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Part I Overview Information

Department of Health and Human Services

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

Components of Participating Organizations
Fogarty International Center (FIC) (http://www.fic.nih.gov)
National Center for Complementary and Alternative Medicine (NCCAM) (http://nccam.nih.gov)
 National Institute on Aging (NIA) (http://www.nia.nih.gov)
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov)
National Institute on Deafness and Other Communication Disorders (NIDCD) (http://www.nidcd.nih.gov)
National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov)
National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov)
National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov)
National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov)
Office of Behavioral and Social Sciences Research (OBSSR) (http://obssr.od.nih.gov/)

Title: International Research Collaboration Behavioral, Social Sciences (FIRCA-BSS) [R03]

Announcement Type
This is a reissue of PAR-05-073, which was previously released March 22, 2005.

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

NOTICE: Applications submitted in response to this 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 should be started at least 4 weeks in advance of the planned submission. See Section IV.

Program Announcement (PA) Number: PAR-06-437

Catalog of Federal Domestic Assistance Number(s)
93.989, 93.213, 93.867, 93.866, 93.273, 93.286, 93.173, 93.279, 93.113, 93.114, 93.115, 93.853

Key Dates
Release/Posted Date: May 31, 2006
Opening Date: May 31, 2006 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not Applicable
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Submission/Receipt Date(s): September 21, 2006; September 21, 2007.
Peer Review Date(s): February/March of year following submission/receipt date
Council Review Date(s): May of year following submission/receipt date
Earliest Anticipated Start Date: July 1 of year following submission/receipt date
Additional Information To Be Available Date (URL Activation Date): Additional information available at the time of publication (http://www.fic.nih.gov/programs/FIRCA.html)
Expiration Date: September 22, 2007

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

Section VIII. Other Information - Required Federal Citations


Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Interests of Participating Institutes and Centers (ICs)

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

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism of Support

This funding opportunity will use the NIH Small Grant (R03) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses just-in-time concepts. It also uses the modular budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement. All applications submitted in response to this FOA must use the modular budget format. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, Modular Budget Component, of the Application Guide).

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

However, the foreign Co-Investigator on an awarded Type 1 FIRCA may submit a new (Type 1) FIRCA application as the PD/PI, directly from his/her home institution (the original foreign site), to follow up on the research in the initial three-year FIRCA period. The original U.S. PD/PI must be included as Co-Investigator unless a change is approved by the FIRCA Program Director.

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

2. Funds Available

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 and the receipt of a sufficient number of meritorious applications.

Facilities and Administrative (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 organization has any of the following characteristics and meets the other eligibility criteria listed below:

The Foreign Collaborator must be at an institution in a developing country defined by the World Bank according to Gross National Income per capita (GNI per capita) as low-income, lower-middle-income and upper-middle-income (see: http://web.worldbank.org/WBSITE/EXTERNAL/DATASTATISTICS/0,,contentMDK:20421402~menuPK:64133156~pagePK:64133150~piPK:64133175~theSitePK:239419,00.html or http://siteresources.worldbank.org/DATASTATISTICS/Resources/CLASS.XLS).

Foreign institutions may only apply if they meet the eligibility requirements for foreign collaborating institutions listed above and the PD/PI and Collaborating Investigators meet the Eligible Individual Criteria listed below in Section 1.B., Eligible Individuals.

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

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research, and who meets the other eligibility requirements below, is invited to work with his/her institution 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.

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

The Foreign Collaborator on a FIRCA must be employed at a developing country institution meeting the eligibility requirements described in Section 1.A., Eligible Institutions.

Applicants may already be FIRCA grantees on another FIRCA at the time of the application.

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

Eligible Parent Grants:

The following NIH research project grants that will be active and funded at the start of the proposed FIRCA budget period are eligible as parent grants:

The parent grant may have been awarded by any NIH Institute or Center (IC), regardless of whether the IC is listed as a Participating Component in this FOA. For the initial FIRCA application, it must have a minimum of 12 months of funding, which may include a no-cost extension, remaining at the time of the FIRCA application deadline to be eligible as the parent grant. For the follow-up application from the foreign collaborator as PD/PI, the U.S. Collaborator’s parent grant must simply be active, in a no-cost-extension and/or submitted for renewal on the FIRCA receipt date.

