and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute of Environmental Health Sciences (NIEHS) |
|
Funding Opportunity Title |
Role of Environmental Chemical Exposures in the Development of Obesity, Type 2 Diabetes and Metabolic Syndrome (R01) |
Activity Code |
R01 Research Project Grant |
Announcement Type |
New |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
PAR-11-170 |
Companion FOA |
R21 Exploratory/Developmental Grant, PAR-11-171 |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.113, 93.865 |
FOA Purpose |
The Program Announcement, issued by the National Institute of Environmental Health Sciences (NIEHS), encourages grant applications to understand the role of environmental chemical exposures in the development of obesity, type 2 diabetes and/or metabolic syndrome. Applications must link an environmental exposure to the increased incidence of weight gain, glucose tolerance/insulin sensitivity and aspects of metabolic syndrome in animal models or human studies. While any exposure window is acceptable it is anticipated that the most sensitive time for exposures to affect the disease outcomes will be during development e.g. in utero and/or neonatal or early childhood. For human studies developmental exposures (in utero and early childhood) should be linked to early biomarkers of disease onset. Animal studies should focus on identifying environmental chemicals that alter endpoints indicative of affecting disease development and the site and mechanism(s) of the effects that lead to the increased disease incidence. |
Posted Date |
March 18, 2011 |
Open Date (Earliest Submission Date) |
April 23, 2011 |
Letter of Intent Due Date |
Not Applicable. |
Application Due Date(s) |
March 9, 2012 per NOT-ES-12-008 (Original dates: May 23, 2011, May 23, 2012, May 23, 2013), by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
November 2011, November 2012, November 2013 |
Advisory Council Review |
January 2012, January 2013, January 2014 |
Earliest Start Date(s) |
March 2012, March 2013, March 2014 |
Expiration Date |
March 10, 2012 per NOT-ES-12-008 (Original date: May 24, 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
The prevalence of obesity has risen dramatically in the United States and in other regions of the world over the past two decades. In the United States, 30% of adults have been defined as clinically obese and 65% defined as overweight. Perhaps more important is that obesity and related diseases, such as diabetes, are rising dramatically in our children. More than sixty percent of children 10 years and older either are or will become obese later in life. There is considerable evidence that obesity risk may begin early in life, during pregnancy, and early childhood. There are numerous studies showing that rapid weight gain in the first few months of life is associated with obesity later in life.
Obesity like other complex diseases is caused by a complex interaction between genetic, behavioral and environmental factors. While there is certainly an important genetic component to obesity, the recent epidemic of obesity cannot be due to genetic changes in the population and therefore must be due to changes in environmental influences. There is no doubt that over-nutrition and lack of exercise are important factors in obesity. However, the view that these two factors alone are the primary variables that explain the obesity epidemic is being challenged as far too simplistic, and other factors are now being considered as contributing to the obesity epidemic.
There is an emerging hypothesis, based on data from several chemicals in animal studies that the obesity epidemic could be due to chemical exposures during vulnerable windows of development, mainly in utero and the first few years of life. Indeed in animal models there are data showing that developmental exposure to endocrine disrupting chemicals such as tributyl tin, bisphenol A, organochlorine pesticides, air pollution, lead, Diethylstilbestrol, perfuorooctanoic acid, monosodium glutamate and nicotine can lead to increased weight gain later in life.
This emerging hypothesis states that exposure to environmental chemicals during development can:
The result is an alteration or deregulation of the endocrine set point or sensitivity for developing obesity later in life. The chemicals that cause increased weight gain in animal models are called obesogens. Chemicals that cause not just weight gain but also affect lipid metabolism and glucose sensitivity are called metabolic disruptors.
