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
NIH Basic Behavioral and Social Science Opportunity Network (OppNet; http://oppnet.nih.gov/) and its member institutes, centers and offices:
Fogarty International Center (http://www.fic.nih.gov/)
National Cancer Institute (NCI) (http://www.cancer.gov/)
National Center for Complementary and Alternative Medicine (NCCAM) (http://nccam.nih.gov/)
National Center on Minority Health and Health Disparities (NCMHD) (http://ncmhd.nih.gov/
National Center for Research Resources (NCRR) (http://www.ncrr.nih.gov/)
National Eye Institute (NEI) (http://www.nei.nih.gov/)
National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/index.htm)
National Human Genome Research Institute (NHGRI) (http://www.genome.gov/)
National Institute on Aging (NIA) (http://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov/)
National Institute of Allergy and Infectious Diseases (NIAID) (http://www3.niaid.nih.gov/)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (http://www.niams.nih.gov/)
National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.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 Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www2.niddk.nih.gov/)
National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov/)
National Institute of General Medical Sciences (NIGMS) (http://www.nigms.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/)
National Library of Medicine (NLM) (http://www.nlm.nih.gov/)
Office of AIDS Research (OAR) (http://www.oar.nih.gov/)
Office of Behavioral and Social Sciences Research (OBSSR) (http://obssr.od.nih.gov)
Office of Dietary Supplements (ODS) (http://dietary-supplements.info.nih.gov/
Office of Disease Prevention (ODP) (http://prevention.nih.gov/
Office of Research on Women’s Health (ORWH) (http://orwh.od.nih.gov/)

Title:  Scientific Meetings for Creating Interdisciplinary Research Teams in Basic Behavioral and Social Science Research (R13)

Announcement Type

New

Update: The following update relating to this announcement has been issued:

Request for Applications (RFA) Number: RFA-CA-10-017

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)

93.113, 93.121, 93.142, 93.143, 93.172,93.173, 93.213, 93.233, 93.242, 93.273,93.279 ,93.286, 93.307, 93.361, 93.389, 93.393, 93.394, 93.395, 93.396, 93.399, 93.837, 93.838, 93.846, 93.847, 93.853, 93.855, 93.856, 93.859, 93.865, 93.866, 93.867, 93.879, 93.989

Key Dates
Release/Posted Date: August 27, 2010
Opening Date:  November 14, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): November 14, 2010
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):  December 14, 2010
Peer Review Date(s): March 2011
Council Review Date(s): May 2011
Earliest Anticipated Start Date(s): July 2011 
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: December 15, 2010

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. Receipt, 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
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 Contacts
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


1. Research Objectives

Purpose

This FOA solicits Research Conference Grant (R13) applications for scientific meetings aimed at building interdisciplinary research teams in basic behavioral and social science research (b-BSSR). Applicants must propose developmental activities (i.e., meetings/workshops) that will build the capacity of interdisciplinary teams to accelerate, expand, and/or strengthen fundamental knowledge in b-BSSR as relevant to the Nation’s health and well-being. Proposed interdisciplinary teams must include at least one investigator from the basic social and/or behavioral sciences, and must include investigators from at least one additional discipline. Applicants are encouraged to either: (1) accelerate, expand, and/or strengthen the scope of investigation of a specific b-BSSR research domain through the integration of disparate approaches from b-BSSR and allied disciplines; or (2) increase the sophistication of theoretical, methodological, and analytical approaches in b-BSSR. These goals may be accomplished by fostering the development of shared scientific terminology, approaches, and methodologies across disciplines in order to address a common b-BSSR research question. Investigators may submit applications to support multiple meetings over a period of up to two years.

About OppNet

The NIH Basic Behavioral and Social Science Opportunity Network (OppNet) is a trans-NIH initiative that funds activities that build the collective body of knowledge about the nature of behavior and social systems, and that deepen our understanding of basic mechanisms of behavioral and social processes. All 24 NIH Institutes and Centers that fund research and four Program Offices within the NIH Office of the Director (ICOs) co-fund and co-manage OppNet. All OppNet initiatives invite investigators to propose innovative research that will advance a targeted domain of basic social and behavioral sciences and produce knowledge and/or tools of potential relevance to multiple domains of health- and life course-related research. Applicants should understand that the NIH Institute or Center (IC) that made this FOA available to the public is not necessarily the NIH IC that ultimately will manage a funded OppNet project. For more information about OppNet and all its funding opportunities, visit http://oppnet.nih.gov

OppNet uses the NIH definition of b-BSSR (b-BSSR) to determine application responsiveness. Consequently, OppNet strongly encourages prospective investigators to consult this definition, OppNet’s answers to frequently asked questions about b-BSSR (http://oppnet.nih.gov/about-faqs.asp), and answers to frequently asked questions regarding this specific FOA. See this FOA’s Scientific Contacts section for individuals with expertise in the research subject matter and the OppNet initiative.

