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
Office of Behavioral and Social Sciences Research (OBSSR) http://obssr.od.nih.gov
Office of Dietary Supplements (ODS) http://ods.od.nih.gov
National Cancer Institute (NCI) http://www.cancer.gov
National Center for Complementary and Alternative Medicine (NCCAM) http://nccam.nih.gov
National Human Genome Research Institute (NHGRI) http://www.genome.gov
National Institute of Aging (NIA) http://www.nia.nih.gov
National Institute of Alcohol Abuse and Alcoholism (NIAAA) http://www.niaaa.nih.gov
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) http://www/niams.nih.gov/
National Institute of Child Health and Human Development (NICHD) http://www.nichd.nih.gov/
National Institute of Deafness and Communication Disorders (NIDCD) http://www.nidcd.nih.gov
National Institute of Dental and Craniofacial Research (NIDCR) http://www.nidcr.nih.gov
National Institute for Drug Abuse (NIDA)  http://www.nida.nih.gov
National Institute of Mental Health (NIMH) http://www.nimh.nih.gov
National Institute of Neurological Disorders and Stroke (NINDS) http://www.ninds.nih.gov
National Institute of Nursing Research (NINR) http://www.ninr.nih.gov  

Title:  NIH Revision Awards for Studying Interactions Among Social, Behavioral, and Genetic Factors in Health  (R21)

Announcement Type

New

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 weeks prior to the grant submission date. See Section IV.

Program Announcement (PA) Number: PAR-08-066

Catalog of Federal Domestic Assistance Number(s)
93.393, 93.394, 93.395, 93.399, 93,213, 93.846, 93.172, 93.866, 93.273, 93.865, 93.173, 93.279, 93.242, 93.853, 93.361

Key Dates
Release Date: January 8, 2008
Opening Date: April 3, 2008 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): April 13, 2008
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 Submission/Receipt Date(s): May 13, 2008
Peer Review Date(s): October/November 2008   
Council Review Date(s): January 2009  
Earliest Anticipated Start Date(s): April 2009
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: May 14, 2008

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
1. Research Objectives

Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants

    A. Eligible Institutions
    B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Submission, Review, and Anticipated Start Dates
          1. Letter of Intent
    B. Submitting an Application Electronically to the NIH
    C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)

2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


Nature of the Research Opportunity

The National Institutes of Health (NIH) issues this Funding Opportunity Announcement (FOA) to invite NIH-funded investigators to submit supplement applications to their currently funded research to study how interactions among genetic and behavioral/social factors influence health and disease. The knowledge gained by such research will improve our understanding of the determinants of disease as well as inform efforts to reduce health risks and provide treatment. This FOA solicits for human and non-human studies to advance our understanding of the interactions among genetic, social and behavioral factors that influence the processes affecting variability in disease and health progression and outcomes. This program is focused on questions concerning the effects of (1) the interaction of genetic and social or behavioral factors and (2) gene-environment-behavioral interactions; and to better understand how the interaction of behaviors and social environmental factors affect gene expression, disease and behavior phenotypes and health outcomes.

Currently, powerful genetic methods are being used for identifying common genomic factors that influence health and disease-related phenotypes and outcomes. These studies are designed to identify relationships between genes with observable traits such as body weight or the presence or absence of a disease or condition. Within this context, the Institute of Medicine Report, “Genes, Behavior and the Social Environment: Moving Beyond the Nature-Nurture Debate suggests that examining the interactions among genetic, social environments, and behavioral factors could greatly enhance the understanding of health and illness. This report, which can be found at http://www.iom.edu/CMS/3740/24591/36574.aspx also recommends ways to foster transdisciplinary research teams necessary to more fully examine the questions raised by these research gaps. The NIH’s Office of Behavioral and Social Sciences Research (OBSSR), located in the Office of the Director, and is leading the implementation of the recommendations produced by this report.

How genetic, behavioral, and social factors interact in human physiological processes and differentially influence disease expression and health outcomes remains understudied.  A number of research gaps have been identified including the following: (1) genetic studies that explore the relationship between genotypes and quantitative traits often do not include social and behavioral factors, and (2) social and behavioral research studies rarely include consideration of genetic factors and related mechanisms when studying social and/.or behavioral phenomena.

