Part I Overview Information


Department of Health and Human Services

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

Components of Participating Organizations
Fogarty International Center (FIC) (http://www.fic.nih.gov)
National Center for Complementary and Alternative Medicine (NCCAM) (
http://nccam.nih.gov)
National Cancer Institute (NCI) (http://www.nci.nih.gov)
National Institute on Aging (NIA) (http://www.nia.nih.gov)
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (
http://www.NIAAA.nih.gov)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)  (http://www.nichd.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD) (
http://nidcd.nih.gov)
National Institute of Dental and Craniofacial Research (NIDCR) (
http://www.nidcr.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)
Office of Research on Women’s Health (ORWH) (http://orwh.od.nih.gov/)
Office of Behavioral and Social Sciences Research (OBSSR) (
http://obssr.od.nih.gov)
National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov)

Title:  Fogarty International Research Collaboration – Behavioral and Social Sciences (FIRCA-BSS) Research Award (R03)

Announcement Type
This Funding Opportunity Announcement (FOA) is a reissue of PAR-06-437.

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-08-223


A compatible version of Adobe Reader is required for download. For Assistance downloading this or any Grants.gov application package, please contact Grants.gov Customer Support at http://grants.gov/CustomerSupport.
Catalog of Federal Domestic Assistance Number(s)
93.989, 93.213, 93.867, 93.866, 93.273, 93.286, 93.173, 93.279, 93.113, 93.114, 93.115, 93.853, 93.865

Key Dates
Release/Posted Date:  July 31, 2008
Opening Date:  August 29, 2008 (Earliest date an application may be submitted to Grants.gov).
Letters of Intent Receipt Date(s): Not applicable
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):  September 29, 2008; September 29, 2009; and September 29, 2010 
AIDS Application Submission/Receipt Date(s): Not applicable
Peer Review Date(s): February/March 2009; February/March 2010; and February/March 2011
Council Review Date(s): May 2009; May 2010; and May 2011  
Earliest Anticipated Start Date(s): July 1, 2009; July 1, 2010; and July 1, 2011
Expiration Date: September 30, 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. 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 and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process

     A. Additional Review Criteria
     B. Additional Review Considerations
     C. Resource Sharing Plan(s)
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


1. Research Objectives

An important role of the FIC is to foster discovery and reduce global health disparities through the support of international research cooperation across the continuum of basic, clinical and applied biomedical, social and behavioral health sciences.  This FOA contributes to the FIC mission, and the broad NIH initiative to reduce health disparities among nations, by strengthening research infrastructure in LMICs, particularly those with the least economic resources.  This FOA responds to a number of goals in the new FIC strategic plan (http://www.fic.nih.gov/about/plan/strategicplan_08-12.htm). 

The main objectives of the FIRCA program are to:  (1) support collaborative research efforts between NIH-funded scientists and LMIC scientists (referred to as the “LMIC collaborator/PD/PI”) on research of high scientific merit, relevant to global health and of mutual interest and benefit; and (2) help build research capabilities and foster further sustained and productive research and research collaborations at the LMIC site.

The opportunity to collaborate internationally provides a means of access to new information and perspectives, innovative concepts and methods, emerging research techniques and technologies, and unique populations and environments important for addressing global health problems.

The FIRCA will extend and enhance the research interests of both the NIH-funded scientist and the collaborating LMIC scientist, and will help build the research and research capabilities of the LMIC investigator and institution. 

The research capacity building goal of the FIRCA is served by both the direct research collaboration between the teams involved in the research and also by the associated training and consultation at the LMIC site. This training and consultation may also involve other investigators and students at the LMIC site thereby helping to build institutional capacity.  The NIH funded PI may spend up to three months of the year under the FIRCA teaching and consulting at the LMIC site. A formal detailed plan with proposed curriculum, audience, schedule and time frame should be presented as part of the research plan.