Background

Investment and support for basic interdisciplinary research have grown as scientific fields have advanced and the complexity of public health problems has increased. While scientific breakthroughs increasingly occur through the integration of disciplines or knowledge sharing across disciplinary boundaries, existing infrastructures, and scientific cultures create artificial barriers between disciplines that divide scientists and impede progress. Mechanisms to effectively address the need for support of initial interactions to overcome many of the current barriers across disciplines remain inadequate. In order to successfully compete for research funding opportunities, an interdisciplinary research team must be formed. Researchers from different disciplines have limited opportunities to interact and establish working collaborations; they are constrained by disciplinary silos and other barriers in the academic environment. Moreover, once they do interact, cross-disciplinary collaborators may use different scientific terminology and may take different approaches to measurement, data collection, and causal inference.

This tailored R13 initiative fills a gap in the tools available to scientists for building interdisciplinary research teams that may advance targeted areas of b-BSSR and lead to the development of projects for the team in the future. The initiative is part of an overall vision for facilitating investigator-initiated interdisciplinary research by building capacity to advance targeted domains of basic social and behavioral sciences and produce knowledge and/or tools of potential relevance to multiple domains of health-and life course-related research. 

In the initial collaborative stage (supported under this mechanism), the research team convenes, members of the team, learns each other’s scientific terminology, synthesizes discipline-specific theoretical perspectives and methodological approaches, and develops workable research plans. This initial stage may be followed by a developmental stage (e.g., via an R21 application) in which the research team conducts exploratory and developmental research needed to address methodological and feasibility questions related to their joint research plans. In the final stage, the research team may submit a research grant application (e.g., R01 or P01) to conduct mature interdisciplinary research. These funding opportunity mechanisms allow multiple principal investigators (PIs) on grant applications. Moreover, these funding opportunity mechanisms (e.g., R21, R01) support “research projects”, which implies that common language, goals, and methods must have already been established. This R13 FOA provides the opportunity to establish needed collaborative fundamentals (e.g., common terminology)

Scope

The purpose of this FOA is to encourage and facilitate interdisciplinary research in basic behavioral and social science research areas that warrant the integration of multiple disciplines, by a team composed of investigators who, collectively, have not previously collaborated. Rarely can a single meeting achieve common understandings and methods across different disciplines. A series of meetings and exchanges over time is often necessary. Thus, this announcement provides the opportunity for a higher level of support than a standard conference grant, in order to enable a series of meetings and exchanges. However, this announcement articulates specific expectations of progress to be made during the award and is not renewable.

Meetings funded through this announcement may include fewer participants than typical conferences. Meetings will center around a core set of research collaborators, although consultants may be included to address specific needs on an ad hoc basis. Researchers may be at the same or different institutions. The application should propose a process for developing an integrated research agenda around a specific high-risk, high-payoff research question in a basic behavioral and/or basic social science area (see http://oppnet.nih.gov/about-bssr.asp and examples below for scientific scope). Investigators are required to produce evidence of their willingness and ability to pursue interdisciplinary work. The scope of activities supported by this grant is limited to the development of the scientific research agenda; this grant does not provide support for time spent writing and preparing subsequent applications.

For the purposes of this FOA, basic interdisciplinary research integrates the conceptual and/or analytical strengths of two or more disparate scientific disciplines while addressing gaps in terminology, approach, and methodology. Its goals are to expand the scope of investigation into b-BSSR scientific problems, yield new and possibly unexpected insights, and increase the sophistication of theoretical, methodological, and analytical approaches by supporting collaborations between two or more disparate scientific disciplines through meetings or workshops that foster the development of shared scientific terminology, approaches, and methodologies. Applicants must justify not only the significance of the research problem that they propose to address, but also the need and potential benefits of bringing a mix of specific disciplines together to address it. This FOA does not require the proposed creation of a new discipline.

