Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov)
National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov)
National Institute on Deafness and Other Communication Disorders (NIDCD), (http://www.nidcd.nih.gov)
National Institute of Environmental Health Sciences (NIEHS),(http://www.niehs.nih.gov)
National Institute of Neurological Disorders and Stroke (NINDS),(http://www.ninds.nih.gov)

TitleRecovery Act Limited Competition:  Research to Address the Heterogeneity in Autism Spectrum Disorders (R01)

Announcement Type

New

Request for Applications (RFA) Number: RFA-MH-09-170

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.701

Key Dates
Release/Posted Date: March 23, 2009
Opening Date: April 12, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): April 12, 2009
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). 
Application Due Date(s):  May 12, 2009
AIDS Application Due Date(s): Optional. Add Information Here
Peer Review Date(s): July 2009
Council Review Date(s): August 2009
Earliest Anticipated Start Date(s): September 30, 2009
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: May 13, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II 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 - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Purpose

Autism Spectrum Disorders (ASD) are neurodevelopmental disorders characterized by differences in three core domains of functioning: social behavior, communication abilities, and restricted, repetitive or stereotyped patterns of behavior.  Although these core features exist at varying degrees among all individuals with ASD, considerable heterogeneity exists within this population, which suggests there may be multiple causal factors as well as multiple developmental trajectories for these individuals.  Indeed, a clear barrier to understanding the causes of ASD has been the heterogeneity within this spectrum of disorders.  In addition, greater knowledge of the range of ASD phenotypes may lead to more precise diagnostic and screening instruments and will increase the potential for more targeted treatment and intervention strategies. 

Approaches to the study of ASD have evolved over time, as more is learned about these disorders.  As with many neurodevelopmental disorders, brain dysfunction may precede behavioral abnormalities by months or years, however without identified biomarkers for detection of those with, or at risk, for an ASD, diagnostic methods must rely on behavioral observations which often occur after the onset of symptoms.  As a result, intervention efforts may miss a critical window of opportunity to alter the developmental trajectory for these individuals.

Differences in policies, resources and organization across geographic regions result in marked disparities in the types of services and supports available, as well as in the associated financial costs to individuals and families.  Very little is known about how differences in policy and infrastructure are related to the variations in access to services and care received, and in turn, how these variations affect outcomes for individuals living with an ASD. 

Most individuals with an ASD will continue to experience difficulties across their lifetime. However symptoms often change in form and severity over time.  Although considerable research has been conducted on the earliest phases of ASD, less is known about adolescence, adulthood, and late life stages, or about the transitions between these stages.  Little research has been carried out to determine prognostic factors or how adults with an ASD currently function or are best supported. 

In response to the urgent public health significance of ASD, Congress passed the Combating Autism Act (CAA) of 2006.  Through this Act, Congress intended to accelerate the pace, and improve coordination of scientific discovery in ASD research.  The CAA required the development of a Strategic Plan for ASD Research (http://iacc.hhs.gov/reports/2009/iacc-strategic-plan-for-autism-spectrum-disorder-research-jan26.shtml), which was created 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, including those relevant to the heterogeneity of ASD, such as the gap areas discussed above. 

To address these and other gap areas of knowledge on ASD, and to ensure appropriate attention is given to the most critical short-term objectives within the Strategic Plan, applications for research projects are being solicited within the following topic areas:

Measurement Development

The diagnosis of an ASD can be reliably made by three years of age, however many children with an ASD demonstrate signs of atypical development prior to two years of age, and several recent studies have indicated that some cases of ASD may be detected as early as twelve months of age through the use of simple behavioral tests.  The current validated diagnostic measures for ASD are time-consuming and require a relatively high level of expertise to administer.  There is an emerging call for streamlined diagnostic approaches that are easy to administer and are sensitive to change.  Diagnostic tools with high sensitivity and specificity to support large-scale epidemiologic and risk factor studies are also needed.  In addition, while specialized screening tools to identify young children who may be at risk for an ASD have been developed that require further testing and refinement for evidence of efficacy, there is a need for screening instruments which can be used outside of specialty clinics, as well as a need for tools that can screen for “at risk” status in older children, adolescents and adults. 

