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: Centers (P50)

Activity Code

P50 Specialized Center

Announcement Type

Reissue of RFA-HD-06-016

Related Notices

NOT-HD-11-003

Funding Opportunity Announcement (FOA) Number

RFA-HD-12-195

Companion FOA

RFA-HD-12-196, R01 Research Project Grant

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 competitive renewal (type 2) applications for the Autism Centers of Excellence: Centers Program, hereafter termed “ACE Centers”.  ACE Centers will focus on supporting the broad research goals of the 2011 Interagency Autism Coordinating Committee Strategic Plan for ASD Research (http://iacc.hhs.gov/strategic-plan/2011/index.shtml.  The P50 mechanism allows for integrative, multi-disciplinary, coordinated programs of research that demonstrate cohesion and synergy across research subprojects and cores.  A companion FOA (RFA-HD-12-196) invites applications for ACE Networks supported by the R01 mechanism.

Key Dates
Posted Date
Letter of Intent Due Date

October 16, 2011

Application Due Date(s)

November 16, 2011  

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 PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

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 FOA solicits applications for ACE Centers supported by the P50 mechanism.  A companion FOA (RFA-HD-12-196) solicits applications for ACE Networks supported by the R01 mechanism.

Centers

This FOA solicits applications for ACE Centers. 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.

Networks

A companion funding opportunity solicits applications for ACE Networks (RFA-HD-12-196).  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 subcontracts to the collaborating sites.  An ACE Network application must include one or more collaborative projects that require multiple sites for optimal design and conduct of studies. For example, an interrelated series of clinical trials of pharmacologic, behavioral interventions, or a combination of these, could be an example of 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.

Research Objectives

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

An ACE Center must include at least one project related to the identification and evaluation of interventions and/or services research. Such projects may also include pilot projects.

Intervention Projects:

Services Projects:

Other priority areas include, but are not limited to:

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

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

All Center 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 Centers 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 Center. 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 PHS398 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 Networks (RFA-HD-12-196). 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

An applicant may request an annual budget for direct costs up to $1.5 million for a Center.

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 a consortium.  For example, a subproject within an ACE Center may be located at a foreign institution and supported through a subcontract.  Funding requests for foreign subcontracts 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 PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program 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.

Center Director (Program Director/Principal Investigator):

Only one individual may serve as the Center Director.  Multiple Center Directors are not permitted.  The Center Director must commit a minimum effort of 2.4 person-months per year overall to the Center.  

Research Project Leaders:

Leaders of individual projects must commit a total minimum effort of 1.8 person-months per year to each project.  Multiple project leaders  are allowed for individual research projects.  If there are multiple project leaders on a project, the combined efforts of the identified project leaders must total at least 1.8 person-months per year. 

Core Leaders:

Multiple Core Leaders are allowed for cores.     

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 principal investigator 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. No more than two awards will be made at each institution. 

Section IV. Application and Submission Information

1. Address to Request Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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

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

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

Application Submission

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

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

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

Sherry Dupere, PhD
Director, Division of Scientific Review
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: 301-451-3415
Email: duperes@mail.nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following modifications:

For new ACE Center (P50) applications, Research Plan page limits are as follows:

Overview of the Program Project (for overall P50)                     12 pages

Research Project Descriptions (each project)      

Core Descriptions (each Core)                 

Research Grant Table of Contents

In lieu of the preprinted Table of Contents outline on Form Page 3 of PHS 398, a Table of Contents should be prepared listing all of the major sections described below and paginated to enable reviewers to find specific information readily.

The Table of Contents should contain the information described below.  It should be divided into the following sections:  Section I - Center Preliminary Pages, Section II - Center Research Plan, and Section III - Appendix. The following guidelines will provide directions and descriptions for preparing each section. Major areas to be listed and paginated in the Table of Contents are underlined.

