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

Collaborative Initiative on Fetal Alcohol Spectrum Disorders (CIFASD) (U24)

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

Reissue of RFA-AA-07-004

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-AA-12-005

Companion FOA

RFA-AA-12-004, U01 Research Project – Cooperative Agreements

Number of Applications

See Section III. 3. Additional Information on Eligibility

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

93.273  

FOA Purpose

This Funding Opportunity Announcement (FOA) issued by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) solicits Cooperative Agreement (U24) applications from current awardees and new applicants to continue the previously funded “Collaborative Initiative on Fetal Alcohol Spectrum Disorders” (CIFASD), a multidisciplinary consortium of domestic and international projects.  The CIFASD aims to accelerate specific areas of research related to the translation of new or improved capabilities in FASD clinical case recognition (through improved diagnosis, enhanced understanding of the domains of neurobehavioral impairment), interventions (behavior-based, nutritional and/or pharmacological) and prevention, by fostering collaboration and coordinating basic, clinical, and translational research. The U24 mechanism is used for support and technical components only.

Key Dates
Posted Date

September 8, 2011

Letter of Intent Due Date

November 14, 2011

Application Due Date(s)

December 14, 2011

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

March-April, 2012

Advisory Council Review

May 2012

Earliest Start Date(s)

July 2012

Expiration Date

December 15, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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. While some links are provided, 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.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of 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) seeks to continue support of the previously funded “Collaborative Initiative on Fetal Alcohol Spectrum Disorders” (CIFASD), a multidisciplinary consortium of domestic and international projects that was established to address the prevention of fetal alcohol spectrum disorders (FASD); the diagnosis of the full range of birth defects associated with prenatal alcohol exposure; and ameliorative interventions for affected individuals.  The initiative aims to accelerate the translation of key research findings by fostering collaboration and coordinating clinical, basic, and translational research.  Through this FOA, applications are sought that will continue research efforts of the CIFASD consortium, building upon existing infrastructure as well as utilizing established or new clinical cohorts as needed.  New applications from investigators not currently part of the consortium may be submitted as long as documentation is provided to establish pre-existing contact and cooperation with the CIFASD infrastructure prior to the time of submission. The new projects should add substantially to the direction and goals of the CIFASD and enhance the progress of future investigation.

Cooperative Agreement (U24) applications in response to this FOA should involve the administrative or resource cores. Applications for individual clinical or basic research projects funded under the U01 mechanism should be submitted in response to the companion FOA (RFA-AA-12-004).

BACKGROUND

FASD is the collective term for the broad array of documented adverse effects resulting from in utero alcohol exposure.  The most serious of these is fetal alcohol syndrome (FAS), a devastating developmental disorder characterized by craniofacial abnormalities, growth retardation, and nervous system impairments that may include mental retardation.  Other FASD diagnostic categories include:  partial FAS, which includes the facial and neurodevelopmental deficits of FAS but not the growth deficits; alcohol-related neurodevelopmental disorder (ARND), in which neurobehavioral deficits are consistent with FAS but the facial or physical features of FAS are absent; and alcohol-related birth defects (ARBD), where physical attributes of FAS are seen in the absence of the full syndrome.  Children with FASD may exhibit multiple cognitive, behavioral, and emotional deficits that impair daily functioning in many domains.

Despite major progress in characterizing the adverse effects of prenatal alcohol exposure and understanding the multiple mechanisms of ethanol teratogenicity in animal models, translational research leading to biomarkers of alcohol exposure, improved diagnosis of FASD, and appropriate treatments or interventions for affected individuals has not advanced sufficiently to improve clinical management of FASD.  Similarly, pharmacological or nutritional interventions have only been minimally investigated.  To address these needs, the CIFASD consortium was established in 2003.  Presently, the consortium is led by a Consortium Coordinator and consists of three core facilities (U24s) and seven individual research projects (U01s) that encompass epidemiology, clinical research, and non-human basic neuroscience research.

RESEARCH OBJECTIVES

The goals of this FOA are: 1) to further refine definitive diagnoses of FASD at different stages of the lifespan based on biological, physical, neurological, or behavioral assessment, or a combination thereof; 2) to develop and validate biomarkers to assess alcohol exposure and insult to the mother and the fetus; 3) to elucidate biological mechanisms that contribute to alcohol teratogenesis in a range of experimental models and in humans; and 4) to develop effective interventions and therapeutic agents that may prevent or mitigate FASD outcomes.  Research projects should focus on one or more of the themes common to the overarching goals of the consortium, while making use of core resources of the consortium.  The composition of research projects and resource cores under the CIFASD consortium should reflect the progress made during the previous funding period as well as new opportunities identified by the consortium.  Continued participant recruitment may be needed to complete current studies. 