To bridge these gaps, this announcement is intended to stimulate theoretically and methodologically rigorous research that integrates genetics, behavioral, and social sciences research efforts to specifically address questions of gene-environment-behavior interactions. This announcement provides the opportunity for current NIH-funded grantees whose research is either (1) social and/or behavioral science-oriented research to add a genetic/genomic component or (2) genetic-focused research to add social and behavioral factors into their research plan. In either case, the proposed research  must be designed to elucidate how the interactions between genetic and social and/or behavioral factors contribute to health and disease. The proposed research can expand the scope of the original project and should be a logical extension of the goals and objectives of the parent grant

To be considered responsive to this announcement, (1) the proposed research must include unambiguous, interdisciplinary perspectives, (2) the hypothesis(es) of the relationship(s) between the genetics, behaviors, social environment, and/or social processes must be clearly stated, (3) hypothesis about the proposed study should investigate how the interactions (not associations) among these variables influence the outcomes under study, and (4) the proposed study should be embedded in a well articulated set of research questions or hypothesis generated from genetic, social and/or behavioral sciences research.

Background

Phenotype and disease variations among individuals within and between populations arise as a function of interactions among genetic, environmental, behavioral, and social factors that vary over the course of a person’s life.  Family, twin, adoption, and association  studies have established the importance of genetic, environmental, and behavioral factors in influencing variation across a large array of disease and behavioral phenotypes related to personality, functional abilities, and health and disease status.  Genetic linkage and association studies in humans and animals, as well as genetic manipulation of animals, have identified specific genes influencing some of these phenotypes.  To further understanding of the mechanisms of action of these genes, innovative projects are needed that investigate the interactions between genetic effects and the environmental, behavioral, and social contexts in which they are expressed. These efforts should involve approaches that (1) integrate molecular and quantitative methods, (2) when possible use well-characterized and measured phenotypes for behavioral systems for which socially determined behaviors or candidate genes are identified, (3) measure biological intermediaries and endophenotypes of the behaviors, (4) (use analytic approaches with adequate statistical power to study the interaction of genes and their products, social and exposure environments, and behavioral factors.

There have been dramatic advances in identifying genes influencing complex diseases, assessing aggregate effects and associations of genetic and environmental factors, and in identifying biological mediators of complex social and behavioral phenotypes. At the same time, the need to examine the interaction among genetic, behavioral and social factors in the context of health and disease systems has become increasingly important. Scientific advances across many disciplines are now making studying the interaction of these factors possible.  Understanding the interaction of genetic, environmental and behavioral factors will require integrating  theoretical models and methodological approaches and harnessing the powerful research tools of multiple disciplines.

This Program Announcement encourages a wide range of research designs with an emphasis on supplementing data collection and/or analyses that will allow new hypotheses to be tested at the intersection of genetics, behavioral and social sciences research.  Major methodological and analytic considerations need to be well articulated including the following:  (1) interpretations of the significance of the genetic, environmental, behavioral, and social factors and their interactions; (2) documentation of rigorous research design and robust measurement characteristics; (3) power analyses to prove the sample sizes are sufficient for analysis of the interactions being studied, and; (4) clear descriptions of the analytic procedures being proposed. The research team must include expertise in genetics (molecular and/or quantitative) and the social and/or behavioral sciences.

Objectives 

This objective of this Program Announcement is to bridge disciplinary boundaries to study how the interactions of genetic, environmental, behavioral and social factors influence health and disease phenotype variations and outcomes. Progress in understanding gene-environment-behavior interactions must rely on integrating the theoretical and methodological approaches.  Improved strategies now exist to identify genes, map quantitative trait loci (QTL), and assess specific genetic and behavioral/social sources of disease variation.  This announcement identifies genetic, and behavioral and/or social factors and their interactions as a research area needing special attention and encouragement since these interactions are understudied and important when understanding disease processes, variations, and health outcomes. This FOA will support research that

Program priority will be given to human and non-human gene-environment-behavior interaction (not association) studies where 1) social and/or behavior science oriented studies add consideration of genetic factors, (2) genetics focused studies add social and/or behavioral factors, or (3) new data analyses of existing data sets contribute to better understanding of how gene X social X behavioral interactions influence health and disease outcomes and phenotype variation.  The proposed research can expand the scope of the original project and be a logical extension of the goals and objectives of the parent grant.

Examples of the revision research areas pertinent to this FOA include but are not limited to the following:

Reference Report

The Institute of Medicine’s report, Genes, Behavior, and the Social Environment: Moving Beyond the Nature/Nurture Debate (2006) reviews a body of knowledge about genetics, behavior, and social environments.  Potential applicants are encouraged to consult this report as a general reference http://www.iom.edu/CMS/3740/24591/36574.aspx.

