Exploratory/Developmental (R21) research grant applications on women's mental health and sex/gender differences in mental health across the lifespan

Exploratory/Developmental (R21) research grant applications on women's mental health and sex/gender differences in mental health across the lifespan is sponsored by National Institutes of Health (NIH). This grant supports exploratory/developmental research projects focused on women's mental health and sex/gender differences in mental health throughout the lifespan.

Expired PA-06-334: 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 Department of Health and Human Services Participating Organizations Health (NIH), ( http://www.

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

nih. gov ) Health and Sex/Gender Differences Research (R21) This is a reissue of PA-03-143 , which was previously released June 20, 2003 and is now divided into separate FOAs for R21 and R01 funding mechanisms. Update: The following update relating to this announcement has been issued: February 20, 2009 - This PA has been reissued as (PA-09-109).

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. 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) SUBMITTED IN PAPER FORMAT.

conjunction with the application guidelines included with this announcement in Grants. gov/Apply for Grants (hereafter called Grants. gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV . Announcement (PA) Number: PA-06-334 Catalog of Federal Domestic Assistance Number(s) Date: May 2, 2006 (Earliest date an application may be submitted to 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): Standard dates apply, please see http://grants1. nih.

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

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

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

htm#reviewandaward for details. Earliest Anticipated Start Date(s) Standard dates apply, please see http://grants1. nih.

gov/grants/funding/submissionschedule. htm#reviewandaward for details. To Be Available Date (Url Activation Date): Not applicable 2009 (now May 8, 2009 per NOT-OD-07-093 ) funding opportunity announcement (FOA) solicits exploratory/developmental (R21) research grant applications on women's mental health and sex/gender differences in mental health across the lifespan.

The epidemiology and disability burden of mental disorders provide clear evidence of the value of a focus on sex 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 across the lifespan. 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, 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 FOA, NIMH seeks to increase the understanding of the significance of sex/gender differences in mental health outcomes and to assess their significance for mental health prevention, treatment and services.

This funding opportunity will utilize the R21 mechanism, but will be run in parallel with a program announcement of identical scientific scope that will utilize the traditional research project grant (R01) ( PA-06-333 ). 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 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; Units of State Tribal government; and Units of Local Tribal government.

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 programs.

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) general information on SF424 (R&R) Application and Electronic Submission, see these the following Web sites: (R&R) Application and Electronic Submission Information: http://grants.

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

nih. gov/ElectronicReceipt/ 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 C. Application Processing 4. Intergovernmental Review 6.

Other Submission Requirements Section V. Application Review 2. Review and Selection Process A.

Additional Review Criteria 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 - Full Text of Announcement Section I. Funding Opportunity 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 PA, 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.

Nonetheless, it is recognized that this distinction is often not clear-cut in the area of brain research, where it has been demonstrated that experience can modify brain This program announcement identifies three major areas for research emphasis: basic and clinical neuroscience; epidemiology and risk factors; and intervention and services Neuroscience - There is increasing evidence that neurobiological sex differences impact a wide array of behaviors and may alter vulnerability to different mental disorders, severity of course, and/or response to different treatments.

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

areas include studies of: differences in brain processes contributing to cognitive and affective behavior as determined by structural and functional brain imaging of normative and 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 differences in genetic or epigenetic factors and/or gene-environment interactions contributing to mental disorders.

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.

differences and sex hormone influences on the pharmacokinetics, pharmacodynamics and pharmacogenetics of psychotropic medications across the development to examine the impact of hormonal transitions across the lifespan on brain physiology and function, including, for example, neural plasticity, of the functional significance of molecular and cellular effects of estrogen, progesterone, and related molecules within circuits mediating cognition and of selective ligands to explore the role of brain hormones and hormone receptors in behavioral control and for in vivo imaging of receptor dynamics across the female lifespan.

sex differences in hormone actions contribute to differences in physiological and behavioral responses to stress. There are also sex/gender differences in the types of stressors an individual is likely to be exposed to. 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, multi-disciplinary approaches are required, ranging from basic research models in animals and humans to clinical research in children, adults, and the elderly.

of genetic, molecular, and cellular brain mechanisms mediating sex differences in the stress effects on mood, cognition, exploration, sleep, aggression, and susceptibility to mental disorders of how biological sex impacts developmental mechanisms determining susceptibility to adverse consequences of stress and risk for mental disorders 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.

This work remains to be done for children and adolescents. The need for such research is particularly pressing, because in many disorders, gender differences emerge first 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 gender-related or gender-specific factors in diagnosis, epidemiology, risk for onset or recurrence, and in the course of mental disorders across the lifespan are needed.

of disparities in prevalence of mental illness and related disability, and in access to care among women and girls of different ethnic and socioeconomic of the reliability, validity and predictive value of approaches to conceptualizing and measuring psychopathology in female populations.

