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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
Fogarty International Center (FIC), (http://www.fic.nih.gov)

Title: Planning Grant for Global Infectious Disease Research Training Program (D71)

Announcement Type
New

Update: The following updates relating to this announcement have been issued:

Program Announcement (PA) Number: PAR-10-262

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 SF 424 Research and Related (R&R) forms and the SF 424 (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)

93.989

Key Dates (additional/updated dates in bold, per NOT-TW-11-022)
Release/Posted Date: August 17, 2010
Opening Date: September 2, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): October 2, 2010, August 21, 2011, April 21, 2012, August 21, 2012, April 21, 2013
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): November 2, 2010, September 21, 2011 (Date Not Applicable per NOT-TW-11-031), May 21, 2012, September 21, 2012 ( Date Not Applicable per NOT-TW-11-031), May 21, 2013
Peer Review Date(s): February/March 2011, February/March 2012, October/November 2012, February/March 2013, October/November 2013
Council Review Date(s): May 2011, May 2012, January 2013, May 2013, January 2014
Earliest Anticipated Start Date(s): June 2011, June 2012, March 2013, June 2013, March 2014
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: May 22, 2013

Key Dates (original dates)
Release/Posted Date: August 17, 2010
Opening Date: September 2, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): October 2, 2010, August 21, 2011, August 21, 2012
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): November 2, 2010, September 21, 2011, September 21, 2012
Peer Review Date(s): February/March 2011, February/March 2012, February/March 2013
Council Review Date(s): May 2011, May 2012, May 2013
Earliest Anticipated Start Date(s): June 2011, June 2012, June 2013
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: September 22, 2012

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Purpose. The Fogarty International Center (FIC), encourages new applications for planning grants in the Global Infectious Disease Research Training Program (GID), The application must propose a plan to develop the components necessary for an international research training program application to submit in response to the D43 FOA for the Global Infectious Disease Research Training Program (GID),. In developing an application for a planning grant, applicants need to be aware of the objectives and special requirements of this program defined in the Global Infectious Disease Research Training Program (GID) (D43),(PAR-10-260) Funding Opportunity Announcement (FOA) The Global Infectious Disease Research Training Program (GID) supports research training that will strengthen the capacity of institutions in low-and middle-income countries (LMIC), defined by the World Bank classification system, to conduct infectious disease (excluding HIV/AIDS) research. FIC will support planning grants for research-training programs that focus on major endemic or life-threatening emerging infectious diseases, neglected tropical diseases, widespread co-infections of HIV/AIDS patients or infections associated with non-communicable disease conditions of poverty in developing countries (see the FIC Strategic Plan http://www.fic.nih.gov/about/plan/strategicplan_08-12.htm and the Global Health Initiative http://www.theglobalhealthinitiative.org/.) The planning grant application should be developed and implemented collaboratively with all designated participating institutions.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Training Planning Objectives

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

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria

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

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

Purpose and Background: The Fogarty International Center (FIC) encourages new applications for planning grants in the Global Infectious Disease Research Training Program (GID). The application must propose a plan to develop the components necessary for an international research training program application to submit in response to the D43 FOA for the Global Infectious Disease Research Training program. In developing an application for a planning grant, applicants need to be aware of the objectives and special requirements of this program defined in the Global Infectious Disease Research Training Program (D43),(PAR-10-260) FOA. The Global Infectious Disease Research Training program supports research training that will strengthen the capacity of institutions in low-and middle-income countries (LMIC), defined by the World Bank classification system, to conduct infectious disease research. FIC will support planning grants for research-training programs that focus on major endemic or life-threatening emerging infectious diseases, neglected tropical diseases, widespread co-infections of HIV/AIDS patients or infections associated with non-communicable disease conditions of poverty in developing countries. The planning grant application should be developed and implemented collaboratively with all designated participating institutions (see Section III Eligibility Information).

