Small Research Project Grant (R03) applications from institutions and organizations to propose studies related to the basic, applied and translational research in neonatal hypoglycemia

Small Research Project Grant (R03) applications from institutions and organizations to propose studies related to the basic, applied and translational research in neonatal hypoglycemia is sponsored by National Institutes of Health (NIH) - Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). This funding opportunity encourages Small Research Project Grant (R03) applications for studies related to basic, applied, and translational research in neonatal hypoglycemia.

Expired PA-11-053: Studies in Neonatal Hypoglycemia (R01) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Institutes of Health ( http://www.

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

nih. gov ) Title: Studies in Neonatal Hypoglycemia (R01) Update: The following update relating to this announcement has been issued: May 30, 2013 ( NOT-OD-13-074 ) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

Announcement (PA) Number: PA-11-053 submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants. gov ( http://www. grants.

gov ) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application BE SUBMITTED IN PAPER FORMAT. in conjunction with the application guidelines included with this announcement in Grants. gov/Apply for Grants (hereafter called Grants.

gov/Apply). 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 IV .

Domestic Assistance Number(s) Opening Date: January 5, 201 1 (Earliest date an application may be Letters of Intent Receipt Date(s): 30 days prior to the application due date NOTE: On-time submission requires that applications be successfully submitted to Grants. gov no later than 5:00 p. m.

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

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

gov/grants/funding/submissionschedule. htm#reviewandaward 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 Information To Be Available Date (URL Activation Date): Not Applicable Expiration Date: May 8, 20 1 4 Purpose .

This funding opportunity announcement (FOA) is issued by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) to encourage Research Project Grant (R01) applications from institutions and organizations to prop ose studies related to basic, applied and translational research in neonatal hypoglycemia.

While much progress has been made in understanding the causes and mechanisms of altered neonatal glucose homeostasis, major gaps remain. Through this FOA, the NICHD is hoping to fill-in such know ledge gaps, which may lead to better monitoring and treatment strategies for altered neonatal glucose homeostasis. of Support.

This FOA will utilize the NIH Research Project Grant (R01) award mechanism, and runs in parallel with FOAs of identical scientific scope, PA-11-054 and PA-11-055 , that encourage applications under the NIH Small Research Grant (R03) and NIH Explora tory/Developmental Research Grant (R21) award mechanisms. Funds Available and Anticipated Number of Awards.

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. The total amount awarded and the number of awards will depend upon the mechanism numbers, quality, duration, and costs of the applications received. Budget and Project Period.

Budgets for direct costs of up to $499,999 per year and project duration of up to 5 years may be requested. For budgets with direct costs of $500,000 or more please see Section IV. 6 for special Research Strategy Length: The R01 R esearch Strategy section may not exceed 1 2 pages, including tables, graphs, fi gure s, di agrams, and charts.

See Table of Page Institutions/Organizations. Institutions/organizations 1. A.

are eligible to apply. Eligible 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. Applicants may submit a renewal application. Application 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 2. Cost Sharing or Matching 3. Other-Special Eligibility Criteria Application and Submission Information 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 Application Review Information 2. Review and Selection Process 3. Anticipated Announcement Administration Information 2.

Administrative and National Policy Requirements Scientific/Research Contact(s) 2. Peer Review Contact(s) 3. Financial/Grants Management Contact(s) Other Information - Required Federal Citations Part II - Full Text of Announcement Section I.

Funding Opportunity Description purpose of this funding opportunity announcement is to stimulate research on a wide range of topics related to neonatal hypoglycemia. The long-term objectives are to fill knowledge gaps, provide an evidence-based platform to monitor, treat, and follow-up neonates with hypoglycemia, and to provide appropriate counseling for their families.

mammalian fetus is entirely dependent upon the intra-uterine transfer of glucose and other nutritional substrates from its mother. As a result, soon after birth, there is a transient drop in blood (or plasma) glucose concentration, in most cases, followed by steady-state equilibrium as a result of a number of metabolic responses.

However, in presence of abnormal situations, such as maternal diabetes, fetal growth restriction, and unexplained macrosomia, perturbations in neonatal glucose homeostasis can occur, leading to low blood or plasma glucose concentrations, or hypoglycemia. severe, hypoglycemia can cause serious clinical problems, including permanent neurological damage.

