Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Human Genome Research Institute (NHGRI)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Funding Opportunity Title

Phenotyping Embryonic Lethal Knockout Mice (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

  • August 23, 2013 - See Notice NOT-HD-13-012. Notice Providing Information about the Availability of Embryonic Lethal and Sub-Viable Knockout Mouse Strains for Applicants.
  • August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.
  • 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.
  • June 5, 2013 - See Notice NOT-HD-13-008. Notice Providing Additional Information for Applicants.

Funding Opportunity Announcement (FOA) Number

PAR-13-231

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.865; 93.172; 93.837; 93.847

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications to phenotype embryonic lethal knockout (KO) mouse strains being generated through the International Mouse Phenotyping Consortium (IMPC) of which the NIH Knockout Mouse Phenotyping Program (KOMP2) is a member.  It is estimated that KO mouse phenotyping efforts will generate 20,000 mouse strains over the next decade of which about 30% will be embryonic or perinatal lethal. A large portion of homozygous lethal mutations are expected to have viable heterozygous phenotypes.  The scientific community has the unique opportunity to leverage these mouse strains while they are being created and bred as part of the IMPC adult mouse phenotyping effort.

Key Dates
Posted Date

May 22, 2013

Open Date (Earliest Submission Date)

September 5, 2013

Letter of Intent Due Date(s)

30 days before application due date(s)

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date

Standard dates apply

Expiration Date

September 8, 2016

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


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Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description


Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications to phenotype embryonic lethal knockout (KO) mouse strains being generated through the International Mouse Phenotyping Consortium (IMPC) of which the NIH Knockout Mouse Program (KOMP2) is a member.  It is estimated that KO mouse phenotyping efforts will generate 20,000 mouse strains over the next decade of which about 30% will be embryonic or perinatal lethal.  A large portion of homozygous lethal mutations are expected to have viable heterozygous phenotypes.  The scientific community has the unique opportunity to leverage these mouse strains while they are being created and bred as part of the IMPC adult mouse phenotyping effort. 

Phenotyping of embryonic lethal KO mouse strains is of strategic importance for several reasons.  Most obviously, these genes are critical to embryonic growth, differentiation, and organogenesis.  Early lethals will have defects in pre- and peri-implantation processes in embryonic or extra-embryonic tissues.  Mid-gestational lethals will die during organogenesis.  Late lethals will die in the fetal or immediate perinatal periods due to failures in the transition to adult functioning organ systems.  All these mice will be extremely useful as models for a range of congenital human diseases, structural birth defects, infertility, and spontaneous abortion.  Viable heterozygote alleles are likely to be widely represented in human disease because of their haploinsufficiency or dominant phenotypic effects.  So, there is significant and complementary value in also phenotyping heterozygote mutants for clinical phenotypes.

Background

The mouse has long been an important mammalian model system for the study of gene function in human health and disease. Mouse mutants with phenotypes that mimic human traits have served as critical research tools in understanding the genetics underlying mammalian biology. Equally important, mouse mutants have been the tools used to begin to understand gene function and pathways as the field has moved from gene identification to mammalian functional genomics.

In 2006, the Trans-NIH Knockout Mouse Project (KOMP) was launched with the goal of  generating KO mutations in 8,500 genes in C57BL/6 mouse lines by deleting all or most of the exons in target genes or producing knockout-first conditional ready alleles.  Together with the European Conditional Mouse Mutagenesis Program (EUCOMM) and the North American Conditional Mouse Mutagenesis Program (NorCOMM), these efforts produced 14,000 mutant mouse embryonic stem cell clones, as well as live mouse lines, frozen embryos and sperm, and vectors which are available from public repositories under the auspices of the International Knockout Mouse Consortium (IKMC).  Thus, the first phase of this resource was completed in 2011, and attention turned toward implementation of the second phase.

In 2011, the Trans-NIH KOMP2 effort comprised of 19 NIH Institutes as well as the Office of the NIH Director, funded three knockout mouse production centers, three phenotyping centers, and one data coordinating center.  Along with international partners under the auspices of the IMPC, a coordinated phenotyping effort is underway employing common and standardized phenotyping platforms for adult mice with common quality control standards eliminating the redundancy and waste inherent in the “cottage industry” approach (www.mousephenotype.org).  It is anticipated that the resulting global resource of KO mice and associated database of gene function will revolutionize both basic and clinical research for the next 20-30 years.