Infectious diseases continue to impose a tremendous health burden in resource-poor countries throughout the world, claiming millions of lives annually and inflicting severe morbidity that results in significant losses in economic productivity and social progress. Attempts to control infectious diseases endemic to developing countries suffer due to an incomplete understanding of the pathogens, their disease manifestations and transmission mechanisms, inadequate preventive measures and interventions, and inadequate health services and disease control efforts. A major barrier to improved research, treatment and control of infectious diseases is the scarcity of scientists and health professionals in endemic countries with relevant infectious disease research knowledge and expertise. Therefore, the overall intent of this funding opportunity is to support LMIC institutions to harness scientific knowledge and skills to enhance prevention, treatment and control of infectious diseases causing major morbidity and mortality in their countries by strengthening research capacity.

FIC will support planning grants for research-training programs that focus on building sustainable infectious disease research capacity at an institution in an endemic developing country. Sustainable research capacity depends on building a critical mass of scientists and health professionals with in-depth scientific expertise and complementary skills that enables the institution to conduct independent, internationally-recognized infectious disease research relevant to the health priorities of their countries. FIC will support research-training programs that focus on major endemic or life-threatening emerging infectious diseases, neglected tropical diseases, widespread co-infections of HIV/AIDS patients or infections associated with non-communicable disease conditions of poverty in developing countries (see the FIC Strategic Plan http://www.fic.nih.gov/about/plan/strategicplan_08-12.htm and Global Health Initiative http://www.theglobalhealthinitiative.org/.) The proposed planning process should consider research training programs structured to provide an appropriate balance of short- and long-term training, degree and non-degree training opportunities for participants designed overall to build sustainable research capacity in partnership with U.S. institutions conducting collaborative research. The proposed planning process should also consider training in sustainable research enhancing areas such as biosafety, data management, scientific writing, grant writing, statistical methods, good clinical practice, medical informatics, data management, management of intellectual property, and English as a second language (if needed). Applicants are encouraged to consider training approaches which use information technology to facilitate trainee data management, access to scientific information, distance learning and collaborative scientific interaction.

Special Program Objectives and Considerations:

The planning grant application should describe a step-wise process to meet the objectives of the planning grant, demonstrate support and expertise of collaborators and partners named in the planning grant application, provide evidence that the leadership of LMIC institution and significant LMIC leaders support the development of research training, and describe how proposed future research training would be relevant to the health priorities of the LMIC. Evidence of country and institutional support in the LMIC for the planning grant as well as sustained support for any subsequent comprehensive program is expected. Such evidence of support could be a statement of support from a senior administrator at the LMIC institution or government leaders that emphasize the long-term commitment to the goals of the award, evidence of cost-sharing by the LMIC or LMIC institution, or plans to provide career development opportunities for the trainees following completion of their training.

The objectives of the Global Infectious Disease Research Training program planning grant are:

The Global Infectious Disease Research Training program planning grant funds institutional research training planning process awards for training programs designed to strengthen the capacity of the LMIC institution to conduct independent training and research through the career development of individual researchers and key personnel. The program is not an individual research training planning fellowship program.

Applicants are encouraged to review the FIC Strategic Plan http://www.fic.nih.gov/about/plan/strategicplan_08-12.htm.

The Global Infectious Diseases Research Training program strongly encourages principal investigator/program directors (PIs/PDs) to include women and individuals from underrepresented racial, ethnic or socially disadvantaged groups in the country as faculty and trainees at all sites. Applicants should consider innovative, culturally sensitive approaches to increasing the diversity of the faculty and trainees involved in planning the proposed training program

Types of Training to be considered in the Program Planning Process: The planning grant application should include a collaborative process to consider an appropriate mix of long-, medium- and short-term research training opportunities to address the specific infectious disease research training needs identified in the LMIC which will be the focus of the proposed program. Research training in basic biomedical or clinical sciences; behavioral or social sciences; prevention research; health services, operations and implementation research can be considered. Applicants are encouraged to design multidisciplinary research training programs. Training to strengthen sustainable research as well as core research support capacity at the LMIC institution can be considered. The planners can create research training opportunities at applicant institution or at partnering U.S. or other institutions, however, training-related research should be planned mainly in the LMIC. While a range of short-, medium- and long-term training is allowed, emphasis should be placed on designing medium- to long-term training, including mid-career training and advanced in-country research.