Section I – Center Preliminary Pages

1.  ACE Center Face Page (Form Page 1):

Complete all items on the application's face page.  For Item 2, enter the number of this FOA and the title, "Autism Centers of Excellence: Centers (P50)”.  Number succeeding pages consecutively.

2. Center Description: Project Summary and Relevance, Project/Performance Site(s), Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells (Form Page 2 and 2-continued):

Describe briefly the proposed research program, indicate the research emphasis of the component Research Projects, and identify the purpose of the proposed Core units.

List all Senior/Key personnel and Other Significant Contributors engaged on the project.  Use continuation pages as necessary, numbering consecutively.

3. Center Table of Contents (Form Page 3):

Prepare the Table of Contents including the major headings as noted above.

4. Center Budget Instructions (Form Page 4):

Prepare a series of composite budget tables for the ACE Center grant as requested below, followed by a detailed budget for each Research Project component and each Core unit.

Composite Budget

Budgets for Individual Research Project Components and Core Components 

Prepare an individual budget for each Research project and Core unit proposed.

5. Biographical Sketches (Biographical Sketch Format Page):

Follow the instructions on the Biographical Sketch Format Page. This section must contain the biographical sketches of all individuals listed as Senior/Key Personnel and Other Significant Contributors, following the order listed on Form Page 2.  Biographical sketches are required for all key personnel participating in the Research Project components and Core units.   Begin with the P50 overall PD/PI  and thereafter, in alphabetical order, submit biographical sketches as described in the Instructions for Form PHS-398. Do not exceed four pages for each person.

6. Resources (Resources Format Page):

Complete the "Resources" page of PHS-398 for the overall project. Briefly describe the features of the institutional environment that are or would be relevant to the effective implementation of the proposed program. As appropriate, describe available resources, such as clinical and laboratory facilities, participating and affiliated units, patient populations, geographical distribution of space and personnel, and consultative resources.

Section II – Center Research Plan

Include a detailed Table of Contents with pagination (numeric only) at the beginning of Section II.

Identify each Research Project component and each Core unit by title. Assign each Research Project component a Roman numeral (I, II, III) and assign each Core unit a capital letter (A, B, C) that reflects the order in which they are presented.

For new ACE Center (P50) applications, Research Plan page limits are described above in the Page Limitations section.

For each Research Project component and Core unit, provide the name of the responsible investigator, and biographical sketches for personnel not identified previously.

1.   ACE Center Introductory Overview (Overview of the Program Project)

Provide an overview of the entire proposed ACE Center describing the central theme and goals.  Describe how the overall ACE Center can achieve its major objectives.  Explain the proposed contribution of each of the projects in achieving the objectives of the center.  Furthermore, the administrative arrangements and support necessary to effect the research should be carefully described in the application.  Shared resources should be described.  In addition, provide detailed information on collaborations, recruitment, facilities and resources.

A. History and Purpose of the Program

Discuss the overall P50 program's objectives and general plans for the proposed grant period, including research grant history with yearly funding level.

B. Administration, Organization, and Operation

Include information on the support and commitment of the parent institution for the program, the authority of the PD/PI, the use of advisory committees, and space assignment. Describe the organizational framework and provide an organizational chart.

C. Research Program

Discuss the proposed research program, highlighting its central theme. List by title and investigator's name the component Research Projects and Core units.  Describe the relationship between the projects and the Core units and their relationship to the central theme.

D. Data Management

Applications must have a clearly defined data management section in the research plan, taking into account the interface with the National Database for Autism Research (NDAR) described above. 

E. Assurances and Collaborative Agreements.

Provide an overview and rationale for any collaborative and cooperative endeavors or subcontracts.  Letters of Assurance/agreement for these arrangements are included in Item 5 described below.

2.  ACE Research Project Description(s)

Identify each project by a Roman numeral (I, II, III...) and a title.

A full description of each project is to be provided following the format and instructions for Form PHS-398 (http://grants.nih.gov/grants/funding/phs398/phs398.html).