Research themes include the study of the FASD brain through imaging (functional and structural); the study of FASD craniofacial morphology using state-of-the-art morphometric technologies; further delineation of the FASD behavioral phenotype through the development of new or utilization of existing standardized neuropsychological tests with diverse populations of individuals with FASD and control populations that include individuals with other developmental disabilities, such as ADHD, as well as non-impaired individuals; exploration of potential screening or diagnostic modalities such as biomarkers of in utero alcohol exposure; development and testing of nutritional and/or age-appropriate behavioral, cognitive, or educational therapies for affected individuals; and pharmacologic studies directed toward the development of new agents that may prevent or mitigate alcohol teratogenic injury.

Specific research areas include but are not limited to those listed below.

Diagnosis of FASD - Diagnosis of FAS and ARND is difficult due to the lack of a definitive biological marker, nonspecific and often subtle symptomatology, differences in the severity and timing of the insult, and the overall complexity and plasticity of brain development.  Diagnosis in neonates and infants is further complicated because neurodevelopmental deficits important to case identification may not be discernable in infancy, and facial features may not be prominent in the neonate.  A clear diagnosis of FAS or ARND at any age greatly facilitates the management and treatment of neurobehavioral deficits and associated secondary disabilities.  Because the physical signs of FAS may lessen with age, and behavioral manifestations of FASD change according to developmental stage, diagnosis during later childhood (puberty and beyond) is even more difficult than at younger ages.  Standardized diagnostic criteria and methods of assessing them are needed for all age groups from infants to adults.

Enhanced understanding of the neurobehavioral phenotype of FAS and ARND – Development of a comprehensive neurobehavioral database derived from data collected across multiple clinical sites remains a priority.  This database will enhance our ability to define diagnostic criteria that distinguish FAS, partial FAS, and ARND in children in different age groups and of different ethnic origins.   Investigations may seek to distinguish deficits that represent developmental delay from those that are the result of permanent structural or functional defects, as well as identify deficits that are shared with other neurodevelopmental disorders (e.g., attention deficit hyperactivity disorder, Williams syndrome, autism) and those that are unique to prenatal alcohol injury.  Knowledge gained from the database will also inform intervention studies targeted to the deficits characteristic of FASD.

Enhanced understanding of FASD dysmorphology through 2-D and 3-D image analyses - Given the subtlety of facial deficits associated with prenatal alcohol exposure, improvements for FAS/FASD facial recognition through 3-D photography and computer analyses remain a high priority.  A database of facial and other structural features obtained by analysis of 2-D and 3-D camera images of individuals with prenatal alcohol exposure was developed during the previous funding period.  Data collection should continue to include images of exposed and unexposed children in different age groups and from different ethnic groups.  In prospective studies, collection of serial images of the same individuals over time is encouraged.   With a sufficiently large database, it may be possible to develop computer-based case recognition based upon machine learning for facial recognition coupled with neurobehavioral and other relevant data measurement (i.e., growth parameters, ethnicity, age).  The possible existence of subtle facial abnormalities in cases of ANRD could also be explored. 

Characterization of structural and functional neurobehavioral deficits - The application of non-invasive imaging techniques, such as MRI, functional MRI, diffusion tensor imaging, and magnetoencephalography (MEG), to assess children with various degrees of prenatal alcohol exposure can enhance our understanding of the brain structural underpinnings responsible for the deficits in many cognitive and behavioral domains.  With detailed data on prenatal alcohol exposure (obtained either prospectively or retrospectively) correlations of structural and functional deficits with quantity and frequency of alcohol exposure, gestational period of exposure, dysmorphic features, and various co-factors may be achieved.  Such correlations may help to define the relationship between specific outcomes or severity of alcohol effects and patterns and/or gestational timing of exposure.

