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.

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

The purpose of this FOA is to facilitate new and innovative comparative medicine research that expands our knowledge of basic and translational strategies to ameliorate human and agricultural animal disease and developmental and metabolic disorders and improve reproductive efficiency. The focal point of the FOA will be to stimulate and strengthen the application of large domestic animal species for addressing and elucidating specific complex biological mechanisms important to both biomedicine and agriculture. New investigators (including Early-Stage Investigators), and PD(s)/PI(s) who received their first R01 under the previous program announcements (PAR-10-276; PAR-13-204) to the National Institutes of Health are highly encouraged to submit research grant applications projected to have a dual benefit for the improvement of health, nutrition, disease prevention, and reproduction in both humans and agriculturally important domestic animals.

A look at the history of biomedical research reveals that agriculturally important domestic animal species such as the pig, sheep, cow, horse, and chicken have been central for the acquisition of basic fundamental knowledge regarding the physiology and pathophysiology of organ systems and the development of reproductive technologies. Despite these documented advances in biomedical research using domestic animal species, their utilization in this era of molecular biology, genomics, and proteomics has often been limited. However, with the recent elucidation of the genome of several of the domestic animal species (cow, horse, pig, chicken, and turkey) and their high gene conservation and similar chromosomal order to humans, these animals become superior genetic models for mapping, as well as the inference of genes associated with disease or physiological mechanisms. While research to curtail human disease is funded primarily by the NIH, the USDA-NIFA provides support for research aimed at improving human health by the provision of safe food with a high nutritive value.

During the past decade, two workshops, convened in 2004 and 2007, highlighted the need for greater interagency cooperation between the NIH and USDA-NIFA so as to better advocate for the utility of these animals as models to study high priority areas in both biomedical and agricultural research. Four priority topics (assisted reproduction/stem cell biology, metabolism with respect to obesity and nutrition, developmental origins of adult disease, and infectious disease) were chosen since it was envisioned that knowledge gained and advances in these areas could greatly benefit both biomedicine and animal agriculture.

In 2007, the American Medical Association and the American Veterinary Medical Association considered a One Health initiative (http://www.onehealthinitiative.com/taskForce.php) to strengthen ties and collaborative efforts between schools of medicine and veterinary science. The basis of this initiative was recognition of the mutualistic relationship humans, animals and ecosystems have in the maintenance of overall health. Recently in March 2015, the Division of Comparative Medicine, Office of Research Infrastructure Programs (ORIP) at NIH convened a workshop to assess the progress of the One Health initiative and suggest future steps. The meeting recognized the contribution of the two successful programs funded jointly by NIH and USDA-NIFA, i.e., "Ecology and Evolution of Infectious Diseases", and "Dual Purpose with Dual Benefit: Research in Biomedicine and Agriculture Using Agriculturally Important Domestic Animal Species". As such, dual purpose for dual benefit research utilizing domestic agricultural animals should not only further stimulate the progression of scientific knowledge towards multipurpose research endeavors, but it should also provide additional funding opportunities for investigators whose research has traditionally been in the domain of either NIH or USDA-NIFA.

Knowledge gained through comparative research using domestic agricultural animal models supported by this FOA will broaden the fundamental understanding of normal animal and human physiology but also the etiology of metabolic and infectious diseases in four main topic areas to advance the development of biomedical and agricultural interventions or therapies to improve both human health and farm animal health and production.