Eligibility is limited to teams that propose to advance a targeted domain of b-BSSR. Participation of scientists from the biomedical and/or physical sciences, engineering, and mathematics, is also encouraged. Integration of approaches and methodologies from both human and animal models of research are encouraged, where appropriate.

Examples of domains within b-BSSR that are appropriate to this FOA and of interest to OppNet include, but are not limited to:

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 R13 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).  

U.S. applicants must complete and submit budget requests using the Research & Related Budget component.

2. Funds Available

OppNet intends to commit approximately $325,000 in total costs (i.e., direct costs plus Facilities and Administrative (F&A) costs) in FY 2011 to fund four to six new grants in response to this FOA. Budgets for direct costs of up to $50,000 per year and a project duration of up to 2 years may be requested for a maximum of $100,000 in direct costs over a 2-year project period.

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 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.

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 to apply:

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.

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. 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 with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered “on-time” (see 3.C.1 for more information about on-time submission).

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.

Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

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 for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).

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 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 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
Research & Related Budget (See Section IV.6., regarding appropriate required budget component.)  
PHS398 Cover Letter File, including Permission-to-Submit Letter from appropriate IC Conference Grant Contact

Optional Components:
Research & Related Subaward Budget Attachment(s) Form

Foreign Organizations (Non-Domestic [non-U.S.] Entities)

NIH policies concerning grants to Foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.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 (U.S.) 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 on 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.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the section of the Research Plan entitled, “Multiple PD/PI Leadership Plan” 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:  November 14, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): November 14, 2010
Application Due Date(s):  December 14, 2010
Peer Review Date(s): March 2011
Council Review Date(s): May 2011
Earliest Anticipated Start Date(s): July 2011 

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 OppNet and review 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:

William N. Elwood, Ph.D.
OppNet Facilitator
Office of Behavioral and Social Sciences Research
Office of the Director
National Institutes of Health
31 Center Drive, Suite B1C19, MSC 2027
Bethesda, MD 20892-2027
Telephone: 301-402-1150
Fax: 301-402-1150
Email: William.elwood@nih.hhs.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. 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.

3.C. Application Processing

3.C.1 Submitting On-Time

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. All applications must meet the following criteria to be considered “on-time.”

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step – applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.

Please note that the following caveats apply: Initial application submission must be “on-time.”

3.C.3 Viewing an Application in the eRA Commons

Once any eRA identified 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 assembled application before it automatically moves forward to NIH for further processing.

Upon receipt, applications will be evaluated for completeness by the NIH Center for Scientific Review (CSR) and responsiveness by the IC. Incomplete and/or non-responsive applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons at https://commons.era.nih.gov/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.

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: 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 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).

In general, conference grant awards should be issued before the actual start date of the conference.

6. Other Submission Requirements 

The following instructions are to be used in conjunction with the SF424 (R&R) Application Guide accompanying the SF424 (R&R) application form.

SF424 (R&R) Cover Component: Enter the title of the scientific conference or scientific meeting in the Descriptive Title of Applicant’s Project field of the SF424 Cover component.

Research and Related Project/Performance Site Locations: Enter the site of the conference or meeting as the Performance Site.

Allowable Costs: Salary (in proportion to the time or effort spent directly on the conference/scientific meeting); rental of necessary equipment; travel and per diem or subsistence allowances; supplies needed for conduct of the meeting (only if received for use during the budget period); conference services; publication costs; funds to help defray registration costs for some select attendees (for example, women, racial/ethnic minorities, persons with disabilities, other individuals who have been traditionally underrepresented in science, graduate students); speakers’ fees.

Non-allowable costs: Purchase of equipment; transportation costs exceeding U.S. carrier coach class fares; visas; passports; entertainment; tips; bar charges; personal telephone calls; laundry charges; dues; honoraria or other payments for the purpose of conferring distinction or communicating respect, esteem or admiration; patient care; alterations or renovations; facilities and administrative costs/indirect costs. Refer to the NIH Grants Policy Statement for additional information regarding costs.

PHS 398 Checklist Component: The checklist is required; however, no information regarding facilities and administrative (F&A) costs (also called indirect costs) should be included as these are not allowable costs for this mechanism.

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.”