The IMPC aims to create 20,000 KO mouse strains over the next ten years, and it is estimated that about 30% of these mice will die during the embryonic or perinatal periods. In addition, a large portion of homozygous lethal mutations also are expected to have viable heterozygous phenotypes. Developing an embryonic phenotyping pipeline for these mouse strains presents the scientific community with a unique opportunity since it will leverage the existing investment in KO mice being created and bred as part of the IMPC adult phenotyping effort. The mouse genetics community has recognized this opportunity as discussed at three IMPC workshops (Toronto, April 2010; Barcelona, February 2011; and London, April 2012).  These discussions have culminated in the Bloomsbury Report on Mouse Embryo Phenotyping:  Recommendations from the IMPC Workshop on Embryonic Lethal Screening (Dis. Model. Mech. 2013 6:571-579).  Currently, within the KOMP2 project, only one of the phenotyping centers has established an embryonic lethal pipeline that will provide dissection, gross morphology, and histopathology of embryos and placentas as well as embryo µComputed Tomography (µCT) and Optical Projection Tomography (OPT) imaging on a limited number of lines.  Efforts are underway to increase primary screening of embryonic lethal KO mice lines within KOMP2.   It is clear that there will be a need for additional embryonic lethal phenotyping as the KO mouse production centers achieve full production.

According to the Bloomsbury Report, based on an analysis of data in the Jackson Laboratory Mouse Genome Informatics (MGI) database, of the 60% of embryonic lethals that exhibit abnormal anatomy, 30% will have urogenital, palate, thymus, lung, trachea, gut, liver, diaphragm, spleen and pancreas defects; 28% will have brain, spinal cord, eye, or ear defects; 26% will have cardiac defects; and, 15% will have skeletal and limb defects.  This funding opportunity will provide one avenue for investigators to phenotype cohorts of embryonic lethal KO mice identified by the IMPC production centers.

Scope

The Bloomsbury Report proposes a tiered triage approach to the phenotyping of embryonic lethals to facilitate flexibility in experimental design and economize on breeding strategies. Primary tier screening will begin at the currently funded production centers, including the KOMP2 centers, with a careful evaluation of genotype ratios during breeding to generate adult cohorts for the adult phenotyping pipeline. A mid-gestation stage of E12.5 is the initial reference time point for a “first look” at strains deemed embryonic lethal or sub-viable and for assessment of developmental anomalies.  Since the alleles used in generating the KO strains also carry a LacZ reporter gene, LacZ analyses of heterozygous mice is also being performed at E12.5 by the KOMP2 embryonic lethal pipelines.  This will provide critical insights into the cellular, tissue, and organ-specific expression of the targeted gene.  Based on the E12.5 analysis, embryos will be triaged for further analyses at either earlier or later time points (e.g., E9.5 or E14.5 in KOMP2 or E18.5 as recommended by the Bloomsbury Report).  It is important to note that the estimated 15% of perinatal lethals should not be neglected as these are likely to represent models of human structural birth defects (e.g., neural tube defects).

Depending upon the observations of the primary tier screening at E12.5, investigators can apply for funding through this FOA to pursue secondary tier screening which would focus upon the acquisition of morphological information with any of a variety of 3D imaging modalities (e.g., magnetic resonance, µCT, high resolution epifluorescence microscopy, OPT, and optical coherence tomography).  It is impossible to dictate the “best” stage or modality for imaging to discover novel phenotypes as developmental processes vary by embryonic stage and the interests of the investigators should dictate these aspects.  It is clear that the IMPC will need to play a leadership role in standardizing operating procedures for 3D imaging of embryos in the same manner that they have developed the common protocols for adult phenotyping.  Indeed, this topic is under active discussion, and potential applicants are encouraged to visit the IMPC website for updated information [http://www.mousephenotype.org/].  It is envisioned that specialized imaging cores and investigators collaborating with them will be in the best position to respond. 

More extensive LacZ analyses of heterozygous lines would also be appropriate as part of the secondary tier screening for a more refined look at cellular level gene expression.  In addition, an optional approach for additional characterization of gene function would be to perform mRNA expression profiling using RNA sequencing (RNAseq) of embryonic tissues to measure global perturbations caused by the KO.  Sequencing technologies are continuously evolving; therefore, it is conceivable that this could be applied to embryonic mouse screening, too.