• Reproduction, Stem cell biology and Regenerative medicine: Expand fundamental knowledge of processes that underlie human and animal reproduction by advancing our understanding of gametogenesis through the identification of molecular, physiological, and developmental mechanisms that regulate oogenesis and spermatogenesis; improve the efficiency of assisted reproductive technologies in human or cloning in farm animals; elucidate the molecular processes regulating reprogramming in early embryos, embryonic stem cells, induced pluripotent stem cells, and other lineage-specific stem cells, and in cloning (somatic cell nuclear transfer) to enhance tools and improve methods for cloning or the generation of transgenic animals; modify genetic traits of large animals using gene-editing technologies for selective breeding and generation of transgenic animals that mimic human diseases, or provide living, functional tissues to repair or replace tissue or organ functionality lost due to age, disease, damage or congenital defects in the human; characterize the core microbiome (including the metabolome of the microbiome) of the reproductive tract and study its impact on physiology and pathophysiology of reproduction.
• Metabolism: Establish the contribution of specific cell types, such as the adipocyte, and central or peripheral factors in the metabolism of lipids and their role in modulating fat accretion in tissues and/or during specific developmental stages; identify genetic and/or exogenous factors, such as diet or hormones, and determine their role in predisposition to or the onset of obesity; characterize the role of gastrointestinal microbiome (including the metabolome of the microbiome) on host metabolism in the context of adipose deposition and obesity. An understanding of the metabolism and regulation of fat accretion will identify ways in which to improve meat quality, thus its nutritive value to humans, and concomitantly provide insight for the development of novel therapies to reduce the current global epidemic of obesity.
• Developmental origin of adult disease: Investigate the role of placenta in health and disease of the mother and her fetus during pregnancy, postnatally in the offspring and during adulthood; Define in utero developmental programming events altered by maternal exposure to environment stressors (e.g. nutrition, drugs, temperature, pathogens, toxicants) or maternal health status (e.g. disease, obesity) that may be the origin of adult disease or may impair growth, fertility, meat quality, disease resistance, and other traits that are particularly important for agriculture; characterize the gestational and perinatal microbiomes (including the metabolomes of their microbiome) and study their relationship to growth, development, anti-microbial resistance, and to the origin of adult diseases. Quantifiable benefits to NIH and the USDA-NIFA will be the creation of innovative interventions that prevent or ameliorate disease and enhance desired traits to promote human and animal health, as well as economically important production traits for agriculture.
• Infectious diseases: Elucidate the genes and physiological mechanisms that regulate resistance and/or susceptibility to infectious pathogens of human or agricultural animals which will allow for the selection and generation of pathogen-resistant animals; develop interventions that decrease or prevent the transmission of pathogens from animal reservoirs to humans; identify environmental factors that contribute to the emergence of infectious pathogens to decrease or eradicate their occurrence; define organ or tissue-specific microbiome (including the metabolome of the microbiome) and its relationship to inflammation, immune response, infectious disease development, and antimicrobial resistance; develop genome editing strategies for treatment of infectious diseases. The prevention or eradication of infectious diseases substantially impacts human health and enables the generation of healthier, more superior farm animals.

The main objective of this FOA is to stimulate and encourage investigations in the four areas identified as high priority issues to both biomedicine and agriculture through the use of pertinent domestic farm animal species that better mimic the specific human developmental, physiological or disease state. Knowledge gained will provide dual benefit to both human and agricultural animal species and advance applications for the improvement of health, productivity and reproductive efficiency. New Investigators, Early Stage Investigators, and PD(s)/PI(s) who received their first R01 under this program are strongly encouraged to apply.

This FOA has been established to encourage the use of domestic agricultural animal species to address four priority research areas of high impact to biomedicine and agriculture. Though research with rodent models has been useful, grasping a more complete fundamental understanding of specific biological questions and translating the knowledge gained to improve both animal and human health and reproduction require the use of models that more closely resemble each other developmentally and physiologically or that exhibit similar susceptibility to common infectious pathogens. The areas of investigation and experimental approaches may involve the characterization of animal models, elucidation of the etiology involved in disease or transmission of pathogens, a determination of environmental insults underlying developmental or epigenetic changes leading to pathophysiology, metabolic studies focused on obesity, or the identification of diagnostic tools (genetic markers, biomarkers, or antibodies). Genomic or proteomic approaches to pinpoint potential gene products or molecular mechanisms involved in the developmental, reproductive, or disease process being investigated are encouraged but findings and interpretations will require validation by cellular, systemic, or in vivo studies. Similarly, in vitro (cellular) studies with downstream functional in vivo (whole animal) studies will be crucial to demonstrate and verify the utility of the findings for applications that improve specific health or reproductive issues addressed. Efforts to address the identification of markers that will predict reproductive capacity of oocytes or embryos should involve non-invasive approaches. This research effort is expected to deepen the fundamental knowledge of biological mechanisms essential to both humans and farm animals, highlight the utility of domestic agricultural animals as more appropriate animal models for specific mechanistic studies, and encourage investigators with farm animal expertise to be involved in research benefiting both agriculture and biomedicine.