The following types of training (but not limited to) should be considered during the planning process:

Applicants should plan a process in which all training-related research projects can receive independent scientific review through a standard procedure established by the proposed program. Proposed programs should include education in the protection of human subjects for mentors and their trainees involved in human subjects research. Such research will need approval from an institutional (or ethical) review board or committee with a Federal-Wide Assurance (FWA) at the applicant institution and, if different, at the LMIC institution in which the research is being conducted. If needed, FWAs should be obtained during the planning process (please see Procedures for Registering Institutional Review Boards and Filing Federal-Wide Assurances of Protection for Human Subjects (FWAs) at http://www.hhs.gov/ohrp/assurances/assurances_index.html ).

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 D71 award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses the non-modular budget format and Just-in-Time information concepts (see SF424 (R&R) Application Guide). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application, following the Instructions for preparing a D43 institutional research training application described in Section IV 6A.

2. Funds Available

Because the nature and scope of the proposed research training 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.

The expected amount for individual awards will be up to $25,000 per year (total direct costs) for one year. Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004. Facilities and administrative costs are limited to 8% for all awards and sub-awards.

The estimated amount of funds available for support of 2-3 projects awarded as a result of this announcement is $50,000-$75,000 for fiscal year 2011. Future year amounts will depend on annual appropriations.

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.

Allowable Costs

Allowable costs for D71 applications include travel, salary, consultative fees, and administrative costs. The total amount of salary and fringe benefits requested for all key personnel must be well justified and compatible with salary scales established for similarly ranked professionals at the applicant or partner institutions. The time commitment for personnel receiving salary should be thoroughly described.

Funds may be requested for round-trip economy airfare on U.S. carriers (to the maximum extent possible) and lodging and per diem for the applicant to attend the annual program network meeting, normally in the U.S.

Facilities and Administrative (F&A) Costs: F&A costs for the applicant organization and consortium participants will be reimbursed at 8 percent of modified total direct costs, exclusive of tuition, fees, equipment, and consortia costs in excess of $25,000, per NIH Grants policy for institutional research training grants http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part11.htm#_Toc54600212

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:

Applications may only be submitted by foreign institutions in the low- and middle-income countries (LMIC), defined by the World Bank classification system Taiwan is not listed in the World Bank income classification list but is considered high-income and therefore is not eligible. Hong Kong is listed as high-income in the World Bank income classification list, so is not considered a LMIC.

The proposed research training program must take advantage of on-going research at the LMIC institution. This research does not need to be NIH-funded, but it needs to be active and able to support the proposed research training program.

Applicants from LMIC institutions must document active relevant research at their LMIC institution, which can support the proposed research training program.

Applicants from LMIC institutions should apply in collaboration with U.S. institutions capable of enhancing their proposed research training opportunities, and must name an individual at the proposed U.S. collaborating institution as the major collaborator.

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research training as the PD/PI is invited to work with his/her organization to develop an application for support. Women and individuals from underrepresented racial, ethnic and socially disadvantaged groups as well as individuals with disabilities are always encouraged to apply for NIH support.

The PD/PI must name at least one individual at each collaborating institution as the major collaborator for that institution. Individuals chosen as major collaborators should be scientists with whom the Principal Investigator or key personnel named in the application have had prior successful collaborations. These collaborations should be described in the application.

The PD/PI must be designated as the PI of at least one active (with at least 18 months of support remaining at the time of submission of the application) research award that is directly relevant to the research training proposed. The research grants may be funded by the NIH or by other national or international organizations. If 18 months will not remain in the parent grant award period at the time of application submission, an applicant must provide documentation that a renewal of a research grant to meet the eligibility requirement is expected, that a no-cost extension has been/will be requested for the research grant to meet the eligibility requirement and it will have sufficient remaining resources to continue the research project, or that other research support will be available to meet the eligibility requirement.