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

Section II. Award Information


1. Mechanism of Support

This FOA will use the NIH Exploratory/Developmental Research Grant (R21) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.  

This FOA uses “Just-in-Time” information concepts. It also uses the modular as well as the non-modular budget formats (see the “Modular Applications and Awards” section of the NIH Grants Policy Statement. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, “Modular Budget Component,” of the Application Guide).

All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.

At this time, it is not known if this FOA will be reissued.

2. Funds Available

The Office of Behavioral and Social Sciences Research (OBSSR) of the Office of the Director intends to commit approximately $3 million dollars in FY2009 to fund 10 to 20 projects.  Specifically, OBSSR intends to commit a total of up to $ 3 million dollars in FY2009 spread across all three Program Announcements.  The financial plan of OBSSR provides support for this program - awards pursuant of this announcement are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. Although the size of award may vary with the nature and scope of research proposed, it is expected that applications will stay within the budgetary guidelines for an exploratory/developmental project. Direct costs are limited to no more than $250,000 in direct costs allowed in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $250,000 for each year award period. The total amount awarded and the number of awards will depend upon the mechanism numbers, quality, duration, and costs of the applications received.  The project period and requested funding for the application submitted in response to this funding opportunity cannot extend beyond the project end date of the parent grant.

NIH grants policies as described in the NOT-OD-05-004, November 2, 2004.  

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application(s) if your institution/organization has any of the following characteristics:

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, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach that clearly does 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 eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions). In the case of a multiPI revision application, the contact PD/PI must be the same as the contact PD/PI of parent award.

The decision of whether to apply for a single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for multiple PD/PI grants will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, 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 PD/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

The applicant must be the Principal Investigator (PI) of an existing NIH-funded Research Project and must be the same person as the current Principal Investigator on the original application. A new or additional co-investigator (i.e., multiple-PIs) may be designated for the revision application. In such a case, one of the PIs or co-PIs must be the PI of the exisiting R21.  A revision application will not be accepted until after the original application has been awarded and may not extend beyond the term of the current grant.  The parent grant must have at least one year remaining at application to be eligible. In all cases, a careful explanation and justification for the revision as a logical extension of the ongoing research must be included.  The investigators should demonstrate that their team has the appropriate (e.g., genomic, epidemiology, social science, or behavioral science) expertise for the project proposed.

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

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, 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 eRA Commons.

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

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

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 PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the 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 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 (MS Word or PDF).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (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 is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include 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.)
Research & Related Budget (required for foreign applications)

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

Foreign Organizations (Non-domestic (non-U.S.) Entity)

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600260.

Applications from foreign organizations must:

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

SPECIAL INSTRUCTIONS

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 of the 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) or Section I of the Research Plan in the PHS 398), 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, including 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.

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 3, 2008 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): April 13, 2008
Application Submission/Receipt Date(s): May 13, 2008
Peer Review Date(s): October/November 2008   
Council Review Date(s): January 2009  
Earliest Anticipated Start Date(s): April 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 the potential review workload and plan the review.

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:

Ronald P. Abeles, Ph.D.
Special Assistant to the Director
Office of Behavioral and Social Sciences Research
Office of the Director National Institutes of Health
Bldg. 31C, Rm. B1C19, MSC 2027
31 Center Drive
Bethesda, MD 20892-2027 (Courier Services Zip Code 20814)
Phone: 301-496-7859
Fax: 301-435-8779
Email: abeles@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/Apply and follow steps 1-4. Note:  Applications must only be submitted electronically.  PAPER APPLICATIONS WILL NOT BE ACCEPTED. 
 
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 submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt 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 business days to view the application image.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. 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 their application status in the Commons.

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

4. Intergovernmental Review

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. 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 award if such costs: are necessary to conduct the project, and 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 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

OVERVIEW

A revision application may be submitted to request support for an expansion of a project’s scope or research protocol.  The Principal Investigator must be the same person as is the current Principal Investigator on the original application.  Applications for revision awards are not appropriate when the sole purpose is to restore awards, administratively reduced by the funding agency, to the full SRG-recommended level.  A revision application will not be accepted until after the original application has been awarded, and may not extend beyond the term of the current grant. An Introduction is required to indicate how the revision is related to but also expands upon the original application.

Research Plan

The body of the application should contain sufficient information a from the original grant application to allow evaluation of the proposal in relation to the goals of the original application.  The regular Research Plan format should be followed but is limited to 10 pages.  The research plan includes specific aims, background and significance, preliminary studies, and research designs and methods.