Although much progress has occurred in the field of glucose metabolism in general, major gaps still exist in our knowledge concerning neonatal hypoglycemia. In fact, there is no agreed upon definition of hypoglycemia as a pathological entity. The risk factors for predicting hypoglycemia are not comprehensive, and the frequency and method of monitoring and treatment have remained empirical.

is no consensus about the short- and long-term consequences of transient neonatal hypoglycemia in asymptomatic infants. The complex nature and maturational features of global and regional brain energy utilization remain to be studied in human neonates. Most published statements and opinions on this topic have been based on low levels of evidence, including human studies in select populations without controls, or longer-term follow-up.

Applicants are encouraged to refer to a report written by an expert panel participating in a NICHD-sponsored workshop, that summarizes the knowledge gaps on this topic and proposes a research agenda (J Pediatr 2009;155:612-7). This FOA invites a wide range of research studies that may include, but are not limited to, animal, experimental, clinical, and epidemiological studies related to neonatal hypoglycemia.

The clinical study proposals may be randomized prospective controlled trials, prospective observational studies, or retrospective cohort studies. The type of the animal models proposed may depend upon the research question being addressed.

However, all studies (clinical or animal-model) should justify the chosen model and the study design, including the adequacy of the cohort and the appropriateness of the study design to answer the aims and objectives.

Some of the specific areas of interest include, but are not limited to the following areas on the topic of neonatal glucose homeostasis, and their impact on short Hypoglycemia and the developing brain brain energy sufficiency including key indicators that are altered when levels of adenosine triphosphate and phosphocreatine decrease.

plasma glucose concentrations that adversely affect brain functions under different conditions (e.g., SGA, infants of diabetic mothers, neonatal encephalopathy, seizures, sepsis) brain cellular use of alternate fuels (e.g., lactate, ketone bodies), as well as alternate fuel production under conditions of diminished glucose availability with physiological and genetically altered animal models.

the relationship between plasma concentrations of energy substrates on brain structure and function, with such techniques as imaging, mass spectroscopy and 1H, 31P nuclear magnetic resonance spectroscopy, and longitudinal phenotypic evaluations in genetically-modified animal models and in human beings to establish cause-and-effect paradigms.

the biologic basis for regional and cellular vulnerability of the brain during hypoglycemia with the methods noted above, as well as MRI/magnetic resonance spectroscopy along with monitoring of the infant’s metabolism.

the factors that prevent brain injury from low glucose supply in exclusively breastfed infants and the potential consequences of formula feeding in such reliable age-based nomograms of postnatal plasma glucose changes in healthy term infants under varying feeding conditions during the first weeks after glucose nomograms for infants with risk factors (e.g., preterm, SGA, large for gestational age, IUGR; maternal history of insulin-dependent and gestational diabetes, obesity) and different diets.

Such nomograms should evaluate variability with infant age and the relationship to neurodevelopmental outcomes. long-term outcomes in neonates with asymptomatic hypoglycemia, focusing on subtle neurocognitive outcomes including executive functions. the effects of co-morbidities (e.g., white matter injury, hypoxia-ischemia, sepsis) and their contribution to adverse outcomes with low plasma glucose.

the effects of the frequency, severity, and duration of episodes of low plasma the effect of clinical signs (e.g., seizures and coma) on neurodevelopmental outcome (Such studies could be prospective and longitudinal, as well as whether scoring systems on the basis of risk factors will generate practically useful measures of plasma glucose concentrations and alternate substrates in Develop noninvasive, continuous, glucose concentration systems that are safe and accurate at all glucose concentrations encountered in newborn infants.

Such equipment needs to account for the effect of local circulatory changes, edema, and shock, and should not interfere with medical care of sick infants or breastfeeding of healthy infants. Develop noninvasive monitoring of alternate substrates (ketone, lactate, and pyruvate) Determine the role for neuroimaging to assess simultaneous changes in brain structure and function with plasma glucose and alternate fuel concentrations.