Examples of relevant research of interest include but are not limited to the following:

Biomarkers/Biological Signatures

Currently, the diagnosis of an ASD or the detection of risk for an ASD is based on behavioral and cognitive signs which may reflect atypical brain development.  However, brain and other biological differences are likely to be present prior to the observable signs.  Biomarkers for ASD can potentially identify individuals with the disorder, or those at risk for developing ASD, before the emergence of behavioral manifestations and the altered developmental trajectories are established, although determining such biomarkers has been complicated by the heterogeneity of the disorder.  Differences in brain structure, and/or functional brain activity patterns can serve as biomarkers, as can hormones, neurotransmitters, receptors, etc.  The identification and validation of robust candidate biomarkers predictive of ASD risk, course, prognosis, and treatment response, will be imperative to understanding and treating ASD.   In all cases, the biomarker should be effective on an individual basis, rather than from pooled individuals. Also, biomarkers appropriate for this funding opportunity announcement may be intended to be used with behavioral measures, but behavioral measures alone are not considered biomarkers here. In addition, an integrated panel of clinically relevant biomarkers (e.g., genes, proteins, brain structure and function) and behavioral indicators could serve to create biological signatures for ASD.  Biomarkers could be noninvasively obtained (e.g., using optical or magnetic resonance imaging, etc.) or obtained with minimal invasiveness (e.g., using genetic, protein or metabolic signatures, physiological measures, etc.) Biomarkers developed may be useful across the lifespan or targeted to particular age groups (e.g. infancy, childhood, adolescence, adulthood).  High-throughput biomarker assays are also encouraged. 

Identifying, parameterizing, optimizing and validating the use of particular biomarkers associated with autism, with regard to their relationship to brain or behavioral function, are among the research activities encouraged. 

Examples of relevant research of interest include but are not limited to the following:

Immune and Central Nervous Systems Interactions

It is well known that there is bi-directional communication between the immune system and the central nervous system (CNS) and that the immune system may modulate the central nervous system differently across the lifespan.   For example, exposure to a neuroimmune challenge early in life can influence brain development, and evidence suggests that neuroimmune molecules may influence normal development and synaptic plasticity of the mammalian brain.  Other studies suggest the possibility that the immune system may play a role in the development of ASD and other neurodevelopmental disorders, e.g. by immune system activation during early development.  In order to understand possible contributions of immune-neural interactions to ASD, it is critical to identify mechanisms by which interactions between the metabolic and/or immune system and the CNS may contribute to neurodevelopmental processes disrupted in ASD.  Studies using relevant cell systems and mammalian and non-mammalian species are appropriate.   Studies spanning multiple levels of analysis (e.g., genes, molecules, cells, circuits, systems, behavior) are appropriate within the constraints of the limited project period.  

Examples of relevant research of interest include but are not limited to the following:

Genetics/Genomics

Autism Spectrum Disorders have a complex genetic etiology and causation is generally thought to involve a complex interplay between genetic factors and non-genetic environmental exposures.  Environmental exposures are thought to mediate gene expression through epigenetic modification at all levels (methylation, histone modification).  Though some progress in identifying genetic susceptibility has been achieved, only a small proportion of the genetic variance is explained and much more research in large cohorts at the level of genomic and epigenomic variation and regulation is needed.  To date, few studies have been focused on potential mechanisms of gene-environment interplay in ASD, and more research to needed to understand how environmental contributors may influence genetic risk. 

Examples of relevant research of interest include but are not limited to the following:

Environmental Risk Factors

The role of the environment in ASD etiology is poorly understood, although there is an emerging appreciation that a complete understanding of ASD will involve a contribution of both genetic and environmental risks. The potential impact of environment on autism risk is supported by recent studies reporting associations of specific exposures during critical periods of development with autism risk and by a rich body of evidence establishing the ability of environmental exposures to affect a range of childhood cognitive and behavioral outcomes that are relevant to the clinical manifestations of ASD. Several challenges remain, however, for research aimed at linking specific exposures with ASD phenotype, including the genetic and phenotypic heterogeneity of ASD, the broad range of environmental exposures with potential to impact key aspects of brain development and limitations in current exposure assessment methodologies. Research is urgently needed to accelerate efforts in this understudied area, as the identification of environmental risk factors provides new opportunities for prevention through reduction or elimination of exposures in susceptible populations.  