Also included within the 10 page limit, the  research plan should cover the following items:  These points should be included above where the Research Plan Is discussed.

Progress Report

A short progress report (if applicable)  is required for revision applications and should be included in the 10 page limit.  Provide the beginning and ending dates for the period covered since the project was last competitively reviewed.  Summarize the previous application’s specific aims and the importance of the findings.  Discuss any changes in the specific aims as a result of budget reductions for the current grant.

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

The NIH requires the PD/PI 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. 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 “Registration FAQs – Important Tips -- Electronic Submission of Grant Applications.”

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 Applicationshttp://era.nih.gov/ElectronicReceipt/preparing.htm#4c.

Warning: Please be sure that you observe the direct cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements. 

PHS398 Research Plan Component Sections

While each section of the PHS398 Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. 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

NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html

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 observe these limitations may be delayed in the review process.   

Foreign Applications (Non-domestic (non-U.S.) Entity)

Plan for Sharing Research Data

Not applicable.

Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement  http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., “Reporting.”

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

Applications submitted for this funding opportunity will be assigned to the IC of the parent grant on the basis of established Public Health Service (PHS) referral guidelines.

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Center for Scientific Review in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

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

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?
For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the PD/PIs and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed.  See item 6 of the Research Plan component of the SF424 (R&R).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated.  See item 7 of the Research Plan component of the SF424 (R&R).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under item 11 of the Research Plan component of the SF424 (R&R) will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate. 

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

Applications from Foreign Organizations: Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed. 

2.C. Sharing Research Data

Not applicable.

2.D. Sharing Research Resources

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590), See Section VI.3., “Reporting.”
 
Model Organism Sharing Plan:  Reviewers are asked to assess the sharing plan in an administrative note. The sharing plan itself should be discussed after the application is scored. Whether a sharing plan is reasonable can be determined by the reviewers on a case-by-case basis, taking into consideration the organism, the timeline, the applicant's decision to distribute the resource or deposit it in a repository, and other relevant considerations. For the R21 mechanism, the presence or adequacy of a plan should not enter into the scoring of the application.

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/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.

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.

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.”       

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

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

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, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

For general information:

Ronald P. Abeles, Ph.D.
Special Assistant to the Director
Office of Behavioral and Social Sciences Research
Office of the Director National Institutes of Health
Bldg. 31C, Rm. B1C19, MSC 2027
31 Center Drive
Bethesda, MD 20892-2027 (Courier Services Zip Code 20814)
Phone: 301-496-7859
Fax: 301-435-8779
Email: abeles@nih.govabeles@nih.gov

Participating Components:

Office of Dietary Supplements (ODS) http://www.ods.od.nih.gov

Rebecca B. Costello, Ph.D., F.A.C.N.
Director of Grants and Extramural Activities
Office of Dietary Supplements
National Institutes of Health
6100 Executive Blvd., Room 3B01, MSC 7517
Bethesda, Maryland 20892-7517
Telephone: (301) 435.2920
Fax: (301) 480.1845
Email: CostellB@od.nih.gov

National Cancer Institute (NCI) http://www.nci.nih.gov/

Tanya Agurs-Collins, Ph.D., R.D.
Health Promotion Research Branch
Behavioral Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute/NIH/DHHS
6130 Executive Blvd., MSC 7335
Executive Plaza North, room 4076
Bethesda, MD 20892-7335 
Rockville, MD 20852 for express mail
Telephone: (301) 594.6637
Fax: (301)  480-2087
Email: collinsta@mail.nih.gov

National Center for Complementary and Alternative Medicine (NCCAM) http://nccam.nih.gov/

Catherine M. Stoney, Ph.D.
Health Scientist Administrator
National Center for Complementary & Alternative Medicine
National Institutes of Health
6707 Democracy Blvd, Suite 401, MSC 5475
Bethesda, Maryland 20892-5475 (for express mail, use 20817)
Telephone.:(301) 402.1272
Fax:: (301) 480.3621
Email: stoneyc@mail.nih.gov

National Human Genome Research Institute (NHGRI) http://www.genome.gov

Jean McEwen, JD, Ph.D.
Program Director, Ethical, Legal and Social Implications Research Program
National Human Genome Research Institute
Division of Extramural Research
5635 Fishers Lane, Suite 4076 MSC 9305
Bethesda, MD 20892-9305
Telephone: (301) 435.5585
Fax: (301) 480.2770
Email: ncewenj@mail.nih.gov

National Institute of Child Health and Human Development (NICHD) http://www.nichd.nih.gov

