Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)

Funding Opportunity Title

Autism Centers of Excellence: Networks (R01)

Activity Code

R01 Research Project Grant

Announcement Type

Reissue of RFA-HD-06-004

Related Notices

NOT-HD-11-004
Frequently Asked Questions (FAQs)

Funding Opportunity Announcement (FOA) Number

RFA-HD-12-196

Companion FOA

RFA-HD-12-195, P50 Specialized Center

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.865, 93.242, 93.853, 93.173, 93.113

FOA Purpose

The Eunice Kennedy  Shriver National Institute of Child Health and Human Development (NICHD), the National Institute on Deafness and Other Communication Disorders (NIDCD), the National Institute of Environmental Health Sciences (NIEHS), the National Institute of Mental Health (NIMH), and the National Institute of Neurological Disorders and Stroke (NINDS) invite new (type 1) and renewal (type 2) applications for the Autism Centers of Excellence: Networks Program, hereafter termed “ACE Networks”.  Each ACE Network will consist of a multi-site project focusing on a specific topic of research for R01 support through this FOA.  The ACE Networks will focus on supporting the broad research goals of the Interagency Coordinating Committee Strategic Plan for ASD Research (http://iacc.hhs.gov/strategic-plan/2011/index.shtml).  Each ACE Network will submit one R01 application that includes subawardss to the collaborating sites.  A companion FOA (RFA-HD-12-195) invites applications for ACE Centers supported by the P50 mechanism.

Key Dates
Posted Date

June 3, 2011

Open Date (Earliest Submission Date)

October 16, 2011

Letter of Intent Due Date

October 16, 2011

Application Due Date(s)

November 16, 2011, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

February/March 2012

Advisory Council Review

May 2012

Earliest Start Date(s)

July 2012

Expiration Date

November 17, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

Autism spectrum disorders (ASD) are complex neurodevelopmental disorders with early childhood onset. The prevalence of ASD may be increasing, and ASD is more common than previously thought.  These disorders, for which there is presently no cure and only limited treatments, generally have lifelong effects.  

The NIH historically has supported a vast array of projects in autism research.  Beginning in 1997, the Collaborative Programs of Excellence in Autism (CPEA) focused on research related to the possible causes of autism, including genetic, immunological, and environmental factors.  The CPEA program resulted from a congressionally mandated conference on the State of the Science in Autism.  The attendees identified gaps in the understanding of autism and articulated directions for future research. Both NICHD and NIDCD sponsored the CPEA program.  As a result of the efforts of researchers affiliated with the CPEA, data now exist on the genetics and phenotypic characteristics of the largest group of well-diagnosed persons with autism in the world.  After the establishment of the CPEA Centers program, Congress enacted the Children's Health Act of 2000.  This legislation mandated the establishment of a new autism research program.   In response, the five Institutes of the NIH Autism Coordinating Committee (NIH-ACC; represented by NICHD, NIDCD, NIEHS, NIMH, and NINDS) implemented the STAART (Studies to Advance Autism Research and Treatment) program in 2002. Each of the eight STAART centers contributed to the autism research base in the areas of causes, diagnosis, early detection, prevention, and treatment.  Collaborations among the STAART centers included a multi-site psychopharmacological clinical trial.  In 2007, consolidation of funding from the CPEA and STAART programs resulted in autism centers and networks called the Autism Centers of Excellence or ACE program. In FY 2007 and 2008, five centers and six networks were funded.

Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage research grant applications to support research designed to elucidate the etiology, epidemiology, diagnosis, treatment, and optimal means of service delivery in relation to autism spectrum disorders (ASD).

In response to the urgent public health significance of ASD, Congress passed the Combating Autism Act (CAA) of 2006.  Through this Act, Congress intends to accelerate the pace, and improve the coordination of scientific discovery in ASD research.  The Strategic Plan for ASD Research, a requirement of the CAA, was developed with the input of the scientific community, as well as advocates and advocacy organizations, including parents, providers, and individuals with ASD.  The plan consists of short and long term research objectives across a range of topics.  This FOA is intended to support the broad research goals of the Strategic Plan for ASD Research (http://iacc.hhs.gov/strategic-plan/2011/index.shtml).

