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)
National Cancer Institute (NCI) ( http://www.cancer.gov)
National Institute of Environmental Health Sciences (NIEHS) ( http://www.niehs.nih.gov)
National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/index.shtml)
National Institute on Aging (NIA) (http://www.nia.nih.gov)
National Eye Institute (NEI) (http://www.nei.nih.gov/)
Office of Dietary Supplements, Office of the Director (ODS) ( http://dietary-supplements.info.nih.gov)
National Institute of Neurological Disorders and Stroke (NINDS) ( http://www.ninds.nih.gov)
National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov/)

Title: Limited Competition for the Global Research Initiative Program, Basic/Biomedical Sciences (R01)

Announcement Type
This Funding Opportunity Announcement (FOA) is a reissue of PAR-07-239

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

• December 8, 2011 - See Notice NOT-TW-12-003. Notice of Termination effective March 9, 2012, for both AIDS and non-AIDS applications.
• August 26, 2011 - See Notice NOT-TW-11-027. This Notice redefines the Eligible PD/PIs to allow for increased opportunities for NIH supported Low- and Middle-Income Countries (LMIC) trainees to apply for this program, and clarifies that the intent of Global Initiative Research Program (GRIP) is to support independent research.
• August 16, 2010 - 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.

Program Announcement (PA) Number: PAR-10-278

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

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

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

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

Catalog of Federal Domestic Assistance Number(s)
93.989, 93.866, 93.113, 93.398, 93.242, 93.396, 93.853 93.286

Key Dates
Release/Posted Date: September 15, 2010
Opening Date: December 10, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): December 10, 2010, December 10, 2011, December 10, 2012
AIDS Letters of Intent Receipt Date(s): February 10, 2011, February 9, 2012, February 8, 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): January 10, 2011, January 10, 2012, (January 10, 2013 Date Removed per NOT-TW-12-003)
AIDS Application Due Date(s): March 10, 2011, March 9, 2012, (March 8, 2013 Date Removed per NOT-TW-12-003)
Peer Review Date(s): June/July 2011, June/July 2012, June/July 2013
Council Review Date(s): October 2011, October 2012, October 2013
Earliest Anticipated Start Date(s): December 2011, December 2012, December 2013
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: (New Date March 9, 2012 per NOT-TW-12-003), Original Date March 9, 2013

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

• Purpose. This Funding Opportunity Announcement (FOA) issued by the Fogarty International Institute (FIC), the National Cancer Institute (NCI), the National Institute on Aging (NIA), the National Institute of Environmental Health Sciences (NIEHS), the Office of Dietary Supplements, Office of the Director (ODS), the National Eye Institute (NEI), the National Institute of Mental Health (NIMH), the National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Biomedical Imaging and Bioengineering (NIBIB) encourages Research Project Grant (R01) applications from institutions/organizations that propose to conduct basic biomedical research relevant to global health. This program is intended to promote productive development of foreign investigators from low- and middle-income countries (LMICs), trained in the U.S. or in their home countries through an eligible NIH funded research or research training grant/award. It is expected that this program will stimulate research on a wide variety of high priority health-related issues in those countries, and advance NIH efforts to address important global health issues.
• Mechanism of Support. This FOA will utilize the NIH Research Project (R01) grant mechanism.
• Funds Available and Anticipated Number of Awards. The total amount to be awarded is $325,000 and the anticipated number of awards is six. 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 may also vary. The total amount to be awarded and the number of awards will depend upon the quality and costs of the applications received.
• Budget and Project Period. Budgets for direct costs of up to $50,000 per year and project duration of up to 5 years may be requested for a maximum of $250,000 direct costs over a 5-year project period.
• Application Research Strategy Length: The R01 Research Strategy section may not exceed 12 pages, including tables, graphs, figures, diagrams, and charts. See Table of Page Limits.
• Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.
• Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/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.
• Applicants must meet all the following three requirements: (1) Low- and middle-income country LMIC scientists, who completed their research training within 4 years prior to the receipt date of this GRIP announcement or who will have completed their research training by the start date of the proposed project; (2) The research training must be supported under the following NIH funded research or research training grant/award: NIH Intramural Visiting Fellow Programs, FIC supported training programs (D43, U2R, and R24), NIDA INVEST/Humphrey Fellowship, and International Research Fellowship Program (F05 or equivalent), NIEHS LMIC trainees under R01, NIA LMIC trainees under R01, R37, and P01, FIC LMIC trainees under FIC TOBAC Program (R01), NICHD LMIC trainees under the Global Partnerships for Social Science AIDS Research (R24) and the Global Network for Women’s and Children’s Health Research (U01); (3) At least two years of research training experience, or at least one year of training experience plus one additional year of well documented mentored research.
• LMIC scientists who propose to conduct infectious diseases research and/or are not eligible for GRIP may consider applying for NIAID’s International Research in Infectious Diseases including AIDS (IRIDA) Program (R01) (http://grants.nih.gov/grants/guide/pa-files/par-08-130.html.
• Number of PDs/PIs. Only one PD/PI may be designated on the application.
• Number of Applications. Applicants may submit more than one application, provided that each application is scientifically distinct.
• Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).
• Renewals. Renewal applications are not permitted in response to this FOA.
• Special Date(s). This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates
• Application Materials. See Section IV.1 for application materials.
• General Information. For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites:
  • SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm
  • General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/
• Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: (301) 451-5936