All non-AIDS-related behavioral and social sciences research topics that are supported by the NIH, and that do not involve biomedical research topics are eligible for inclusion under the FIRCA-BSS program.  For biomedical research (BB), see the companion FOA, “Fogarty International Research Collaboration – Biomedical Research Award”  (FIRCA-BB) program (PAR-08-222).   Research topics related to human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS) are not eligible for FIRCA funding.  Investigators working on topics related to HIV/AIDS and wishing to conduct collaborative research involving LMIC countries should note the other opportunities listed at (http://grants.nih.gov/grants/guide/notice-files/NOT-TW-07-002)

Interests of Participating Institutes and Centers (ICs)

Applicants can obtain information and research interests for each of the sponsoring ICs listed on the first page of this announcement at their websites, or by contacting the IC program contact listed in Section VII, “Agency Contacts.”  Some of the participating ICs have provided additional statements of interest:

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 Small Grant (R03) 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 the “Modular Applications and Awards” section of the NIH Grants Policy Statement. All domestic applications submitted in response to the FOA must use the modular budget format (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).

This FOA uses the detailed (non-modular) budget format for all foreign institutions applications (that is, complete the Research & Related Budget component of the SF424 (R&R) application forms – not the PHS398 Modular Budget component).   See NOT-OD-06-096), August 23, 2006.

Renewal (formerly “competing continuation”) applications will not be accepted for the R03 grant mechanism. Small grant support may not be used for thesis or dissertation research. Up to two resubmissions of a previously reviewed small grant application may be submitted. See NOT-OD-05-046, April 29, 2005.  

No renewal (formerly “competing continuation” or “Type 2”) applications are accepted. However, the LMIC Investigator on an awarded “Type 1” FIRCA may submit a new (Type 1) FIRCA application as the PI, directly from his/her home institution (the original LMIC site), to follow-up on the research in the initial three-year FIRCA period.

For specific information about the R03 programs, see: http://grants.nih.gov/grants/funding/r03.htm.

2. Funds Available

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 NIH Institutes and Centers (ICs) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Budget for direct costs for up to $50,000 per year and a project duration of up to three years may be requested for a maximum of $150,000 direct costs over a three year period.

F&A costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November 2, 2004.

The participating organization(s), the Fogarty International Center (FIC), the National Center for Complementary and Alternative Medicine (NCCAM), the National Cancer Institute (NCI), the National Institute on Aging (NIA), the National Institute of Alcohol Abuse and Alcoholism (NIAAA), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Institute of Deafness and Other Communication Disorders (NIDCD), the National Institute of Dental and Craniofacial Research (NIDCR), the National Institute on Drug Abuse (NIDA), the National Institute of Environmental Health Sciences (NIEHS), the Office of Research on Women’s Health (ORWH), the National Heart, Lung, and Blood Institute (NHLBI), and the Office of Behavioral and Social Sciences Research (OBSSR), intend to fund 10 to 20 applications.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

The LMIC collaborator/PD/PI must be from an institution located in a LMIC country ”defined by the World Bank, according to Gross National Income (GNI) per capita as “low-income,” “lower-middle-income,” and “upper-middle-income” (see:  http://siteresources.worldbank.org/DATASTATISTICS/Resources/CLASS.XLS).

LMIC institutions may only apply if they meet the eligibility requirements for LMIC collaborating institutions listed above and the PD/PI and Collaborating Investigators meet the criteria listed below in Section 1.B., “Eligible Individuals.”

Occasionally, scientific opportunities may arise that warrant a formal collaborative effort between the PD/PI and individuals from more than one country.  Such applications may be considered only after consultation with the FIC Program Officer.   

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 grant 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. 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 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.

The scientist who applies as the contact PD/PI must either (1) be an NIH-funded Investigator or (2) have previously been the LMIC collaborator on an awarded FIRCA.

The LMIC collaborator/PD/PI on a FIRCA must be employed at a LMIC institution that meets the eligibility requirements described in Section 1.A., “Eligible Institutions.”

Applicants may already be FIRCA grantees on another FIRCA at the time of the application.  Applicants may submit more than one application, provided that each application is scientifically distinct.

Consistent with FIRCA requirements 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

Applicants may submit a resubmission application, but such application must include an Introduction addressing issues raised in the previous critique (Summary Statement).

Applicants may not submit a renewal application.