NIH will consider “centers” as well as “networks” in response to the ACE initiative.  This funding opportunity solicits applications for ACE Networks supported by the R01 mechanism.  A companion FOA (RFA-HD-12-195) solicits applications for ACE Centers supported by the P50 mechanism.  

Networks

This funding opportunity solicits applications for ACE Networks.  A network will consist of multiple sites focusing on a specific topic of research for R01 support through this funding opportunity.  Each network will submit one R01 application that includes subawards to the collaborating sites.  An ACE Network application must require multiple sites for optimal design and conduct of the study. For example, an interrelated series of clinical trials of pharmacologic, behavioral interventions, or a combination of these, could be  the focus of such a network.  Another example could be a multi-site epidemiology study of risk factors for ASD.  Special populations requiring large numbers of participants for each protocol may also be studied best under a network because of enhanced recruitment and other benefits of multi-site subject accrual.

Centers

A companion FOA solicits applications for ACE Centers (RFA-HD-12-195). Centers bring together expertise, infrastructure and resources focused on major questions about autism.  Centers should involve collaborations of basic and clinical scientists optimally suited to address the research questions posed.  NIH expects Centers to provide an environment and core resources to bring together biomedical, behavioral, and clinical science investigators to study autism.  Collaborations involving more than one institution are strongly encouraged to provide optimal resources and expertise. The Centers should provide investigators with well-characterized patients and control subjects, family information, and other scientific resources that facilitate research projects. Applications for Centers must include a minimum of three but no more than six research projects. 

An ACE Center must support major multidisciplinary research programs, consisting of interdependent and interrelated subprojects.  Meaningful and committed interactions among the disciplines must be evident.  Subprojects may share materials, results, data, patient populations, or methodologies. Results of one subproject may well affect the understanding and interpretation of data from another project and thereby influence the nature of the research performed in one or more of the other subprojects. In addition, each subproject must have goals and objectives that focus on the common unifying theme that interrelates the subprojects.

Research Objectives

The highest priority will be given to projects related to gaps identified by the IACC 2011 Strategic Plan. Please indicate, when appropriate, to which short or long term objective or area of opportunity from the IACC strategic plan your project responds. At least one of the following priorities must be addressed:

Intervention and evaluation of interventions and services for ASD:

Intervention Projects:

Services Projects:

Other priorities include but are not limited to:

The minimal structural requirements of an ACE Network under this FOA are:

The minimal data collection requirements of an ACE Network under this FOA are:

Network applications must include collection of data using the following forms or a justification of why the forms are not appropriate. Additional modifications to these forms may occur periodically. 

The NIH National Database for Autism Research (NDAR) houses research data of all types (genetic, imaging, clinical assessment, etc.) from human subjects involved in ASD studies, and is currently on track to receive data from tens of thousands of such subjects.  NDAR’s first data release occurred in November 2010, making mostly clinical assessment data from over 10,000 research subjects available to qualified investigators.  It is expected that in the next several years, ASD data from more than 90% of new investigations will be available in or through NDAR.

All ACE Networks will be required to contribute data to NDAR.  Data sharing is required and NDAR will be involved to facilitate sharing activities.  NDAR will function as a data repository for all ACE projects.  Central clinical coordination and local data management for data cleaning and entry and bio-statistical consulting will be the responsibility of the ACE Network. For more information on NDAR, please visit http://ndar.nih.gov/ndarpublicweb/

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The NICHD, NIDCD, NIEHS, NIMH, and NINDS intend to commit approximately $26 million total for the first year of funding for this funding opportunity and the companion FOA for ACE Centers (RFA-HD-12-195). The first year of funding will be in either FY2012 or FY2013. Approximately 10 to 15 ACE awards are anticipated in response to the two FOAs. 

Although the financial plans of the IC(s) provide support for this program, the number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation (see NOT-OD-05-004).To estimate the cost of data sharing, please visit http://ndar.nih.gov/ndarpublicweb/Documents/NDAR_Data_Submission_Costs.xls.   