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://grants.nih.gov/grants/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. 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.

For background information on the Multiple PD/PI initiative, see http://grants.nih.gov/grants/multi_pi/index.htm

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. Applicant institutions may submit more than one planning grant application, provided that each application is scientifically distinct.

Resubmissions.Resubmission applications will be accepted. See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Such application must include an Introduction addressing the previous peer review critique (Summary Statement). (NOT-OD-09-003, NOT-OD-09-016)

Renewals. Renewal applications are not allowed for this research training planning grant program.

The Planning Grants for the Global Infectious Disease Research Training program strongly encourages principal investigator/program directors (PIs/PDs) to include women and individuals from underrepresented racial, ethnic or socially disadvantaged groups in the country as trainees.

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 eRA Commons.

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

1) Organizational/Institutional Registration in Grants.gov/Get Registered http://www.grants.gov/applicants/get_registered.jsp

2) Organizational/Institutional Registration in the eRA Commons

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

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

International applicants may obtain more information on the registrations required for grants.gov and eRA Commons at:

http://era.nih.gov/ElectronicReceipt/files/Tips_for_International_Applicants.pdf. http://era.nih.gov/ElectronicReceipt/files/international_support.pdf

http://era.nih.gov/ElectronicReceipt/files/international_qa.pdf http://era.nih.gov/ElectronicReceipt/preparing_grantsgov_reg.htm.

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 301-710-0267, Email: [email protected].

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 Profile (Expanded)
PHS 398 Training Budget
PHS 398 Research Training Program Plan
PHS 398 Cover Page Supplement
PHS398 Checklist

Optional Components:
PHS398 Cover Letter

Research and Related Training 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:

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 Training Program 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. A single Contact PD/PI must be designated for the purpose of communicating with the NIH, although other individuals may contact the NIH on behalf of the Contact PD/PI when necessary.

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

Applications Involving a Single Institution

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

Application Involving Multiple Institutions

When multiple institutions are involved, one institution must be designated as the prime institution, and funding for the other institutions(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 Budget Sub-award Budget Attachments(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the sub-award budget form.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review and Anticipated Start Dates
Opening Date: September 2, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): October 2, 2010, August 21, 2011, August 21, 2012
Application Due Date(s): November 2, 2010, September 21, 2011, September 21, 2012
Peer Review Date(s): February/March 2011, February/March 2012, February/March 2013
Council Review Date(s): May 2011, May 2012, May 2013
Earliest Anticipated Start Date(s): June 2011, June 2012, June 2013

3.A.1. Letter of Intent

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

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

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

The letter of intent should be sent to:

Barbara Sina Ph.D.
Division of International Training and Research
Fogarty International Center
31 Center Drive
Building 31, Room B2C39
Bethesda, MD 20892
Telephone: (301) 402-9467
FAX: 301 402-0779
Email: [email protected]

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://grants.nih.gov/grants/ElectronicReceipt/support.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:

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 CSR. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the eRA 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 periodically check 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. However, the NIH will accept a resubmission application and such an application must include an Introduction (limited to 3 pages) addressing the critique from the previous review.

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: 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 NIH Grants Policy Statement: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

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.

SF 424 Research and Related (R&R) Cover Component

SF 424 R&R Other Project Information Component:

SF 424 Senior/Key Person Profile (Expanded) Component: In addition, include at least ONE person at each of the U.S. and foreign collaborating institutions as senior/Key Personnel and list their role as Collaborator. Be sure to attach bio-sketches for the collaborators. Attach current and pending support documentation for collaborators.

Budget Pages: Use the 424 R&R Budget pages for expenses. Budget forms should be completed for the year ( Period ) for which funding is being sought. Follow the instructions below and refer to the relevant FOA specific allowable costs.

Use Section A to submit costs for Senior/Key personnel.

Use Section B to enter salary support for administrative staff.

Use Section D to submit costs for key personnel travel including annual network meeting.