Examples of research topics considered appropriate to this FOA include, but are not limited to the following:

• Study ovarian function and dysfunction, including the mechanisms that regulate follicle endowment, follicular development, ovulation, development and function of the corpus luteum, and ovarian pathologies that affect fertility
• Establish or improve methods for the in vitro expansion of spermatogonial stem cells, their cryopreservation, and testicular repopulation that can be applied 1) as an alternative approach for male germplasm preservation, 2) towards regenerative medicine to alleviate detrimental male-inherited traits or gonadotoxic exposure, or 3) as an alternative transgenesis tool.
• Design studies to enhance the efficacy of assisted reproduction technology (ART) and reduce simultaneous multiple pregnancies in humans and thus, the risks associated with multiple births such as prematurity, small for gestational age, and improve the efficacy of in vitro conditions for the manipulation of oocytes by: Identifying molecular mechanisms that regulate oocyte and embryo competency; Pinpointing and validating biomarkers and other types of non-invasive hallmarks that may be used reliably to determine oocyte and embryo quality; Investigating the effect of current and novel in vitro oocyte maturation methods on embryo competency.
• Elucidate mechanisms that regulate nuclear reprogramming, including maintenance of genomic integrity and, the identification of factors in the in vitro milieu that trigger epigenetic changes to improve cloning or transgenesis methodologies.
• Establish the core microbiome (including the metabolome of the microbiome) of the reproductive tract, and design studies to understand the effect of altered microbiome on fertility and infertility.
• Improve or identify novel interventions to prevent or decrease the incidence of obesity in humans and to improve the carcass quality of farm animals by: Identifying central and peripheral factors involved in the regulation of energy balance and examining their role in nutrient utilization and/or feeding behavior with respect to obesity.
• Elucidate the biology of the adipocyte, including mechanisms that regulate lipid metabolism, generation of adipose tissue-derived cytokines (adipokines), and fat accretion
• Deciphering genetic, dietary or hormonal influences on the regulation of pre- or postnatal adiposity.
• Characterize the role of gastrointestinal microbiome (including the metabolome of the microbiome) on host metabolism in the context of obesity.
• Examine the impact of environmental factors, the mother s physical state, and placental structure and/or metabolism on in utero developmental programming of the embryo and fetus and their role in the etiology of subsequent pathogenesis in adulthood that 1) negatively impacts the ability to thrive or survive, 2) increases disease susceptibility and/or 3) decreases fertility and reproductive capacity in humans and farm animals through: the identification of fetal/placental developmental factor, placentation, or epigenetic changes influenced by exposure of the mother to specific environmental stressors (e.g. malnutrition, obesity, toxicants, drugs, temperature, disease) that alter development processes in the embryo and fetus and directly increase the incidence of disease susceptibility, pathogenesis, or decreased fertility and reproductive capacity in adulthood.
• Investigate the effects of specific nutrients on gene expression and the elucidation of genetic components that modulate unique responses (i.e. nutrigenomics) to determine its application for the prevention, alleviation or treatment of chronic disease or to enhance reproduction.
• Study the role of gestational and perinatal microbiomes (including the metabolomes of their microbiome) on growth, development, antimicrobial resistance, and to the origin of adult diseases.
• Identify interventions that halt the transmission of infectious diseases from animal reservoirs to abrogate disease in the hosts through: the elucidation of the factors and mechanisms that regulate horizontal and vertical transmission of virulent infectious pathogens and the genetic factors that predispose susceptibility of a human or animal.
• The identification of determinants, such as human demographics and behavior, practices in technology, industry or agriculture and economic development that contribute to the emergence of eradicated and relatively new infectious pathogens.
• Define organ or tissue-specific microbiome (including the metabolome of the microbiome) and its relationship to inflammation, immune response, infectious development and antimicrobial resistance
• Develop genome-editing strategies for the treatment of infectious diseases
• The development of vaccines or novel therapies to block transmission and/or abrogate susceptibility.