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Anticipated Announcement and Award Dates

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

Section VII. Agency Contacts
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

This program is intended to promote productive development of foreign investigators from LMIC, trained in the U.S. or in their home countries through NIH funded research or research training programs, which are to enhance the scientific research infrastructure in LMIC, to stimulate research on a wide variety of high priority health-related issues of importance in those countries, and to advance NIH efforts to address health issues of global importance.

The specific goal of this initiative is to provide funding opportunities for the increasing pool of foreign basic and biomedical scientists, upon their return to their home countries, with state-of-the-art knowledge of research methods to advance the critical issues in global health through basic and biomedical sciences research.

After their term of research training, LMIC participants supported by this announcement are expected to continue independent and productive scientific careers, including providing expert training and consultation to others, and/or research on basic and biomedical science issues within their home institutions.

This announcement contributes to the FIC mission and the broad NIH initiative to reduce health disparities among nations by strengthening research infrastructure in LMIC, particularly those with the least economic resources. It also provides the opportunity for recently trained international health and health care researchers to continue their projects after returning home.

Definitions of basic science and biomedical science. For the purposes of this initiative, the term basic science refers to laboratory studies that are not aimed at specific problems, but that provide the necessary knowledge and background for later applied research or the fundamental approach to understanding how systems work. Basic research takes place in the laboratory and often involves studies at genetic, molecular, cellular, systems and behavioral levels. The term biomedical science encompasses applied science that deals with human and animal health including the study, research and knowledge of health and the application of that knowledge to improve health, cure diseases, and increase our understanding of how humans and animals function.

Through various programs, the NIH has made a significant investment in training biomedical and behavioral researchers. For example, the NIH Visiting Fellows Program currently hosts more than 1,600 junior scientists from almost 100 countries for periods of one to five years. In addition, the NIH D43 research training and capacity building and the U2R cooperative agreement grant mechanisms allow hundreds of foreign researchers to receive training at prominent institutions in both the U.S. and their home countries in a range of biomedical and behavioral research areas critical to advancing global health. Training supported by NIH is critical to these young investigators as they develop independent research careers.

As junior scientists complete training programs in the U.S. and in their home institutions under FIC D43, U2R and R24 programs, many find it difficult to secure the support needed to continue their research projects and careers as independent researchers in their home countries. This Global Research Initiative Program (GRIP) provides the opportunity for junior foreign scientists to compete for such funds through a peer-reviewed process. This is a critical adjunct in the continuation of promising independent research careers that will be of benefit to the investigators home countries and the world at large. Women and underrepresented minority scientists in their countries are especially encouraged to apply for these re-entry grants. Project proposals should be geared toward the research interests of the applicant and the focus on high-priority health and health care problems in the investigator’s home country that also carry global importance, and are of interest to the collaborating NIH Institutes, Centers and Offices (ICs) listed on the first page of this announcement, as well.

It is expected that research topics will be diverse. Specific research interests of participating NIH ICs can be found on the ICs websites, as listed in the beginning of this announcement. Research related to women’s health, including studies of gender differences in disease onset and progression, are particularly encouraged. Research related to the health effects of human exposures to environmental agents is encouraged. We also encourage applications on studies of single ingredients or complex mixtures that examine the transport, metabolism, mechanism of action, associated enzymes, binding sites, regulatory mechanisms or excretion of dietary supplements in order to elucidate their physiological or biochemical role. Also of interest is the development of improved methodology for the isolation and characterization of constituents of natural products and on their determination in the natural matrix.