Use Section F for other costs and describe fully in budget justification.

Cumulative Budget: All values on this form are calculated automatically. They present the summations of the amounts that you have entered previously, for each of the individual budget periods. Therefore, no data entry is allowed or required.

If any of the amounts displayed on this form appear to be incorrect, you may correct them by adjusting one or more of the values that contribute to that total. To make any such adjustments, you will need to revisit the appropriate budget period form(s) to enter corrected values.

PHS 398 Research Training Program Planning Components

Use the following instructions, in place of those for this section in the Instructions for SF424 Application

The components in section 2.2-2.3 (Background and Program Plan, must fit within the combined 12 page limit. The sections will be uploaded as individual pdf files, but when combined need to fit within the 12 page limit.

The instructions for the Data Tables required for this FOA have been adapted to the international focus of this planning grant FOA and are described below. The requested Data Tables ( http://grants.nih.gov/grants/funding/424/index.htm) should be included in the application at the point indicated (PHS 398 Research Training Plan, 13. Data Tables) and should not be inserted in the narrative for Sections 8.9.2-8.9.5. The information in the data tables will be used by reviewers and NIH staff during peer review and in reaching funding decisions.

Introduction to Application (Item 1) Required for Resubmission applications

Background (Item 2): Use this section to provide the rationale for the research training program and to describe the environment in which the research training program will take place. Suggested components of this section might:

Do not complete Tables 1 and 3.

For Table 2. Participating Faculty Members, include information relevant to the planning grant proposal for key personnel from all participating institutions who will be involved in the planning grant.

Program Plan (Item 3)

Include a description of the administrative structure of the planning grant and the distribution of responsibilities within it and how the PD/PI will obtain continuing advice with respect to the planning and development of the application for the future research training program.

If multiple PDs/PIs are involved in the research training program, applicants must describe how the planning process for the research training program will benefit from the arrangement and include the required Leadership Plan. See Section III.1.B and Section IV.2 in this FOA for NIH multiple PD/PI instructions: Multiple Principal Investigators, and information in Section 8.7.10 of the Research Training Program Plan Component Instructions.

This section should describe the past research training experience of the partner institutions, the PD/PI, and other key personnel that is relevant for the future research training in the LMIC. If potential preceptors/mentors are identified, provide short descriptions of relevant research and research training information for them. Include a description of the success of former trainees from the proposed or similar LMIC in establishing productive scientific careers.

Complete Tables 4-6 per directions below. Use these tables to demonstrate the ability of identified key personnel and faculty to support the research and research training of trainees from LMICs and the success of these trainees in generating publishable research results.

Complete Table 4. Grant and Contract Support of the Participating Faculty Members., Limit information to the active and pending research grants in which the PD/PIs, key personnel and mentors/faculty have played a key role. Include institution name with faculty member name. Please include source of support and grant number (if applicable), grant title, project period and current year direct costs. Indicate the PI name for each grant and the role of the faculty member in the Grant Title section.

In the narrative section, provide a short description of the funded research in Table 4 that will support the research environment and/or trainee research experience for the proposed research training program. If relevant, clearly identify the grants that are being used for eligibility for this FOA in Table 4 and in the narrative.

Complete Table 5. Pre and Postdoctoral Trainees of Participating Faculty Members- Include information for trainees who are from LMICs (indicate the country) for participating faculty from all collaborating institutions.

Complete Table 6 Publications of Research Completed by Trainees (or Potential Trainees). Only include trainee publications for the trainees listed in Table 5 that have been published in peer-reviewed journals, including local journals. Do not include abstracts, not yet accepted papers, or conference presentations and posters. These data constitute part of the Progress Report (see Section 8.9.6 Progress Report below).

Describe the specific goals, objectives of the planning grant and how it will meet the objectives outlined in the FOA and the needs of the LMIC and LMIC institution.

Describe a step-wise plan of activities to meet the objectives of the planning grant, The plan should provide enough details of the activities that will be used to accomplish the objectives for the reviewers to evaluate the probability of success.

