and Human Services (HHS)
EXPIRED
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 Eye Institute (NEI) (http://www.nei.nih.gov)
National Institute on Aging (NIA) (http://www.nia.nih.gov)
National Institute of Biomedical Imaging and
Bioengineering (NIBIB) ( http://www.nibib.nih.gov/)
National Institute of Environmental Health Sciences
(NIEHS) ( http://www.niehs.nih.gov)
National Institute on Neurological Disorders and
Stroke (NINDS) ( http://www.ninds.nih.gov)
Office of Dietary Supplements, Office of the Director
(ODS) ( http://dietary-supplements.info.nih.gov)
Title: Global
Research Initiative Program, Basic/Biomedical
Sciences (R01)
Announcement Type
This
is a conversion of PAR-06-394, to
accommodate for the electronic grant application process.
Update: The following update relating to this announcement has been issued:
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.
Program Announcement (PA) Number: PAR-07-239
Catalog of Federal
Domestic Assistance Number(s)
93.989, 93.396, 93.866, 93.853, 93.113,
93.114, 93.115, 93.286
Key Dates
Release/Posted Date: March 1, 2007
Opening Date: July 21, 2007 (Earliest date an application may be submitted to
Grants.gov).
Letters of Intent Receipt Date(s): August 21, 2007; August 21, 2008; August 21, 2009 (per issuance of NOT-TW-09-005)
AIDS Letters of Intent Receipt Date(s): November 19, 2007; November 18, 2008; November 18, 2009 (per issuance of NOT-TW-09-005)
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 Receipt Date(s): September 21, 2007; September 22, 2008: September 22, 2009 (per issuance of NOT-TW-09-005)
AIDS Application Submission/Receipt Date(s): December 18, 2007; December 18, 2008; December 18, 2009 (per issuance of NOT-TW-09-005)
Peer
Review Date(s): February/March 2008; February/March 2009; February/March 2010 (per issuance of NOT-TW-09-005)
Council Review Date(s): May 2008; May 2009
Earliest Anticipated Start
Date(s): July 2008; July 2009; July 2010 (per issuance of NOT-TW-09-005)
Additional Information To Be
Available Date (Activation Date): Not Applicable
Expiration: New Date December 19, 2009 (per issuance of NOT-TW-09-005) December 19, 2008
Due Dates for E.O. 12372
Not Applicable
Additional
Overview Content
Executive Summary
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria
Section
IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and
Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application
Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
Section VII. Agency 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
As part of its global health initiative under the Department of Health and Human Services (DHHS), the Fogarty International Center (FIC), in partnership with the National Cancer Institute (NCI), the National Institute on Aging (NIA), the National Institute of Biomedical Imaging and Bioengineering (NIBIB), the National Institute of Environmental Health Sciences (NIEHS), the National Institute on Neurological Disorders and Stroke (NINDS), and the Office of Dietary Supplements/Office of the Director (ODS/OD), invites applications from current and former NIH-supported foreign research trainees to compete for funds that will support their research efforts upon their return to their home countries. In order to be eligible, foreign scientists must meet at least one of the following criteria:
All such training and research must 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 or other eligible award mechanism as described above and completed within four years of the receipt date of this announcement.
Candidates who are more than five years beyond their training, but who have interrupted their careers because of illness or family commitments, may also apply. These candidates must clearly explain the interruption and must clearly demonstrate the potential for productive independent research.
Current NIH Intramural 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.
Through various programs, the NIH has made a significant investment in training basic science and biomedical researchers. For example, the NIH Intramural 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 basic science and biomedical research areas critical to advancing global health. In summary, 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 or U2R programs, many find it difficult to secure the support needed to continue their research projects and careers as independent researchers in their home countries. The 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 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 participating NIH Institutes, Centers and Offices (ICs) listed in the beginning 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. 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 the broad NIH initiative to reduce the health disparities among nations by strengthening research infrastructure in low- to middle-income 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.
Evaluation of the program will occur on an ongoing basis. Because this is a program to move research trainees to the status of independent investigator, there are several outcomes to be measured:
As part of its assessment of the impact and scientific productivity of this program, FIC plans to track researchers and their trainees for at least ten years after beginning their independent research. Evaluation may focus on the successes of researchers (as measured by the number and quality of publications, presentations, courses, awards, subsequent employment, etc.), their sustained commitment to research careers, their ability to attract funding for their work, their contributions to future international collaborations, their influence on the development of scientific research in their countries, and their ability to act as consultants, teachers and role models to other local investigators and further disseminate the lessons learned. Applicants should describe potential metrics that would indicate the success of the individual researcher and the success in capacity building at the home institution, including the impact of the program on research at the institution in the home countries of researchers and their trainees.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this
announcement.
