Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Funding Opportunity Title

Effects of In Utero Alcohol Exposure on Adult Health and Disease (R21)

Activity Code

R21 Exploratory/Developmental Research Grant Award

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.

Funding Opportunity Announcement (FOA) Number

PA-12-292

Companion Funding Opportunity

PA-12-291, R01 Research Project Grant

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.273

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA), issued by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), is intended to support novel research on how prenatal alcohol exposure may contribute to the etiology of chronic diseases and health conditions later in life.  Central to this theme is the developmental origins of health and disease (DOHaD) concept which suggests that fetal adaptations in response to adverse intrauterine conditions may increase the risk for childhood and adulthood disease.  The goal of this FOA is to stimulate a broad range of research to: 1) leverage existing prospective birth cohorts to define the role of maternal alcohol consumption in the DOHaD process; 2) investigate the biological, cellular, and molecular mechanisms by which prenatal alcohol exposure may impact disease outcomes later in life; and 3) identify biomarkers associated with gestational alcohol exposure that may predict adult disease susceptibility in exposed offspring.  Studies supported by this FOA will provide fundamental insights into a possible fetal-basis to adult disease that is influenced by maternal alcohol use.

Key Dates
Posted Date

September 28, 2012

Open Date (Earliest Submission Date)

January 16, 2013

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, 2016

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

Purpose:

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) invites Exploratory/Developmental Research Grant Award (R21) applications to examine a potential association between prenatal alcohol exposure and the development of chronic diseases and conditions across the lifespan (e.g., of the child, adolescent, and adult).  Studies applying the developmental origins of health and disease (DOHaD) approach reveal susceptibilities to adult-onset disease (e.g., cardiovascular disease, type 2 diabetes, obesity, select cancers, asthma, behavioral disorders) which are programmed in utero in response to maternal conditions and environmental exposures other than alcohol.  As many as 1 in 8 women report alcohol use during pregnancy.  Understanding how exposure of the embryo and fetus to alcohol, a known teratogen, may alter health and chronic disease later in life represents a significant public health concern and warrants investigation.  Research using animal models and emerging “-omic” approaches to generate new mechanistic and clinical insights into alcohol’s contributions to the DOHaD paradigm are encouraged.  Such work may help to define strategies for disease prevention in exposed individuals as it relates to maternal alcohol use. 

Background:

Chronic alcohol use represents an enormous global health burden.  According to the World Health Organization (2011), harmful alcohol use is a causal factor in more than 60 types of disease and injuries, resulting in approximately 2.5 million deaths annually.  Heavy alcohol consumption contributes to the etiology of major diseases involving the liver, pancreas, heart, vascular system and the brain.  In addition, alcohol use is a significant risk factor for several types of cancer.  By contrast, moderate levels of drinking may have beneficial effects, such as reducing coronary heart disease and preventing osteoporosis.  Despite extensive studies on the health consequences of alcohol use during adolescence and adulthood, little is known about how alcohol exposure much earlier in life, prior to birth, will impact the risk for chronic diseases later in life. 

Epidemiological research over the last two decades has shaped the DOHaD concept, a theory that physiological adaptations made by the fetus in response to adverse changes in the intrauterine environment may enhance adult disease susceptibility.  The DOHaD paradigm originates from observations that newborn birth weight and adult death rate due to ischemic heart disease are inversely correlated.  This seminal finding lead to the Barker hypothesis, which suggests that undernutrition during pregnancy reprograms the fetal physiology (e.g., structural, functional, or metabolic changes) in such a way to increase the risk for coronary heart disease later in life.  Further investigation lead to the thrifty phenotype hypothesis, a theory of how adult-onset diabetes may arise from permanent alterations in fetal glucose metabolism triggered by maternal malnutrition.  The predictive adaptive response further suggests that the fetus may “predict” the optimal adult phenotype for survival based on intrauterine cues which in turn induce physiological and metabolic adaptations that align best with future expectations.  Consequently, adult-onset diseases may emerge if inconsistencies exist between the anticipated and actual postnatal environment.  It is now evident that other complex diseases such as hypertension, asthma, obesity, osteoporosis, mental illness, and some cancers may also be developmentally programmed early in life in response to adverse intrauterine conditions. 