Describe the plans for considering how to integrate any new research training into existing research capacity building activities at the LMIC institution(s). If relevant, describe how the planning process will address duplication of research training activities with other FIC research training awards in which the applicant and collaborating institutions participate.

Do not complete Tables 7A, 7B, 8A, 8B, 9A and 9B.

Recruitment and Retention Plan to Enhance Diversity (Item 4) - Not Applicable

Plan for Instruction in the Responsible Conduct of Research (item 5) - Not Applicable

Progress Report (Item 6) - Not Applicable

You do not need to complete Table 11, Appointments to the Training Grant For Each Year of the Past Award, Table 12A Predoctoral Trainees Supported by this Training Grant and Table 12B Postdoctoral Trainees Supported by this Training Grant.

Human Subjects (Item 7) - Not Applicable

Vertebrate Animals (Item 8) - Not Applicable

Select Agent Research (Item9) - Not Applicable

Follow the instructions in the SF424 Application Guide for items 10, 11,

Participating Faculty Biosketches (Item 12)- Only attach those for faculty listed in Table 4.

Data Tables (Item 13) - http://grants.nih.gov/grants/funding/424/index.htm#data. The instructions above provide guidance for completion of Data Tables 2, 4, 5, 6, which are required for all applications. The information in the data tables will be used by reviewers and NIH staff during peer review and in reaching funding decisions.

Attach one PDF file with all of the Data Tables (1-12B), although only Tables 2, 4, 5, and 6 are required for this FOA.

Letters of support (Item 14): Attach appropriate letters here from all individuals listed as Senior/Key Personnel to confirm their roles in the project. Attach letters of support from all of the participating institutions.

Research publications of trainees and mentors are not normally included as part of the Training Grant applications, but are allowed. Other types of publications reflecting on the activities of the program as a whole may also be included. When publications are allowed, appendix materials should be limited to those which are not publicly available, such as:

Do not include unpublished theses or abstracts/manuscripts submitted, but not yet accepted, for publication.

Publications that are publicly accessible must not be included in the appendix. For such publications, the URL or PMC submission identification numbers along with the full reference should be included as appropriate in the Bibliography and References Cited/Progress Report Publication List section of the Research Plan, and/or in the Biographical Sketch.

Some materials other than publications that are unique to training grant applications (but not typically included in research grant applications) may be included as appendices. The appendix may be used to provide samples of materials that are referred to in the body of the application, but are too cumbersome to include in the Training Program Plan without disrupting the narrative flow. Examples include:

i. Additional tables not requested in the SF424 (R&R) Application Guide instructions designate these by letter, rather than number, to avoid confusion with the numbered required tables;

ii. Syllabi for key courses, core courses and electives, including courses in Responsible Conduct of Research, Survival Skills for Research, etc.;

iii. Retreat, seminar series, and other program activity agendas, rosters, and schedules;

iv. Examples of forms used to document trainee progress and monitoring by the program;

v. Examples of materials used in recruitment and particularly recruitment and retention to enhance diversity of the student pool.;

vi. Lists of meetings attended by students and their presentations;

vii. Student biosketches; and

viii. Letters of support, collaboration, and commitment of institutional resources.

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.

Section V. Application Review Information

1. Criteria

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

2. Review and Selection Process

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

Review 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:

The goal of this NIH-supported research training opportunity is to help ensure that a diverse pool of highly trained scientists is available in adequate numbers and in appropriate research areas to address the biomedical, behavioral, and clinical research needs of LMICs.

Overall Impact: Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the planning grant to produce a competitive and responsive D43 application to the Global Infectious Disease Research Training Program (GID), in consideration of the following five scored review criteria, and additional review criteria (as applicable for the research training proposed).

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 scientific impact and contribute to a competitive and responsive D43 application to the Global Infectious Disease Research Training Program (GID).

Training Program and Environment:

Training Program Director(s)/Principal Investigator(s) (PD/PIs):

For applications designating multiple PD/PIs:

Preceptors/Mentors:

Training Record:

Additional Review Criteria

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

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

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

Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

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

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

Resubmission Applications: When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the program.