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

No renewal (formerly “competing continuation” or “Type 2”) applications are accepted. However, the LMIC collaborator on an awarded “Type 1” FIRCA may submit a new (Type 1) FIRCA application as the PD/PI, directly from his/her home institution (the original LMIC site), to follow-up on the research in the initial three-year FIRCA period. 

Eligible Funding Mechanisms for Consideration as FIRCA “Parent Grants”

The following NIH research project grant mechanisms are eligible as FIRCA “parent grants” (and must be both active and funded at the start of the proposed FIRCA budget period):

Among the mechanisms not generally accepted are:  training grants, contracts, Small Business Innovation Research (R43/R44) and Small Business Technology Transfer (R41/R42) Awards.

The active funded “parent grant” may have been awarded by any NIH Institute or Center (IC), regardless of whether the IC is listed as a participating component in this FOA. To be eligible, the grant must have a minimum of 12 months of funding, which may include a no-cost extension, remaining at the time of the initial FIRCA application deadline.  For the follow-up application from the LMIC collaborator as PD/PI no active grant for the former FIRCA collaborator is necessary. 

If the initial FIRCA research application, submitted by the NIH-funded Investigator, is an extension or a new direction of the parent grant research, it must not overlap with research already supported by the parent grant or by other sources.  If the FIRCA application is for work that is not an obvious extension  FIRCA parent grant, the FIRCA research must be clearly within the expertise and field of interest of both FIRCA collaborators, as indicated by other research support and published work.  Such research should ideally make use of the comparative strengths and expertise of both collaborators.

Special consideration will be given to proposed research which addresses significant global health problems, particularly those of high relevance to the LMIC country or region, and to research that makes use of unique of special resources, circumstances, or environment of the LMIC site.

To continue the collaboration under the FIRCA program, LMIC collaborators on previously funded FIRCA grants that have ended, or will end before the new FIRCA application deadline, must apply for a FIRCA as PD/PI either with their original FIRCA collaborator or a new collaborator as justified by the needs of the research. Current grantees and collaborators may want to consider whether their collaboration has developed to the point where they can submit a Research Project (R01) grant application (direct foreign grant or domestic grant with a foreign component). 

Section IV. Application and Submission Information


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

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

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

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

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

Grants.gov Customer Support
Contact Center Phone: 800-518-4726
Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
Email
support@grants.gov

Foreign (non-US) organizations will need to obtain an NCAGE number.  See http://www.dlis.dla.mil/Forms/Form_AC135.asp

2) Organizational/Institutional Registration in the eRA Commons

eRA Commons Help Desk
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Business hours M-F 7:00 a.m. – 8:00 p.m. Eastern Time
Email
commons@od.nih.gov

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(s)/PI(s) 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 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 301-451-0088.

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.

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.)

Optional Components:
PHS398 Cover Letter File
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 in item 15 of the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of “PD/PI.” Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the “Credential” field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

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

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

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

Checklist

Facilities and Administrative (F & A) Costs:  F & A costs must be calculated on the basis of the off-site rate, if one has been approved, for U.S. sponsoring institutions. 

For applications from foreign institutions and applications that have foreign consortium agreements, F & A costs of up to eight percent of total direct costs (less equipment) may be requested by the LMIC institutions.  See NOT-OD-01-028, March 29, 2001. 

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date:  August 29, 2008 (Earliest date an application may be submitted to Grants.gov).
Letters of Intent Receipt Date(s): Not applicable
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):  September 29, 2008; September 29, 2009; and September 29, 2010 
AIDS Application Submission/Receipt Date(s): Not applicable
Peer Review Date(s): February/March 2009; February/March 2010; and February/March 2011
Council Review Date(s): May 2009; May 2010; and May 2011  
Earliest Anticipated Start Date(s): July 1, 2009; July 1, 2010; and July 1, 2011

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

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 electronicallyPAPER APPLICATIONS WILL NOT BE ACCEPTED.

In order to expedite the review, applicants are requested to notify the Fogarty International Center (FIC) by email (Firca@nih.gov) when the application has been submitted.  Please include the FOA number and title, PD/PI name, and title of the application.