Section
II. Award Information
1. Mechanism of Support
This Funding
Opportunity Announcement (FOA) will use the NIH Research Project Grant (R01) award mechanism.
The applicant will be solely responsible for planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts. It also uses the non-modular budget format (see http://grants.nih.gov/grants/funding/modular/modular.htm).
All
foreign applicants must complete and submit budget requests using the Research
& Related Budget component found in the application package for this FOA. See NOT-OD-06-096,
August 23, 2006.
This award is non-renewable. An investigator cannot receive a second award in
this program.
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 may also vary. Although the financial
plans of the Institutes and Centers (ICs) provide support for this program,
awards pursuant to this funding opportunity are contingent upon the
availability of funds and the submission of a sufficient number of meritorious
applications.
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.
The participating organization(s), the Fogarty International Center (FIC), the National Cancer Institute (NCI), the National Institute on Aging (NIA), the National Institute of Biomedical Imaging and Bioengineering (NIBIB), the National Institute of Environmental Health Sciences (NIEHS), the National Institute of Neurological Disorders and Stroke (NINDS), and the Office of Dietary Supplements/Office of the Director (ODS/OD), intend to commit approximately $300,000 in fiscal years 2007 and 2008 to fund six applications per year.
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.
F&A costs requested by consortium participants are not
included in the direct cost limitation. See NOT-OD-05-004,
November 2, 2004.
Section
III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit an
application(s) if your institution/organization has any of the following
characteristics:
Only institutions in low- to middle-income ( developing ) 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, a low- to middle-income country is defined as a country that has a Gross National Income (GNI) per capita below $10,000, according to the World Bank classification system (refer to the GNI per capita ranking in the left-hand column labeled Atlas Methodology at http://www.finfacts.com/biz10/globalworldincomepercapita.htm). (Do NOT refer to the right-hand column headed Purchasing Power Parity.) For the purposes of this announcement, institutions in the following countries or geographical regions are eligible: North Africa, West Africa, East Africa, Central Africa, Southern Africa, Russia, the Newly Independent States, Eastern Europe (except Slovenia), the Middle East (except Israel), India, Asia (except Japan, Singapore, South Korea and Taiwan), the Pacific Islands region (except Australia and New Zealand), Latin America and the Caribbean.
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 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 at least one of the following criteria:
1. At least two years of research training experience under an FIC-supported training grant (classified by the D43 international training grant mechanism or the U2R cooperative agreement mechanism).
2. One year of such D43 or U2R training experience coupled with one year of significant, well-documented mentored research experience (e.g., through an NIH research award such as NIAID Small Research (R03) (IRID-NIAID) program).
3. One year of the NIDA INVEST or Humphrey Fellowships plus at least one additional year of mentored research (http://www.drugabuse.gov/International/HHHRF.html).
4. At least two years of research training experience through the NIH Intramural Visiting Fellows Program.
5. One year of training through an F05 international fellowship program and one subsequent year of mentored research.
6. Recipients of Long-Term Fellowship awards through the Human Frontier Science Program, who come from low- and middle-income countries, and who have spent at least two years in research training.
7. At least one year of training in the U.S. and one additional year of significantly mentored research, in the U.S. or abroad, leading to a completed master’s degree or doctoral degree, at least partially funded through a Fogarty International Center research training program, with pre-approval by the program director.
8. Foreign researchers from low- to middle-income countries mentored under NIEHS R01, R37, and P01 programs described at http://www.niehs.nih.gov/dert/programs/capacity.htm.
All training and research, to meet eligibility requirements, must 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 or U2R award mechanism, and completed within four years of the receipt date of this announcement.
Applicants must return to a research position in their home country institution or in another low- to middle-income country 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 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.
Only one PD/PI may be designated on the application responding to this announcement. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
2.
Cost Sharing or Matching
This program does not require cost
sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special
Eligibility Criteria
Applicants
may submit only one application to this program per cycle and may only receive
one such award overall.
