for different kinds of perinatal mental disorders and distinguishing risk factors. This critical gap must be addressed, as clinical and epidemiology studies form the basis of intervention research.

The prevalence of perinatal depression in different racial/ethnic groups of women is undetermined, with some reports of much higher rates in low-income and/or ethnic minority women and other reports of comparable rates among women.

Below are examples of clinical, epidemiological, and risk factors research encouraged by NIMH: studies to identify risk and protective factors for postpartum non-psychotic depression and anxiety disorders, especially in women with different clinical patterns and histories (e.g., reproductive-related mood changes, recurrent and epidemiological studies to identify the characteristics of pregnancy-onset depression and to examine its functional impact and course.

of health disparities in perinatal depression, other peri-natal mental disorders, and in co-occurring behavioral and medical conditions.

and epidemiological studies of women with bipolar disorder or schizophrenia to identify risk factors for perinatal mood disorders onset; studies to aid in the early identification and treatment of serious perinatal psychosis among on psychiatric and social functional status associated with infertility, miscarriage, stillbirth, and elective abortion.

Below are examples of research encouraged by NICHD: and epidemiological studies of pregnancy complications and birth and neonatal outcomes in women with perinatal mood or anxiety disorders or psychosis. and epidemiological studies of treated versus untreated perinatal mood, anxiety, and other mental disorders during pregnancy and lactation in relation to child outcomes such as development and mental health.

Below is an example of research encouraged by NIDA: Studies exploring the effects of current or lifetime drug abuse, including treatment status and comorbid conditions, on onset and course of mental disorders during the perinatal Basic and Clinical Neuroscience Very little basic neuroscience research is currently aimed specifically at addressing the neurobiology of perinatal mood disorders.

There is a need to apply the knowledge of hormone-sensitive brain circuits and neurotransmitter systems to developing an understanding of the neurobiology of perinatal mood disorders in clinical populations. The development of appropriate models of the peripartum period will be essential for understanding the neurobiology of perinatal mood disorders.

Consideration of combined genetic and environmental influences on postpartum hormonal status, emotionality, and maternal behavior is also appropriate for model development. Finally, new tools are needed to advance the understanding of neuroendocrine control of mood and cognition in humans, non-human primates, and other species.

The following are examples of clinical neuroscience research encouraged by NIMH: aimed at identifying neurobiological, endocrine, and behavioral characteristics that distinguish perinatal mood disorders from perinatal psychotic disorders and from mental disorders occurring at other times across the lifespan.

studies of normal and patient populations of women during different perinatal intervals to identify functional changes in brain neurochemistry in relation to to identify unique hormone sensitivities in women with histories of perinatal mental disorders in order to predict risk of subsequent perinatal mood disorders and to identify subsets of women vulnerable to developing mood disorders following other hormonal events (e.g., menstruation; menopause).

to identify genetic polymorphisms/markers of vulnerability in women at high risk for the development of perinatal mood disorders or postpartum psychosis. The inclusion of subsets of women with more homogeneous psychological symptoms during pregnancy and post-partum is particularly encouraged.

inclusion of women with a history of perinatal mood disorders in genetic studies of depression and bipolar disorder in order to identify additional vulnerability markers for the disorders in relation to perinatal triggers. Below are examples of model development research development of models of hormone changes occurring during and after pregnancy for neurobiological and behavioral studies.

development of models to examine the combined environmental and genetic influences of resilience and vulnerability to mood and cognitive disorders during the perinatal period. development of models to study the impact of perinatal disorders during pregnancy and lactation and pharmacological treatments for the disorders on the behavioral and neural development of offspring.

of relevant objective and quantitative measures including assessment of neuroendocrine activity (pituitary, gonadal, thyroid hormone systems), brain activation (EEG, PPI, ERP), and the development of simplified behavioral measures with parallel application across species including humans, non-human primates, Below are examples of tool development research of research tools to visualize the influence of post-partum hormonal changes on brain gene expression and on activation of brain circuits regulating mood and of more selective hormone receptor ligands and radioligands (e.g., estrogen receptor agonists and thyroid receptor ligands) for basic and clinical of novel tools and approaches to visualize activation of steroid hormone receptors in brain imaging studies across the reproductive cycle and throughout Below is an example of research encouraged by NIDA: elucidating the effects of drug abuse or drug abuse history and other comorbid conditions (e.g., HIV infection, hepatitis) on maternal neurobiology during the Below is an example of research encouraged by NICHD: studies of the impact of perinatal mood disorders on human fetal and infant nervous system development.

