Women's Mental Health and Sex/Gender Differences Research (R21)

Women's Mental Health and Sex/Gender Differences Research (R21) is sponsored by National Institutes of Health (NIH). This Funding Opportunity Announcement encourages Exploratory/Developmental Grant (R21) applications from institutions/organizations that propose to study women's mental health and sex/gender differences in mental health.

Expired PA-09-109: Women's Mental Health and Sex/Gender Differences Research (R21) This notice has expired. Check the NIH Guide for active opportunities and notices. Part I Overview Information of Health and Human Services Institutes of Health (NIH), ( http://www.

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

nih. gov ) Title: Women's Mental Health and Sex/Gender Differences Research (R21) This is a reissue of PA-06-334 . Update: The following updates relating to this announcement have been issued: August 16, 2010 - IMPORTANT NOTE!

NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123 .

September 29, 2010 (NOT-OD-11-007) - NIH to Require Use of Updated Electronic Application Forms in 2011. Adobe B1 forms are required for due dates on or after May 8, 2011. This FOA has been updated to reflect the new requirements from NIH’s Enhancing Peer Review Initiative.

The new requirements are effective for submissions intended for due dates January 25, 2010 and beyond. If submitting an application intended for a due date of January 25, 2010 and beyond, follow the guidance below and be sure to use the Adobe-Forms-B version of the application forms and instructions.

If applying for a due date before January 25, 2010, follow the guidance in the archived version of this FOA and be sure to use the Adobe-Forms-A version of the application forms and instructions. Program Announcement (PA) Number: PA-09-109 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) 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 (4) weeks prior to the grant submission date. See Section of Federal Domestic Assistance Number(s) Opening Date: May 16, 2009 (Earliest date an application may be submitted of Intent Receipt Date(s): Not 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).

Standard dates apply, please see http://grants1. nih. gov/grants/funding/submissionschedule.

htm AIDS Application Due Date(s): Standard dates apply, please see http://grants1. nih. gov/grants/funding/submissionschedule.

htm#AIDS . 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 Expiration Date: May 8, 2012 Additional Overview Content Purpose . This Funding Opportunity Announcement (FOA) encourages Exploratory/Developmental Grant (R21) applications from institutions/organizations that propose to study womens mental health and sex/gender differences in mental health.

Support. This FOA will use the NIH Exploratory/Developmental (R21) award mechanism and runs in parallel with an FOA of identical scientific scope, PA-09-108 , that solicits applications under the Research Project Grant (R01) award mechanism. Funds Available and Anticipated Number of Awards.

Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. Budget and Project Period. The 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 any single year. Application Research Strategy Length: Item 3 of the R21 application Research Plan component of the PHS398 may not exceed 6 pages, including tables, graphs, figures, diagrams, and charts. See http://grants1.

nih. gov/grants/funding/funding_program. htm Institutions/Organizations.

Institutions/organizations listed in Section III. 1. A.

are eligible to apply. Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the of Applications. Applicants may submit more than one application, provided that each application is scientifically distinct.

Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). See new NIH policy on resubmission (amended) applications ( NOT-OD-09-003 , NOT-OD-09-016 ).

Renewals. Exploratory/developmental grant support is for new projects only; competing renewal (formerly competing continuation) applications will not be accepted. Materials.

See Section IV. 1 for application materials. general information on SF424 (R&R) Application and Electronic Submission, (R&R) Application and Electronic Submission Information: http://grants.

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

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

Funding Opportunity Section II. Award Information Section III. Eligibility Information 2.

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

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

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

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

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

Resource Sharing Plan(s) 3. Anticipated Announcement and Award Dates Section VI. Award Administration 2.

Administrative and National Policy Requirements 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 The epidemiology and disability burden of mental disorders provide clear evidence of the value of a focus on sex and gender differences research. There are differences in both the prevalence and clinical course of mental disorders between men and women. Starting in childhood, girls have higher rates of anxiety disorders than boys.

Boys have higher rates of autism and attention deficit disorder. After puberty, women have higher rates than men of depression, eating disorders, and anxiety disorders, including post-traumatic stress disorder. Men are more likely to suffer from substance abuse disorders.

For other serious mental disorders, such as schizophrenia and bipolar disorder, gender disparities in incidence are not found. However, significant differences in clinical course have been demonstrated. This pattern of disparities in the epidemiology of mental disorders in males and females provides indirect evidence of genetic, hormonal, biological, social, cultural and developmental factors in etiology and course.