3.C. Application Processing

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

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

Upon receipt, applications will be evaluated for completeness by the 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. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an “Introduction” addressing the previous critique. Note that such an application is considered a "resubmission" for the SF424 (R&R).

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

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

Awards are made to the PD’s/PI’s institution to support a collaborative research project that will be carried out mainly at the LMIC collaborator’s/PD’s/PI’s research site.  The major portion of the funds and items purchased with these funds must be used at the LMIC site to support this research in accordance with the following allowed budget allocations:

Budget: 

6. Other Submission Requirements and Information

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 Applications.”

PHS398 Research Plan Component Sections

Page limitations of the PHS398 Research Plan component must be followed as outlined in the SF424 (R&R) Application Guide. While each section of the 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.  

Supplementary Instructions

Follow instructions In the SF424 “RESEARCH & RELATED” section except as described below for the FIRCA R03 applications:

Other Project Information:

Project Summary Abstract:  For FIRCA applications from the NIH funded PD/PI’s institution, please include in this section the name of the LMIC collaborator, collaborator country and institution, and the parent grant number and project period (e.g., “This research will be done primarily in Peru at Lima University in collaboration with Jorge Smith, as an extension of NIH Grant No. R01HL98765, 9-30-2006 to 9-30-2011”).  For applications from the LMIC Institution, please include the name of the collaborator and the collaborator country and institution.

Other Attachments:  Upload a letter (on institutional letterhead) from the LMIC collaborator/PD/PI (for applications from the LMIC institution) confirming his/her role in the project.  Please include full contact information, including email address and telephone and fax numbers for the LMIC collaborator/PD/PI.  Provide a statement in the same or separate letter, confirming the LMIC organization’s willingness to comply with all pertinent U.S. Federal regulations and policies.  For example, the institution must be willing to support the collaboration with time and resources for the LMIC collaborator/PD/PI, and to provide necessary documentation to the Office of Human Research Protections (OHRP) for human subject involvement:  http:///www.hhs.gov/ohrp/ and to the Office of Laboratory Animal Welfare (OLAW) for animal subjects http://grants.nih.gov/grants/olaw/olaw.htm.  The institution must also agree to comply with all required NIH policies on awards involving LMIC institutions.  The FIRCA is awarded either as a domestic grant with a LMIC component (consortium agreement) or as a direct award to a LMIC institution with a U.S. component.  Refer to the following NIH Grants Policy Statement regarding LMIC grants and consortia for information on policy and requirements (search on “LMIC” to get to the appropriate part of the Web page):  http://grants2.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm. The letter must be co-signed by the Head of a Department, a Dean or another academic official.

Project/Performance Site Locations:  Provide the full name and address of the LMIC institution where the research will be performed (or the collaborating U.S. institution if the application is from a LMIC institution).

Budget Justification Page,: Under “Senior/Key Person” list all project personnel, including their names, level of effort, and roles on the project.  Since no salary is allowed for the NIH-funded HIC collaborator, minimal effort be determined by the applicant institution may be listed.

Research Plan:  Follow the SF424 instructions except as described below and note that the research plan must not exceed 10 pages for items 2-5, (excluding the Introduction for revised/resubmitted applications):

Appendix Materials

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

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

Resource Sharing Plan(s)

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

(a) Data Sharing Plan: Not Applicable

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

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

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.

Indicate how the proposed project will enhance the ability of the LMIC collaborator/PD/PI and LMIC country site to conduct research of particular relevance to global health or health concerns of the country or region. 

Section V. Application Review Information


1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).  

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 on the basis of established PHS referral guidelines to the ICs for funding consideration.

Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by CSR and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using 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 NIH R03 small grant is a mechanism for supporting discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding.  Because the Research Plan component is restricted to 10 pages, a small grant application will not have the same level of detail or extensive discussion found in an R01 application. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem, placing less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.

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 comments, 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. The scientific review group will address and consider each of these criteria in assigning the application's 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 meritorious 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.

For example, an investigator may propose research on an important topic in a developing country with underdeveloped research infrastructure but with unique resources, environment, or knowledge not readily available in the U.S. or other developed nations.  Such projects may be slower to achieve their scientific goals, but may receive special consideration for their potential to build research capacity along with scientific impact in the long-term.