Tertiary tier screening would involve more focused phenotyping of stains of interest to specific investigators based on the initial phenotyping performed by the IMPC efforts. Applications proposing tertiary screening also would be appropriate under this FOA.  These types of analyses could include more detailed immunohistochemistry, laser capture micro-dissection, or the development of cell-based assays, for example. 

It is anticipated that secondary and tertiary level phenotyping will involve collaborations between the IMPC production centers and networks of collaborators interested in advancing their research agendas by pursuing analyses of focused sets of mutants.  An important aspect of secondary and tertiary tier screening will be the integration of phenotypic data into the exiting database supported by the IMPC.  It is strongly suggested that investigators develop a data management and data sharing strategy in consultation the IMPC data coordinating center at the European Bioinformatics Institute (the EBI-KOMP2 Mouse Phenotyping Informatics Infrastructure Consortium) as noted in Section IV.2. Resource Sharing Plan.

Research Interests of Participating Institutes

The participating NIH Institutes have provided a brief outline of their interests as they related to the goals of this FOA.  These brief mission statements are intended to indicate the breadth of the biomedical areas of interest.

NHGRI

NHGRI supports the development of high throughput, genome-wide methods that identify animal models of human disease. Of interest here is the opportunity to improve the utility of the KOMP2 program or otherwise enhance the value of this community resource.

NHLBI

The NHLBI encourages submission of applications that propose phenotyping pipelines directed toward evaluation of cardiovascular, pulmonary, or blood development defects. 

NICHD 

NICHD is interested in the evaluation of KO lines with defects in embryonic development, including but not limited to those affecting:  gastrulation; organogenesis, especially those that affect multiple organ systems; limb development; formation of the lymphatic system; neurogenesis; neural crest migration; neural tube formation; neuronal migration, differentiation, and pathfinding; gliogenesis; formation of the blood/brain barrier; and, generalized brain structure including micro/macrocephaly.  Also of interest would be evaluation of KO lines with defects in trophoblast development, allantois-chorion fusion, or placental function. 

NIDDK

Of interest to NIDDK are applications focused on developmental defects in organ systems of primary importance to the institute.  Of particular interest are studies concentrating on aberrant or incomplete development of the following organs and tissues:  gastrointestinal tract and liver; kidney and lower urinary tract; pancreas, adipose or other endocrine tissues influencing development of major metabolic diseases, diabetes or obesity; hematopoietic system, especially studies focused on defects leading to bloodless and/or severe anemia.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Renewal
Resubmission
Revision

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Budgets for direct costs of up to $499,999 per year may be requested.

Award Project Period

The scope of the proposed project should determine the project period.  The maximum project period is 5 years.  

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Program Directors/Principal Investigators (PDs/PIs)

All PDs/PIs must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.   

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility


Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

Although 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.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

The letter of intent should be sent to:

Lorette C. Javois, PhD
US Postal Mail:  Bldg. 6100, Rm. 4B01D
9000 Rockville Pike MSC 7510
Bethesda, MD 20814-7510
FedEx or UPS:  NIH/NICHD/DBSVB
6100 Executive Blvd., Rm 4B01D
Rockville, MD 20852
Telephone: 301-496-5541
Email: javoisl@mail.nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Letter

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.   

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  

Investigator(s)    

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?   

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?      

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.   

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.  

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the Center for Scientific Review (CSR), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information


1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Phone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Lorette C. Javois, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-5541
Email: javoisl@mail.nih.gov

Colin Fletcher, PhD
National Human Genome Research Institute (NHGRI)
Telephone:  301-451-1340
Email:  fletcherc2@mail.nih.gov

Charlene Schramm, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone:  301-435-0510
Email:  schrammc@mail.nih.gov

Kristin Abraham, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone:  301-451-8048
Email:  abrahamk@mail.nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Bryan S. Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov

Cheryl Chick
National Human Genome Research Institute (NHGRI)
Telephone:  301-435-7858
Email:  chickc@mail.nih.gov

Teresa Marquette
National Heart, Lung, and Blood Institute (NHLBI)
Telephone:  301-435-0166
Email:  marquett@mail.nih.gov

Christina Coriz
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone:  301-594-8848
Email: corizc@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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