The initial FIRCA research proposal submitted by the NIH-funded Co-Investigator may be an extension or a new direction of the parent grant. However, the proposed research must not overlap with research already supported by the parent grant or by other sources. If the proposal is for work that is not an obvious extension of the parent grant, the research must be clearly within the expertise and field of interest of both Co-Investigators, as indicated by the general area of science in the parent grant and other research support and published work. Such research should ideally make use of the comparative strengths and expertise of both Co-Investigators.

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

Foreign Collaborators on previously funded FIRCA grants, which have ended or will end at least six months before the new FIRCA application deadline, must apply for a FIRCA as PD/PI with their original FIRCA collaborator as Co-Investigator, if they wish to continue the collaboration under the FIRCA program. Current grantees and collaborators may want to consider whether their collaboration has developed to the point where they can submit a Research Project (R01) grant application (direct foreign grant or domestic grant with a foreign component).

Section IV. Application and Submission Information

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

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

PD/PIs should work with their institutions/organizations to make sure they are registered in the NIH 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 Started

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.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

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

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

For further assistance contact GrantsInfo, Phone 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 (MS Word or PDF).

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 Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

Required Components:

SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget

Optional Components:

PHS398 Cover Letter File
R&R Subaward Budget Attachment(s) Form

Note: While both budget components are included in the SF424 (R&R) forms package, the NIH R03 uses ONLY the PHS 398 Modular Budget. (Do not use the detailed Research & Related Budget.)

Supplementary Instructions

Description Section: For FIRCA applications from the U.S. institution, please include the name of the Foreign Collaborator, country and institution and the parent grant number in this section (e.g., This research will be done primarily in Peru at Lima University in collaboration with Jorge Smith, as an extension of NIH Grant No. R01HL98765 ). For applications from the Foreign Institution, please include the name of the U.S. collaborator and their parent grant number.

Performance Site Section: Provide full name and address of the foreign institution where the research will be performed (or the collaborating U.S. institution if the application is from a foreign institution). Also, provide the full number of the NIH parent grant of the U.S. collaborator and the dates of the award (e.g., R01HL98765-01; 9/30/2002 9/29/2005).

Budget Justification Page Under Senior/Key Person : List all project personnel, including their names, percent of effort, and roles on the project. Since no salary is allowed for the NIH-funded U.S. collaborator, minimal percent effort of five to ten percent may be listed.

Budget: Applications must be submitted using the PHS398 Modular Budget for this Program Announcement funding opportunity but refer to Section IV.5., Funding Restrictions, for restrictions that must be considered in the development of the budget. Please list in the text of the budget section the purpose for which the funds are being requested. Also refer to http://www.fic.nih.gov/grantsinformation/Costs.html.

Research Plan Special Instructions: Follow the instructions except as described below (and note that the research plan must not exceed 10 pages for Items 2-5, excluding the Introduction):

Collaborator Assurance Section: Attach a letter (on institutional letterhead) from the Foreign Co-Investigator (for applications from the U.S.) or the U.S. Co-Investigator (for applications from the foreign institution) confirming his/her role in the project. Please include full contact information, including email address and telephone and fax numbers for the Co-Investigator. Provide a statement in the same or separate letter, confirming the foreign, applicant or collaborating, organization’s willingness to comply with all pertinent U.S. Federal regulations and policies. For example, the institution must be willing to support the collaboration with time and resources for the Foreign Collaborator, and to provide necessary documentation to the Office of Human Research Protections (OHRP) for human subject involvement and to the Office of Laboratory Animal Welfare (OLAW) for animal participation. The institution must also agree to comply with all required NIH policies on awards involving foreign institutions. The FIRCA is awarded either as a domestic grant with a foreign component (consortium agreement) or as a direct award to a foreign institution with a U.S. component. Refer to the following NIH Grants Policy Statement regarding foreign grants and consortia for information on policy and requirements (search on "foreign to get to the appropriate part of the Web page): http://grants2.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm.

The letter must be co-signed by the Head of a Department, Dean, or other academic official.