See Section VIII. Other Information for award authorities and regulations.

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.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (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.

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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. 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.

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.

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

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Applicants must obtain 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.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

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:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Ravi (Neelakanta) Ravindranath, DVM, PhD
Fertility and Infertility Branch (FIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Rm8B01G, MSC 7510
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: 301-435-6889
Fax: 301-480-2389
Email: [email protected]

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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

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

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

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

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

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

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

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 as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed.

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

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.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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 and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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.

This initiative is not subject to intergovernmental review.

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.

NIFA awards are subject to the terms and conditions, cost principles, and other considerations described in 7 CFR 3430, Competitive and Noncompetitive Non-formula Grant Programs General Grant Administrative Provisions.

Section 7132 of the Food, Conservation, and Energy Act of 2008 (Pub. L. 110-246) amended section 1462(a) of the National Agricultural Research, Extension, and Teaching Policy Act of 1977 (7 U.S.C. 3310(a)) on recovery of indirect costs. The recovery of indirect costs on awards made by USDA-NIFA under this program may not exceed the lesser of the institution's official negotiated indirect cost rate or the equivalent of 22 percent of total Federal funds awarded. If an applicant is selected for an award by USDA-NIFA, they will be instructed to resubmit their budget forms in accordance with this limitation.

Funds made available for grants under this FOA shall not be used for the construction of a new building or facility or the acquisition, expansion, remodeling, or alteration of an existing building or facility (including site grading and improvement, and architect fees).

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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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 and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Applicants are required to follow our Post Submission Application Materials policy.

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.

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).

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.

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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?

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?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

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?

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.

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 Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

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.

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

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.

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.

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.

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).

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) Genomic Data Sharing Plan (GDS).

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, 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:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

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:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

For applications that are not awarded by NICHD, the written critique (Summary Statement) may be shared with appropriate staff at USDA for their consideration.

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

USDA-NIFA Award Notices:

Applicants selected for USDA-NIFA funding will be required to submit additional forms and documents as detailed in A Guide for Preparation and Submission of NIFA Applications via Grants.gov (PDF) (http://www.csrees.usda.gov/funding/grant_forms/adobe_grants_gov_instructions.pdf). All awards made from the USDA will be limited to an indirect cost cap of 22% of the total Federal funds awarded. Revised budgets will be requested if these guidelines are not met by an application to be awarded by USDA/NIFA.

USDA-NIFA award documents will provide pertinent instructions and information and shall include at a minimum the following:

1. Legal name and address of performing organization or institution to which the Director has issued an award under the terms of this FOA;

2. Title of project;

3. Name(s) and institution(s) of PDs chosen to direct and control approved projects;

4. Identifying award number assigned by the Department;

5. Award type, specifying whether the grant is a standard or continuation award;

6. Project period, specifying the amount of time the Department intends to support the project without requiring re-competition for funds, and that no-cost extensions of time beyond the five year performance period will be granted only in extenuating circumstances, require prior approval and will be contingent on a satisfactory merit review conducted by NIFA;

7. Total amount of Departmental financial assistance approved by the Director during the project period;

8. Legal authority(ies) under which the award is issued;

9. Appropriate Catalog of Federal Domestic Assistance (CFDA) number;

10. Applicable award terms and conditions (see http://www.nifa.usda.gov/business/awards/awardterms.html to view NIFA award terms and conditions);

11. Approved budget plan for categorizing allocable project funds to accomplish the stated purpose of the award; and

12. Other information or provisions deemed necessary by NIFA to carry out its respective awarding activities or to accomplish the purpose of a particular award.