An increasing body of basic and clinical research also provides evidence of neurobiological sex differences that may predispose to clinical differences in mental disorders. The finding of sex/gender differences in epidemiological, basic, and clinical studies has also increased interest in the application of that knowledge to improving interventions and services for males and females.

In recognition of the importance of studying sex/gender differences in health outcomes, the National Institutes of Health (NIH) has provided guidelines to researchers for inclusion of women and men in clinical research and for gender analysis of clinical trials outcomes.

Through research such as that called for in this Funding Opportunity Announcement (FOA), the National Institute of Mental Health (NIMH) seeks to increase the understanding of the significance of sex/gender differences in mental health outcomes and to assess their significance for basic neuroscience, mental health prevention, treatment, and In April 2001, the Institute of Medicine issued a report entitled "Exploring the Biological Contributions to Human Health: Does Sex Matter?"

In order to improve conceptual research models, the report recommended greater precision in terminology used to refer to findings from studies comparing health outcomes in males and females.

Therefore, in this FOA issued by the NIMH, the term "sex difference" is used to refer to primarily biological variables and the term "gender difference" is used to refer to psychosocial and cultural variables supports research grant applications that fulfill the objectives of the Mental Health NIMH has three major areas for research emphasis related to sex and gender differences: basic and clinical neuroscience; epidemiology and risk factors; and intervention and services 1) Basic and Clinical Neuroscience - There is increasing evidence that neurobiological sex differences influence a wide array of behaviors and may alter vulnerability to: different mental illnesses, severity of course, and/or treatment response.

Basic studies in animals and humans as well as human clinical studies in subjects with mental illnesses are appropriate for developing knowledge of the processes underlying sex differences.

Examples of research areas include, but are not limited to, studies Sex differences in brain processes contributing to cognitive, affective and social behaviors as determined by structural and functional brain imaging of normative and clinical populations or by a systems level of analysis in appropriate animal models.

Sex differences in the molecular and cellular bases of behavior, including neurotransmitter and peptide signaling, trophic factor response, neurogenesis and glial biology, synaptic plasticity and neural circuitry mediating cognition and mood.

Sex differences in genetic and/or epigenetic factors and/or gene-environment interactions contributing to mental Sex differences in the developmental-organizing and activating influences of sex steroids on brain and behavior, as well as interactions with thyroid- and hypothalamic-pituitary adrenal axes, the neuroimmune system, and neurotransmitters and peptides in brain.

Sex differences in, and sex hormone influences on, the pharmacokinetics, pharmacodynamics and pharmacogenetics of psychotropic medications across the lifespan. The influence of hormonal transitions across the lifespan on brain physiology and function, including, for example, neural plasticity, cognition, social behavior and affective behavior.

Determination of the functional significance of molecular and cellular effects of estrogen, progesterone, and related molecules within circuits mediating cognition, social behavior, and Development of selective ligands to explore the role of brain hormones and hormone receptors in behavioral regulation and for in vivo imaging of receptor dynamics across the female lifespan.

Evidence suggests that sex differences in hormone actions contribute to differences in physiological and behavioral responses to stress relevant to cognitive and emotional regulation and mental disorders. There are also sex/gender differences in the types of stressors to which an individual is likely to be exposed.

For example, epidemiological studies show that females are more likely to have experienced early childhood sexual abuse, a severe stress with potential long-term impact on stress responsiveness.

To understand this complex area, multidisciplinary approaches are required, ranging from basic research in animals and humans to clinical research in children, adults, Examples of relevant research areas include, but are not limited to: Examination of genetic, molecular, and cellular brain mechanisms mediating sex differences in the stress effects on mood, arousal, sleep, cognition, affiliative behavior, and susceptibility Elucidation of how biological sex influences developmental mechanisms that underlie susceptibility to adverse consequences of stress and risk for mental disorders throughout life.

2) Epidemiology and Risk Factors - During the past two decades, advances in diagnosis and in survey methodologies have enabled researchers to establish general estimates of the impact of mental disorders in women and men and their intervention and service needs.

Such research remains to be done for children and adolescents and is particularly pressing, because in many disorders, gender differences first emerge in adolescence when early intervention strategies may be most effective in preventing full-blown mental disorders.