All research must be performed in accordance with NIH and U.S. Government (USG) regulations regarding the responsible conduct of research. This announcement precludes the support of research involving enrollment in pilot studies for clinical trials or the actual support of clinical trials since the resources and infrastructure to support and oversee such trials generally exceed the resources available under this award mechanism. Applicants are encouraged to visit the website of the Office for Human Research Protections (OHRP) (http://www.hhs.gov/ohrp), which outlines these regulations. For information on animal protection in research, see http://grants.nih.gov/grants/olaw/olaw.htm.

This announcement contributes to the FIC mission and to the broad NIH initiative to reduce the health disparities among nations by strengthening research infrastructure in developing countries, particularly those with the least economic resources. Additionally, it provides the opportunity for recently trained international health and health care researchers to continue their projects after returning home.

The GRIP program is to move research trainees to the status of independent investigator, there are several outcomes to be expected:

• Development of the laboratory capabilities or research projects;
• Training of other potential researchers;
• Publications in international peer-reviewed journals, as well as local journals;
• Participation in workshops, seminars, and international conferences;
• Collaborations with past mentors, as well as other U.S., international, or local researchers;
• Attraction of funding from other sources.

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

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

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

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 IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

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

An applicant can request up to $50,000 per year in direct costs, plus facilities and administrative (F & A) costs to a maximum of eight percent for a foreign institution. Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

The estimated amount of funds available for support of 6 projects awarded as a result of this announcement is $325,000 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.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application(s) if your home institution/organization is a Non-Domestic (non-U.S.) Entity (Foreign Organization) in a low- and middle-income country, based on Gross National Income (GNI) per capita, as classified by the World Bank ( http://data.worldbank.org/about/country-classifications/country-and-lending-groups), and is one of the following organizations/institutions that are eligible to apply:

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education
• Non-domestic (non-U.S.) Entities (Foreign Organizations)

Only institutions in low- and middle-income countries are eligible to apply. Institutions in countries that have the least economic resources are particularly encouraged to apply. For the purposes of this announcement, Hong Kong and Taiwan are considered high income, and thus not eligible.

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.

Only one PD/PI may be designated on the application responding to this FOA. The PD/PI must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (seehttp://grants.nih.gov/grants/ElectronicReceipt/preparing.htm for instructions).

Only applicants from institutions in eligible countries may apply. FIC strongly encourages applications from women and individuals from underrepresented racial, ethnic and socially disadvantaged groups.

In order to be eligible, applicants must meet all the following three requirements:

• LMIC scientists, who completed their research training within 4 years prior to the receipt date of this GRIP announcement or who will have completed their research training by the start date of the proposed project;
• The research training must be supported under the following NIH funded research or research training grant/award:
  • NIH Intramural Visiting Fellow Programs;
  • FIC supported training programs (D43, U2R, and R24);
  • NIDA INVEST or Humphrey Fellowship;
  • International Research Fellowship Program (F05 or equivalent);
  • NIEHS supported LMIC trainees under R01;
  • NIA supported LMIC trainees under R01, R37, and P01;
  • LMIC trainees of the TOBAC program (R01);
  • NICHD supported LMIC trainees of the Global Partnerships for Social Science AIDS Research (R24), and the Global Network for Women’s and Children’s Health Research (U01).
• At least two years of research training experience, OR at least one year of training experience plus one additional year of well documented mentored research.

All such training and research must either have been done in the U.S. or have been part of in-country research associated with a degree or mentored post-doctoral research under the D43, U2R or R24 award mechanism and completed within four years of the receipt date of this announcement.

Candidates who are more than four years beyond their training, but who have interrupted their careers because of illness or family commitments, may also apply. They must clearly explain the interrupted hiatus and must clearly demonstrate the potential for productive independent research.

Current NIH Visiting Fellows are encouraged to apply in a timely fashion, i.e., as they begin their preparation to return home. They, as all applicants, may apply within four years of completing training.

Applicants must return to a research position in their home country institution or in another LMIC in order to carry out research supported by this award. The award will be made to the home institution on the investigator’s behalf only after the investigator has arrived in that country. Therefore, the application must be submitted by the institution to which the applicant has returned or will be returning. It is expected that the PI will demonstrate that he/she has an appointment at an academic or other institution in his/her home country and will demonstrate or provide a letter of support indicating that the institution will have the capacity to support the research proposed. The GRIP award will support up to one-half the investigator s salary, commensurate with the salary structure of the home institution. Funds from the institution, national government, local science research council or other public or private organization may be used to support this program. The remainder of the U.S. funds from this grant may pay for equipment, travel, supplies, or other research personnel’s salary working on the same project.