Lisa Freund, Ph.D.
Program Director, Developmental Cognitive Psychology, Behavioral Neuroscience, and Psychobiology
Child Development and Behavior Branch
National Institute of Child Health and Human Development
6100 Executive Blvd 7510
Rockville, MD  20892-7510
Telephone: (301) 435-6879
Fax:  (301) 480-0230
Email: freundl@mail.nih.gov

National Institute of Dental and Craniofacial Research (NIDCR) http://www.nidcr.nih.gov

Ruth Nowjack-Raymer, MPH, Ph.D
Director, Health Disparities Research Program
National Institute of Dental and Craniofacial Research
45 Center Drive, Building 45, Room 4AS-43F
Bethesda, MD 20892-6401
Tel.: (301) 594-5394
FAX: (301) 480-8322
Email: Ruth.Nowjack-Raymer@nih.gov

National Institute on Aging (NIA) http://www.nia.nih.gov

Erica Spotts, Ph.D
Health Scientist Administrator

Behavioral and Social Research Program
National Institute on Aging
7201 Wisconsin Avenue, Gateway 533
Bethesda, MD 20892
Telephone: (301) 496.3131
Fax: (301) 402.0051
Email: spottse@mail.nih.gov

National Institute on Alcohol Abuse and Alcoholism (NIAAA) http://www.niaaa.nih.gov/

Zhaoxia Ren, MD, Ph.D.

Program Director, Genetics

Genetics, Division of Neuroscience and Behavior
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2063
Bethesda, MD 20892-9034
Telephone: (301) 443.5733
Fax: 301-443-1650
Email: zren@mail.nih.gov

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) http://www.niams.nih.gov

Madeline Turkeltaub, CRNP, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases
6701 Democracy Boulevard, Suite 800
Bethesda , MD 20892
Telephone: (301) 594.2463
Fax: (301) 480.4543
Email: mturkeltaub@mail.nih.gov

National Institute on Deafness and Communication Disorders (NIDCD) http://www.nidcd.nih.gov/

Dr. Lana Shekim

Health Scientist Administrator
National Institute on Deafness and Other Communication Disorders
6120 Executive Blvd., MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 496.5061
Email: shekiml@nidcd.nih.gov

National Institute of Dental and Craniofacial Research (NIDCR) http://www.nidcr.nih.gov

Ruth Nowjack-Raymer, MPH, PhD
Director, Health Disparities Research Program
National Institute of Dental and Craniofacial Research
45 Center Drive, Building 45, Room 4AS-43F
Bethesda, MD 20892-6401
Telephone: (301) 594.5394
Fax: (301) 480-8322
Email: Ruth.Nowjack-Raymer@nih.gov

National Institute on Drug Abuse (NIDA) http://www.nida.nih.gov/

Kevin Conway, Ph.D.
Associate Director
Division of Clinical Neuroscience and Behavioral Research (DCNBR)
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5185, MSC 9589
Bethesda, MD 20892-9589
Telephone.: (301) 402.1817
Email:  kconway@nida.nih.gov

National Institute of Mental Health (NIMH) http://www.nimh.nih.gov

Eve K. Moscicki, Sc.D., MPH
Division of Pediatric Translation Research and Treatment Development
National Institute of Mental Health
6001 Executive Boulevard, Room 6183, MSC 9617
Bethesda, MD 20892-9617
Telephone: (301) 443.5944
Fax: (301) 480.4415
Email: em15y@nih.gov

National Institute of Neurological Disorders and Stroke (NINDS) http://www.ninds.nih.gov

Margaret Sutherland, Ph.D.
Program Director
National Institute of Neurological Disorders and Stroke
Neuroscience Center, Room 2203
6001 Executive Blvd.
Bethesda, MD 20892

Telephone.: (301) 496.5680
Fax: (301) 480.1080
Email: sutherlandm@mail.nih.gov

National Institute of Nursing Research (NINR) http://www.ninr.nih.gov/

Alexis Bakos, Ph.D.
Program Director

National Institute of Nursing Research
6701 Democracy Blvd., MSC 4870
One Democracy Plaza
Bethesda, MD 20892-4870
Telephone.:(301) 594.2542
Email: bakosa@mail.nih.gov

2. Peer Review Contacts:

Bob Weller, Ph.D., Chief
Health of the Population (HOP) Integrated Review Group
Center for Scientific Review, NIH
6701 Rockledge Drive, Room 3136, MSC 7770
Bethesda, MD 20892 (20817 for overnight mail)
301-435-0694
301-480-1056 (fax)