Section IV. Application and Submission Information
To download a SF424
(R&R) Application Package and SF424 (R&R) Application Guide for
completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/applicants/apply_for_grants.jsp and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Registered
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Both the PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application Information
Applicants must
download the SF424 (R&R) application forms and 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 and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The SF424 (R&R) application 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., Special Instructions, regarding appropriate
required budget component.)
Research
& Related Budget (required for foreign applications)
Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form
Foreign
Organizations (Non-domestic (non-U.S.) Entity)
NIH policies concerning grants to
foreign (non-U.S.) organizations can be found in the NIH Grants Policy
Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from foreign organizations must:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
SPECIAL INSTRUCTIONS
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.
3.
Submission Dates and Times
See Section IV.3.A. for details.
3.A.
Submission, Review, and Anticipated Start Dates
Opening Date: July 21, 2007 (Earliest
date an application may be submitted to Grants.gov) .
Letters of Intent Receipt Date(s): August 21, 2007; August 21, 2008.
AIDS Letters of Intent Receipt Dates: November 19, 2007; November 18, 2008.
Application
Submission/Receipt Date(s): September
21, 2007; September 22, 2008.
AIDS Application Receipt Dates: December 18, 2007; December 18, 2008.
Peer
Review Date(s): February/March
2008; February/March 2009.
Council
Review Date(s): May 2008; May 2009.
Earliest
Anticipated Start Date(s): July 2008;
July 2009.
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
Although
a letter of intent is not required, is not binding, and does not enter into the
review of a subsequent application, the information that it contains allows IC
staff to estimate the potential review workload and plan the review.
The letter of
intent is to be sent by the date listed in Section
IV.3.A.
The letter of
intent should be sent to:
Aron Primack, M.D., M.A.
Division of
International Training and Research
Fogarty
International Center
31
Center Drive, MSC 2220
Building 31, Room B2C39
Bethesda,
MD 20892-2220
Telephone:
(301) 496-4596
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.
In order to expedite the review, applicants are requested to notify the Fogarty International Center Referral Office by email ([email protected]) when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
3.C.
Application Processing
Applications may be submitted on or after the opening date and must be
successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt
date(s) and time, the application may be delayed in the review process or not
reviewed.
Once an application package has been successfully submitted through Grants.gov, all errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.
Upon receipt, applications will be evaluated for
completeness by CSR. Incomplete applications will not be reviewed.
There will
be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR receives
the Grants.gov acknowledgments. The AOR 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. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).
4. Intergovernmental Review
This initiative is not
subject to intergovernmental
review.
5.
Funding Restrictions
All NIH awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants
Policy Statement.
Pre-award costs are not allowed.
6. Other Submission
Requirements
PD/PI Credential (e.g., Agency Login)
The NIH requires the PD/PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.
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
Items 2-5 of the PHS398 Research Plan component are limited to 25 pages. While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
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:
Special Instructions for Modular Grant applications
Foreign organizations may not submit modular budgets. See NOT-OD-06-096.
Appendix Materials
IMPORTANT NOTE: NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html
Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Note: While each section of the PHS398 Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to monitor better formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
Foreign Applications (Non-domestic (non-U.S.) Entity)
Plan for Sharing Research Data
Not applicable.
Sharing
Research Resources
NIH
policy expects that grant recipients make unique research resources readily
available for research purposes to qualified individuals within the scientific
community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each Non-Competing Grant
Progress Report (PHS 2590). See Section VI.3.,
Reporting.
Supplemental Instructions
Budget Instructions
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.
Other Requirements
Applications not conforming to these guidelines will be
considered unresponsive to this announcement and will be returned without further review.
Section
V. Application Review Information
1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
Only the review criteria described below will be considered in the review process.
2. Review and Selection Process
Applications
submitted for this funding opportunity will be assigned to FIC.
Appropriate scientific review groups convened in
accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm)
will evaluate applications for scientific and technical merit.
Applications that are complete and responsive to the FOA will be evaluated for
scientific and technical merit by an appropriate peer review group convened by the Center for Scientific Review in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
An award will not be made until the applicant has actually returned to his/her home country (or other low- to middle-income country). A change of grantee institution that involves the transfer of a grant to or between foreign institutions or international organizations requires competitive re-review and approval of the IC Advisory Council/Board.
The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.
Note that an
application does not need to be strong in all categories to be judged likely to
have major scientific impact and thus deserve a high priority score. For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.