There is a need to develop more systematic knowledge about the impact of known pharmacological and psychosocial depression treatments for perinatal mood disorders. There is also a need to develop new behavioral interventions for these conditions, in particular interventions that can be adapted to general medical or group settings.

The following are examples of the kinds of intervention studies encouraged by NIMH: of the efficacy, safety, pharmacokinetics, and pharmacodynamics of pharmacotherapies for treatment of perinatal mood disorders, especially those occurring during pregnancy and lactation.

studies to develop effective non-pharmacological interventions to prevent of pharmacological maintenance treatments during pregnancy and postpartum for women with serious mental illnesses such as psychosis and studies of pharmacological prophylaxis strategies for these conditions in women at high risk for a recurrence of psychotic perinatal conditions.

studies of non-pharmacological interventions, such as psychosocial therapies or light therapy for perinatal depression. of innovative non-pharmacological interventions as alternatives to traditional one-on-one interventions for identifying, preventing, and treating perinatal mood disorders (e.g., self-help; support groups; Web-based approaches to reduction of subsyndromal symptoms before they become disorders).

of outcome measures of maternal functioning and/or child functioning, which can be incorporated into assessments of the effectiveness of interventions.

The development of innovative interventions for preventing and treating perinatal mood disorders, which are aimed at the reduction of risk for poor parenting and child psychopathology and that can be easily adapted to medical and other real-world settings (e.g., community-based Below is an example of research encouraged by NICHD: effect of maternal pharmacologic or non-pharmacological interventions on fetal, neonatal and infant outcomes.

Below is an example of research encouraged by NIDA: Studies of the effects of current or lifetime diagnosis of drug abuse and comorbid conditions on behavioral and pharmacological treatment of maternal mental disorders during the perinatal period. Studies to develop and test behavioral treatments and other non-pharmacological interventions for pregnant and post-partum women with comorbid mental health and drug use disorders.

Studies to prevent or reduce infectious disease (e.g., HIV, hepatitis) in women with comorbid mental health and substance use disorders during the perinatal period. Increased screening and referral to accurate, accessible, and sustainable mental health assessment, treatment, and needed services is a public health strategy with the potential to improve outcomes in perinatal mood disorders.

To determine the effectiveness of such an approach, a variety of factors must be evaluated at the individual, practitioner, organizational, community, and systems levels.

The following are examples of services research dealing with clinical decision-making in personal-encounter care for individual patients with perinatal mood disorders; research to identify risk factors for the development of such disorders in clinical settings; factors that are important in the natural history of these disorders, including co-morbid that elucidate the critical components of effective collaborative models for screening/referral partnerships within and across systems of care (e.g., between primary care and mental health care, between public and private health care systems, or between health care providers/systems and employers).

Such studies should seek to understand issues relevant to successful implementation on the impact of various forms of managed care and physician payment methods on the detection, assessment, referral and treatment of perinatal mood disorders, and performing economic analyses of practice patterns of different health providers and systems in addressing such disorders.

development of community collaborative models for screening/referral partnerships between researchers and public and private health care systems and between health care providers/systems and employers. of the mechanisms by which stigma associated with perinatal mental illness affects the behavior of providers and consumers in terms of creating barriers to recognition, help-seeking, or referral for or acceptance of treatment.

that provide insights into differences in quality and outcomes of care in various practice types, and analysis of the appropriateness of treatment, to determine the need for and barriers to utilization of mental health services for mothers with postpartum mood disorders, including assessment and rehabilitation of functional disability.

exploring the feasibility and efficacy of parenting-related services that address special issues of parenting and illness management for women with serious mental illnesses. related to issues of culture, social systems, and social networks as they relate to help-seeking, use and provision of services, and effectiveness, quality, and outcomes of services.

R21 awards should describe projects distinct from those supported through the traditional R01 mechanism. For example, long-term projects, or projects designed to increase knowledge in a well-established area, will not be considered for R21 awards. Applications submitted under this mechanism should be exploratory and novel.

These studies should break new ground or extend previous discoveries toward new directions or applications. Information - Required Federal Citations , for policies related to this This FOA will use the NIH Exploratory/Developmental Research Grant (R21) award mechanism . As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

just-in-time concepts. It also uses the modular budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement .

Specifically, since you 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).

Exploratory/developmental grant support is for new projects only; competing renewal (formerly competing continuation ) applications will not be accepted. Up to two resubmissions (formerly revisions/amendments") of a previously reviewed exploratory/developmental grant application may be submitted.

See NOT-OD-03-041 , 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. The total project period for an application submitted in response to this funding opportunity may not exceed 2 years.