Award Budget

Applicants for an ACE Network may request up to $2 million in direct costs per year (excluding subaward F & A costs).  

Award Project Period

The scope of the proposed project should determine the project period.  The maximum project 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 may not serve as the applicant organization.  However, they may participate as part of the network consortium.  For example, a site within an ACE Network may be located at a foreign institution and supported through a subaward.  Funding requests for foreign subawardss must be made in U.S. dollars.  Facilities and administrative costs on foreign consortia will be awarded at 8 percent of the total direct costs less equipment.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept any application 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.

Each PD/PI may submit only one application for either an ACE Center or an ACE Network.  This does not exclude multiple applications from a single institution, provided each application is submitted by a different principal investigator.   

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

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:

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

The letter of intent should be sent to:

Alice Kau, PhD
Program Director for Research on Autism Spectrum Disorders
Intellectual and Developmental Disabilities Branch (IDD)
Center for Developmental Biology and Perinatal Medicine (CDBPM)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 4B09F, MSC 7510
Bethesda, MD  20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone:  301-496-1383
FAX: 301-496-3791
Email:  kaua@mail.nih.gov

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

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

Other Project Information Component

Facilities and Other Resources (Item 10. of R & R Instructions)

R&R Budget Component

The Applicant organization should submit R & R budget forms for the ACE network R01, following the standard R & R Budget Component instructions.   Participating research sites should prepare subaward budget pages according to Section 4.8 of the R & R Instructions (Special Instructions for Preparing Applications with a Subaward/Consortium).   Budgets for the applicant organization and all network sites should include a detailed budget for the entire proposed project and a Budget Justification for each site according to the R & R instructions.

Data Coordinating Center –  If the DCC will be located at an organization distinct from the applicant organization and the network research sites, the DCC budget should be prepared as a subaward to the R01 budget.  If the DCC will be located at the applicant organization, the DCC budget should be included as part of the overall R01 budget.  If the DCC is located at one of the participating research sites, the DCC budget should be included as part of the subaward budget for that particular site.   DCC budgets that are included as part of either the R01 or research site budgets should be explained and justified in the respective budget justification section.     

ACE Network budgets and subaward budgets must include travel funds for key investigators to attend annual two-day ACE meetings in Bethesda, Maryland.  The Network PD/PI(s), leaders of the various network sites, and the leader of the Data Coordinating Center (DCC) should plan to attend the annual meeting to share findings, research approaches, and information about core instrumentation.

Budget Justifications and Explanations --Describe the specific functions of all key personnel, consultants, collaborators, and support staff. For all years, explain and justify any unusual items such as major equipment or alterations and renovations. For additional years of support requested, justify any significant increases or decreases in any category over the first 12-month budget period. If a recurring annual increase in personnel or other costs is anticipated, give the percentage; however, current NIH practice limits escalation to 3%. In addition, for renewal applications, justify any significant increases in any category over the current level of support.

PHS 398 Research Plan Component

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

Research Strategy (12 page limit)

Purpose and Objectives of the ACE Network -- Provide an overview of the entire proposed ACE Network, including the relevant history leading up to the ACE network application, the central theme, and the overall objectives.  Describe how the network will achieve those objectives.  Explain the contribution of each of the proposed research studies in achieving the objectives of the network.  The administrative arrangements and support necessary to effect the research should be carefully described in the application.  In addition, provide detailed information on collaborations, subject recruitment, facilities, and any resources not described in the Resources section. Provide documented evidence of subject recruitment capability specific to each study proposed.  Discuss the philosophy and objectives of the ACE network and general plans for the proposed grant period. 

Administration, Organization, and Operation of the ACE Network -- Include information on the support and commitment of the institution serving as clinical coordinating center for the ACE network, the authority of the ACE network Director, and the use of advisory committees.  Identify any investigators new to the field of autism (junior and/or established investigators) that will be involved directly in network activities.  Describe any additional efforts that will be made to recruit and/or train new investigators over the course of the award.