Significance: Does this study address an important problem? If
the aims of the application are achieved, how will scientific knowledge or
clinical practice be advanced? What will be the effect of these studies on the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field? Is the health problem that is addressed specifically a
priority health issue in the Principal Investigator’s home country? If the aims of the project are achieved, how will the
Principal Investigator’s research career be enhanced?
Approach: Are the
conceptual or clinical framework, design, methods, and analyses adequately
developed, well integrated, well reasoned, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics? Are the administrative plans for the management of the
research project appropriate, including plans for resolving conflicts? Is the research hypothesis-driven or hypothesis-generating?
Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
Investigators: Are the PD/PI and other key personnel appropriately
trained and well suited to carry out this work? Is the work proposed
appropriate to the experience level of the Principal Investigator and other
researchers? Do the PD/PI and investigative team bring complementary and
integrated expertise to the project (if applicable)? Are proposed collaborators
sufficient for the project? Do they individually
represent strengths in the subdisciplines essential to the project? How will
this award enhance the Principal Investigator’s career development and help the
Principal Investigator achieve a position of scientific leadership in his/her home country? Do the letters of support
document a strong commitment to help the Principal Investigator develop his/her
career?
Environment: Does the
scientific environment(s) in which the work will be done contribute to the
probability of success? Do the proposed studies benefit from unique features of
the scientific environment, or subject populations, or employ useful
collaborative arrangements? Is there evidence of institutional support? Has the Principal Investigator’s home institution made a convincing commitment to the Principal
Investigator (e.g., provided a research/academic appointment and partial salary
support)? What is the continuing commitment of the U.S. collaborating
institution (e.g., the institution associated with the NIH D43, U2R or other training program; the NIH intramural program
laboratory; or the research program) to further develop the Principal
Investigator’s career and research interest?
2.A.
Additional Review Criteria
In addition to the above criteria, the
following items will continue to be considered in the determination of
scientific merit and the priority score:
Resubmission Applications (formerly revised/amended applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?
Protection
of Human Subjects from Research Risk: The involvement of human
subjects and protections from research risk relating to their participation in
the proposed research will be assessed. See the Human Subjects Sections
of the PHS398 Research Plan component of the SF424 (R&R)..
Inclusion of Women, Minorities and Children in Research: The adequacy of
plans to include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated. See the Human Subjects Sections of the PHS398 Research
Plan component of the SF424 (R&R)
Care and Use of Vertebrate Animals in Research: If vertebrate animals
are to be used in the project, the adequacy of the plans for their care and use
will be assessed. See the Other Research Plan Sections of the PHS398 Research
Plan component of the SF424 (R&R).
2.B. Additional
Review Considerations
Budget and Period of Support: The reasonableness of the proposed budget and the
appropriateness of the requested period of support in relation to the proposed
research may be assessed by the reviewers. The priority score should not be
affected by the evaluation of the budget.
Applications from Foreign Organizations: Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed.
2.C.
Sharing Research Data
Not Applicable
2.D. Sharing Research
Resources
NIH policy expects that
grant recipients make unique research resources readily available for research
purposes to qualified individuals within the scientific community after
publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
Program staff will be responsible for the
administrative review of the plan for sharing research resources.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and
resource sharing plans with the awardee before recommending funding of an application. The final version of the
data and resource sharing plans negotiated by both will become a condition of
the award of the grant. The effectiveness of the resource sharing will be
evaluated as part of the administrative review of each Non-Competing Grant
Progress Report (PHS 2590), See Section VI.3.,
Reporting.
Model
Organism Sharing Plan: Reviewers are asked to assess the sharing plan in an administrative note. The sharing
plan itself should be discussed after the application is scored. Whether a
sharing plan is reasonable can be determined by the reviewers on a case-by-case
basis, taking into consideration the organism, the timeline, the applicant's
decision to distribute the resource or deposit it in a repository, and other
relevant considerations.
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
Awardees will be
required to submit the Non-Competing Grant
Progress Report (PHS 2590) annually and financial statements as required in
the NIH
Grants Policy Statement.
We
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research, peer review, and financial or grants
management issues:
1.
Scientific/Research Contact(s):
FIC/NIH:
Aron Primack, M.D., M.A.