Early case identification - Neurobehavioral research has shown that initiation of interventions at very early ages enhances performance outcomes.  However, this requires early case identification, which for FAS and ARND has been hampered by the difficulty of making diagnoses in neonates and infants.  To increase the potential for early case recognition, studies are needed to identify biomarkers of prenatal alcohol exposure or alcohol-induced fetal injury utilizing clinical samples obtained from subjects identified prospectively or from animal models of prenatal alcohol exposure.  Genomic, epigenomic, proteomic, metabolomic and 3-D facial imaging approaches may be appropriate. The utility of prenatal ultrasound as a screening or diagnostic modality may also be explored.  In addition, biomarkers of alcohol consumption may have utility for identifying women whose drinking places their fetuses at risk.

Interventions to reverse or ameliorate neurobiological deficits - Brain damage resulting from ethanol teratogenesis leads to a broad array of neurobiological deficits that affect daily functioning in many domains.  Therapies of all types are needed at different developmental stages from infant to adult, and in different settings, in order to enable individuals affected by prenatal alcohol to reach their full potential.  Knowledge of the neurobehavioral characteristics of children with FAS and ARND will enhance development or application of targeted interventions.  A coordinated strategy combining a variety of therapeutic approaches, including medications, nutritional supplements, behavioral or cognitive therapy, and family therapy, may be needed to maximize the effectiveness of interventions.  It will be important to establish standardized protocols for testing potential therapies, which may include informative non-invasive functional imaging.

Animal models of FASD are an important avenue for identifying potential interventions.  For example, dietary supplementation of the neurotransmitter precursor choline had beneficial effects on learning and memory performance in rats exposed to prenatal alcohol.  In another study, enhanced synaptic plasticity in the cerebellum of FASD rats was correlated with improved performance on a motor task after intensive training.   Pre-clinical evaluation of new combinations of behavioral and pharmacological therapies targeted to specific deficits would be appropriate.  Innovative exploratory research, such as repair and regeneration approaches, is also encouraged.

In utero therapeutics to prevent FASD - In previous animal research using rodents, nutritional fortifications or pharmacologic agents administered during pregnancy have shown some potential as preventive therapeutics.  For example, antioxidants, trophic factors, receptor agonists/antagonists, and specific neuroprotective peptides have been shown to exert significant protection from prenatal alcohol injury.  Promising agents may warrant further investigation as to mechanism or efficacy and safety in additional models.  Limited trials in humans may be proposed.

ORGANIZATION OF THE CIFASD CONSORTIUM

The following Support Cores will use the U24 mechanism as described in this FOA.

Administrative Coordinating Core - An Administrative Coordinating Core is to be submitted by the designated Consortium Coordinator.  The administrative coordinating core will continue to provide oversight, coordination, and direction to the consortium.  It will coordinate use of core resources among the research projects, facilitate communications among the PD/PIs, and facilitate data collection.  It will be responsible for managing the Scientific Advisory Panel and the Data and Safety Monitoring Board and overseeing the activities of the clinical and basic research Steering Committees.  The administrative coordinating core may include an exploratory R21-like high-risk and high-return component.  The anticipated number of developmental projects to be supported each year must be stated, and the process for selection and management of these types of projects must be described.  A brief description of the projects to be supported should include the rationale, objectives, approach, investigators, and importance to the consortium.

Dysmorphology Core – The Dysmorphology Core will continue to implement a standard comprehensive protocol for physical evaluation of children and collaborate with other consortium projects to better understand the full range of FASD features.  Modification of the activities of this core to better meet the needs of consortium projects may be proposed.

Informatics Core - The Informatics Core will continue to collaborate with all projects and cores within the consortium and provide support and guidance to the research project components with respect to data collection, data entry, and statistical analyses.  Improvements or refinements of the current database operations may be proposed.

Individual Clinical and Basic research projects must use the U01 mechanism described in the accompanying FOA (RFA-AA-12-004).

Clinical Research Component - Clinical projects should include cohorts of subjects at multiple sites, where appropriate and feasible, to increase the probability that results can be generalized to diverse FASD populations in terms of age, ethnicity, level of alcohol exposure, and postnatal environment.  Every effort should be made to include existing cohorts from either the CIFASD or other prenatal alcohol exposure projects.  New cohorts may be proposed, provided their use will enhance the research goals of the consortium and feasibility can be demonstrated.

Basic Research Component - Basic science projects must be clearly translational in nature and complement the clinical research projects.  Clinical biological samples should be used whenever it is feasible.  However, hypothesis-driven animal or in vitro studies that could not be conducted using clinical samples or human subjects may be proposed, provided the potential application to humans is clearly described. 

