Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

This limited competition Funding Opportunity Announcement (FOA) invites a cooperative agreement (U01) application from projects funded within the Collaboration on Fetal Alcohol Spectrum Disorders Prevalence (CoFASP). The purpose of this limited competition is to allow additional follow-up for the development and use of a standardized diagnostic system to evaluate and report clinical characteristics of FASD among affected children and establish prevalence rates. This FOA supports continuation of the Collaboration on FASD Prevalence (CoFASP).

This FOA invites applications from the current awardees of the CoFASP collaboration to undertake continued follow-up of active case ascertainment and case conferences to establish reasonable, reproducible and generalizable estimates of FASD within defined regions of the U.S.

The purpose of this FOA is to allow additional time for CoFASP multi-disciplinary teams of investigators to continue recruitment and assessment of FASD affected families and controls and examination of criteria across multiple diagnostic schema in order to better inform standardization of diagnostic approaches in FASD research. In addition, a primary goal is the development of a standardized diagnostic system and standard analytical methods to establish representative and generalizable prevalence estimates across all CoFASP sites. Applicants may, but are not required to, propose additional analytic strategies to evaluate clinical characteristics of FASD among affected children.

NIAAA has supported the CoFASP collaboration since September 2010. To date, CoFASP sites have screened 5,277 first grade-aged children.

In 2010, NIAAA issued an RFA entitled, Case Ascertainment to Estimate the U.S. Prevalence of Fetal Alcohol Spectrum Disorders in Young Children (U01) (RFA-AA-10-005), for the purpose of determining within defined geographical areas of the U.S. a prevalence rate for fetal alcohol spectrum disorders (FASD), including fetal alcohol syndrome (FAS), partial FAS and alcohol-related neurodevelopmental disorders (ARND), among young children in the United States. Awards to two projects from this RFA established the Collaboration on FASD Prevalence (CoFASP), comprising multi-disciplinary teams using active case ascertainment to recruit school-aged children and establish generalizable estimates of FASD prevalence across multiple selected geographic regions reflective of the general population in those areas. The RFA required the development of culturally appropriate measurement tools and establishment of clear thresholds for diagnostic criteria to reliably classify children affected by prenatal alcohol exposure. Awarded projects have begun to accomplish the goal of determining reliable regional prevalence estimates in some sites using standardized criteria developed as part of the CoFASP collaboration. However, during the course of operationalizing adopted diagnostic criteria to produce reproducible and generalizable prevalence estimates, CoFASP investigators realized that within the field of FASD research, globally, disagreements in rates across the diagnostic schema have resulted. These challenges have ensued from the use of different diagnostic thresholds across a multitude of published diagnostic schema.

At the time the Case Ascertainment FOA was issued, a limited number of studies had published prevalence rates on selected heavily drinking populations in the U.S. Early publications from individual CoFASP sites have included a range of prevalence rates that highlight the need for a more thorough and precise examination of criteria across multiple diagnostic schema in order to better inform standardization of diagnostic approaches in the FASD field globally and within the U.S. This broadened understanding requires additional analyses that exceed requirements stated in the original FOA focused on CoFASP-derived general population data. For the purposes of this FOA, new analyses should include the following:

• Comparisons of use of clinical judgment approaches to assign FASD diagnostic categories in clinical settings (e.g., ICD-10 criteria) versus research-based epidemiological criteria to inform recommendations for standardized epidemiological and clinical practice protocols regarding assessment of maternal drinking and FASD diagnoses in young children.
• Modification of diagnostic criteria to reduce the derived false positive and negative prevalence rates and increase overall accuracy of rates from epidemiological as well as clinical studies of FASD.
• Use of CoFASP aggregate data to develop comparisons of rates using other frequently used diagnostic schema to diagnose FASD (for example, Canadian, DSM-5 Neurodevelopmental Disabilities [ND-PAE]).
• Use of CoFASP aggregate data to refine and clarify the salience of the contribution of growth to the diagnosis of FAS, fetal alcohol exposure FAE, and other categories within the FASD spectrum.