There is also relatively little information about the influence of gender-related or gender-specific factors on such important clinical aspects of mental disorders as risk for recurrence, chronicity, comorbidity and disability in later life.

Studies to further elucidate the role of sex/gender-related or sex/gender-specific factors in diagnosis, epidemiology, risk for onset or recurrence, and in the course of mental disorders across the lifespan and across ethnic and cultural groups are needed.

Examples of relevant research areas include, but are not limited to: Elucidation of disparities in prevalence of mental illness and related disability, and in access to care among women and girls of different ethnic and socioeconomic backgrounds. Assessment of the reliability, validity and predictive value of approaches to conceptualizing and measuring psychopathology in female populations.

Identification of demographic variables and social, cultural, behavioral and environmental factors related to gender differences in mental disorders (e.g., work and family roles, marriage, gender discrimination, response to psychosocial stressors, propensity to Elucidation of childhood risk and protective factors related to the emergence of gender disparities in incidence and course of mental disorders (particularly mood, anxiety, and eating disorders).

The roles of hormonal, genetic, and social factors in the emergence of sex/gender differences in susceptibility to mental disorders, mood, and cognitive disruption during defined transitional periods including puberty, pregnancy, the postpartum period, 3) Intervention and Services Research - There are an increasing number of findings indicating sex/gender differences in response to interventions as well as in preferences for different kinds of services and interventions.

Additionally, women's social roles and reproductive status raise special issues related to choices of treatments and services. Interventions are defined here to include preventive, treatment, services-system and rehabilitative strategies at the individual, provider, organizational and systems levels. There is a need to incorporate consideration of such issues in the design and analysis of outcomes in mental health research.

Examples of relevant research areas include, but are not limited to, Sex/gender differences in acute and maintenance treatment outcomes for mental disorders and suicidal behaviors. Sex/gender differences in treatment adherence and side effects of treatments and in treatment preferences, expectancies, provider behaviors, and services use.

Drug-drug interactions (e.g., supplements, replacement hormones, and psychotropic and other medications) in females Strategies for early detection of precursors to depression, anxiety, eating disorders, suicidality, and other behavioral disorders in female children and adolescents; the development of interventions targeting these manifestations; and the development of effective mechanisms for successful referral and adherence to treatment.

Interventions aimed at improving outcomes in women and girls at risk for mental disorders or diagnosed with mental disorders co-morbid with other disorders (e.g., anxiety disorders in depression; substance abuse in women with bipolar disorder or schizophrenia, depression, and medical illness).

Preventive interventions for mental disorders with female-specific risk factors (e.g., stressors in caregiver roles, Taxonomies of functional outcomes and disabilities in women and girls with mental disorders and instruments to measure functional changes following interventions.

Screening and identification of women with mental disorders and of women who are at high risk for the development of such disorders in general medical settings and in non-traditional settings, with the development of effective strategies for referral and and vitality of the biomedical sciences require a constant infusion of new ideas, techniques, and points of view.

These may differ substantially from current thinking or practice and may not yet be supported by substantial preliminary data. By using the R21 mechanism, the NIH seeks to foster the introduction of novel scientific ideas, model systems, tools, agents, targets, and technologies that have the potential to substantially advance biomedical research.

The R21 mechanism is intended to encourage new exploratory and developmental research projects. For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research. Another example could include the unique and innovative use of an existing methodology to explore a new scientific area.

These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research. Applications for 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.

Projects of limited cost or scope that use widely accepted approaches and methods within well established fields are better suited for the R03 small grant mechanism. Information on the R03 program can be found at http://grants. nih.

gov/grants/funding/r03. htm. VIII, Other Information - Required Federal Citations , for policies related to this announcement.

This FOA will use the NIH Exploratory/Developmental Research Grant (R21) award mechanism . The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project. FOA uses Just-in-Time information concepts see SF424 (R&R) Application Guide ) .

It also uses the modular as well’s the non-modular budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement .

Specifically, if 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 3. 4, Modular Budget Component, of the Application Guide).

must complete and submit budget requests using the Research & Related 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 ICs provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

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. F&A costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004 , November 2, NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to Section III.