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 use substances).

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).

developmental issues are of interest: 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, and perimenopause.

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 Examples of relevant research areas include studies of: differences in acute and maintenance treatment outcomes for mental disorders differences in treatment adherence and side effects of treatments and in treatment preferences, expectancies, provider behaviors, and services use.

interactions (e.g., supplements, replacement hormones, and psychotropic and other medications) in females across the life span.

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 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).

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

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 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. 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.

See Section VIII, Other Information - Required Federal Citations , for policies related to this announcement. T his funding opportunity will use the Exploratory/Developmental mechanism(s). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses 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 IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. 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 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 Units of State Tribal government Units of Local Tribal government 1. B.

Eligible Individuals 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. 2.

Cost Sharing or Matching Not applicable. This program does not require cost sharing as defined in the current NIH Grants Policy Statement . 3.

Other-Special Eligibility Criteria Applicants may submit more than one application, provided each application is scientifically distinct. IV. Application and Submission Information 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 Signing Official (SO) or their designee who is already registered in the Commons.

Both the PD/PI and SO need separate accounts in the NIH eRA Commons since both are required to verify that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization.

Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government. 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 1. Request Application Information Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.

gov/Apply . Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected] . Telecommunications for the hearing impaired: TTY 301-451-5936. Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide 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 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 following components: Research & Related Project/Performance Site Research & Related Other Project Information Research & Related Senior/Key Person Note: While both budget components are included in the SF424 (R&R) forms package, the NIH R21 uses ONLY the PHS 398 Modular Budget.

(Do not use the detailed Research & Related Budget.) 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. administrative costs (excluding equipment) may be requested. See NOT-OD-01-028 , 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 Proposed research should provide a unique research opportunity not available in the United States. 3. Submission Dates and Times Submission, Review and Anticipated Start Dates date an application may be submitted to Grants.

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

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

htm#AIDS Peer Review Date: http://grants. nih. gov/grants/funding/submissionschedule.

htm Council Review Date: http://grants. nih. gov/grants/funding/submissionschedule.

htm Start Date: http://grants. nih. gov/grants/funding/submissionschedule.

htm not required for the funding opportunity. 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 APPLICATIONS WILL NOT BE ACCEPTED. Applications may be submitted on or after the opening date and must be successfully received by Grants.

gov no later than 5:00 p. m. local time (of the applicant institution/organization) on the application submission/receipt date(s).

(See Section IV. 3. A.

for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review 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 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 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 the NIH late policy guidelines and may not be accepted.

The reason for this delay should be explained in the cover letter attachment. the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants. gov and the Commons . Information related to the assignment of an application to a Scientific Review Group is also in the NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application.

The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique.

Note such an application is considered a "resubmission" for the SF424 This initiative is not subject to intergovernmental All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Costs are allowable.

A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new 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 The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred.

NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. Grants Policy Statement .

PD/PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.

gov. For additional information, see Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications .

(formerly competing continuation or Type 2 ) applications are not All application instructions outlined in the SF424 (R&R) application are to be followed, with the following requirements for R21 applications: R21 applications will use the modular budget format and "Just-in-Time" concepts, with direct costs requested in $25,000 modules, up to the total direct costs limitation of $275,000 over an R21 two-year period.

No more than $200,000 in direct costs will be allowed in any single year. Although preliminary data are not required for an R21 application, they may be included. Items 2-5 of the Research Plan of the R21 application may not exceed 15 pages, including tables, graphs, figures, diagrams, and charts.

for a resubmission application) is limited to one page. required but may be included if available. Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files.

This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a . pdf extension must be R21 appendix materials should be limited, as is consistent with the exploratory nature of the R21 mechanism.

The following materials may be included in the appendix: manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to this project. Do not include manuscripts submitted for publication. Include only a publication list with a link to the publicly available on-line journal article or the PubMed Central (PMC) submission identification number.

Do not include the entire article. publication but not yet published: The entire article may be submitted electronically as a PDF attachment. Manuscripts published but an online journal link is not available: The entire article may be submitted electronically as a PDF attachment.

data collection instruments, clinical protocols, and informed consent micrographs, etc. provided that the image (may be reduced in size) is also included within the 15-page limit of Items 2-5 of the Research Plan. No images may be included in the Appendix that are not also represented within the Research Plan. to circumvent the page limitations of the Research Plan.

An application that does not observe these limitations may be delayed in the review Plan for Sharing Research Data data sharing plan is not required; however, one may be proposed. 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