Establish the role of serial Magnetic Resonance Imaging (MRI) with diffusion weighted cuts and high-resolution imaging in different layers of cortex in infants with hypoglycemia to assess the specificity of reported MR spectroscopy lesions to hypoglycemia. Establish longitudinal trends in MRI results in symptomatic cases of hypoglycemia. Develop outcome prediction paradigms on the basis of neuroimaging.

Improve EEG/aEEG methods for application in hypoglycemia to help correlate the findings with simultaneous plasma glucose concentrations in the presence of co-morbidities (e.g., post-HIE depression, seizures, coma) and milder neurologic signs attributed to low blood glucose. See Section VIII, Other Information - Required Federal for policies related to this announcement.

This FOA will use the NIH Research Project Grant (R01) award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project. Just-in-Time information concepts (see SF424 (R&R) Application Guide ) .

It also uses the modular as well as the non-modular budget formats (see http://grants. nih. gov/grants/funding/modular/modular.

htm ). Specifically, a U.S. organization submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs) should use the PHS398 Modular Budget component. U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component .

scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary.

Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation see NOT-OD-05-004 .

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this III. Eligibility Information 1. A.

Eligible Institutions organizations/institutions are eligible to apply: Controlled Institutions of Higher Education Institutions of Higher Education Historically Black Colleges Tribally Controlled Colleges Alaska Native and Native Hawaiian Serving 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) Eligible Agencies of the Federal Faith-based or Community-based 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 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 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 . program does not require cost sharing as defined in the current NIH Grants Policy Statement . 3.

Other-Special Eligibility Criteria 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). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and renewal applications are permitted only a single amendment (A1).

See new NIH policy on resubmission (amended) applications ( NOT-OD-09-003 , NOT-OD-09-016 ). Original new and renewal applications that were submitted prior to January 25, 2009 are 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. Applicants may submit a renewal application. Section 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, 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.

registrations with Grants. gov and eRA Commons must be completed on or before the due date in order to successfully submit an application . Several of the steps of the registration process could take four weeks or more.

Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants. gov and the Commons . All registrations must be complete by the submission deadline for the application to be considered on-time (see 3.

C. 1 for more information about on-time submission). is required for institutions/organizations at both: Grants.

gov ( http://www. grants. gov/applicants/get_registered.

jsp ) and 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. additional separate actions are required before an applicant can submit an electronic application, as follows: 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: Business Hours: M-F 7:00 a. m. - 9:00 p.

m. Eastern Time 2) Organizational/Institutional Registration in the eRA 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 Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide . The individual(s) designated as PDs/PIs on the application must be registered also in the NIH eRA Commons. In the case of multiple PDs/PIs, all PDs/PIs must be registered and be assigned the PI role in the eRA Commons prior to the submission of the application.

hold a PD/PI account in the Commons. Applicants should not share a Commons account for both an Authorized Organization Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have both a PD/PI role and an Internet Assisted Review (IAR) role, both roles should exist under one Commons account. When multiple PDs/PIs are proposed, all PDs/PIs at the applicant organization must be affiliated with that organization.

PDs/PIs located at another institution need not be affiliated with the applicant organization, but must be affiliated with their own organization to be able to access the Commons. This registration/affiliation must be done by the AOR/SO or his/her designee who is already registered in the Commons. and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants. gov and eRA Commons as soon as their organization has obtained a DUNS number.

Only one DUNS number is required and the same DUNS number must be referenced when completing Grants. gov registration, eRA Commons registration and the SF424 (R&R) Request Application Information download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants. gov/Apply .

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one For further assistance, contact GrantsInfo -- Telephone 301-710-0267, Email: [email protected] .

Telecommunications for the hearing impaired: TTY: Content and Form of Application Submission applications using the SF424 (R&R) application forms for this FOA through Grants. gov/Apply and in accordance with the SF424 (R&R) Application Guide ( http://grants. nih.

gov/grants/funding/424/index. htm ). Application Guide is critical to submitting a complete and accurate application to NIH.

Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH ( e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID ). Agency-specific instructions for such fields are clearly identified in the Application Guide.

For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications . The SF424 (R&R) application has several components. Some components are required, others are optional.

