and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Heart, Lung, and Blood Institute (NHLBI) |
|
Funding Opportunity Title |
Etiology and Pathophysiology of Sleep Disordered Breathing in Pregnancy (R01) |
Activity Code |
R01 Research Project Grant |
Announcement Type |
New |
Related Notices |
None |
Funding Opportunity Announcement (FOA) Number |
PA-11-122 |
Companion FOA |
None |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.233, 93.361, 93.865 |
FOA Purpose |
This FOA issued by the National Heart, Lung, and Blood Institute (NHLBI), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and the National Institute of Nursing Research (NINR), encourages research project grant applications (R01) investigating: (1) mechanisms underlying the etiology of incident sleep disordered breathing (SDB) in pregnancy; (2) mechanisms coupling SDB to maternal heart, lung, and blood pathophysiology; (3) mechanisms through which SDB affects placental development and function and associated adverse pregnancy outcomes; and (4) mechanisms linking SDB to conditions in the intrauterine environment that result in altered fetal development and predispose offspring to obesity, metabolic, and cardiovascular disease. The goal of this program is to identify clinically relevant mechanisms of SDB etiology and pathophysiology that will open new avenues to develop therapeutic strategies to reduce the maternal and fetal risks of SDB exposure during pregnancy. Multi-disciplinary research teams are strongly encouraged.. |
Posted Date |
February 14, 2011 |
Open Date (Earliest Submission Date) |
May 5, 2011 |
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) |
Standard dates apply, by 5:00 PM local time of applicant organization. |
Scientific Merit Review |
Standard dates apply |
Advisory Council Review |
Standard dates apply |
Earliest Start Date(s) |
Standard dates apply |
Expiration Date |
May 8, 2013 |
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.
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
This FOA encourages the submission of research project grant applications (R01) to investigate
(1) mechanisms underlying the etiology of incident sleep disordered breathing (SDB) during pregnancy (2) mechanisms coupling SDB exposure to maternal heart, lung, and blood (HLB) pathophysiology (3) mechanisms through which sleep disordered breathing affects placental development and function and associated adverse pregnancy outcomes and (4) mechanisms underlying the contribution of sleep disordered breathing to conditions in the intrauterine environment that result in altered fetal development and predispose offspring to obesity, metabolic, and cardiovascular disease. SDB is characterized by pauses in breathing or shallow breaths during sleep that are sometimes associated with low blood oxygen (intermittent hypoxemia), excessive daytime sleepiness, and loud chronic snoring. Mounting epidemiological evidence indicates that SDB symptoms are common during pregnancy and are associated with a 2-3 fold increase in the frequency of gestational high blood pressure and insulin resistance. Extrapolating from epidemiological findings in the general adult population, untreated sleep apnea increases the overall risk of incident hypertension, diabetes, stroke, and all-cause mortality. The etiology and pathophysiological implications of untreated SDB during pregnancy are not well understood. Mechanistic, hypothesis-driven studies are needed to elucidate the etiology of SDB in pregnancy, and to identify the principal pathophysiological pathways coupling untreated SDB to HLB diseases in pregnant women. In addition, studies are needed to understand mechanisms by which untreated SDB affects (a) placental development and function and associated adverse pregnancy outcomes, as well as (b) potential alterations in the intrauterine environment and to fetal development predisposing offspring to future cardiovascular and metabolic disease risk. Improving our understanding of these fundamental relationships will facilitate efforts to identify the women at greatest risk for SDB related adverse pregnancy outcomes and create new opportunities for intervention.
The pathophysiological profile of SDB resembles that of other cardiovascular disease risk indicators including elevated sympathetic tone, oxidative stress, systemic inflammation, insulin resistance, hyperlipidemia, hypercoaguability, and increasing cardiac wall stress. In adults, untreated moderate to severe SDB is associated with a 2-3 fold increased risk of incident hypertension, coronary artery disease, diabetes, arrhythmia, stroke, and all-cause mortality. Recent findings link apnea-like intermittent hypoxia and sleep disturbance to an array of abnormalities in glucose and fatty-acid metabolism, endothelial function, vascular remodeling, chemosensitivity, thrombosis, non-dipping blood pressure, ventricular mass, adiposity, stem cell proliferation, immunological function, and posttranslational protein processing.
Epidemiology findings suggest the prevalence of clinically significant SDB is low in women of childbearing age. However, accumulating evidence indicates that SDB symptoms are reported by 10-30% of women during pregnancy, and that SDB symptom reports are associated with an increased frequency of gestational high blood pressure, pre-eclampsia, gestational diabetes, and other adverse pregnancy outcomes, including fetal growth restriction. These findings suggest a previously unrecognized health risk and the need for research to define basic mechanisms underlying the etiology and pathophysiology of SDB in maternal HLB diseases.
Elucidating the pathophysiology of untreated SDB in pregnancy is a substantial unaddressed challenge for biomedical research. Pregnancy itself is associated with a spectrum of physiological changes. Mechanistic studies are needed to identify physiological adaptations during pregnancy that contribute to SDB etiology and to elucidate the aspects of maternal HLB physiology most vulnerable to SDB exposure. Research is poised to discover specific vulnerabilities to SDB during pregnancy, identify causal mechanisms coupling SDB pathophysiology to HLB disease processes, and build the platform of evidence needed to inform translational-level study design and develop effective intervention strategies.
Airway narrowing has been observed in pregnancy and is more severe in cases of pre-eclampsia. Research is needed to identify and characterize factors contributing to the severity of airway narrowing and related upper airway control abnormalities in pregnancy. Sensitivity to CO2 and ventilatory drive are increased during pregnancy. Whether women developing SDB during pregnancy have altered chemosensitivity during sleep that fails to protect breathing during sleep is not known. At a molecular level, the intermittent hypoxia of SDB triggers an array of pathophysiology including free radical production and endothelial dysfunction. Studies are needed to determine whether SDB interferes with the normally reduced vascular resistance associated with healthy pregnancy, perhaps by interfering with signaling by nitric oxide and other vasoregulating factors.