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? How is this research relevant to the LMIC country involved? 

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?  For applications designating multiple PDs/PIs, does the Leadership Plan ensure that there will be sufficient coordination and communication among the PDs/PIs?  Are the administrative plans for the management of the research project appropriate, including plans for resolving conflicts? 

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 or methodologies, tools, or technologies for this area?  Does the project make use of unique or special expertise, resources, circumstances, or environment at the LMIC site to frame or address the research question?  Does the project propose innovative or special ways to incorporate capacity building or training into the research program at the LMIC site? 

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(s) of the principal investigator(s) and other researchers? Do the PD/PIs and investigative team bring complementary and integrated expertise to the project (if applicable)? If the LMIC collaborator is submitting as the PD/PI, is she/he able to undertake and direct the continuation of the research efforts independently but with some level of collaboration with the original (or new) FIRCA collaborator as justified by the needs of the research?  How will this award continue to enhance the LMIC PD/PI’s research and career development and help her/him towards achieving a position of scientific leadership in her/his home country and field?

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(s), or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?   Has the LMIC collaborator/PD/PI’s home institution made a convincing commitment (e.g., provided a research/academic appointment and salary support)?  Are the resources necessary to perform the research available or obtainable? 

Research Capacity BuildingIf the research is not on a biomedical problem of particular relevance for the LMIC country involved, how will the award contribute to building needed biomedical research capacity/capability at the LMIC site ? For new FIRCA collaborations does the collaboration have the potential to enhance the research capability of the LMIC collaborator/PD/PI and the LMIC site?  Does the research constitute a substantial scientific endeavor of the LMIC collaborator/PD/PI, including creative and scientific input to the research proposal?  The LMIC site and investigator should not be used merely to gather biological samples (clinical, plants, etc.) or behavioral data (interviews, surveys, etc.).  In all cases, the LMIC collaborator/PD/PI should be actively involved in analyzing and interpreting the data.   If the PD/PI is from the LMIC site, how will the award contribute to advancing his/her research and career, research at the PD’s/PI’s institution and the field of research in the PD/PI’s country? 

2.A. Additional Review Criteria:

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

Resubmission Applications: Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

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 the “Human Subjects Sections” of the PHS398 Research Plan component of the SF424 (R&R).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both 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 the “Human Subjects Sections” of the PHS398 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 adequacy of the plans for their care and use will be assessed. See the “Other Research Plan Sections” of the PHS398 Research Plan component of the SF424 (R&R).

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 and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. The priority score should not be affected by the evaluation of the budget.

2.C. Resource Sharing Plan(s)

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

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 the 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.

In the Performance Site block on the PHS2590, grantees must list the LMIC site at which the FIRCA work is being carried out and the parent contact at the LMIC site.  Please include full contact information, including telephone and fax numbers and email addresses for the NIH-funded investigator and the LMIC collaborator PD/PI should be collaborator PD/PI. 

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, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

FIC/NIH:
Xingzhu Liu, M.D., Ph.D.
FIRCA-BSS Program Officer
Division of International Training and Research
Fogarty International Center
Building 31, Room B2C39
31 Center Drive, MSC 2220
Bethesda, MD    20892-2220
Telephone: (301) 435-6031
Fax: (301) 402-0779
Email:   liuxing@mail.nih.gov

NCCAM/NIH:
Deborah Hayes, MS
International Health Program Specialist
Office of International Health Research
National Center for Complementary & Alternative Medicine
National Institutes of Health (NCCAM/NIH)
6707 Democracy Boulevard, Suite 401
Bethesda, MD 20892-5475
Telephone: (301) 496-2583
Fax: (301) 480-3287
Email: dhayes@mail.nih.gov

NCI/NIH:
Michele Bloch, M.D., Ph.D.
Tobacco Control Research Branch
Behavioral Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
6120 Executive Boulevard, EPN Room 4044, MSC 7337
Bethesda, MD 20892-7337 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS courier/express delivery)
Telephone:  (301) 496-8584
Fax:  (301) 496-8675
Email:  blochm@mail.nih.gov