3. Financial or Grants Management Contacts:

National Cancer Institute (NCI) 

Crystal Wolfrey
Chief, Cancer Control and Population Sciences Grants Branch
Office of Grants Administration
National Cancer Institute
National Institutes of Health
6120 Executive Blvd., Suite 243
Bethesda, MD 20892
Telephone: (301)496.8634
Fax: (301).496.8601
Email: wolfreyc@mail.nih.gov

National Center for Complementary and Alternative Medicine (NCCAM) http://nccam.nih.gov/

George Tucker
Grants Management Officer
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Blvd., Room 401, MSC 5475
Bethesda, MD 20892-5475
Telephone: (301) 594,9102
Fax: (301) 480.3504
Email: tuckerg@nccam.nih.gov

National Human Genome Research Institute (NHGRI) http://www.genome.gov

Cheryl Chick
Scientific Review Branch/Grants Administration Branch
National Human Genome Research Institute, NIH
5632 Fishers Lane, Suite 4076, MSC 9306
Bethesda, MD 20892-9306
Telephone: (30) 435.7858
Fax: (301) 402.1951
Email: ChickC@mail.nih.gov

National Institute on Aging (NIA) http://www.nia.nih.gov

John Bladen
Grants Management Specialist
The National Institute on Aging
Grants and Contracts Management Office
Gateway Blvd., Suite. 2N212

7201 Wisconsin Avenue
Bethesda, MD 20902
Telephone: (301) 496.1472
Fax: (301) 402.3672
Email: bladenj@nia.nih.gov

National Institute on Alcohol Abuse and Alcoholism (NIAAA) http://www.niaaa.nih.gov/

Judy Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3023
Bethesda, MD 20892-9034
Telephone: (301) 443.4704
Fax: (301) 443.3891
Email: jfox@mail.nih.gov

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) http://www.niams.nih.gov

Gail Hamilton
Grants Management Specialist
National Institute of Arthritis and Musculoskeletal and Skin Diseases
6701 Democracy Boulevard, Suite 800
Bethesda, MD 20892
Telephone.: (301) 594.3506
Fax: 301.480.5450
Email: hamiltog@mail.nih.gov  

National Institute of Child Health and Human Development (NICHD) http://www.nichd.nih.gov

Bryan S. Clark, M.B.A.
Chief Grants Management Officer
National Institute of Child Health and Human Development
6100 Executive Boulevard, 8A01, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-6975
Email:  clarkb1@mail.nih.gov

National Institute on Deafness and Communication Disorders (NIDCD) http://www.nidcd.nih.gov/

Chris Myers
Grants Management Branch
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 400B
6120 Executive Blvd., MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 402.0909
Fax:  (301) 402.1798
Email: myersc@nidcd.nih.gov

National Institute of Dental and Craniofacial Research (NIDCR) http://www.nidcr.nih.gov

Mary Daley
Chief Grants Management Officer
National Institute of Dental and Craniofacial Research
45 Center Drive, Building 45, Room 4AN-44B
Bethesda, MD 20892-6402
Telephone: (301) 594.4808
Fax: (301) 480.3562
Email: md74u@nih.gov

National Institute on Drug Abuse (NIDA) http://www.nida.nih.gov

Edith Davis
Grants Management Branch
National Institute on Drug Abuse,
6101 Executive Boulevard, Room 270,   MSC 8403
Rockville, MD 20852
Telephone.: (30) 443.6710
Fax: (301) 594.6849
Email: edavis1@nida.nih.gov

National Institute of Mental Health (NIMH) http://www.nimh.nih.gov

Rebecca Claycamp, CRA
Division of Extramural Activities
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:  Rececca.Claycamp@nih.hhs.gov

National Institute of Neurological Disorders and Stroke (NINDS) http://www.ninds.nih.gov

Gavin Wilkom
Grants Management Specialist
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd., MSC 9537
Bethesda, MD 20892-9537
Telephone.: (301) 496.7480
Fax: (301) 451.5635
Email: wilkomg@ninds.nih.gov

National Institute of Nursing Research (NINR) http://www.ninr.nih.gov/

Brian Albertini
Chief, Grants Management
National Institute of Nursing Research
6701 Democracy Blvd., Suite 710
One Democracy Plaza
Bethesda, MD 20892-4870
Telephone: (301) 594.6869
Fax: (301) 402.4502
Email: albertib@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

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 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.

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.

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.

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. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools, including the Authors' Manual.

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) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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 and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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. 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
NIH Funding Opportunities and Notices


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