PHS398 Research Plan Component Sections

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

In the “Conference Plan” section of the application (uploaded as the Research Strategy attachment), describe the objectives, specific program, and logistical arrangements for the meeting(s). Describe the format and list the agenda and speakers, including the principal topics to be covered, problems to be addressed, and developments or contributions the meeting(s) might stimulate. Provide a detailed justification for the meeting(s), including the scientific need, timeliness, and usefulness of the meeting(s) to the creation of interdisciplinary teams and goal to either (1) accelerate, expand, and/or strengthen the scope of investigation of a specific b-BSSR research domain; or (2) increase the sophistication of theoretical, methodological, and analytical approaches in b-BSSR. Describe the potential impact of the meeting(s) and the creation of the interdisciplinary team on our understanding of basic mechanisms of behavior or social processes. Demonstrate how proposed investigator(s), interdisciplinary team, and meeting(s) will support the development of a synergistic approach to address basic behavioral or social science research questions. Describe the composition and role of the organizing committee(s) and the proposed interdisciplinary team. Provide the names and credentials of key participants in the meeting(s), including the basis for their selection and documentation of their agreement to participate.

Describe plans for the appropriate involvement of women, minorities, and persons with disabilities in the planning and implementation of, and participation in, proposed meeting(s) and transdisciplinary team(s). Describe plans to identify resources for childcare and other types of family care at the conference site to allow individuals with family care responsibilities to attend. That information should allow attendees to arrange for family care as needed. Estimate the expected size and composition of the meeting(s) audience, as well as the method of participant selection. Describe plans for publicizing the conference/meeting to all interested participants and for publishing meeting(s) proceedings, conceptual reviews, or other scholarly products to foster the development and dissemination of shared scientific terminology, approaches, and methodologies across disciplines. Identify related conferences/meetings held on the subject during the past 3 years [and how the proposed meeting is similar to, and/or different from these, and why it is still necessary and useful].

Applications requesting multiple meetings and/or multiple years of support must provide the following additional information for each meeting and future year requested, in as much detail as possible: meeting topic(s); tentative dates, locations, and participants; and contingency plans for future meetings dependent upon, for example, the outcome of prior meeting(s) or developments in the field. Briefly describe evaluation plans for each meeting and the developmental progress of interdisciplinary team.   

A critical part of the application for NIH support of conferences/meetings is documentation of appropriate representation of women, racial/ethnic minorities, persons with disabilities, and other individuals who have been traditionally underrepresented in science. Attendance for some individuals will be dependent on the availability of resources for family care. A broad cross section of individuals must be included in all aspects of planning, organization, and implementation of NIH-sponsored and/or supported conferences/meetings. “Appropriate representation” means representation based on the availability of these scientists from these groups known to be working in a particular field of basic behavioral and social sciences and biomedical research. If appropriate representation is not apparent, no award will be issued until program staff members are assured of concerted recruitment efforts. Organizers of scientific conferences/meetings must document compliance with the Guidelines for Inclusion of Women, Minorities, and Persons with Disabilities in Scientific Meetings Supported by the NIH (http://grants.nih.gov/grants/funding/r13/index.htm). This Web site also includes addresses and information for offices at NIH that support conference/meeting activities. 

Budget Component

U.S. applicants 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.

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. An application that does not comply with the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

The following resource sharing policies do not apply to this FOA:

Foreign Applications (Non-Domestic [non-U.S.] Entities)

Indicate how the proposed project has specific relevance to the mission and objectives of the NIH/IC and has the potential for significantly advancing the health sciences in the United States.

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

Review Process

Applications that are complete will be evaluated for scientific and technical merit by (an) appropriate scientific review group(s) convened by NCI 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:

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. 

Overall Impact. After considering all of the review criteria, briefly summarize the significant strengths and weaknesses of the application and judge the likelihood that the proposed conference/meeting and the creation of an interdisciplinary team will have a substantial impact on the pursuit of the goals of NIH supported research, which is to advance our understanding of biological systems, to improve the control of disease, and to enhance health. 

Scored 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 this conference/scientific meeting 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 endeavors on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

In addition, specific to this FOA: Are the proposed aims relevant to OppNet goals and mission? Do the meeting(s) and the creation of the interdisciplinary team identify an important opportunity to advance knowledge about the nature of behavior and/or social systems and/or deepen our understanding of basic mechanisms of behavioral and social processes?