Begin the presentation of each Research Project component on a separate page, and include the following:

A. Research Project Cover Page (1 page)

B.  Project Description (1 page; use PHS-398 Form Page 2)

C. Content of Research Plan (Begin each section with a section header)

1.  Specific Aims

2.  Research Strategy (Significance, Innovation, and Approach):  Start each section with the appropriate section heading—Significance, Innovation, Approach. Cite published experimental details in the Research Strategy section and provide the full reference in the Bibliography and References Cited section.  For new applications, include information on Preliminary Studies.  For renewal applications, provide a Progress Report within the 12 page research strategy limit.  Indicate the Research Project's use of Core unit services, including why they are needed and the advantages and cost effectiveness of Core unit usage for the project.

3.   Inclusion Enrollment Report (renewal applications only)

4.   Bibliography and References Cited, Progress Report Publication List

5.   Protection of Human Subjects

6.   Inclusion of Women and Minorities

7.   Targeted/planned Enrollment Table

8.   Inclusion of Children

9.   Vertebrate Animals

10.  Select Agent Research  

11.  Multiple Project Director/Principal Investigator (PD/PI) Leadership Plan:  Multiple PD/PIs are allowed for individual research projects. However, a Leadership Plan not applicable.  

12.  Consortium/contractual arrangements

13.  Letters of Support:  Include pertinent letters of assurance and collaboration for     the Research Project.  For off-site projects, justification should be provided for the project's location, and plans for interaction and cooperation with the other components of the program should be addressed.

14.  Resource Sharing Plan – note the following modifications to the PHS398 Application Guide:

Sharing Human Data via the National Database for Autism Research:

In order to advance the goal of widespread data sharing among ASD researchers, investigators funded under this FOA who are collecting data from humans are expected to share those data 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 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).  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.  The mission of the NIH and hopefully a mission shared by the research community is to promote discoveries to improve the health care and treatment of people.  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, etcetera, (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: 

3.  ACE Core Descriptions

Identify each proposed core unit by a letter (A, B, C…) and a title (Administrative, Research Training and Education, etc...). Provide a full description of each Core unit.  Begin the presentation of each Core unit on a separate page.  For each proposed core, address cost effectiveness and plans for quality control, as appropriate.  Include the following:

A. Core Unit Cover Page

B. Core  Unit Description ( use PHS-398 Form Page 2)

C. Core unit Structure, Administration, and Services

Administrative Core:

Research Training and Education Core:

Additional Core(s):

4. Progress Report Publication List (for renewal applications only)

List publications prepared during current grant period (or the past five-year period) which report results of research supported by the grant.

5. Letters of Assurance/Agreement  

Any arrangements for collaborative and cooperative endeavors or subcontracts not already described under the individual research projects should be highlighted here. Include letters of 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.

Appendix

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

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

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

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by 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.

Overall Impact - Overall

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the Center 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 Center proposed).

Scored Review Criteria - Overall

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

Significance

Does the Center address an important problem or a critical barrier to progress in the field? If the aims of the Center 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 Center? 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 Center? 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 Center 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 - Overall

As applicable for the Center 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.

Center as an Integrated Effort and Contribution to Autism Research

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 Center involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

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

Revisions

Not Applicable

Additional Review Considerations - Overall

As applicable for the Center 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

Not applicable.

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.

Scored Review Criteria for Individual Research Projects

For each of the ACE Research Projects, 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?

Review Criteria for Core Components

Reviewers will assign an impact/priority score for each core unit component, based on the assessment of each Core unit independently in terms of the specified review criteria for Cores. Separate criterion scores will not be assigned for Cores. 

For all Cores, the following review criteria will be used:

For the Administrative Core, the following review criteria will be used:

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 and 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 Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

Scientific/Research Contact(s)

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, PhD
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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Research (OER)
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Bethesda, Maryland 20892
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