It is expected that the CoFASP establishes a Steering Committee that must meet up to two times per year to establish standardization in protocols, data analysis and interpretation. These 1-day meetings of the CoFASP Steering Committee must be held for the purpose of discussing progress on establishing standardization in protocols and implementation of plans for data synchronization, analysis and interpretation, and creation of a database that is accessible to the public within a year of study completion. The CoFASP Steering Committee also must meet via bi-monthly teleconference calls.

The application may also include a Data Analysis Coordination Unit (DACU) that will collaborate with project sites and the CoFASP Steering Committee regarding standardization, data analysis and interpretation of results to create a database that is accessible to the public within a year of study completion.

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.

Only institutions with active U01 CoFASP awards are eligible to apply.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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 SF424 (R&R) Application Guide.

Only PDs/PIs of active U01 CoFASP awards are eligible to apply.

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.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Applicants must obtain 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, including Supplemental Grant Application Instructions 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.

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:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Abraham Bautista, PhD
Telephone: 301-443-9737
Fax: 301-433-6077
Email: bautista@mail.nih.gov

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed. with the following modifications:

Descriptive Title of Applicant's Project: To allow NIH to identify a group of applications as a related set of collaborative applications, the titles for each application in the set must have the following format: a "1/N" indicator + Identical Title (e.g., "1/3", where the 1/3 means this is site 1 of 3 sites in the set. A set of applications is defined as all applications submitted in response to this FOA. The other sites will be labeled 2/3, etc.). Titles may not exceed 200 characters in length, including the tag, e.g., 1/3, at the beginning of the title.

Cover Letter Attachment: The Cover Letter is one pdf file only. The following collaborative information is required in the Cover Letter: a listing of all the applications that are a part of the set of collaborative applications being submitted, including for each: 1) the PD/PI(s) name(s), 2) the Title (including the tag, e.g., "1/3"), and 3) the Applicant Institution. Each site should submit an identical listing.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

Investigators should budget for travel to the Washington, DC area to attend up to two face to-face Steering Committee meetings per year for the duration of the project period.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy: The application from each site must contain a Research Strategy that clearly describes those aspects of the project that are common to all sites of the collaboration. All variations in the Research Strategy between sites, no matter how minor, should be highlighted in a subsection of the Research Strategy with the heading "Elements Unique to This Site." In this subsection, PDs/PIs should describe, for example, how the research site has a unique role in the collaboration, such as unique subpopulations, data coordination, and statistical analyses.

Coordination and integration of linked applications

The application must include under this heading the following information:

• Description of coordination, integration, synergy, and mutual reinforcement between the individual research projects and resources, such as the Data Analysis and Coordination Unit (DACU).
• Description of scientific and administrative integration of the proposed program through the CoFASP Steering Committee and DACU.
• Description of value added of conducting the proposed research as a collaboration rather than through separate research efforts.
• Description of thematic cohesion to the CoFASP and scientific interrelationship of individual research projects and resources. This must include a description of the collaboration among the CoFASP investigators, DACU and the Steering Committee to facilitate consensus on standardization of: a) clinical criteria; b) study protocols and measures; and c) analytic approaches to arrive at representative and generalizable prevalence estimates. CoFASP members are expected to work in collaboration with each other, the CoFASP Steering Committee, the selected DACU, and the NIAAA Project Scientist(s) to achieve the goals of the initiative. It should also include a description of the development of a final FASD prevalence dataset that must ensure optimal data compatibility for analysis, establish consensus on consistent approaches for classification systems, including standardized case definitions and criteria for diagnosis of clinical and complementary neurological and neurocognitive features to establish reasonable prevalence of FAS, pFAS, and ARND.
• Description of the DACU. The application must highlight practical solutions for data management and analysis in collaboration with CoFASP investigators and NIAAA. Description must include plans to coordinate for core data compatibility and merging, and to address issues related to human subjects protection including confidentiality and community needs (e.g., cultural sensitivity).

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

Application must include plans, by the DACU, for data sharing with investigators outside of the CoFASP. Specifically, the application must include plans by the DACU, in collaboration with the CoFASP Steering Committee, to create a database that will be accessible to the public within a year of study completion.

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.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to 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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date 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.