Eligibility Information organizations/institutions are eligible to apply: Controlled Institutions of Higher Education Institutions of Higher Education Black Colleges and Universities (HBCUs) Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Insti tutions with 501(c)(3) IRS Status (Other than Institutions of Higher Education) without 501(c)(3) IRS Status (Other than Institutions of Higher Education) Organizations (Other than Small Businesses) American Tribal Governments (Federally Recognized) American Tribally Designated Organizations Housing Authorities/Indian Housing Authorities U.S. Territory or Possession American Tribal Governments (Other than Federally Recognized) (non-U.S.) Entities (Foreign Organizations) Agencies of the Federal Government or Community-based Organizations.

1. B. Eligible Individuals Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a team science approach and therefore clearly do 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 electronic Research Administration (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 grant with a single PD/PI or multiple PDs/PIs grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below.

When considering the multiple PD/PI option, 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 PDs/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 . This program does not require cost sharing as defined in the current NIH Grants Policy Statement . Number of Applications.

Applicants may submit more than one application, provided that each application is scientifically distinct. Resubmissions.

Applicants may submit a resubmission application, but such application must include an Introduction Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications will be permitted addressing the previous peer review critique (Summary Statement). only a single amendment (A1). See http://grants.

nih. gov/grants/guide/notice-files/NOT-OD-09-003. html and NOT-OD-09-016 .

Original new and competing renewal applications that were submitted prior to January 25, 2009 will be permitted two amendments (A1 and A2). For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date. Renewals.

Exploratory/developmental grant support is for new projects only, competing renewal (formerly competing continuation) applications will not be accepted. Section IV. Application and To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the Apply for Grant Electronically button in this FOA or 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/applicants/get_registered.

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

htm ) PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons. Several additional separate actions are required before an applicant can submit an electronic application, as follows: 1) Organizational/Institutional Registration in Grants. gov/Get Registered .

Your organization will need to obtain a Data 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 CCR registration. The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days. Direct questions regarding Grants.

gov registration to: Grants. gov Customer Support 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 Organizations Registered in NIH eRA Commons.

Direct questions regarding the Commons registration to: 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 than the PD/PI. This registration/affiliation must be done by the Authorized Organization Representative/Signing Official (AOR/SO) or their designee who is already registered in the Commons.

Both the PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image. 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 Applicants must download 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 all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide ( MS 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/PIs 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 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 following components: SF424 (R&R) (Cover component) Research & Related Project/Performance Site Research & Related Other Project Information Research & Related Senior/Key Person PHS398 Cover Page Supplement PHS398 Modular Budget or Research & Related Budget, as appropriate IV. 6 .

, Special Instructions , regarding appropriate required budget component.) Research & Related Subaward Budget Attachment(s) Foreign Organizations (Non-domestic [non-U.S.] Entities) NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants. nih.

gov/grants/policy/nihgps_2003/NIHGPS_Part12. htm#_Toc54600260 . Applications from Foreign organizations must: Prepare detailed budgets for all applications (that is, complete the Research & Related Budget component of the SF424 (R&R) application forms not the PHS398 Modular Budget component)( see NOT-OD-06-096 ); charge-back of customs and import fees; specifications, which are based upon a standard U.S. paper size of 8.

5 x funds for up to 8% Facilities and Administrative (F&A) costs (excluding equipment) ( see NOT-OD-01-028 , March 29, policies on human subjects, animals, and biohazards; and Comply with Federal/NIH biosafety and biosecurity regulations (see Section VI. 2 .

, Administrative and National Policy Requirements) 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 (U.S.) or that augment existing U.S. resources.

Applications with Multiple 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. for the Contact PD/PI should be entered in Item 13 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 All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed 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, 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, and should include 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.

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 (NoA). Applications Involving a Single all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple 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 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 3.

4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component. Submission Dates and Times See Section IV. 3.

A for details. 3. A.

Submission, Review, and 2009 (Earliest date an application may be submitted to Grants. gov) Application Due Date(s): Standard dates apply, please see http://grants. nih.

gov/grants/funding/submissionschedule. htm AIDS Application Due Date(s): Standard dates apply, please see http://grants1. nih.

gov/grants/funding/submissionschedule. htm#AIDS Date(s): Standard dates apply, please see http://grants1. nih.

gov/grants/funding/submissionschedule. htm#reviewandaward Date(s): Standard dates apply, please see http://grants1. nih.

gov/grants/funding/submissionschedule. htm#reviewandaward Anticipated Start Date(s): Standard dates apply, please see http://grants1. nih.

gov/grants/funding/submissionschedule. htm#reviewandaward A letter of intent is not required for the funding 3. B.

Submitting an