For the purposes of this FOA, the environment is defined broadly to include, but not be limited to, pesticides and agrichemicals, air pollution and combustion byproducts, endocrine active chemicals, metals, nutrition, pharmaceuticals and other medical exposures, infectious agents and psychosocial stressors.

Examples of relevant research of interest include, but are not limited to, the following:

Model Development

Behavioral Model Development

The development of animal models is critical to identifying the neurobiological systems most disrupted in ASD, following the developmental trajectory that leads to these disruptions, determining the genetic and environmental factors that influence the expression of ASD symptoms, and to testing the efficacy and/or safety of ASD interventions and treatments.  To be useful for these types of studies, animal behavioral models of ASD should replicate one or more of the core behavioral features of ASD.  Projects can include the development, standardization, and/or comparison of behavioral measurements in these or other clinically significant domains. Behavioral measurements in both highly controlled and ethologically valid environments are encouraged.  Behavioral assays that capture ASD-relevant sex differences and/or allow for analysis of sex as a factor are also strongly encouraged.  Behavioral assays should be appropriate for use with animals from early post-natal life through adulthood. 

Behaviors of interest include, but are not limited to:

Models for Understanding Neurobiological Mechanisms

Experimental models play an important role in promoting a deeper understanding of the molecules and brain systems involved in ASD.  Through the use of cell systems and intact model systems, multiple levels of analysis can be applied in order to examine the molecular, cellular, and circuits contributing to the phenotypic outcomes of ASD, and novel pharmacologic and behavioral interventions can be tested. 

Examples of relevant research of interest include but are not limited to the following:

Pre-Clinical Treatment Development – Targeted Therapeutics

Existing medications do not adequately treat the range of core deficits in ASD.  Medications partially improve some of the behavioral and affective symptoms associated with ASD, but none have been shown in controlled trials to improve social behavior or communication.  Novel approaches are needed to identify effective treatment targets for therapeutic discovery both for treatment and to prevent the developmental emergence of symptoms of ASD. 

Examples of relevant research of interest include but are not limited to the following:

Treatment and Intervention

A wide range of treatments and interventions are in use to address the core symptoms and comorbid conditions associated with ASD, but most of these have not been rigorously studied.  There is a need for demonstration of efficacy of existing widely-used but untested treatments, as well as for emerging treatments or interventions in development, taking into account the need for interventions for individuals across the lifespan, and the knowledge that symptoms change in expression and severity across development.  Given the vast heterogeneity in this population, efficacious methods are needed for core symptoms of various levels of severity, for addressing comorbid conditions, for personalizing treatment, and for matching individuals to appropriate interventions.  Studies are needed to rigorously test the efficacy of treatments and interventions that address pressing needs and gaps in the range of available evidence-based treatments and interventions for individuals with ASD across the lifespan.   Of interest are studies of treatments and interventions for which preliminary and pilot data on safety, tolerability, and feasibility already exist.  Applications must present strong evidence that a fully-powered randomized controlled trial is feasible within the constraints of the two-year award.  

Examples of relevant research of interest include but are not limited to the following:

Services Research

Studies of existing individual and family supports and services are needed to establish their effectiveness in optimizing outcomes for persons with ASD across the lifespan (e.g., childhood, adolescence, transition to adulthood, and adulthood).  Areas of interest include services addressing ongoing daily needs, as well as those addressing special needs during critical periods (e.g. times of transition) or times of crisis.  Services research studies that target optimizing availability, access, organization, financing and quality of care are encouraged. 

Examples of relevant research of interest include but are not limited to the following:

The National Database for Autism Research (NDAR) has been established to serve the autism research community as a common platform for exchanging data, tools, and research-related information (http://ndar.nih.gov) and to serve as a portal to and for the broad autism research community. Autism researchers funded under this Request for Applications who are collecting phenotypic, genetic, or image data from humans are expected to share those data via NDAR, using its global unique identifier (GUID) technology.  Such data that are generated by grants funded under this Request for Applications are expected to be quality-certified before submission, and checked again after submission, by investigators.  Phenotypic data are to be submitted every January 15 and July 15, and all other data submitted before the end of the project period (see data submission information agreement at http://ndar.nih.gov/ndarpublicweb/Documents/NDAR%20Submission%20Request.pdf.   NDAR staff will work with investigators to help them submit data other than phenotypic, genetic, or image.  For answers to frequently asked questions, contact information for the NDAR manager, and other information, please see http://ndar.nih.gov.