In order to build upon experience, partnership, mentorship and prior investments, applicants are encouraged to submit applications in collaboration with the NIH-supported institution or intramural laboratory from which they have received or are receiving research training, although such collaborations are not imperative. Through letters of support, U.S. collaborators should demonstrate how this program will support ongoing research collaborations. For those applicants who are eligible through both a year of training and a year of significant, well-documented, mentored research, letters of support should be received from both mentors.

While recognizing that this program is intended to foster the independence of the applicant, FIC recognizes the value of continued collaboration with NIH or other U.S. mentors. This relationship should be documented in the application.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

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

Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications are permitted only a single amendment (A1). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Original new and competing renewal applications that were submitted prior to January 25, 2009 are permitted two amendments (A1 and A2). For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.

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

Section IV. Application and Submission Information

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

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered on-time (see 3.C.1 for more information about on-time submission).

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

• Grants.gov (http://www.grants.gov/applicants/get_registered.jsp) and
• eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm)

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 http://www.grants.gov/applicants/get_registered.jsp

• Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
• If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
• The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
• Direct questions regarding Grants.gov registration to:
  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

2) Organizational/Institutional Registration in the eRA Commons

• To find out if an organization is already Commons-registered, see the "List of Grantee Organizations Registered in NIH eRA Commons.
• Direct questions regarding the Commons registration to:
  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.

• The individual(s) designated as PDs/PIs on the application must be registered also in the NIH eRA Commons. In the case of multiple PDs/PIs, all PDs/PIs must be registered and be assigned the PI role in the eRA Commons prior to the submission of the application.
• Each PD/PI must hold a PD/PI account in the Commons. Applicants should not share a Commons account for both an Authorized Organization Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have both a PD/PI role and an Internet Assisted Review (IAR) role, both roles should exist under one Commons account.
• When multiple PDs/PIs are proposed, all PDs/PIs at the applicant organization must be affiliated with that organization. PDs/PIs located at another institution need not be affiliated with the applicant organization, but must be affiliated with their own organization to be able to access the Commons.
• This registration/affiliation must be done by the AOR/SO or his/her designee who is already registered in the Commons.

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

1. Request Application Information

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

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

For further assistance, contact GrantsInfo -- Telephone 301-710-0267, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

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

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

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

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

• Request budgets in U.S. dollars;
• Prepare detailed budgets for all 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);
• Not include any charge-back of customs and import fees;
• Comply with the format specifications, which are based upon a standard U.S. paper size of 8.5 x 11 within each PDF;
• If appropriate, request funds for up to 8% Facilities and Administrative (F&A) costs (excluding equipment) ( see NOT-OD-01-028, March 29, 2001);
• Comply with Federal/NIH policies on human subjects, animals, and biohazards; and
• Comply with Federal/NIH biosafety and biosecurity regulations (see Section VI.2., Administrative and National Policy Requirements )

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

Not applicable.

Applications Involving a Single Institution

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

Applications Involving Multiple Institutions

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

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

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review and Anticipated Start Dates
Release/Posted Date: September 15, 2010
Opening Date: December 10, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): December 10, 2010, December 10, 2011, December 10, 2012
AIDS Letters of Intent Receipt Date(s): February 10, 2011, February 9, 2012, February 8, 2013
Application Due Date(s): January 10, 2011, January 10, 2012, January 10, 2013
AIDS Application Due Date(s): March 10, 2011, March 9, 2012, March 8, 2013
Peer Review Date(s): June/July 2011, June/July 2012, June/July 2013
Council Review Date(s): October 2011, October 2012, October 2013
Earliest Anticipated Start Date(s): December 2011, December 2012, December 2013

3.A.1. Letter of Intent

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

• Descriptive title of the proposed research training.
• Name, address, and telephone number of the PD(s)/PI(s).
• Names of other key personnel.
• Participating institutions.
• Number and title of this funding opportunity.

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:

Xingzhu Liu, MD, PhD
Division of International Training and Research
Fogarty International Center
31 Center Drive, MSC 2220
Building 31, Room B2C39
Bethesda, MD 20892-2220
Telephone: (301) 496-1653
Fax: (301) 402-0779
Email: liuxing@mail.nih.gov

3.B. Submitting an Application Electronically to the NIH

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

• All registrations must be complete prior to the submission deadline
• The application must receive a Grants.gov tracking number and timestamp (or eRA help desk ticket confirming a system issue preventing submission) by 5:00 p.m. local time on the submission deadline date.
• Any system identified errors/warnings must be corrected and the submission process completed within the error correction window.