Milestones

Future NIH support for CoFASP projects is contingent upon adequate progress. In the event that investigators fail to achieve the milestones specified below, NIAAA may consider restricting/withholding support and or negotiating an orderly phase-out of the grant. Please note that the restriction of funds specified below must remain in effect until the Notice of Award has been revised to rescind the restriction.

• Funds in the amount of $187,500 total costs, representing approximately 50% of the Project Year One budget, will be restricted until the receipt and acceptance of interim progress reports documenting progress toward or completion of the following milestones:
• Within three months of award, CoFASP projects must submit a document depicting a timeline and outline for a publication of a single manuscript specifying CoFASP consensus-based descriptive study protocols that must be used to calculate prevalence estimates at each site that is generalizable to the population from which the sample is drawn.
• Within six months of award, CoFASP projects must submit for publication in a refereed journal a draft manuscript describing the final CoFASP consensus-based sampling, diagnostic and analytic methodology for establishing all site-based prevalence rates.

Applications must be submitted electronically following the instructions described in the SF424 (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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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 SF424(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. See Section III of this FOA for information on registration requirements.

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 System for Award Management. 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 and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIAAA Referral Office by email at bautista@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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 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.

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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?

Does the application from each site describe the significance of the project that is common to all sites of the collaboration?

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?

Do the CoFASP investigators have the expertise in screening and identification of at-risk maternal drinking in addition to dysmorphology and neurodevelopmental assessment of children? Does the investigative team have the expertise in sampling/biostatistical, data collection, and data management expertise and capability, including appropriate application of sampling weights to establish site-based prevalence estimates that are representative of and generalizable to the geographic population from which each sample is drawn?

Are the DACU investigators experienced in coordination and statistical analysis of data from clinical and/or epidemiological studies, developing and maintaining a quality control system, maintaining quality assurance of data and in data monitoring and coordination?

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?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Does the study design propose practical solutions for data management and analysis?

Does the application describe the collaboration with the CoFASP investigators and NIAAA regarding all data coordination and analyses?

Does the DACU describe the collaboration with the CoFASP Steering Committee, in the development and implementation of plans to create a database that is accessible to the public within a year of study completion?

Does the application from each site describe those aspects of the project that are common to all sites of the collaboration?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

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 score, but will not give separate scores for these items.

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 Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Not Applicable

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

Not Applicable

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 score.

Not Applicable

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).

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) Genomic Data Sharing Plan (GDS).

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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 NIAAA, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Institute on Alcohol Abuse and Alcoholism National Advisory Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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’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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this 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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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 Part 75, 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 PD(s)/PI(s) 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 investigators for the project as a whole, although specific tasks and activities may be shared among the investigators and the NIH as defined below.

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

• Developing the research design and study protocol, including definition of diagnostic criteria, sample weighting and power calculations, and data collection, data quality control, interim data and safety monitoring, final data analysis and interpretation, and publication of results in accordance with consensus-based CoFASP policies and procedures.
• Participating in the CoFASP Steering Committee to implement and coordinate the project(s). PD(s)/PI(s) will name investigators to serve as members on the CoFASP Steering Committee and other subcommittees, as appropriate, meeting periodically. PD(s)/PI(s) will be required to accept and implement the common protocol(s) and procedures approved by the Steering Committee, including methods for data analysis and interpretation.
• Establishing procedures for data quality and completeness. Investigators are responsible for ensuring accurate and timely assessment of the progress of each project site, including development of procedures to ensure that data collection and management are adequate for quality control and analysis and sufficiently staffed for processing and submission to the DACU. Investigators will adhere to a plan for analysis of core data, as developed by the Steering Committee.
• Carrying out and completing pilot studies as recommended and approved by the CoFASP Steering Committee--e.g., anthropometric studies; standardizing/harmonizing data within other well-known FASD schema, such as ICD-10-CM, DSM-5 ND-PAE, etc.; prevention intervention development for prenatally alcohol-exposed children.
• Submitting interim progress reports, when requested, to the NIAAA Program Director including as a minimum, summary data on milestone completion as described in Section IV.6. The NIAAA Program Director may require additional information from individual investigators/sites. Such reports are in addition to the required annual noncompeting continuation progress report.

Each project site is required to ensure that data will be submitted expeditiously to the Data Analysis Coordination Unit (DACU).