Checklist

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

For applications from foreign institutions and applications that have foreign consortium agreements, F&A costs of up to 8% of total direct costs (less equipment) may be requested by the foreign institutions. See NOT-OD-01-028, March 29, 2001.

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates

Opening Date: May 31, 2006 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not Applicable
Application Submission/Receipt Date(s): September 21, 2006; September 21, 2007.
Peer Review Date(s): February/March of year following submission/receipt date
Council Review Date(s): May of year following submission/receipt date
Earliest Anticipated Start Date(s): July 1 of year following submission/receipt date

3.A.1. Letter of Intent

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

3.B. submitting an Application Electronically to the NIH

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

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, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

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.

Awards are made to the PD s/PI’s institution, to support a collaborative research project that will be carried out mainly at the developing country collaborator’s research site. The major portion of the funds and items purchased with these funds must be used at the foreign site to support this research.

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

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

6. Other Submission Requirements

The NIH requires the PD/PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.

Renewal (formerly competing continuation or Type 2 ) applications are not permitted.

All application instructions outlined in the SF424 (R&R) Application Guide (MS Word or PDF) are to be followed, with the following requirements for R03 applications:

Specific issues and opportunities related to sharing resources developed at the foreign site should be discussed in the application.

Warning: Please be sure that you observe the direct cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.

Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan 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.

Plan for Sharing Research Data

Not applicable.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (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 plan for sharing research resources 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.

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

Applications submitted for this funding opportunity will be assigned to the ICs on the basis of established PHS referral guidelines.

Applications that are complete will be evaluated for scientific and technical merit by an appropriate review group, convened by the Center for Scientific Review, NIH, in accordance with the standard NIH peer review procedures and the criteria stated below.

As part of the initial merit review, all applications will:

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

The FIC is interested in all eligible applications and will fund or co-fund each FIRCA award. Special consideration will be given to proposed research that addresses significant global health problems, particularly those of high relevance to the foreign country or region. Special consideration may also be given to research that makes use of unique or special resources, circumstances or environment of the foreign site.

The various Institutes and Centers each support FIRCA research in their respective areas of interest. Applicants can obtain further information for each of the sponsoring Institutes at the web addresses listed on the first page of this announcement or by contacting the respective program contact listed in this announcement.

The NIH R03 FIRCA small grant is a mechanism for supporting discrete, well-defined projects that realistically can be completed in three years and that require limited levels of funding. Because the research plan is restricted to 10 pages, a small grant application will not have the same level of detail or extensive discussion found in an R01 application. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem, placing less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written 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 research on an important topic in a developing country with underdeveloped research infrastructure but with unique resources, environment or knowledge not readily available in the U.S. or other developed nations. Such projects may be slower to achieve their scientific goals, but may receive special consideration for their potential to build research capacity along with scientific impact in the long-term.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is an important problem relevant to global health issues addressed? How is this research relevant to the foreign country involved?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? In conducting an evaluation of the scientific assessment of Approach criterion, SRGs will also evaluate the involvement of human/animal subjects, and the proposed plans for inclusion of minorities and members of both sexes/genders. The evaluation will be factored into the overall score of scientific and technical merit of the application

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? Does the project make use of unique or special expertise, resources, circumstances, or environment at the foreign site to frame or address the research question? Does the project propose innovative or special ways to incorporate capacity building or training into the research program at the foreign site?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the PD/PIand the Co-Investigator? Does the investigative team bring complementary and integrated expertise to the project? The collaborators may each be at various stages in their respective careers and may or may not have prior collaborations. If the Foreign Collaborator is submitting as the PD/PI, is she or he able to undertake and direct the continuation of the research efforts independently but still with some level of collaboration with the original (or pre-approved new) FIRCA Co-Investigator? How will this award continue to enhance the Foreign PD/PI’s research and career development and help her or him towards achieving a position of scientific leadership in her/his home country and field?

Environment: Does the scientific environment 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 Foreign Collaborator’s (or Foreign PD/PI s) home institution made a convincing commitment (e.g., provided a research/academic appointment and salary support)? Are the resources necessary to perform the research available or obtainable?