See Section VIII, Other Information - Required Federal Citations, for laws and policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This FOA will use the NIH Research Project Grant (R01) award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.  

This FOA uses “Just-in-Time” information concepts (see SF424 (R&R) Application Guide). It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, a U.S. organization submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs) must use the PHS398 Modular Budget component.

U.S. applicants requesting more than $250,000 in annual direct costs must complete and submit budget requests using the Research & Related Budget component.

2. Funds Available

This initiative supported by funds provided to the NIH under the American Recovery & Reinvestment Act of 2009 (“Recovery Act” or “ARRA”), Public Law 111-5. The NIH intends to commit approximately $57,000,000 in total costs for FY2009 and FY2010 to support approximately 40-50 grants in response to this FOA and the companion Collaborative R01, R21, and R34/Collaborative R34 FOAs, contingent upon the submission of a sufficient number of scientifically meritorious applications. The total project period for an application submitted in response to this R01 FOA may not exceed two years.

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. Although the financial plans of the participating NIH Institutes and Centers (“IC(s)”) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004.

This program is supported by funds provided to the NIH under the Recovery Act.  The purpose of the Recovery Act is to stimulate the American economy through job preservation and creation, infrastructure investment, energy efficiency and science, and other means.  Consistent with these goals, domestic (United States) institutions/organizations planning to submit applications that include foreign components should be aware that requested funding for any foreign component should not exceed 10% of the total requested direct costs or $25,000 (aggregate total for a subcontract or multiple subcontracts), whichever is less.

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

1.A. Eligible Institutions

The following organizations/institutions are eligible and encouraged to apply. Consistent with the purposes of the Recovery Act (in particular, to preserve and create jobs and promote economic recovery in the United States, and to provide investments needed to increase economic efficiency by spurring technological advances in science and health), applicants must be a domestic (United States) institution/organization. The United States institution/organization must be located in the 50 states, territories and possessions of the United States, Commonwealth of Puerto Rico, Trust Territory of the Pacific Islands, or District of Columbia. NIH encourages applications from all interested organizations/institutions, including those from Institutional Development Award (IDeA) states and Academic Research Enhancement Award (AREA)-eligible institutions. Foreign organizations/institutions are not permitted as the applicant organization.

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the 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.

More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a “team science” approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application.  Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct.

Resubmissions.  Resubmission applications are not permitted in response to this FOA.

Renewals.  Renewal applications are not permitted in response to this FOA.

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the “Apply for Grant Electronically” button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.

Several additional separate actions are required before an applicant can submit an electronic application, as follows:  

1) Organizational/Institutional Registration in Grants.gov/Get Registered

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Both the PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Several steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo -- Telephone 301-435-0714; Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY: (301) 451-5936

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are necessary for processing (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget or Research & Related Budget, as appropriate (See Section IV.6., “Special Instructions,” regarding appropriate required budget component.)  

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

Applications with Multiple PDs/PIs

When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact” PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the Contact PD/PI should be entered in item 15 of the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of “PD/PI.” Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the “Credential” field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled “Multiple PD/PI Leadership Plan” [Section 14 of the Research Plan Component in the SF424 (R&R)], must be included. A rationale for choosing a multiple PD/PI approach should be described.  The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan.  In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award (NoA).

Applications Involving a Single Institution

When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions 

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form. 

When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 5.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: April 12, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): April 12, 2009
Application Due Date(s): May 12, 2009
Peer Review Date(s): July 2009
Council Review Date(s): August 2009
Earliest Anticipated Start Date(s): September 30, 2009

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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 and plan for the potential review workload.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Lisa Gilotty, Ph.D.
Division of Developmental Translational Research
National Institute of Mental Health
6001 Executive Boulevard, Room 6179, MSC 9617
Bethesda, MD 20892-9617
Telephone: (301) 443-3825
Fax: (301) 480-4415
Email: gilottyl@mail.nih.gov

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp  and follow Steps 1-4. Note:  Applications must only be submitted electronically.  PAPER APPLICATIONS WILL NOT BE ACCEPTED. 

Applicants are requested to notify the NIMH Referral Office by email NIMHReferral@mail.nih.gov when the application has been submitted.  Please include the FOA number and title, PD/PI name, and title of the application.