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

USDA-NIFA Administrative and National Policy Requirements:

Several Federal statutes and regulations apply to USDA-NIFA grant applications considered for review and to project grants awarded under this program.

These include, but are not limited to:

7 CFR Part 1, subpart A USDA implementation of the Freedom of Information Act.

7 CFR Part 3-USDA implementation of OMB Circular No. A-129, regarding debt collection

7 CFR Part 15, subpart A USDA implementation of Title VI of the Civil Rights Act of 1964, as amended.

7 CFR Part 331 and 9 CFR Part 121 USDA implementation of the Agricultural Bioterrorism Protection Act of 2002.

7 CFR Part 3015 USDA Uniform Federal Assistance Regulations, implementing OMB directives (i.e., OMB Circular Nos. A-21 and A-122 (2 CFR Parts 220 and 230) and incorporating provisions of 31 U.S.C. 6301-6308 (formerly the Federal Grant and Cooperative Agreement Act of 1977, Pub. L. No. 95-224), as well as general policy requirements applicable to recipients of Departmental financial assistance.

7 CFR Part 3017 USDA implementation of Governmentwide Debarment and Suspension (Nonprocurement).

7 CFR Part 3018 USDA implementation of Restrictions on Lobbying. Imposes prohibitions and requirements for disclosure and certification related to lobbying on recipients of Federal contracts, grants, cooperative agreements, and loans.

7 CFR Part 3019 USDA implementation of OMB Circular A-110, Uniform Administrative Requirements for Grants and Other Agreements With Institutions of Higher Education, Hospitals, and Other Nonprofit Organizations (2 CFR Part 215).

7 CFR Part 3021 Governmentwide Requirements for Drug-Free Workplace (Financial Assistance).

7 CFR Part 3052 USDA implementation of OMB Circular No. A-133, Audits of States, Local Governments, and Nonprofit Organizations.

7 CFR Part 3407 NIFA procedures to implement the National Environmental Policy Act of 1969, as amended.

7 CFR 3430 Competitive and Noncompetitive Non-formula Grant Programs--General Grant Administrative Provisions.

29 U.S.C. 794 (section 504, Rehabilitation Act of 1973) and 7 CFR Part 15b (USDA implementation of statute) prohibiting discrimination based upon physical or mental handicap in Federally assisted programs.

35 U.S.C. 200 et seq. Bayh Dole Act, controlling allocation of rights to inventions made by employees of small business firms and domestic nonprofit organizations, including universities, in Federally assisted programs (implementing regulations are contained in 37 CFR Part 401). For additional information on NIFA patents, inventions and copyrights requirements, visit

http://www.nifa.usda.gov/business/awards/intellprop.html.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually 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.

USDA-NIFA Awards:

NIFA reports its awards on the new REEport system. Information is made available at https://portal.nifa.usda.gov/portal

For informational purposes, the Federal Financial Report, Form SF-425, consolidates into a single report the former Financial Status Report (SF-269 and SF-269A) and the Federal Cash Transactions Report (SF-272 and SF-272A). The NIFA Agency specific Terms and Conditions include the requirement that Form SF-425 is due on a quarterly basis no later than 30 days following the end of each reporting period. A final Federal Financial Report, Form SF-425, is due 90 days after the expiration date of this award.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Ravi (Neelakanta) Ravindranath, DVM, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6889
Email: [email protected]

Mark Mirando, PhD
Institute of Food Production and Sustainability
USDA National Institute of Food and Agriculture
Telephone: 202-401-4336
Email: [email protected]

Elaine Sierra-Rivera, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-1043
Email: [email protected]

Bryan S. Clark, MBA
Grants Management Branch (NICHD)
Telephone: 301-435-6975
Email: [email protected]

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.

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 Part 75.