Data Coordinating Center -- Applications must have a clearly defined Data Coordinating Center (DCC) section in the research plan that describes the DCC’s functions in detail and explains how it will operate independently from data collection sites.   Applicants must provide evidence that the data collection sites and DCC are functionally separate, with separate chains of command. 

Network Preliminary Data -- The proposal should present, in condensed form, previously published and/or preliminary data that support the rationale for the proposed ACE network activities and research project.  Cite relevant publications where appropriate.  Renewal applications must submit a progress report detailing the progress made on ACE Network projects funded by the previous ACE FOA.  Citations should be listed in the Progress Report Publication List (see below).

Letters of Support

Any arrangements for collaborative and cooperative endeavors or subawards should be described here.  Include letters of assurance/agreement from consultants. For projects to be conducted off site, i.e., at an institution other than the applicant institution, a letter of assurance signed by the off-site institutional officials must be submitted with the application.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:

Sharing Human Data via the National Database for Autism Research:

Sharing Human Data via the National Database for Autism Research: In order to advance the goal of advancing autism research as broadly and effectively as possible, investigators funded under this FOA who are collecting data from humans are expected to share those data among ASD researchers through a broadly accessible repository addressing the needs of the autism research community, e.g., via the National Database for Autism Research (NDAR; http://ndar.nih.gov). Fulfilling this expectation by the awardee will be among the terms and conditions of the award.  Established by the NIH, NDAR, for example, is a secure bioinformatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research data, tools, and supporting documentation.  NDAR links data across research projects through its Global Unique Identifier (GUID) and Data Dictionary technology.  Investigators funded under this FOA would be able to  use these technologies to submit data to NDAR.  To accomplish this objective, it will be important to formulate a) an enrollment strategy that will obtain the information necessary to generate a GUID for each participant, and b) a budget strategy that will cover the costs of data submission.  The NDAR web site provides two tools to help investigators develop appropriate strategies: 1) the NDAR Data Sharing Checklist (http://ndar.nih.gov/ndarpublicweb/Documents/NDAR_Data-Sharing_Checklist_10152009.pdf) -- A list of critical steps in the data submission process, including informed consent language and GUID generation; and 2) the NDAR Data Submission Planning Cost and Effort Model (http://ndar.nih.gov/ndarpublicweb/Documents/NDAR_Data_Submission_Costs.xls) -- A customizable Excel worksheet that includes tasks and hours for the Principal Investigator and Data Manager.  Investigators are expected to certify the quality of all data generated by grants funded under this FOA prior to submission to the repository and to review their data for accuracy after submission.  Submission of descriptive data is expected semi-annually (every January 15 and July 15); submission of all other experimental data is expected after the primary objectives of the grant have been met (the primary objectives of a grant will be determined in consultation with the investigator’s Program Officer prior to award).  For reference, the NDAR Data Sharing Policy (http://ndar.nih.gov/ndarpublicweb/policies.go) is available for review on the NDAR web site.  NDAR staff will work with investigators to help them submit data types other than phenotypic, genetic, or imaging. For answers to frequently asked questions and how to contact the NDAR Manager, please see: http://ndar.nih.gov.

Genetics and other Data Sharing in the ACE Program 

The rapid dissemination of data and biomaterials is of increasing importance to the NIH for advancing research.  The mission of the NIH and a goal of NIH policies are to promote discoveries to improve the health care and treatment of people, which is a mission that should be shared by the research community.  The expedient sharing of data and biomaterials collected under scientific studies facilitates that mission.  The NIH supports several databases through the NCBI, and the NIMH supports a repository for biospecimens of interest to mental health (http://nimhgenetics.org) to enable rapid sharing of data and biospecimens. These resources offer centralized sources of curated materials that are widely accessible to investigators in the international scientific community.

Investigators applying for awards under this FOA are encouraged to deposit data and biospecimens in NIH designated databases and appropriate repositories.  However, depending on the nature of the data or biomaterials, there may not be an appropriate NIH supported resource for deposition.  In such cases, alternative venues for data sharing can be considered.  The sharing of data through NIH resources would not necessarily be exclusive and the data could be additionally shared through other investigator suggested venues.