This hypothesis changes the focus from classical genetics to epigenetics and to nutrition and environmental chemical exposures during critical developmental milestones; most importantly, it changes the focus from intervention to prevention. The prediction from the hypothesis is that the focus should be on pregnancy and infancy, and possibly also early childhood through puberty, as sensitive periods for the development of obesity. Thus, this hypothesis focuses on improving nutrition and prevention of exposure to environmental chemicals during vulnerable windows in development. Obesity is notoriously difficult to treat; thus, a better understanding of the etiology of obesity is critical to developing primary prevention strategies. The optimistic view is that if the chemicals that are related to the obesity epidemic are removed from products that are the primary contributors to human exposures, there would be reason to hope that the current trend of increasing obesity can be reversed.
Along with obesity, the prevalence of type 2 diabetes has also risen dramatically in the United States over the past few decades. Diabetes poses a tremendous and increasing clinical and public health burden for Americans; 19.3 million Americans over the age of 20 years are affected, one third of whom are undiagnosed. Seventy percent of type 2 diabetes risk is attributed to overweight/obesity suggesting a metabolic link between weight gain and type 2 diabetes. Indeed obesity is the leading cause of type 2 diabetes. Of particular concern is the fact that the incidence of type 2 diabetes is increasing in children and adolescents along with the rise in obesity. One in four overweight children has impaired glucose tolerance. Type 2 diabetes is more common in girls than boys and girls are less insulin sensitive as early as 5 years of age.
Blood glucose homeostasis, like control of weight gain, involves a complex gene-environment communication between different tissues, including the liver, skeletal muscle, adipose tissue, brain and pancreas. Altered glucose homeostasis leads to type 2 diabetes, which consists of defects in both insulin secretion and insulin action (insulin resistance). There is currently no experimental link between environmental chemical exposures and the development of type 2 diabetes. However, epidemiology studies report an increased risk of obesity and/or type 2 diabetes in women who smoke or who were exposed to persistent organic pollutants (including PCBs, DDE or dioxin) during pregnancy and there are animal data linking bisphenol A, atrazine and arsenic exposures to altered glucose tolerance and insulin resistance.
Metabolic syndrome is also associated with the rise in obesity and may progress to type 2 diabetes. It is defined clinically as a combination of at least three of the following five dysfunctions: hypertension, central adiposity, increased serum triglycerides and low serum HDL and fasting high blood sugar. There is significant data supporting the idea that metabolic syndrome is programmed during development and that there is a role for maternal diet in its etiology. While there are no data linking developmental exposures to environmental chemicals to actual metabolic syndrome, there are data showing effects of exposures on the development of obesity and type 2 diabetes.
There is a strong relationship between obesity, type 2 diabetes and metabolic syndrome. In addition, preliminary data in animal models suggest that environmental exposures that cause one of these diseases also, in many cases, cause the others also. Thus it is important to understand the role of environmental exposures not just in one of these diseases but in the development of all of them in the same study to really understand the impact of the environmental exposures on metabolism. It may be that certain environmental exposures lead to the development of obesity, type 2 diabetes and metabolic syndrome and others are specific for one disease or the other. This is an important question to answer.
Thus, the overall goal of this program announcement is to provide the data to prove/disprove the hypothesis that environmental chemical exposures during development (or other windows of sensitivity) can lead to weight gain, altered glucose/insulin sensitivity and altered lipid metabolism that lead to the development of obesity, type 2 diabetes and/or metabolic syndrome in animal models or human studies.
The following topics, while not comprehensive, provide research ideas that fit this program announcement.
To understand the site(s) and mechanisms(s) whereby environmental chemicals can lead to altered adipose tissue metabolism, numbers of adipocytes, glucose tolerance/insulin resistance, and/or lipid metabolism at the cellular and molecular level.
To understand the effects of environmental exposures on lipid profiles and blood pressure in addition to weight gain and altered glucose tolerance and insulin resistance in order to link the exposures to actual metabolic syndrome.
To understand the interaction of genetic background, nutrition (such as alterations in the microbiome, alterations in protein, sugar or fat content of diets including, soy infant formula and high fructose corn syrup), stress, drugs, infections, alterations in the circadian system and alterations in the immune system focusing on inflammation with environmental exposures during development that would lead to obesity, type 2 diabetes and/or metabolic syndrome later in life. Note that for this program announcement these factors cannot be studied alone but only as they interact with environmental exposures leading to weight gain, type 2 diabetes and/or metabolic syndrome.