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

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

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

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

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

Please note that the following caveats apply:

• Initial application submission must be on-time.
• The AOR/institutions is expected to enforce that application changes made within the error correction window are restricted to those necessary to address system-identified errors/warnings. NIH may reject any application that includes additional changes.
• Proof of on-time submission (e.g., Grants.gov timestamp and tracking number) and description of all changes made within the window must be documented in the PHS 398 Cover Letter component of the application.

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.

• If everything is acceptable, no further action is necessary. The application will automatically move forward to the Division of Receipt and Referral in the Center for Scientific Review for processing after two weekdays, excluding Federal holidays.
• Prior to the submission deadline, the AOR/SO can Reject the assembled application and submit a changed/corrected application within the two-day viewing window. This option should be used if it is determined that some part of the application was lost or did not transfer correctly during the submission process, the AOR/SO will have the option to Reject the application and submit a Changed/Corrected application. In these cases, please contact the eRA Help Desk to ensure that the issues are addressed and corrected. Once rejected, applicants should follow the instructions for correcting errors in Section 2.12 of the SF 424 (R&R) application guide, including the requirement for cover letters on late applications. The Reject feature should also be used if you determine that warnings are applicable to your application and need to be addressed now. Remember, warnings do not stop further application processing. If an application submission results in warnings (but no errors), it will automatically move forward after two weekdays if no action is taken. Some warnings may need to be addressed later in the process.
• If the two-day window falls after the submission deadline, the AOR/SO will have the option to Reject the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn t transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue.
• If the AOR/SO chooses to Reject the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted, but it will be subject to the NIH late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment.
• Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two weekdays.

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 Commonshttps://commons.era.nih.gov/commons/. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on 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. However, the NIH will accept a resubmission application, but such application must include an Introduction 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 are not allowed.

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.

PHS398 Research Plan Component Sections

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

• Introduction (required for a resubmission or revision application) is limited to 1 page.
• Specific Aims is limited to 1 page.
• Research Strategy, including tables, graphs, figures, diagrams, and charts, is limited to 12 pages. See Table of Page Limits.

Budget Component

Applicants may request direct costs of up to $50,000 per year. The total direct costs must be requested in accordance with the program guidelines and the instructions described below:

• Under Personnel: List all project personnel, including their names, percent of effort, and roles on the project. The PI is expected to devote at least 50 percent of his/her total effort to this project. The PI may only request support of up to 50 percent of his/her total effort on this project. The PI’s salary and any other salaries should be commensurate with the salary structure at the applicant institution.

• Under Facilities and Administrative (F & A) Costs: F & A costs of up to eight percent should be shown under the calculation section on the Checklist page. The F & A costs calculation may not exceed eight percent of total direct costs less equipment. Applicants do not need to complete the section regarding agreements above the calculation section. Applicants should mark the modified total direct costs base box below the calculation section.

Other Requirements

• In the biosketch, the application needs to document her/his eligibility, including the name/title of the training or research program, the funding mechanism, the specific grant/award (project number,, title, and name of PI, name of the mentor), the dates of the training/research experience, a description of the training/research experience including courses taken, and a summary of the program and of the research. Include evidence of at least two years of training or one year of training plus one year of significant, well-documented mentored research (i.e., add the specific grant number under which the training was done and the name of the Principal Investigator). The applicant should list the date that he/she returned or expects to return to his/her home country. This must be written within the four page limit of the biosketch and should not be written as the Appendix to circumvent the page limitations.
• The applicant must have a letter from the home institution describing its involvement in the proposed research plan and the support to it including any financial and/or in-kind anticipated support. The letter should also addresses the abilities of the applicant, specifically indicating the ability to become a leader in scientific pursuits. Please attach a PDF document and include it in Item 14 of the Research Plan.
• All applications should include a letter from the mentor outlining the nature of a potential future collaborative relationship between the applicant and the mentor, and how the mentor will support a continued collaboration with the investigator, using all appropriate resources. The letter should also indicate the dates of research training/research experience and a summary of the program. For applicants eligible through one year of research training plus one year of significant mentored Please attach a PDF document and include it in Item 14 of the Research Plan
• Checklist: this page should be completed and submitted with the application. Applications submitted by foreign or international institutions can request F & A costs up to a maximum of eight percent. Please see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html for more information on the allow ability of F & A costs for foreign and international organizations.

