Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Nursing Research (NINR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Funding Opportunity Title

Maternal Nutrition and Pre-pregnancy Obesity: Effects on Mothers, Infants and Children (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

  • 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.
  • July 17, 2012 - See Notice NOT-HD-12-024. Participation of NICHD.
  • January 25, 2012 - See Notice NOT-NR-12-007. This Notice is to inform potential applicants that the National Institute of Nursing Research (NINR) is correcting information relating to “Award Project Period”.

Funding Opportunity Announcement (FOA) Number

PA-12-061

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.361, 93.865

FOA Purpose

This Funding Opportunity Announcement (FOA) issued by the National Institute of Nursing Research encourages R01 applications to improve health outcomes for women, infants and children, by stimulating interdisciplinary research focused on maternal nutrition and pre-pregnancy obesity. Maternal health significantly impacts not only the mother but also the intrauterine environment, and subsequently fetal development and the health of the newborn.   

Key Dates
Posted Date

December 15, 2011

Open Date (Earliest Submission Date)

January 5, 2012

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

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

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date(s)

Standard dates apply

Expiration Date

January  8, 2015

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (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

This Funding Opportunity Announcement (FOA) issued by the National Institute of Nursing Research encourages R01 applications to improve health outcomes for women, infants and children, by stimulating interdisciplinary research focused on maternal nutrition and pre-pregnancy obesity. Maternal health significantly impacts not only the mother but also the intrauterine environment, and subsequently fetal development and the health of the newborn. One in five women is obese when she becomes pregnant. Maternal pre-pregnancy obesity is a contributing factor in the etiology of poor maternal outcomes such as gestational diabetes, pregnancy-induced hypertension, pre-eclampsia and eclampsia and venous thrombo-embolism. Furthermore, obese women have a higher rate of instrumental delivery and caesarean section, and longer postpartum hospital stays than non-obese women. In addition, the obstetric management of morbidly obese pregnant women (BMI >40 kg/m2) is particularly challenging, and these women are even more likely to develop the above complications during pregnancy. Maternal obesity contributes to development of a number of negative maternal health outcomes, more complicated deliveries, and greater use of health care services and resources.

Maternal health can have a significant impact on the uterine environment and, thus, on fetal development and the health of the newborn. A growing body of evidence illustrates that infants born to obese women are more likely to be born prematurely and have low birth weight, experience birth defects, have higher mortality rates, and have long-term risks for obesity later in life. Among overweight and obese women, the risk of adverse infant outcomes varies by pre-pregnancy weight and is further impacted by gestational weight gain. Children born to obese women are twice as likely to be obese and develop Type 2 diabetes later in life. Thus, prevention and management of overweight and obesity in pregnancy is of major concern to nurses, obstetricians and gynecologists.

In addition to pre-pregnancy obesity, factors in the uterine environment, primarily maternal nutrition, can also impact infant outcomes, predisposing the developing fetus to obesity in childhood, adolescence or adult life. Environmental factors during intrauterine development or in early post-natal life can have life-long impact on gene expression and phenotype. Maternal diet and nutrient supply are principal environmental factors which can alter structure, function and metabolism of the developing embryo. Alterations of the maternal diet have been shown to produce modifications in the fetal epigenome.  In macaques, a chronic high- fat, calorie-dense maternal diet leads to epigenetic alterations of fetal genes such that accumulation of fetal liver triglycerides occurs. Maternal nutrition may also play a role in regulating accumulation of white adipose tissue mass after birth. In rats, high-fat diets and maternal obesity during gestation and lactation promote not only obesity but also insulin resistance. On the other hand, maternal undernutrition also promotes hyperphagia, cardiometabolic dysfunction and obesity in the offspring, through increased NPY expression and corticosterone secretion. In rodents, protein malnutrition during gestation leads to elevated hepatic glucose production and elevated levels of cholesterol in the liver, with trans-generational effects, resulting in obese and insulin-resistant progeny even in the second generation. In humans, dietary restriction in early gestation results in greater risk of adult CHD and obesity.  Modification of the maternal diet should aim at optimizing the perinatal environment to ensure the appropriate metabolic response of the offspring in later life.

Research suggests that appetite and energy homeostatic mechanisms are programmed during critical periods in the intrauterine and early postnatal environment, when placental function and the plasticity of the nervous system allow perinatal factors to influence fetal fuel supply, metabolic pathways, organ growth and organ function, inducing changes that carry into adulthood and across generations.  Maternal undernutrition coinciding with the period of maximal placental growth is thought to lead to increased abundance of mRNA for IGF-I and IGF-II receptors in fetal adipose tissue and increased sensitivity to or production of cortisol by fetal adipocytes, thus promoting adiposity.  Increased maternal nutrition in late gestation, however, appears to result in decreased fetal adiposity. It is probable that energy homeostasis is centrally mediated and genetically determined. However, the plasticity of central neural pathways during the perinatal period lends itself to modification by extrinsic factors. For instance, development of adipose tissue mitochondria may be reprogrammed in late gestation. Hence, nutritional interventions delivered during these critical periods of development could potentially be developed in order to modify genetic susceptibility to obesity of the offspring. Through metabolic imprinting, the set-point for body weight achieved during adulthood could be established.    