It is possible that the structure and function of some of the existing resource cores may be modified to increase efficiency and facilitate the consortium goals.  This process may include conversion of a core to an individual research project (U01), elimination of some cores that have outlived their utility, distribution of core objectives to multiple sites in order to take advantage of different expertise, or restructuring existing cores to enhance services and resources.  Any changes to the current resource core structure must be addressed and justified in the Administrative Coordinating Core application and the appropriate applications where they reside.  In addition, other functional cores may be proposed as deemed appropriate for the conduct of the project.  

Section II. Award Information
Funding Instrument

Cooperative Agreement

Application Types Allowed

New
Renewal

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIAAA intends to commit $4 million in FY 2012 to fund the continuation of the CIFASD consortium.  The set-aside for the clinical and basic research components will be about $3 million and $1 million, respectively.  Approximately 8-10 new and/or renewal cooperative agreement awards are anticipated in response to this FOA and the companion FOA (RFA-AA-12-004).    

Award Budget

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

Award Project Period

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.

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 PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

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

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

Applicants must demonstrate that their projects relate to one or more of the integrated themes of the CIFASD consortium.  Investigators who are currently a member of the CIFASD consortium may submit a renewal or a new application.  Applicants not previously funded under the CIFASD consortium must have established a collaborative relationship with the CIFASD consortium before the application is submitted.  A letter of collaboration from the Program Director(s)/Principal Investigator(s) of the Administrative Core in the application is required as evidence of this eligibility criterion.   

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 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.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

The letter of intent should be sent to:

Abraham P. Bautista, Ph.D.
Director, Office of Extramural Activities
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health
5635 Fishers Lane, Room 2089, MSC 9304
Bethesda, MD 20892 (U.S. Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: 301-443-9737
Email: bautista@mail.nih.gov

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the appendix files must be sent to:

Abraham P. Bautista, Ph.D.
Director, Office of Extramural Activities
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health
5635 Fishers Lane, Room 2089, MSC 9304
Bethesda, MD 20892 (U.S. Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: 301-443-9737
Email: bautista@mail.nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed.

Research Plan

All instructions in the PHS398 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 PHS398 Application Guide, with the following modification:

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide, with the following modification:

Foreign Institutions

Foreign (non-US) Institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the PHS398 Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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 received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by NIAAA. Applications that are incomplete and/or nonresponsive will not be reviewed.  

Other Submission Requirements for Administrative Coordinating Core

The responsibilities and activities of the Administrative Coordinating Core were outlined in Part 2, Section I under "Organization of the CIFASD Consortium".  The application for this core must be submitted by the Consortium Coordinator. The Progress Report in the application will report on the overall success of the consortium and the specific activities of the consortium, including those of the Steering Committee and Advisory Panel.  Any changes in objectives or scope of the consortium that occurred during the previous funding period and the reasons should be described.  Materials developed by any resource cores that have been eliminated should be in the appendix.  The Research Strategy will include an administrative management plan for the consortium that describes how the various responsibilities of the Administrative Coordinating Core will be accomplished. The rationale for any changes in the number and/or structure of existing resource cores should be described.

Exploratory project component:  If an exploratory project component is planned, a separate section for this component should be included in the application.  The component should describe all of the exploratory projects initially proposed for the consortium.  It is recognized that additional new projects may be proposed in later years of the renewal period.  The plan for selecting new projects and administering the projects, including the process for terminating projects should it become necessary, should be described fully, though succinctly.  The total number and anticipated scientific directions of the exploratory projects for the entire renewal period should be provided.  A description of each study proposed for the first two years and their significance for the consortium should be addressed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact - Overall

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 - Overall

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?   

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?  

Innovation

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

Approach

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

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

Environment

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

Cohesiveness and Integration Between Research Projects and Resource Components

If the research project is part of a consortium, does the project contribute to the overall goals and objectives of the consortium?  Does the nature of the project warrant its inclusion in the consortium?  Is there sufficient evidence that this project will involve significant collaboration within the consortium?  Is the application well integrated with other projects and will it utilize the research resources or support components of the consortium?  Does the expertise of the investigators strengthen the consortium as a whole? 