Homeostatic adaptations during pregnancy include some degree of insulin resistance and increased adiposity, which allow maternal and fetal metabolic requirements to be met. Studies are needed to elucidate the effects of SDB on physiological patterns of metabolic adaption in pregnancy, and whether overall metabolic sensitivity to SDB in pregnancy contributes to the development of maternal HLB morbidity.
Pregnancy may complicate the prothrombotic effects of SDB. Adult SDB is associated with decreased fibrinolytic activity and increased levels of fibrinogen and plasminogen activator inhibitor (PAI-1). Although PAI-1 levels increase with gestation, significantly higher plasma concentrations are associated with early-onset preeclampsia. Basic research is needed to determine whether SDB exacerbates mechanisms underlying hypercoaguability in pregnancy.
Pregnancy related modifications in the maternal immune system have been implicated in gestational vascular complications and miscarriage. SDB is associated with changes in mast cell and natural killer cell function, and elevated markers of macrophage activation and cytokines, such as tumor necrosis factor. Studies are needed to determine whether pro-inflammatory pathways activated by SDB predispose pregnant women to HLB pathology and to identify underlying mechanisms of susceptibility.
Obesity is a hallmark for SDB risk. The prevalence of obesity is also increasing in women of reproductive age and currently it is estimated that nearly 60% of pregnant women are overweight or obese. Pre-conceptional obesity and excessive weight gain during pregnancy are associated with gestational diabetes, hypertensive disorders, thromboembolic complications, higher postpartum weight retention, and future risk for CV and metabolic morbidity. Studies are needed to elucidate the mechanisms by which SDB and obesity are involved independently and synergistically in gestational HLB pathophysiology.
Normal pregnancy requires trophoblastic remodeling of the maternal spiral arteries and transformation of the maternal uterine circulation from a high- to low-pressure system during placental development. Hypoxia, oxidative and nitrative stress alter placental development and may be a mechanism linking maternal untreated SDB with adverse pregnancy outcomes, such as preeclampsia and fetal growth restriction. Studies are needed to determine whether SDB interferes with placental development and the normally reduced vascular resistance associated with healthy pregnancy, perhaps by interfering with signaling by nitric oxide and other vaso-regulating factors. Research is also needed on the effects of SDB on placental function throughout gestation.
The fetal origins hypothesis holds that intrauterine stressors such as hypoxia, can elicit structural, physiological, and genetic/epigenetic responses in the fetus that translate to enhanced risk for future poor health, including obesity, metabolic disorders, and cardiovascular disease. However, research has not examined the effects of SDB-related intermittent hypoxia on the intrauterine environment or fetal development. Studies are needed to understand mechanisms through which intermittent hypoxia associated with SDB may alter the intrauterine environment in ways that predispose offspring to heart, lung, and blood disease later in life.
Recent data indicating that SDB is unexpectedly common in pregnancy and associated with maternal HLB morbidity and adverse pregnancy outcomes reveals an important, but not well-understood clinical problem. These findings highlight the need for basic and clinical research to elucidate mechanisms underlying the etiology and HLB pathophysiology of SDB in pregnancy. Studies of animal or human pregnancy may include clinical, physiological, molecular, and cellular based investigations that will be most informative for the discovery of mechanisms linking maternal HLB disease to opportunities for translational-level research. This line of investigation presents numerous scientific opportunities for integrative multi-disciplinary teams with expertise in cardiology, pulmonology, and hematology to work with cross-cutting disciplines such as sleep disorders and maternal-fetal medicine. This FOA strongly encourages multi-disciplinary research.
Research topics sought by NHLBI in this FOA include, but are not limited to those listed below:
Research examples encouraged by NICHD include, but are not limited to:
NINR will consider the full range of research under this FOA.
For this FOA, studies of sleep disruption directly coupled to maternal SDB are appropriate. Studies centered on other sleep disorders including insomnia, parasomnias, shift work syndrome, circadian phase disorders, restless legs syndrome, and hypersomnia would not be within the scope of this FOA. Proposals that aim to develop new cohorts, extend the longitudinal follow-up of large existing cohorts, assess intervention efficacy or effectiveness, and develop therapeutic devices or new pharmacotherapies would also not be within the scope of this program. Epidemiologic studies of the incidence or prevalence of SDB in pregnancy would not be considered to be within the scope of this FOA. Unless they include efforts to elucidate mechanistic pathways, studies of the association of SDB with pregnancy outcomes (e.g. preeclampsia, stillbirth, fetal growth restriction, birth weight, length of gestation) would not be considered to be within the scope of this FOA.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Funding Instrument |
Grant |
Application Types Allowed |
New 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 scope of the proposed project should determine the project period. The maximum period is 5 years. |
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
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 (non-U.S.) components of U.S. Organizations are allowed.
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 Directors/Principal Investigators (PD/PIs) 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
four (4) weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Project Director/Principal
Investigator (PD/PI) is invited to work with his/her organization to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply for
NIH support.
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 SF 424 (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.
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.
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.
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..
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 application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.
All page limitations described in the SF424 Application Guide and the Table of Page Limits 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 (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the SF424 (R&R Application Guide),.
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 (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide.
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.
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.
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/PIs 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/PI
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.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
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/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).
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/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be
managed?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
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.
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.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.
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 submitted in response to this FOA . 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:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
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 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.
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.
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 Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
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.
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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 Parts 74 and 92.
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