It is expected that the investigator’s data sharing plan will specify the following elements:  (1) description of what data will be collected including clinical data, diagnostic data, and physiological measurements such as MRI, (2) description of what biospecimens will be collected, (3) description of the data that will be derived from the biospecimens such as genotyping, sequence, metabolomic measures, proteomic measures, etc., (4) what data and/or biospecimens will be made available for deposit in databases or in a repository accessible to the research community, (5) a timetable for deposition of the data and/or biomaterials, and a specified time interval after which those data and materials can be released to the research community.

Guidelines have evolved from extensive discussion within NIH Program staff, consultations with human genetics researchers and advocacy members, recommendations from the Genetics Workgroup of the National Advisory Mental Health Council (NAMHC), and requirements of the National Database for Autism Research recommending shortened timelines for data deposition and reduced proprietary periods before the data is released to the research community.  The deposition of data is encouraged to occur at intervals throughout the period of the award and not be detained until the end of the award period.  Similarly, the proprietary period for data release is encouraged to be short to facilitate rapid data release.  Adherence to shortened time intervals for data deposition and release is highly desirable. This is expected to result in all data being released to the scientific community no later than the end of the award period, even if a competing renewal application is submitted. More rapid sharing is strongly encouraged.  Requests for exemptions or extensions will require compelling justification and will be fully evaluated through peer review and by program staff.

NIMH, in consultation with NIH’s Office of the General Counsel, the National Human Genome Research Institute's Ethical, Legal, and Social Implications Research Program and the Department of Health and Human Services' Office for Human Research Protections, has developed a model consent form for use in human genetic research at: https://www.nimhgenetics.org/documents/NIMH%20Human%20Genetics%20Initiative%20Consent.pdf. This model consent may serve as a template that is subject to modification and/or approval by local institutional review boards.  It is expected that the applicant’s approved consent form addresses the following:

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Foreign Organizations

Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

ACE Networks supported under this FOA will consist of multiple sites focusing on a specific topic of research.  Each network R01 application will include subawards to the collaborating sites.  An ACE Network application must include one or more collaborative research projects that require multiple sites for optimal design and conduct of studies.  The scored review criteria outlined below will be considered in relation to all components of the network, including the various participating sites, investigators, and research project or projects. 

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

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

Significance

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

Investigator(s)    

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

Innovation

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

Approach

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

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

Environment

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

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

ACE Network as an Integrated Effort and Contribution to Autism Research:

Data Coordinating Center:

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

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 NICHD, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned initially to NICHD for purposes of review. Once the review is completed, meritorious 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 appropriate National Advisory Council or Board. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

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

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Alice Kau, PhD
Program Director, Research on Autism Spectrum Disorders
Intellectual and Developmental Disabilities Branch (IDD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Phone: 301-496-1385
Email: kaua@mail.nih.gov

Judith Cooper, PhD
Division of Scientific Programs
National Institute on Deafness and Other Communication Disorders (NIDCD)
Phone: 301-496-5061
Email: Cooperj@nidcd.nih.gov

Cindy Lawler, PhD
Division of Extramural Research and Training
National Institute of Environmental Health Sciences (NIEHS)
Phone: 919-316-4671
Email: lawler@niehs.nih.gov

Lisa Gilotty, PhD
Division of Developmental Translational Research
National Institute of Mental Health (NIMH)
Phone: 301-443-3825
Email: gilottyl@mail.nih.gov

Deborah Hirtz, MD
Extramural Research Program
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 2212, MSC 9250
Bethesda, MD   20892-9250
Phone: 496-5821
Email: hirtzd@ninds.nih.gov  

Peer Review Contact(s)

Sherry Dupere, Ph.D.
Director, Division of Scientific Review
Eunice Kennedy Shriver
National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-1485
Email: duperes@mail.nih.gov

Financial/Grants Management Contact(s)

Bryan S. Clark, MBA
Chief Grants Management Officer
Eunice Kennedy Shriver National Institute of Child Health and Human Development  (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov

Christopher Myers
Grants Management Office
National Institute on Deafness and Other Communication Disorders (NIDCD)
Phone: 301-435-0713
Email: myersc@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


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