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time of the applicant institution/organization on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday – Friday, excluding Federal holidays) to view the application image to determine if any further action is necessary.

Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the IC. Incomplete and non-responsive applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons. 

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an “Introduction” describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review, as indicated in the NIH Grants Policy Statement.

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. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see the NIH Grants Policy Statement).

6. Other Submission Requirements and Information

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

Special Instructions for PHS398 Research Plan Component (Section 5.5 of SF424 (R&R) Application)

Research Plan: The Research Plan is limited to a total of 12 pages.

PHS398 Research Plan Component Sections

Item Number and Title

Instructions

1. Introduction to Application

Omit (N/A: Resubmissions and Revisions not allowable)

2. Specific Aims

One page maximum. Separate PDF attachment

3. Background and Significance

Combined in a single PDF in item 5

4. Preliminary Studies/Progress Report

Combined in a single PDF in item 5

5. Research Design and Methods

Item 5 consists of Items 3-5 and is limited to 12 pages. Attach the 12-page Research Plan encompassing items 3-5 as a single PDF document. Figures and illustrations may be included but must fit within the specified page limit. Do not include links to Web sites for further information. Do not include animations.

Excluded from the 12 -page Research Plan limitation are the following items:

Note the 12-page limit also excludes the Project Summary/Abstract; Bibliography and Literature Cited; and Biographical Sketches (separate PDFs).

All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.   

Appendix Materials

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not comply with the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.)

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact (see Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.)

 (b) Sharing Model Organisms: Regardless of the amount requested, all applications in which the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible (see Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.)

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition.  For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (NOT-OD-07-088) and http://grants.nih.gov/grants/gwas/.

(d) Sharing Human Data via the National Database for Autism Research: The National Database for Autism Research (NDAR) has been established to serve the autism research community as a common platform for exchanging data, tools, and research-related information (http://ndar.nih.gov) and to serve as a portal to and for the broad autism research community. Autism researchers funded under this Request for Applications who are collecting phenotypic, genetic, or image data from humans are expected to share those data via NDAR, using its global unique identifier (GUID) technology.  Such data that are generated by grants funded under this Request for Applications are expected to be quality-certified before submission, and checked again after submission, by investigators.  Phenotypic data are to be submitted every January 15 and July 15, and all other data submitted before the end of the project period (see data submission information agreement at http://ndar.nih.gov/ndarpublicweb/Documents/NDAR%20Submission%20Request.pdf.   NDAR staff will work with investigators to help them submit data other than phenotypic, genetic, or image.  For answers to frequently asked questions, contact information for the NDAR manager, and other information, please see http://ndar.nih.gov.

Section V. Application Review Information


1. Criteria 

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability.  As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system. 

Applications that are complete and responsive to this FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by (NIMH) and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

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 five core review criteria, and additional review criteria (as applicable for the project proposed).  Reviewers will also factor into their assessment the project’s responsiveness to the short-term goals and objectives of the Strategic Plan for ASD Research as defined by the Interagency Autism Coordinating Committee (http://iacc.hhs.gov/reports/2009/iacc-strategic-plan-for-autism-spectrum-disorder-research-jan26.shtml).

Core Review Criteria.  Reviewers will consider each of the five review criteria below in the determination of scientific and technical 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, technological advances, technical capability, clinical practice, and/or health be improved?  How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Are the specific aims of the project responsive to the short-term goals and objectives of the IACC Strategic Plan for ASD Research?

Investigator(s).  Are the PD/PIs, collaborators, and other researchers well suited to the project?  If Early Stage Investigators or New Investigators, 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, technological developments, 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? 

2.A. Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects.  For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

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.

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.

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.

2.B. Additional Review Considerations

As applicable for the project proposed, reviewers will address 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.

Budget and Period Support.  Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

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:

The NIH will not accept appeals of the review process outcome for applications in response to this FOA. See NOT-OD-09-054, Recovery Act of 2009: NIH Review Criteria, Scoring System, and Suspension of Appeals Process.

Applications submitted in response to this FOA will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information


1. Award Notices

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 NIH eRA Commons

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General. In addition, as part of “just-in-time” information for those Recovery Act awards, for any modular budget application, a detailed budget will be required prior to award.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

The terms of the NoA will reference the requirements of the Recovery Act.

