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 & Alternative Medicine (NCCAM), (http://nccam.nih.gov/)
National Eye Institute (NEI) (http://www.nei.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)

Announcement Type
This is a modification of PA-02-057, which was previously released February 6, 2002.

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

Program Announcement (PA) Number: PAR-05-073

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

Key Dates
Release Date: March 22, 2005
Application Receipt Dates(s): September 21 each year beginning with the September 21, 2005 receipt date.
Peer Review Date(s): February/March of the following year.
Council Review Date(s): May of the following year.
Earliest Anticipated Start Date: July 1 of each year.
Additional Information To Be Available Date (Url Activation Date): (http://www.fic.nih.gov/programs/FIRCA.html )
EXPIRATION DATE for R03 Non-AIDS Applications: September 22, 2005

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(s) 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. Address to Request Application Information
    2. Content and Form of Application Submission
    3. Submission Dates and Times
      A. Receipt and Review and Anticipated Start Dates
        1. Letter of Intent
      B. Sending an Application 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
    A. Cooperative Agreement Terms and Conditions of Award
      1. Principal Investigator Rights and Responsibilities
      2. NIH Responsibilities
      3. Collaborative Responsibilities
      4. Arbitration Process
  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:

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 this announcement (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(s) of Support

This funding opportunity will use the NIH R03 award mechanism(s). Competing continuation (type 2) applications are not accepted. However, the foreign Co-Investigator on an awarded type 1 FIRCA may submit a new (type 1) FIRCA application as the PI, directly from their home institution (the original foreign site), to follow up on the research done in the initial three-year FIRCA period. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses just-in-time concepts. It also uses the modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/modular/modular.htm). One module of $32,000 of direct costs per year, for up to three years, may be requested. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_I_1.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 costs requested by consortium participants are not included in the direct cost limitation, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization meets the other eligibility criteria listed below and has any of the following characteristics:

The Foreign Collaborator must be at an institution in a “developing country” defined as countries that have a Gross National Income per capita (GNI per capita) below $9,000, 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.worldbank.org/data/databytopic/GNIPC.pdf; do NOT refer to the right-hand column headed “Purchasing Power Parity”).

Foreign Institutions may only apply if they meet the eligibility requirements for foreign collaborating institutions listed above and the Principal and Collaborating Investigators meet the “Eligible Individual Criteria” listed below (Section 1B).

Occasionally, scientific opportunities may arise that warrant a formal collaborative effort between the 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 their institution to develop an application for support. Women, Individuals from underrepresented racial, ethnic and socially disadvantaged groups and individuals with disabilities are always encouraged to apply for NIH programs.

The scientist who applies as Principal Investigator (PI) must either be 1) a 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 listed above in Section 1A (“Eligible Institutions”).

Applicants may already be FIRCA grantees on another FIRCA at the time of application. However, only one FIRCA application may be submitted by the same Principal Investigator, or involve the same foreign collaborator as Co-investigator, per review cycle. No Foreign Collaborator may be involved in more than one competing new FIRCA award per fiscal year or be involved in more than two awarded FIRCAs active at any one time.

2. Cost Sharing or Matching

Cost sharing is not required.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.

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:

Among the mechanisms NOT generally accepted as parent grants:

The parent grant may come from any NIH institute or center whether or not the IC is listed as participating in this PAR. 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 FIRCA application.

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, may apply for a FIRCA as Principal Investigator with their original FIRCA collaborator. Current grantees and collaborators may want to consider whether their collaboration has developed to the point where they can submit an R01 research grant (direct foreign grant or domestic grant with a foreign component).

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms at http://grants.nih.gov/grants/funding/phs398/phs398.html. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

Additional important information and clarifications may be found under the Frequently Asked Questions section of the FIC FIRCA website at http://www.fic.nih.gov/programs/firca.html/.

Supplementary Instructions:

Please follow the instructions for the PHS 398 except as described below:

Description Section: Please include the name of the foreign country and institution, the Foreign Collaborator, 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 #R01HL98765.”)

Performance Site Section: Provide full name and address of the foreign institution where the research will be performed. Also provide the full number of the NIH parent grant and the dates of the award (e.g., “R01HL98765-01; 9/30/2002 – 9/29/2005.”)

Budget Justification Page - Under Personnel: List all project personnel, including their names, percent of effort, and roles on the project. Since no salary is allowed for the NIH-funded collaborator, minimal percent effort of five to ten percent may be listed. The Foreign Collaborator is expected to devote at least 50 percent of his/her total effort to this project.

Research Plan - special instructions: Follow the instructions for the PHS 398 except as described below (and note that the research plan must not exceed ten pages for Sections a-d):

Introduction (Not included in the ten page Research Plan limit): Original FIRCA applications should have a one-page introduction in which the nature of the proposed collaboration should be described. Also discuss any relevant previous collaborative arrangement(s). For cases in which the Principal Investigator has previously served as a mentor to the Foreign Collaborator, address the independence of the Foreign Collaborator in regards to the proposed FIRCA research. In particular, address respective contributions to the preparation of the research proposal. Note that two introduction pages are allowed for revised applications to allow for response to the critiques. The introduction is not included in the ten page research plan limit.

Specific Aims Section: List the specific aims of the parent grant exactly as written in the parent grant. If these are longer than one page, you may summarize them and indicate that you have done so. If the FIRCA is more closely related to another funded, but not FIRCA-eligible, grant, please be sure to give the specific aims of that grant here also. Then, list the specific aims of the FIRCA proposal. Finally, discuss how the specific aims of the FIRCA relate to the aim(s) of the parent grant, and/or other relevant grant, if applicable.