Renewal Applications. Renewals are not allowed for this FOA.

Additional Review Considerations

As applicable for the program 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.

Diversity Recruitment and Retention Plan: Not applicable.

Training in the Responsible Conduct of Research: Not applicable. Select Agents Research: Not applicable.

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 activities.

Selection Process

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:

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.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the Notice of Award (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.

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 Fogarty International Center (FIC) to the grantee business official.

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

Tables 12A and 12B, Enrollment and Trainee Diversity Reports - Not applicable

3.A. Additional Reporting Requirements

Financial Status Report (FSR): Al FSR is required and must be submitted within 90 days of the end of the grant budget period.

Trainee Reporting Requirements: Not applicable

Publication and Sharing of Research Results: For any journal publication that results from this planning grant, NIH support should be acknowledged in language similar to the following: This investigation was supported by the Fogarty International Center, (add NIH co-sponsoring institutes, centers or offices for the grant) of the National Institutes of Health under the (Global Infectious Disease Research Training Program (grant number). In addition, news releases and other documents about the project must acknowledge federal funding as provided in Public Policy Requirements and Objectives-Availability of Information-Acknowledgment of Federal Funding.

Peer-reviewed publications that arise from support of the planning grant must be submitted to PubMed Central in accord with the Public Access Policy, and the PubMed Central reference number (PMCID) or NIH Manuscript Submission reference number (NIHMS ID) provided. If the publication was already submitted because it also arose as the result of other NIH support, simply provide the PMCID or NIHMS ID. If the PMCID is not yet available because the Journal submits articles directly to PMC on behalf of their authors, indicate "PMC Journal - In Process." A list of these Journals is posted at:http://publicaccess.nih.gov/submit_process_journals.htm

Evaluation: In carrying out its stewardship of human resources-related programs, the NIH may request information essential to an assessment of the effectiveness of this Program.

Inventions: Not applicable

Copyrights: Except as otherwise provided in the terms and conditions of the award, the recipient is free to arrange for copyright without approval when publications, data, or other copyrightable works are developed in the course of work under a PHS grant-supported project or activity. Any such copyrighted or copyrightable works shall be subject to a royalty-free, nonexclusive, and irrevocable license to the Government to reproduce, publish, or otherwise use them, and to authorize others to do so for Federal Government purposes.

Final Reports: A Final Progress Report and Financial Status Report are required at the end of the grant project period or upon relinquishment of an award. Evaluation results should be included as part of the Final Progress Report.

Human Embryonic Stem Cells (hESC): Only approved hESC lines listed on the NIH Human Embryonic Stem Cell Registry http://stemcells.nih.gov/registry/ may be used for research training activities. The abstract of the application must provide the registry identifying numbers of the HESC lines to be used.

Failure by the grantee institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award. Forms may be found on the NIH Website at http://grants.nih.gov/grants/forms.htm.

Section VII. Agency Contacts

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

1. Scientific/Research Contact(s):

Barbara Sina Ph.D.
Division of International Training and Research
Fogarty International Center
31 Center Drive
Building 31, Room B2C39
Bethesda, MD 20892
Telephone: (301) 402-9467
FAX: 301 402-0779
Email: [email protected]

2. Peer Review Contact(s):

Dan Gerendasy, Ph.D
Biology of Development and Aging IRG
Center for Scientific Review
6701 Rockledge Drive, Room 5136
Bethesda, MD 20892-7840
Telephone: (301) 408-9164
FAX: 301 480-3567
Email: [email protected]

3. Financial/Grants Management Contact(s):

Ms. Angela Smith
Grants Management Office
Fogarty International Center
31 Center Drive
Building 31, Room B2C29
Bethesda, MD 20892
Telephone: (301) 402-9592
FAX: 301 594-1211
Email: [email protected]

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), Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 287b) and under Federal Regulations 42 CFR 63A, 42 CFR 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 NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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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