Although the size of award may vary with the scope of research proposed, it is expected that applications will stay within the budgetary guidelines for an exploratory/developmental project; direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year.

Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year award period. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this Program Announcement funding opportunity.

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004 . Section 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 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 as the Project Director/Principal Investigator (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.

This program does not require cost sharing as defined in the current NIH Grants Policy Statement . Applicants may submit more than one application, provided each application is scientifically distinct. Section IV.

Application and 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/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both: Grants. gov ( http://www. grants.

gov/GetStarted ) eRA Commons ( http://era. nih. gov/ElectronicReceipt/preparing.

htm ) should work with their institutions/organizations to make sure they are registered in the eRA Commons. additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows: Organizational/Institutional Registration in Grants.

gov/Get Your organization will need to Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants. gov registration process. If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time.

A valid TIN or EIN is necessary for The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days. Direct questions regarding Grants. gov registration to: Grants.

gov Customer Support Business Hours: M-F 7:00 a. m. - 9:00 p.

m. Eastern Time 2) Organizational/Institutional Registration in the eRA Commons To find out if an organization is already Commons-registered, see the " List of Grantee Organizations Registered in NIH eRA Commons. Direct questions regarding the Phone: 301-402-7469 or 866-504-9552 (Toll Free) Business hours M-F 7:00 a.

m. 8:00 p. m.

Eastern Time Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) The individual designated as the PD/PI on the application must also be registered in the NIH eRA Commons. It is not necessary for PDs/PIs to register with Grants. gov. The PD/PI must hold a PD/PI account in the Commons and must be affiliated with the applicant organization.

This account cannot have any other role attached to it other This registration/affiliation must be done by the Authorized Organization Representative/Signing Official (AOR/SO) or their designee who is already registered in the Both the PD/PI and AOR/SO need separate accounts in the NIH eRA Commons.

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 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 the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants. gov/Apply . Note: Only the forms package directly attached to a specific FOA can be used.

You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA. For further assistance, contact GrantsInfo: Telephone 301-710-0267, Email: [email protected] . Telecommunications for the hearing impaired: TTY 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 ( MS Word or PDF ). 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 Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications . The SF424 (R &R) application is comprised of data arranged in separate components. Some components are required, others are optional.

The forms package associated with this FOA in Grants. gov/APPLY will include all applicable components, required and optional.

A completed application in response to this FOA will include the 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 Subaward Budget Attachment (s) Form Note: While both budget components are included in the SF424 (R&R) forms package, the NIH R21 uses ONLY the PHS398 Modular Budget.

(Do not use the detailed Research & Related Budget.) 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" within each PDF. Funds for up to 8% administrative costs (excluding equipment) may 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. For additional information, see the NIH Grants Policy Statement regarding foreign grants: http://grants. nih.

gov/grants/policy/nihgps_2003/NIHGPS_Part12. htm#_Toc54600260 . 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.

See Section IV. 3. A for details.

Submission, Review, and Anticipated Start Dates Opening Date: May 2, 2004 (earliest date an application may be submitted to Application Submission Date(s): http://grants. nih. gov/grants/funding/submissionschedule.

htm AIDS Application Submission Date(s): http://grants1. nih. gov/grants/funding/submissionschedule.

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

htm#reviewandaward Council Review Date(s) http://grants1. nih. gov/grants/funding/submissionschedule.

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

htm#reviewandaward A letter of intent is not required for the funding 3. B. Sending an Application to To submit an application in response to this FOA, applicants should access this FOA via http://www.

grants. gov/Apply 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 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 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. everything is acceptable, no further action is necessary.

The application will automatically move forward for processing by the Division of Receipt and Referral, Center for Scientific Review, NIH, after two business days. to the submission deadline, the AOR/SO can Reject the assembled application and submit a changed/corrected application within the two day viewing window. This option should be used if the AOR/SO determines that warnings should be addressed.

Reminder: warnings do not stop further application processing. If an application submission results in warnings (but no errors) it will automatically move forward after two business days if no action is taken. Please remember that some warnings may not be applicable or may need to be addressed after application submission.

the two day window falls after the submission deadline, the AOR/SO will have the option to Reject the application if, due to an eRA Commons or Grants. gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn t transfer correctly during the submission process).

The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. NIH will not penalize the applicant for an eRA Commons or Grants. gov system issue.

the AOR/SO chooses to Reject the image after the submission deadline for a reason other than an eRA Commons or Grants. gov system failure, a changed/corrected application still can be submitted but it will be subject to