Division
of International Training and Research
Fogarty
International Center
Building
31, Room B2C39
31
Center Drive, MSC 2220
Bethesda,
MD 20892-2220
Telephone:
(301) 496-4596
Fax:
(301) 402-0779
Email: [email protected]
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: [email protected]
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: [email protected]
NIBIB/NIH:
John W. Haller, Ph.D.
National Institute of Biomedical Imaging and
Bioengineering
6707 Democracy Blvd., Suite 200
Bethesda, MD 20892-5649
Telephone: (301) 451-4780
Fax: (301) 480-1614
Email: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
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 (express/courier use Bethesda, MD 20817)
Telephone: (301) 594-6830
Fax: (301)
480-1677
Email: [email protected]
3. Financial/Grants Management Contact(s):
Elizabeth Cleveland
Grants Management Specialist
Fogarty International Center
Building 31, Room B2C29
31
Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone:
(301) 451-6830
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 IRB rules,
as well as local, State and Federal laws and regulations, including the Privacy
Rule. Reviewers will consider the data sharing plan but will not factor the
plan into the determination of the scientific merit or the priority score.
Access
to Research Data through the Freedom of Information Act:
The Office of
Management and Budget (OMB) Circular A-110 has been revised to provide access
to research data through the Freedom of Information Act (FOIA) under some
circumstances. Data that are (1) first produced in a project that is supported
in whole or in part with Federal funds and (2) cited publicly and officially by
a Federal agency in support of an action that has the force and effect of law
(i.e., a regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has provided
guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
Sharing of
Model Organisms:
NIH is committed
to support efforts that encourage sharing of important research resources
including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH
Grants Policy Statement. Beginning October 1, 2004, all investigators
submitting an NIH application or contract proposal are expected to include in
the application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.
Inclusion of
Women And Minorities in Clinical Research:
It is the policy
of the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a clear
and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of the
research. This policy results from the NIH Revitalization Act of 1993 (Section
492B of Public Law 103-43). All investigators proposing clinical research
should read the "NIH Guidelines for Inclusion of Women and Minorities as
Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the SF424 (R&R) application; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of
Children as Participants in Clinical Research:
The NIH
maintains a policy that children (i.e., individuals under the age of 21) must
be included in all clinical research, conducted or supported by the NIH, unless
there are scientific and ethical reasons not to include them.
All
investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as participants
in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required
Education on the Protection of Human Subject Participants:
NIH policy
requires education on the protection of human subject participants for all
investigators submitting NIH applications for research involving human subjects
and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human
Embryonic Stem Cells (hESC):
Criteria for
federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research. Applications that do not provide this
information will be returned without review.
NIH Public Access Policy:
NIH-funded
investigators are requested to submit to the NIH manuscript submission (NIHMS) system
(http://www.nihms.nih.gov/) at PubMed
Central (PMC) an electronic version of the author's final manuscript upon
acceptance for publication, resulting from research supported in whole or in
part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.
NIH is
requesting that authors submit manuscripts resulting from 1) currently funded
NIH research projects or 2) previously supported NIH research projects if they
are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms,
cooperative agreements, contracts, Institutional and Individual Ruth L.
Kirschstein National Research Service Awards, as well as NIH intramural
research studies. The Policy applies to peer-reviewed, original research
publications that have been supported in whole or in part with direct costs
from NIH, but it does not apply to book chapters, editorials, reviews, or
conference proceedings. Publications resulting from non-NIH-supported research
projects should not be submitted.
For more
information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov// and view the Policy or other Resources and Tools, including the Authors' Manual.
Standards for Privacy of Individually Identifiable
Health Information:
The Department
of Health and Human Services (HHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health
Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information, and is administered and enforced by the HHS
Office for Civil Rights (OCR).
Decisions about
applicability and implementation of the Privacy Rule reside with the researcher
and his/her institution. The OCR website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and
proposals for NIH funding must be self-contained within specified page
limitations. For publications listed in the appendix and/or Progress report,
Internet addresses (URLs) 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 or Health
Systems Agency review. Awards are made under the authorization of Sections 301
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards
are subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants
Policy Statement.
The PHS strongly
encourages all grant recipients to provide a smoke-free workplace and
discourage the use of all tobacco products. In addition, Public Law 103-227,
the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in
some cases, any portion of a facility) in which regular or routine education,
library, day care, health care, or early childhood development services are
provided to children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.
Loan Repayment
Programs:
NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the next
generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov/.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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