Although explanations for these epidemiological findings have been offered, the mechanistic basis underlying the fetal programming of adult diseases is not yet fully understood.  Proposed mechanisms include: 1) perturbed homeostatic control of fetal growth and development involving  the insulin-like growth factor I (IGF-1) pathway and the glucocorticoid-mediated regulation of the hypothalamo-pituitary-adrenal (HPA) axis; 2) altered cellular differentiation leading to structural and physiological changes in tissues and organs 3) increased oxidative stress and mitochondrial dysfunction altering cellular metabolism; and 4) altered gene expression via aberrant modifications to the fetal epigenome.  Many of these findings are based on animal data, thus their relative contribution to the DOHaD model in humans remains to be established.  Importantly, interplay may exist among these and other mechanisms during the complex interactions between the mother and her offspring in response to an adverse intrauterine environment. 

Epigenetics, or the study of heritable changes in gene expression without alterations to the DNA sequence, is a current focus of the DOHaD field.  Epigenetic mechanisms allow for developmental plasticity, permitting an organism to alter its phenotype based on interactions with its environment.  The molecular bases of epigenetics involve:  1) methylation of CpG-rich promoter and regulatory regions of DNA; 2) post-translational modification of DNA-associated histone proteins with the addition of methyl, acetyl and phosphate groups; and 3) non-coding RNA mediated post-transcriptional effects.  In general, these epigenetic marks regulate chromatin accessibility and protein binding along the DNA, either to promote or inhibit gene transcription in a pattern-specific manner.  During human development, genome-wide demethylation and subsequent remethylation occur during periods of epigenetic programming in utero.  This reprogramming takes place shortly after fertilization and again during primordial germ cell development, characterized by the preservation or re-establishment of methylation patterns to imprinted genes, respectively.  Additional marks are further refined in a tissue-specific fashion as cellular differentiation proceeds in utero.  Given the dynamic nature of reprogramming events, these developmental periods represent critical windows in which the intrauterine environmental may impinge upon the fetal epigenome.

Indeed, specific aspects of the early life environment do alter the fetal epigenome.  Maternal lifestyle choices are a factor, as seen by evidence of aberrant DNA methylation in children prenatally exposed to tobacco smoke.    Conditions such as maternal diet, either caloric-limiting or rich, have been shown to modify the epigenetic profiles of exposed offspring, although establishing causality related to disease has been challenging thus far.  Many nutrition-related epigenetic changes do influence phenotypic characteristics of the offspring.  For example, maternal dietary methyl-donor supplementation in the form of folate, choline, and methionine causes hypermethylation of the variable yellow agouti (Avy) and AxinFu metastable epialleles of mouse offspring, leading to changes in coat color and tail morphology.  Perhaps the strongest association between fetal epigenomic alterations contributing to adult health involves exposure to environmental toxicants.  Prenatal exposure to vinclozolin, an anti-androgenic fungicide known to alter DNA methylation, promotes transgenerational inheritance of a variety of disease phenotypes in offspring including male infertility, cancer, behavioral abnormalities, and diseases of the prostate, kidney and immune system.  A phenomenon propagated through the male germ line, vinclozolin-induced epigenetic reprogramming is detectable in progeny for at least three generations after initial exposure.  As well, epigenomic perturbations associated with altered brain development and increased susceptibility to breast and prostate cancer are seen following prenatal and neonatal exposure to the endocrine disruptor bisphenol A (BPA).  Interestingly, methyl donor supplementation counteracts the hypomethylating effects of BPA exposure, offering the possibility of therapeutic approaches to lessen the harmful effects on the embryonic and/or fetal epigenome.  Despite progress in the DOHaD field, further investigation is needed to understand the mechanistic basis by which these and other adverse exposures alter the fetal epigenome and to what extent these modifications contribute to adult-onset disease.