In addition to the standard NIH terms of award, all awards will be subject to the HHS Standard Terms and Conditions for Recovery Act awards.  The full text of these terms approved for NIH awards can be found in the following document: Standard Terms and Conditions for AARA Awards.

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. See Section IV.5., “Funding Restrictions.”       

In addition, recipients of Recovery Act funds are reminded that such funds must be separately tracked and monitored independently of any non-Recovery Act funding. Additional terms may be applied to the actual award.

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.

3. Reporting

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.

In addition, grantees must comply with the requirements set forth in the Recovery Act, including, but not limited to, the reporting requirements described in Section 1512 of the Act, as well as applicable OMB guidance regarding the use of Recovery Act funds.  As noted above, grantees must also comply with the HHS Standard Terms and Conditions for Recovery Act awards.  The full text of these terms approved for NIH awards can be found in the following document: Standard Terms and Conditions for AARA Awards.

Recovery Act-related reporting requirements will be incorporated as a special term of award.

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.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research (program), peer review, and financial or grants management issues:

1. Scientific/Research Contact(s):

Lisa Gilotty, Ph.D.
Division of Developmental Translational Research
National Institute of Mental Health
6001 Executive Boulevard, Room 6179, MSC 9617
Bethesda, MD 20892-9617
Telephone: (301) 443-3825
Fax: (301) 480-4415
Email: gilottyl@mail.nih.gov

Judith Cooper, Ph.D.
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 400C-11, MSC 7180
Bethesda, MD  20892-7180
Telephone:  (301) 496-5061
FAX:  (301) 402-6251
Email:  cooperj@nidcd.nih.gov

Alice Kau, Ph.D.
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B09F, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1383
FAX:  (301) 496-3791
Email:  kaua@mail.nih.gov

Deborah Hirtz, M.D.
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 2212, MSC 9250
Bethesda, MD  20892-9250
Telephone:  (301) 496-5821
FAX:  (301) 480-1080
Email:  hirtzd@ninds.nih.gov

Cindy P. Lawler, Ph.D.
Program Administrator
Cellular, Organ, Systems and Pathobiology Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, Mail Drop K3-15
Research Triangle Park, NC  27709
Telephone:  (919) 316-4671
FAX:  (919) 541-5064
Email:  lawler@niehs.nih.gov

2. Peer Review Contact(s):

David Armstrong, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6138, MSC 9606
Bethesda, MD 20892-9606
Telephone: (301)443-3534
Fax:  (301)443-4720
Email:  armstrda@mail.nih.gov

3. Financial/Grants Management Contact(s):

Rebecca Claycamp, CRA
Chief Grants Management Officer
National Institute of Mental Health
6001 Executive Boulevard, Room 6122, MSC 9605
Bethesda, MD  20892-9605
Telephone:  (301) 443-2811
FAX:  (301) 443-6885
Email:  rc253d@nih.gov

Bryan S. Clark, M.B.A.
Chief Grant Managements Officer
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 8A01A, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 435-6975
Fax: (301) 402-0915
Email: clarkb1@mail.nih.gov

Christopher Myers
Chief, Grants Management Office
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, EPS Room 400-B, MSC 7180
Bethesda, MD  20892-7180
Telephone:  (301) 402-0909
Fax:  (301) 402-1758
Email:  myersc@nidcd.nih.gov

Lerlita Garcia
Grants Management Branch
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-22
Research Triangle Park, NC  27709
Telephone:  (919) 316-4638
FAX:  (919) 541-2860
Email:  garcial@niehs.nih.gov

Tijuanna DeCoster, MPA
Chief, Grants Management Officer
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 3258, MSC 9537
Bethesda, MD  20892-9537
Telephone:  (301) 496-9231
Fax:  (301) 402-0219
Email:  decostert@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

The American Recovery And Reinvestment Act of 2009 (Pub. L. No. 111-5): http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h1enr.pdf

Standard Terms and Conditions for Recovery Act Awards: The full text of these terms approved for NIH awards can be found in the following document: http://grants.nih.gov/grants/policy/NIH_HHS_ARRA_Award_Terms.pdf

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (“NIH Policy for Data and Safety Monitoring,” NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies and local institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are: (1) first produced in a project that is supported in whole or in part with Federal funds; and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under Sections 301 and 405 of the Public Health Service Act, as amended (42 USC 241 and 284) and are subject to 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.


Weekly TOC for this Announcement
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