NIA/NIH:
Dallas W. Anderson, Ph.D.
Program Director, Population Studies
Dementias of Aging Branch
Neuroscience and Neuropsychology of Aging Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 350, MSC 9205
Bethesda, MD    20892-9205
Telephone: (301) 496-9350
Fax: (301) 496-1494
Email:
andersda@nia.nih.gov

NIAAA/NIH:
Margaret M. Murray, M.S.W.
Office of the Director
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2013, MSC 9304
Bethesda, MD    20892-9304
Telephone: (301) 443-2594
Fax: (301) 480-1726
Email:
pmurray@mail.nih.gov

NIDCD/NIH:
Lana Shekim, Ph.D.
Director, Voice and Speech Programs
Division of Scientific Programs
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, EPS-400C, MSC 7180 ”
Bethesda, MD    20892-7180
Telephone: (301) 496-5061
Fax: (301) 402-6251
Email:
shekiml@nidcd.nih.gov

NIDCR/NIH:
Melissa W. Riddle, Ph.D.
Director, Behavioral and Social Sciences Research Branch
National Institute of Dental and Craniofacial Research
6701 Democracy Boulevard, Room 648, MSC 4878
Bethesda, MD   20892-4878
Telephone: (301) 451-3888
Fax: (301) 480-8318
Email:   riddleme@nidcr.nih.gov

NIDA/NIH:
Steven Gust, Ph.D.
Director, International Program
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5-274, MSC 9581
Bethesda, MD    20892-9581
Telephone: (301) 443-6480
Fax: (301) 443-9127
Email:
ipdirector@nida.nih.gov

NIEHS/NIH:
Kimberly Gray, Ph.D.
Scientific Program Administrator
National Institute of Environmental Health Sciences
Division of Extramural Research and Training
Community-based Participatory Research (CBPR)
P.O. Box 12233, EC-27
79 T. W. Alexander Drive
Research Triangle Park, NC    27709
Telephone: (919) 541-0293
Fax: (919) 541-4937
Email:
gray6@niehs.nih.gov

ORWH/NIH:
Erika Elvander
Health Policy Analyst
Office of Research on Women’s Health
Office of the Director
National Institutes of Health
6707 Democracy Boulevard, Suite 400
Bethesda, MD  20892
Telephone: (301) 496-9186
Fax:  301-402-1798
Email:  elvander@od.nih.gov

OBSSR/NIH:
Dana M. Sampson, M.S.
Program Analyst
Office of Behavioral and Social Sciences
Office of the Director
National Institutes of Health
31 Center Drive, Room B1C19
Bethesda, MD  20892
Telephone: (301) 402-1146
Fax:  301-402-1150
Email:  sampsond@od.nih.gov

NHLBI/NIH:
Peter G. Kaufmann, Ph.D. 
Division of Prevention and Population Sciences
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 10106, MSC 7936
Bethesda, Maryland  20892-7936
Telephone: (301) 435-2467
FAX: (301) 480-1773
Email: KaufmannP@mail.nih.gov

NICHD/NIH
Daniel Singer, Ph.D.
Health Scientist Administrator
Office of the Director
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 2A01, MSC 7510
Rockville, MD  20852-7510
Telephone:  301-435-7565
Fax:  (301) 435-0009
Email: singerda@mail.nih.gov

2. Peer Review Contacts:

Sherry L. Dupere, Ph.D.
Chief, Biology of Development and Aging IRG
Center for Scientific Review
6701 Rockledge Drive, Room 5136, MSC 7840
Bethesda, MD    20892-7840
(For express/courier service use ZIP 20817)
Telephone: (301) 435-1021
Fax: (301) 480-3567
Email:
duperes@csr.nih.gov

3. Financial or Grants Management Contacts:

FIC/NIH:
Angela Smith
Grants Management Specialist
Fogarty International Center
Building 31, Room B2C29
31 Center Drive, MSC 2220
Bethesda, MD   20892-2220
Telephone: (301) 496-5710
Fax: (301) 594-1211
Email: smithangela@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. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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

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

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

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

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

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

Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

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/.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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