At this time, the impact of prenatal alcohol exposure on the development of adult-onset disease and health conditions is largely unknown.  Epigenetic effects of alcohol are seen in model systems of alcohol-induced injury.  Possible modes of action include alteration of one-carbon metabolism, NAD+-dependent enzyme function, histone modification, and microRNA levels.  Despite this knowledge, alcohol’s impact on the epigenome appears complex and dependent on cell type, target organ, exposure amount and other variables.  Emerging evidence suggests that alcohol-mediated epigenetic effects may contribute to deficits associated with fetal alcohol syndrome/fetal alcohol spectrum disorders (FAS/FASD).  Studies using the Avy mouse have linked both preconceptional and early gestational alcohol exposure to epigenetic-mediated phenotypic changes in exposed offspring.  Reports of preconceptional effects mediated by paternal alcohol use further support an epigenetic component to FASD etiology.  It has been hypothesized that alcohol’s impact on fetal programming of the HPA axis and subsequent vulnerability to stress-related and behavioral disorders later in life may have epigenetic origins.  Given the influence of maternal diet on the fetal epigenome, it is important to note that alcoholics often experience nutritional deficiencies during pregnancy.  As a caveat, studies modeling FAS/FASD typically explore effects from moderate to high levels of prenatal alcohol exposure thus little is known about the actions of alcohol on the fetal epigenome at lower doses and across a variety of developmental timepoints.  Although somewhat limited, evidence does exist that prenatal alcohol exposure may increase the risk for adult diseases typically not associated with FAS/FASD.  Animals exposed to alcohol in utero exhibit increase susceptibility to developing breast cancer, respiratory infections, and immune system impairments in adulthood.  Alterations in circadian clock function and kidney development have also been noted.  Given the prevalence of alcohol use among pregnant women in the United States, the question of whether prenatal alcohol exposure at any level or pattern of exposure may enhance the biological risk for chronic diseases later in life remains largely unexplored and warrants further investigation.

Scope and Areas of Research Interest:   

In response to this FOA, investigators are encouraged to examine health conditions and chronic diseases not typically associated with FAS/FASD.  The resulting information may be critical in optimizing strategies for disease prevention in individuals with a wide range of alcohol exposure.  This FOA does not seek to support applications limited to traditional examination of physical abnormalities or neurobehavioral deficits of FAS/FASD. 

Submitted studies should address the functional and molecular bases for the DOHaD model as it relates to prenatal alcohol exposure.  Multidisciplinary approaches using animal models and high-throughput “-omics” technologies are encouraged.  Studies focused on low to moderate levels of exposure modeling a broader range of alcohol use are also strongly encouraged.

Research areas warranting attention include, but are not limited to, the following topics.

A)  Research on the epidemiological underpinnings of the DOHaD concept as it relates to prenatal alcohol exposure:

B)  Research on the biological, cellular, and molecular mechanisms by which in utero alcohol exposure may influence adult-onset health outcomes:

C)  Research on identifying biomarkers associated with prenatal alcohol exposure that may be predictive of adult disease outcomes:

Section II. Award Information
Funding Instrument

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

Application Types Allowed

New
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

The combined budget for direct costs for the two (2) year project period may not exceed $275,000. No more than $200,000 may be requested in any single year.

Award Project Period

The maximum project period is two (2) 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 Directors/Principal Investigators (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/Principal Investigator)

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.   

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

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

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.

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/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.

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.

For this particular announcement, note the following:

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

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/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?   

Innovation

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

Approach

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

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

Environment

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

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/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.

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) convened by the NIAAA, 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/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, 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)

William Dunty, Ph.D.
Program Director
Division of Metabolism and Health Effects
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: (301) 443-7351
Email: duntyw@mail.nih.gov

Peer Review Contact(s)

Ranga V Srinivas, Ph.D.
Chief, Extramural Project Review Branch
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: (301) 451 2067
Email: srinivar@mail.nih.gov

Financial/Grants Management Contact(s)

Judy Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: (301) 443-4704
Email: jfox@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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