The risk of adverse infant outcomes varies with maternal pre-pregnant weight, the maternal diet, and the timing of nutrient restriction or excess, but is further impacted by other factors such as gestational diabetes, gestational weight gain, parity, environmental factors, maternal exposure to smoking, maternal psychosocial stress,  maternal sleep health, the maternal microbiome, and other facets of the maternal lifestyle.

Offspring born to women with gestational diabetes, having been exposed to both hyperglycemia and hyperinsulinemia from exogenous insulin, demonstrate either increased fetal weight, or small birth weights if insulin -resistance develops. Leptin from placenta of diabetic mothers may also cross to the fetus, impacting neural pathways through its neurotropic effects and plausibly regulating energy homeostasis. Gestational weight gain is also found to be directly associated not only with the birth weight of the offspring, but also their risk for obesity in childhood and adolescence.

Maternal parity may play a role in subsequent adiposity, as offspring of primiparous mothers although smaller appear to deposit more adipose tissue than those born to multiparous mothers. Suggestions have been made that this may be due to accelerated loss of brown adipose tissue-specific UCP1 and decreased metabolism, or a resetting of the leptin and glucocorticoid axis within the adipocyte. From animal studies it appears that increased maternal age may also contribute to increased fat deposition in the offspring. In animals, post-natal factors can overcome genetic predisposition to obesity. Post-natal nutrition and the nutrients and hormones in breast milk are modifiable factors that may impact future obesity risk. Maternal diet is a primary determinant of milk composition. Feeding dams a high fat diet in association with maternal obesity have an additive effect on increasing weight and promoting hypertension and hyperglycemia in the offspring as they reach adulthood.  The amount of milk consumed and the composition of the milk affect development of obesity in later life. Studies are needed to understand if similar consequences occur in humans.

The gut microbiome is believed to play a role in regulating fat storage and predisposition to obesity. The nutritional value of food can be influenced by the mother's gut microbiota and their microbiome. Low levels of beneficial bacteria Bacteriodetes observed in obese adult patients, however, can be induced to increase following weight loss with a low calorie diet. Switching diets, therefore, could modify the microbiota and alter microbiome gene expression.

Maternal care is known to have direct effects on gene expression and stress pathways. Maternal pre- and post-natal stressors, both psychosocial and physical, may impact neuro-endocrine pathways that cause changes, related both to metabolism and the stress response, that carry on to adulthood.

Reports indicate that there is a dose-dependent association between maternal smoking during pregnancy and childhood obesity. Many aspects of the maternal lifestyle also appear to be related to childhood obesity, such as sleep duration.  Prevalence of childhood obesity is reported to be lower among mothers who slept more than 8 hours during early pregnancy. Women who slept less than 6 hours a night had longer labors and were more likely to have cesarean deliveries. 

Other post-natal factors such as neonatal feeding practices, breastfeeding initiation and duration, ambient temperature at rearing, vitamin supplementation can be modified to optimize the perinatal environment. Healthy practices during this period may help to ensure appropriate metabolic responses of the both offspring and mother, thus preventing obesity and promoting health in both.

Identifying modifiable factors during pregnancy and the immediate post-partum period, and implementing health promotive strategies that achieve primal, primary and secondary prevention of obesity, reduction of risks for adverse events and improvement of health outcomes for mother, infants and children are the focus of this FOA.

Examples of projects considered to be appropriate to this announcement include but are not limited to those that:

These suggested areas of research are not listed in any priority and are not to be viewed as an exhaustive or exclusive list. This FOA is not intended to support epidemiological studies on the incidence or prevalence of obesity. Studies using animal models would not be considered appropriate to this announcement..

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal
Resubmission
Revision

The OER Glossary and the SF 424 (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

Application budgets are not limited, but need to reflect actual needs of the proposed project.

Award Project Period

The total project period for an application submitted in response to this funding opportunity may not exceed 3 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 must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (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 in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

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.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory 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.

Page Limitations

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

PHS 398 Research Plan Component

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 modification:

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-US) 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 in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application 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 SF 424 (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 SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD(s)/PI(s) Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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 Central Contractor Registration (CCR). 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.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff 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 SF 424 (R&R) Application Guide.  

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/priority 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(s)/PI(s), 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/priority 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/priority 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), in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments 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(s)/PI(s) 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, CCR 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 Non-Competing Continuation Grant Progress Report (PHS 2590) 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. 

Section VII. Agency Contacts

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

Application Submission Contacts

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

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Xenia Tigno, PhD, Program Director, Office of Extramural Activities
National Institute of Nursing Research (NINR)
Telephone: (301) 594-2775
Email: tignoxt@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)

Randi Freundlich, Grants Management Specialist, Office of Grants Management

National Institute of Nursing Research (NINR)
Telephone: (301) 594-5974 
Email: Freundlichr@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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