Study investigators are encouraged to publish and to release publicly and disseminate results and other products of the study, in accordance with established final CoFASP FASD classification criteria, final consensus-based analytic strategies and steering committee publication policies.

Investigators will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

Designated NIAAA Program Staff members will have substantial programmatic involvement as Project Scientists. Specifically, the NIAAA Project Scientists will serve as the contact point for all facets of the scientific interaction with the PD(s)/PI(s).

The Project Scientist is a partner within the research team representing the government's interest in the substantive work of the research team. The primary role of the Project Scientist(s) is to facilitate the work of the PD(s)/PI(s) and the Steering Committee.

In addition, as required for the coordination of activities and to expedite progress, NIAAA may designate additional NIAAA staff, contractors or consultants to provide advice to the PD(s)/PI(s) or Steering Committee on specific scientific and/or analytic issues. Such staff may include another Project Scientist, who will provide direct technical assistance to the PD(s)/PI(s) to optimize the conduct and/or analysis of the study; or who may assist in the coordination of activities across multiple sites.

Moreover, an agency program official or NIAAA program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. NIAAA will appoint a Project Officer, apart from the Project Scientist(s), who will:

• Conduct normal monitoring of awards including review and approval of all progress and milestone reports and all budgetary decisions.
• Monitor project site progress, and may request that a project site be closed for failure to meet milestones. The NIAAA will not permit further expenditures of NIAAA funds for a project site after requesting closure except as specifically approved by the NIAAA.
• Make recommendations for continued funding based on: a) overall study progress; b) cooperation in carrying out the research (e.g., attendance at Steering Committee meetings, implementation of group decisions on data analysis and publication, compliance with the terms of award and reporting requirements); and/or c) maintenance of a high quality of research, which will allow merging of data and comparisons across project sites for common data elements.
• Have the option to withhold support to a participating institution if technical performance requirements, such as compliance with the protocol and milestones are not met.
• Carry out continuous review of all activities to ensure objectives are being met.

The NIAAA will have access to and may periodically review all data generated under an award. NIAAA project scientists may co-author publications of findings with PD(s)/PI(s) consistent with NIH and study policies

Areas of Joint Responsibility include:

CoFASP Steering Committee

The overall guidance and management of the research program will be provided by the CoFASP Steering Committee. The Steering Committee will be assembled from among all CoFASP investigators. The Steering Committee will provide a forum to share program activities regarding final diagnostic criteria, data management and analysis. The Steering Committee will consist of the Principal Investigators and Co-Principal Investigators of all awarded grants, and the NIH Project Scientist(s). Each PD/PI and NIAAA, will have one vote on the Steering Committee. The Steering Committee will be charged with the task of combining multiple perspectives and research agendas across sites into a coherent plan of action. Applicants should request funds to attend up to two meetings in the Washington, D.C. area for the purpose of protocol implementation and information sharing in each budget year.

The Steering Committee will:

• Plan the design and implementation of the CoFASP plan of action.Participate in decision-making regarding: operationalizing key measures relevant to establishing final case definitions and developing analysis plans to calculate valid, reproducible and generalizable, site-based prevalence rates.
• Uphold the publication policy for all CoFASP site-based and collaborative publications; and publish results, conclusions, and interpretations of the cooperative planning activity. Due publication credit will be given to all work done cooperatively.
• Agree to accept the coordinating role of the DACU and the cooperative nature of the group process.

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

Data Analysis and Coordination Unit (DACU)

One applicant will be selected to serve as the Data Analysis Coordination Unit (DACU). The selected DACU applicant will collaborate with all CoFASP projects in developing policies for data management procedures, and guidelines for site-based analyses of core CoFASP data. The DACU also are expected to conduct data analyses, share them with the investigators, and integrate them with the overall research teams, consistent with achieving the goals of the program. There will be a single DACU selected.

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 PD/PI. This special dispute resolution procedure does not alter the PD/PI'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.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) 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.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Marcia S. Scott, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-402-6328
Email: mscott@mail.nih.gov

Ranga Srinivas, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-451-2067
Email: srinivar@mail.nih.gov

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: jfox@mail.nih.gov

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 Part 75.