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

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:

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 item 6 of the 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 item 7 of the Research Plan component of the SF24 (R&R).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under item 11 of the Research Plan component of the SF424 (R&R) will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. Is the percent effort listed for the PD/PI appropriate for the work proposed? Is each budget category realistic and justified in terms of the aims and methods?

2.C. Sharing Research Data

Not applicable.

2.D. Sharing Research Resources

NIH policy requires that grant awardee 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 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.

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 eRA Commons.

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

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

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

2. Administrative and National Policy Requirements

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

3. Reporting

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

In the performance site block on the PHS2590, grantees must list the foreign site at which the FIRCA work is being carried out and the primary collaborator contact at the foreign site. Please include full contact information, including telephone and fax numbers and email addresses for the Collaborator.

Section VII. Agency Contacts

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

1. Scientific/Research Contacts:

FIC/NIH:
Kathleen Michels, Ph.D.
FIRCA Program Officer
Division of International Training and Research
Fogarty International Center
Building 31, Room B2C39
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 496-1653
FAX: (301) 402-0779
Email: [email protected]

NCCAM/NIH:
Craig Carlson, M.P.H.
International Health Program Specialist
Office of International Health Research
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Boulevard, Suite 401, MSC 5475
Bethesda, MD 20892-5475
Telephone: (301) 496-2583
FAX: (301) 480-3621
Email: [email protected]

NEI/NIH:
Ellen Liberman, Ph.D.
Program Director
Lens and Cataract Glaucoma Programs
Division of Extramural Research
National Eye Institute
National Institutes of Health
Suite 1300
5635 Fishers Lane, MSC 9300
Bethesda, MD 20892-9300
(For express/courier service, use Rockville, MD 20852.)
Telephone: (301) 451-2020
FAX: (301) 402-0528
Email: [email protected]

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

NIAAA/NIH:
Margaret M. Murray, M.S.W.
Chief, Health Sciences Education Branch
Office of Research Translation and Communications
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3105, MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 443-2594
FAX: (301) 480-1726
Email: [email protected]

NIDCD/NIH:
Lana Shekim, Ph.D.
Director, Voice and Speech Programs
Division of Scientific Programs
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, EPS-400-C, MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 496-5061
FAX: (301) 402-6251
Email: [email protected]

NIDCR/NIH
Kevin Hardwick, DDS, MPH
Extramural Training Officer
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AS-13
Bethesda, MD 20892
Telephone: (301) 594-2765
FAX: (301) 402-7033
Email: [email protected]

NIDA/NIH
Steven Gust, Ph.D.
Director, International Program
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5-274
Bethesda, MD 20892-9581
Telephone: (301) 443-6480
FAX: (301) 443-9127
Email: [email protected]

NIEHS/NIH:
Dennis Lang, Ph.D.
Deputy Director
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC20
Research Triangle Park, NC 27709
Telephone: (919) 541-7729
FAX: (919) 541-2843
Email: [email protected]

NINDS/NIH:
Yuan Liu, Ph.D.
Chief, Office of International Activities
National Institute of Neurological Disorders and Stroke
Neuroscience Building, Room 2187
6001 Executive Boulevard, MSC 9523
Bethesda, MD 20892-9523
Telephone: (301) 496-3108
FAX: (301) 402-1501
Email: [email protected]

2. Peer Review Contacts:

Sherry L. Dupere, Ph.D.
Chief, Biology of Development and Aging IRG
Center for Scientific Review
6701 Rockledge Drive, Room 5136
Bethesda, MD 20892-7840
(For express/courier service, use ZIP 20817)
Telephone: (301) 435-1021
FAX: (301) 480-3567
Email: [email protected]

3. Financial or Grants Management Contacts:

FIC/NIH:
Randolph Williams
Grants Management Specialist
Fogarty International Center
Building 31, Room B2C39
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 496-5710
FAX: (301) 594-1211
Email: [email protected]

NIA/NIH:
Linda Whipp
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2N212, MSC 9205
Bethesda, MD 20892
Telephone: (301) 496-1472
FAX: (301) 402-3672
Email: [email protected] (email correspondence is preferred)

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 (45CFR46) 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.

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 (DHHS) 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 DHHS 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. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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 PA 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 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.

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NIH Funding Opportunities and Notices


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