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

A completed application in response to this FOA includes the data in the following components: Project/Performance Site Locations Research & Related Other Project Information Research & Related Senior/Key Person PHS398 Cover Page Supplement PHS398 Modular Budget or Research & Related Budget , as appropriate (See Section IV. 6. regarding appropriate required budget component.)

Research & Related Subaward Budget Attachment(s) Organizations ( Non-domestic [non-U.S.] Entities) 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 . from Foreign organizations must: Request budgets in U.S. dollars; 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 ); Not include any charge-back of customs and import Comply with the format specifications, which are based upon a standard U.S. paper size of 8.

5 x 11 within each PDF; If appropriate, request funds for up to 8% Facilities and Administrative (F&A) costs (excluding equipment) ( see NOT-OD-01-028 , March 29, Comply with Federal/NIH policies on human subjects, animals, and biohazards; and with Federal/NIH biosafety and biosecurity regulations (see Section Administrative and National Policy Requirements ) Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States (U.S.) or that augment existing U.S. resources.

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 Contact PD/PI should be entered on 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 PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the 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.

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 Involving a Single Institution within a single institution, follow the instructions contained in the SF424 Involving Multiple Institutions 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 modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format.

See Section 5. 4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component. 3.

Submission Dates and Times See Section IV. 3. A.

for details. 3. A.

Submission, Review, and Date: January 5, 201 1 (Earliest date an application may be submitted to Grants. gov) Letters of Intent Receipt Date(s): 30 days prior to the application due date NOTE: On-time submission requires that applications be successfully submitted to Grants. gov no later than 5:00 p.

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

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

nih. gov/grants/funding/submissionschedule. htm#reviewandaward 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 applicants are asked to submit a letter of intent that includes the following Descriptive title of proposed research.

Name, address, and telephone number of Names of other key personnel. Participating institutions. Number and title of this funding a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

intent is to be sent by the date listed in Section IV. 3. A.

intent should be sent to: Pregnancy and Perinatology Branch (PPB), CDBPM Eunice Kennedy Shriver National Institute of Child Health and Human Development Executive Boulevard, Room 4B03 (Rockville, Maryland 20852 for non 3. B. Submitting an Application Electronically to the To submit an application in response to this FOA, applicants should access this FOA via http://www.

grants. gov/applicants/apply_for_grants. jsp and follow Steps 1-4.

Note: Applications must only be submitted electronically . PAPER APPLICATIONS WILL NOT BE ACCEPTED. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .

pdf 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 due date(s). (See Section IV. 3.

A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed.

All applications must meet the following criteria to be considered on-time : registrations must be complete prior to the submission deadline application must receive a Grants. gov tracking number and timestamp (or eRA help desk ticket confirming a system issue preventing submission) by 5:00 p. m.

local time on the submission deadline date. visit http://era. nih.

gov/electronicReceipt/app_help. htm for detailed information on what to do if Grants. gov or eRA system issues threaten your ability to submit on time.

Submission to Grants. gov is not the last step applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

an Application in the eRA Commons Once any eRA identified 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 weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.

acceptable, no further action is necessary. The application will automatically move forward to the Division of Receipt and Referral in the Center for Scientific Review for processing after two weekdays, excluding Federal holidays. 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 it is determined that some part of the application was lost or did not transfer correctly during the submission process, the AOR/SO will have the option to Reject the application and submit a Changed/Corrected application. In these cases, please contact the eRA Help Desk to ensure that the issues are addressed and corrected.

Once rejected, applicants should follow the instructions for correcting errors in Section 2. 12 of the SF 424 (R&R) application guide, including the requirement for cover letters on late applications. The Reject feature should also be used if you determine that warnings are applicable to your application and need to be addressed now.

Remember, warnings do not stop further application processing. If an application submission results in warnings (but no errors), it will automatically move forward after two weekdays if no action is taken. Some warni ngs may need to be addressed later in the process.

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 Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH . Incomplete applications will not be reviewed. will be an acknowledgement of receipt of applications from Grants.

gov and the Commons . The submitting AOR/SO receives the Grants. gov acknowledgments.

The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons. unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.

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. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

4. Intergovernmental Review subject to intergovernmental All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement . costs are allowable.

A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or