Investigator(s). Is(are) the PD/PI(s) well suited for organizing and fulfilling the goals of this conference/scientific meeting? Are the qualifications and past performance of the PD/PI(s) appropriate, and are they well suited for their described roles in the conference/scientific meeting? Are the key personnel and selected speakers appropriate and well suited for their described roles in the conference/scientific meeting?

In addition, specific to this FOA: Are the proposed interdisciplinary team members uniquely qualified to advance knowledge about the nature of behavior and/or social systems and/or deepen our understanding of basic mechanisms of behavioral and social processes?

Innovation. Does the conference/meeting employ novel approaches or methods to fulfill its purpose? Does the conference/scientific meeting draw together appropriate experts who may otherwise not have an opportunity to meet and collaborate?

Approach. Are the format and agenda for the conference/meeting appropriate for achieving the specified goals? Is the conference/meeting timely for the subject matter? For applications designating multiple PDs/PIs, is the Leadership Plan approach, including the designated roles and responsibilities, governance and organizational structure consistent with and justified by the topics of the conference/meeting and the expertise of each of the PD/PIs?

Environment. Is the conference/scientific meeting site appropriate? Does the applicant organization have the ability to contribute to the probability of success? Do the proposed meetings, exhibits, interactions, etc., take advantage of unique features of the environment or employ useful collaborative arrangements? Is institutional support evident?

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.

Appropriate Representation. How well do the plans for inclusion of women, racial/ethnic minorities, persons with disabilities, and other individuals who traditionally have been underrepresented in science provide for their appropriate representation in the planning, organization, and execution of the proposed conference/scientific meeting? See Inclusion of Women, Minorities and Persons with Disabilities in NIH-Supported Conference Grants at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-066.html.

Protections for Human Subjects. Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Inclusion of Women, Minorities, and Children. Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Vertebrate Animals. Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Biohazards. Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Resubmission Applications. Resubmissions are not applicable to this FOA.

Renewal Applications.  Renewals are not applicable to this FOA.

Revisions. Revisions are not applicable to this FOA.

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.

Provision of Family Care Facilities. Are the plans to inform attendees about family care resources adequate?

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

Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:  1) Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

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

Selection 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.

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.

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

All conference material (promotional materials, agenda, publications an internet sites) related to this project must include an acknowledgement of NIH grant support and a disclaimer stating the following:  “Funding for this conference was made possible [in part] by [insert grant number] from [insert IC name]. The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.”

3. Reporting

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

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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. Applicants are encouraged to communicate with the Scientific/Research Contact(s) in order to verify that the disciplinary mix and topic proposed is appropriate to the goals of this FOA.

1. Scientific/Research Contacts:

Kara L. Hall, Ph.D.
Behavioral Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Boulevard, EPN Room 4078, MSC 7338
Bethesda, MD 20892-7326
Rockville, MD 20852
Telephone: 301-594-9056
Fax: 301-480-2087
Email: hallka@mail.nih.gov

Lis Nielsen, Ph.D.
Division of Behavioral and Social Research
National Institute on Aging
7201 Wisconsin Avenue, #533
Bethesda, MD 20892-9205
Telephone: 301-402-4156
Fax: 301-402-0051
Email: nielsenli@nia.nih.gov

Mariela C. Shirley, Ph.D.
Division of Epidemiology and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2086, MSC 9304
Bethesda, MD 20892-9304 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Phone: 301-443-9787
Fax: 301-443-8614
Email: shirleym@mail.nih.gov

2. Peer Review Contact:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-3428
Fax: (301) 402-0275
Email: ncirefof@dea.nci.nih.gov

3. Financial/Grants Management Contacts:

Crystal Wolfrey
Office of Grants Administration
National Cancer Institute
6120 Executive Boulevard, EPS Suite 243, MSC 7150
Bethesda, MD 20892-7150 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: 301-496-8634
Fax: 301-496-8601
E-mail: wolfreyc@mail.nih.gov

Jeff Ball
Grants & Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2N212
Bethesda, MD 20892-9205 (for U.S. Postal Service express or regular mail)
Bethesda, MD 20814 (for non-USPS delivery)
Telephone: 301-402-7732
Fax 301-402-3672
E-mail: ballj@nia.nih.gov

Judy Fox
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3023, MSC 9304
Bethesda, MD 20892-9304
Telephone: 301-443-4704
Fax: 301-443-3891
Email: jfox@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 institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

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-09-116.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 Policy 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 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/.


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