Upon receipt, applications will be evaluated for completeness by the CSR. Incomplete applications will not be reviewed.

Appendix Materials

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

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

Resource Sharing Plan(s)

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 should 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

Section V. Application Review Information

1. Criteria

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

2. Review and Selection Process

Review Process

Applications 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 scientific review group(s) convened by the Center of Scientific Review (CSR) in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.

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

• Undergo a selection process in which only those applications deemed to have the highest scientific and technical merit, generally the top half of applications under review, will be discussed and assigned an impact/priority score;
• Receive a written critique; and
• Receive a second level of review by the Fogarty International Center Advisory Board and the appropriate national advisory council or board of co-sponsoring partners.

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

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project 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 major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria

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

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

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

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

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

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 project.

Renewal Applications. Renewals are not allowed for this FOA.

Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

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

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

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

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

Selection Process

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

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Geographic balance.
• Level of need, as measured by economic resources in the applicant’s home country.

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

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

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Section IV.5., Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.

3. Reporting

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

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

Section VII. Agency Contacts

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

1. Scientific/Research Contact(s):

FIC/NIH:

Xingzhu Liu, MD, PhD
Division of International Training and Research
Fogarty International Center
31 Center Drive, MSC 2220
Building 31, Room B2C39
Bethesda, MD 20892-2220
Telephone: (301) 496-1653
Fax: (301) 402-0779
Email: liuxing@mail.nih.gov

NCI/NIH:

Susan A. McCarthy, Ph.D.
Program Director for Molecular Immunology
Cancer Immunology and Hematology Branch
Division of Cancer Biology
National Cancer Institute
EPN Room 5058
6130 Executive Boulevard, MSC 1360
Rockville, MD 20892-1360
Telephone: (301) 496-7815, (301) 594-8785
Fax: (301) 480-2844
Email: mccarths@mail.nih.gov

NEI/NIH:

Lisa Neuhold, Ph.D.
Program Director
Retinal Diseases
5635 Fishers Lane
Building 5635FL, Suite 1300
Rockville, MD 20892
Telephone: (301) 451-2020
Fax: 301-402-0528
Email: lneuhold@nei.nih.gov

NIA/NIH:

Tamara Jones, Ph.D.
International Research Activities Coordinator
National Institute on Aging
Building 31, Room 5C05
31 Center Drive, MSC 2292
Bethesda, MD 20892-2292
Telephone: (301) 451-8835
Fax: (301) 496-2793
Email: tamjones@nia.nih.gov

NIEHS/NIH:

David M. Balshaw, Ph.D.
Center for Risk and Integrated Sciences
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, EC-27
79 T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: (919) 541-2448
Fax: (919) 541-4937
Email: Balshaw@niehs.nih.gov

NINDS/NIH:

Yuan Liu, Ph.D.
Chief, Office of International Activities
National Institute of Neurological Disorders and Stroke
NSC, 6001 Executive Boulevard, Room 2187
Bethesda, MD 20892-9523
Telephone: (301) 496-0012
Fax: (301) 402-1501
Email: liuyuan@ninds.nih.gov

ODS/OD/NIH:

Mary Frances Picciano, Ph.D.
Senior Nutrition Research Scientist
Office of Dietary Supplements
Office of the Director
National Institutes of Health
6100 Executive Boulevard, Room 3B01
Bethesda, MD 20892-7517
Telephone: (301) 435-3608
Fax: (301) 480-1845
Email: piccianm@od.nih.gov

NIBIB/NIH:

John Haller, Ph.D.
Program Director
Division of Applied Science and Technology
Democracy Plaza II, Suite 200
Telephone: (301)-451-4780
Fax: (301)-489-1614
Email: John.Haller@nih.gov

2. Peer Review Contact(s):

Dan Gerendasy, Ph.D.
Scientific Review Administrator
International Cooperative Programs
Center for Scientific Review
6701 Rockledge Drive, Room 5132
Bethesda, MD 20892-7843 (use ZIP 20817 for overnight mail)
Telephone: (301) 594-6830
Fax: (301) 480-1677
Email: gerendad@csr.nih.gov

3. Financial/Grants Management Contact(s):

Rhea Hubbard
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: hubbardrhea@mail.nih.gov

Section VIII. Other Information

Required Federal Citations

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

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

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

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

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

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

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

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

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

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

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

Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

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

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

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

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

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

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

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

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