To develop biomarkers of exposure that would indicate increased susceptibility to obesity, type 2 diabetes and/or metabolic syndrome.
To define which environmental chemicals and mechanisms will result in only obesity or type 2 diabetes verses those chemicals which will lead to the development of obesity, type 2 diabetes and metabolic syndrome. Part of this assessment could be the determination of the gene expression pathways affected by environmental chemical exposure and to then link those to the disease pathways/networks as a predictor of which diseases the exposure would lead to.
To develop and utilize high-throughput screens to detect chemicals that alter pathways that lead to weight gain, altered metabolism, alter glucose tolerance/insulin sensitivity or lipid metabolism indicating the potential for obesity, type 2 diabetes and/or metabolic syndrome.
To examine the role of environmental chemical exposures in the phenomenon of metabolic adaptation that leads to the return of fat after dieting.
To examine the possible role of soy infant formula in the obesity epidemic using human clinical or epidemiology studies. (Studies of individual phytoestrogens are not acceptable for this announcement).
To examine the role of environmental exposure in the development of diabetes by exploring the interaction with gestational diabetes.
To add measurements of environmental chemical exposures to existing epidemiology studies focusing on obesity, type 2 diabetes and/or metabolic syndrome. This could be questionnaire based through reanalysis of existing data or analysis of banked samples to assess environmental exposures.
To add intermediate markers (precursors) of obesity, type 2 diabetes, or metabolic syndrome to epidemiology studies with well characterized environmental exposures.
Additional Considerations
Multiple PD/PII applications (one PI with documented expertise in toxicology and environmental health sciences and one with expertise in the basic biology or endocrinology of obesity, diabetes or metabolic syndrome) are encouraged.
Multiple PD0PI applications where each PD/PI has expertise in a particular aspect of obesity, combined with expertise in type 2 diabetes and/or metabolic syndrome, as well as expertise in toxicology and environmental health sciences are also encouraged.
In addition, when possible dose responses should be assessed, internal levels of environmental chemicals should be measured and sex differences should be examined. Note also that just measuring weight gain is not sufficient to indicate obesity; actual size and composition of adipose tissue depots, including both brown and white adipose tissue should be assessed.
The focus of this program announcement is to understand the role of chemical exposures in the development of obesity, type 2 diabetes and metabolic syndrome. It is not focused on the comorbidities that result from these diseases/dysfunctions. Thus, for example, the effect of obesity on reproductive or cardiovascular function is not responsive.
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. For applications requesting $500,000 or more in direct costs see Section lV.6. |
Award 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 Program 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, with the following modifications:
Appendix
Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Foreign (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.
The Principal Investigators for each grant awarded under this program announcement, as well as other collaborators, should plan to attend annual NIEHS-sponsored meetings in Research Triangle Park, NC or Bethesda, MD. All applicants should include a request for funds to support attendance at the annual meeting.
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.
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
Not Applicable.
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) convened by the Center for Scientific Review , 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 National Advisory Environmental Health Sciences Council. 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.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Grants.gov
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Jerrold Heindel, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0781
Email: [email protected]
Gilman Grave, MD
Eunice
Kennedy Shriver National Institute of Child Health and Human
Development (NICHD)
Telephone: 301-496-5593
Email: [email protected]
Connie M. Silva, PhD
National Institute of Diabetes and Digestive
and Kidney Diseases (NIDDK)
Telephone: 301-451-7335
Email: [email protected]
Michael Knecht, PhD
National Institutes of Health (NIH)
Telephone: 301-435-1046
Email: [email protected]
Michael Knecht, PhD
National Institutes of Health (NIH)
Telephone: 301-435-1046
Email: [email protected]
Lisa Archer Edwards, MBA
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0751
Email: [email protected]
Bryan S. Clark, M.B.A.
Eunice
Kennedy Shriver National Institute of Child Health and Human
Development (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 Parts 74 and 92.
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