Additional Review Criteria - Overall

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

Not Applicable

Renewals

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

Revisions

Not Applicable

Additional Review Considerations - Overall

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 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 National Advisory Council on Alcohol Abuse and Alcoholism. 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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

Areas of Joint Responsibility include:

Scientific Advisory Panel - The CIFASD consortium will include an external scientific advisory panel whose purpose is to assess progress and provide feedback to the clinical and basic research Steering Committees on the proposed goals of the consortium each year.  The panel will also advise the Steering Committees on research design issues and data quality and analysis.  The external advisors will be appointed by the Consortium Coordinator in consultation with NIAAA Project Scientist.  They will be research scientists not involved in the consortium.

Consortium Coordinator’s Rights and Responsibilities - The Consortium Coordinator coordinates the scientific and administrative activities of the CIFASD consortium and is responsible for the overall operation of the consortium, including the scientific and technical direction of the research projects.  The Consortium Coordinator also administers the selection and award of exploratory projects in consultation with the Steering Committees and reports on their progress.  The Consortium Coordinator ensures that all projects within the consortium are fully integrated within the scientific scope and mission of the consortium, including full access to all core resource facilities.  In addition, the Consortium Coordinator chairs the clinical and basic research Steering Committees (see below) and like all other participating investigators, must abide by the operating rules and guidelines developed by the Steering Committee.  The Consortium Coordinator agrees to accept participation of NIAAA Project Scientist in those aspects of management of the project described under “NIH Responsibilities.”  Finally, the Consortium Coordinator ensures the timely dissemination of information generated by the individual consortium projects to both the consortium investigators and the scientific public.

Steering Committees - The CIFASD consortium will have two Steering Committees, one for the clinical research component and one for the basic research component.  These committees are the main governing board for their respective components. Each committee develops collaborative protocols, sets research priorities, defines parameters for study, identifies technological impediments to success and strategies to overcome them, and decides when data and resources generated by the respective consortium component should be made available to the scientific community.  In addition, each Steering Committee will review the policies and procedures for oversight of the consortium currently in place and amend them as necessary.  The committees will also be responsible for monitoring compliance with those policies and procedures.

Each Steering Committee is composed of the Consortium Coordinator or his/her designate, who serves as the chairperson, the Principal Investigators of the relevant research project components and the core resource facilities, and the NIAAA Project Scientist.  Each Steering Committee may, when deemed necessary, invite additional, non-voting scientific advisors to the meetings at which research priorities and opportunities are discussed.  The NIAAA also reserves the right to augment the expertise of the Steering Committees when necessary, and to appoint additional NIAAA staff as non-voting members of the Steering Committees and any subcommittees.  Each Steering Committee may establish subcommittees to facilitate the planning and operation of the respective consortium components.

Each Steering Committee will conduct monthly telephone conferences and will meet two times each year to review progress and to set research priorities, modify goals or scientific directions of its respective research component, integrate relevant new information, and discuss any proposed modifications to the scientific approaches of individual projects.    In addition, proposed new exploratory projects that are relevant to the particular research component will be discussed and voted upon annually.  The two Steering Committees may meet jointly if the Consortium Coordinator deems that such a meeting is needed.  

Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

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

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 C. Dunty, Jr., Ph.D.
Program Director
Division of Metabolism and Health Effects
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health
5635 Fishers Lane, Room 2120 (MSC 9304)
Bethesda, MD 20892-9304
Rockville, MD 20852-1705 (for express/courier service; non-USPS service)
Telephone: 301-443-7351
Fax: (301) 594-0673
Email: duntyw@mail.nih.gov

Dale Hereld, M.D., Ph.D.
Program Director
Division of Metabolism and Health Effects
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health
5635 Fishers Lane, Room 2027 (MSC 9304)
Bethesda, MD 20892-9304
Rockville, MD  20852-1705 (for express/courier service; non-USPS service)
Telephone: 301-443-0912
Fax: 301-594-0673
Email: hereldd@mail.nih.gov

Peer Review Contact(s)

Ranga Srinivas, Ph.D.
Chief, Extramural Project Review Branch
Office of Extramural Activities
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2085, (MSC 9304)
Bethesda, MD 20892-9304
Rockville, MD 20852-1705 (for express/courier service; non-USPS service)
Telephone: (301) 451-2067
Fax: (301) 443-6077
Email: srinivar@mail.nih.gov

Financial/Grants Management Contact(s)

Ms. Judy Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3023, (MSC 9304)
Bethesda, MD 20892-9304
Rockville, MD 20852-1705 (for express/courier service; non-USPS service)
Telephone: (301) 443-4704
Fax: (301) 443-3891
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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.