Research and Design Methods Section: Follow the instructions described in the PHS 398 instructions. However, at the end of this section, outline the proposed contributions of the U.S. Principal Investigator and the Foreign Collaborator to the study. Describe exactly where and when each aspect of the work to be carried out and by whom the work will be done. This will allow reviewers to assess the contributions of each laboratory and predict the likelihood of success. Where appropriate, the design of projects should take into account potential sex and gender differences that may affect the questions asked and the analyses performed. These might include different responses to and impacts of health interventions, differences in physiology, and different behavioral bases for disease prevention strategies.

Collaborator Assurance Section: Attach a letter (on institutional letterhead) from the Foreign Collaborator confirming his/her role in the project. Please include full contact information, including e-mail address and telephone and fax numbers for the Foreign Collaborator. Also, provide a statement, in the same or separate letter, confirming the foreign 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 and animal subject involvement, if necessary. The letter must be co-signed by the Head of a Department, Dean or other academic official.

Budget: Applications must be submitted using the modular grant application process, but refer to Section five (5) “Funding Restrictions” for restrictions that must be considered in the development of the modular budget. Please list in the text of the budget section what the funds will be used for, although actual costs do not need to be indicated.

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 subcontracts, F & A costs of up to eight percent of total direct costs (less equipment) can be requested by the foreign institutions. Please see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html for more information on the F & A costs allowed for foreign institutions and international organizations.

3. Submission Dates and Times
Applications must be mailed on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Application Receipt Dates: September 21 of each year.
Peer Review Dates: February/March of each year
Council Review Date: May of each year
Earliest Anticipated Start Date: July 1, 2004

3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. The application, along with all required supplemental information, must be submitted as a single package by the PI's institution. Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. If the receipt date falls on a weekend or holiday, the deadline is automatically extended to the following Monday or business day. Upon receipt, applications will be evaluated for completeness by CSR and responsiveness by the FIC. Incomplete and/or nonresponsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial 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 a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

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. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm (see also Section VI.3. Reporting).

Awards are made to the Principal Investigator'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.

FIRCA grants will have the following budget restrictions:

1.Travel funds for the Principal Investigator, Foreign Collaborator, or colleagues to visit the research sites must not exceed $7,000 annually.

2. Travel funds for the Foreign Collaborator to attend scientific conferences must not exceed $2,000 annually.

3. Consultant fees or salary supplement for the Foreign, developing country Collaborator(s) or Foreign PI must not exceed a total of $5,000 annually. Salary/consultant fees for the NIH-funded Principal Investigator/collaborator, or any other staff at the non-developing country site, is not allowed.

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation 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 or continuation award.

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

6. Other Submission Requirements

Competing continuation (Type 2) applications are not accepted.

Specific Instructions for Modular Grant applications.

The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. FIRCA applicants may request direct costs in one module of $32,000. Section C of the research grant application instructions for the PHS 398 at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

This policy applies to all investigator-initiated new (type 1), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

Data Sharing Plan: Only applicants requesting more than $500,000 in direct costs in any year of the proposed research are required to include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing.

Sharing Research Resources

NIH policy requires that grant 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/index.htm and 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, http://grants.nih.gov/grants/funding/2590/2590.htm). 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.

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.

2. Review and Selection Process

Applications submitted for this funding opportunity will be initially assigned to FIC.

An appropriate scientific review group, with a broad multidisciplinary focus, convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm), by the Center for Scientific Review of NIH, will evaluate applications for scientific and technical merit.

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

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. The various Institutes and Centers each support 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 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.

1. 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?

2. 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, the proposed plans for inclusion of minorities and members of both sexes/genders. The evaluation will be factored into the overall score for scientific and technical merit of the application.

3. 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?

4. 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 Principal Investigator and 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 PI, is she or he able to undertake and direct the continuation of the research efforts independently but with continued collaboration with the original (or pre-approved new) FIRCA collaborator? How will this award continue to enhance the Foreign PI's research and career development and help him or her towards achieving a position of scientific leadership in his/her home country and field?

5. 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 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?

6. 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 for 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?

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 the Research Plan, Section E on Human Subjects in the PHS Form 398).

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 Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

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/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). 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.

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

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 Principal Investigator will also receive a written critique called a Summary Statement.

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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document.

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

The scored summary statements will be sent with a letter from FIC, via e-mail, to the Principal Investigator at the e-mail address provided on the application. Unscored summary statements are sent directly from the Center for Scientific Review. Notices of Grant Award will be sent via e-mail or standard U.S. Mail to the grantee institution.

For FIRCA applications that must receive U.S. State Department Clearance for the non-U.S. site, performance at the foreign site may be restricted until the clearance has been received, according to the terms of the individual Notice of Grant Award.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

2.A. Cooperative Agreement Terms and Conditions of Award
Not applicable

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) 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 e-mail address 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:
Dr. Kathleen Michels
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: FIRCA@nih.gov

NCCAM/NIH:
Craig Carlson, MPH
International Health Program Specialist
Office of International Health Research
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Blvd., Suite 401, MSC 5475
Bethesda, MD 20892-5475
Telephone: (301) 496-2583
FAX: (301) 480-3621
Email: carlsonc@mail.nih.gov

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 courier service use Rockville, MD 20852)
Telephone: (301) 451-2020
FAX: (301) 402-0528
Email: esl@nei.nih.gov

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

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: pmurray@mail.nih.gov

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

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: ipdirector@nida.nih.gov

NIEHS/NIH:
Dr. Christopher Schonwalder
Director
Office of International Programs
National Institute of Environmental Health Sciences
111 Alexander Drive
Research Triangle Park, NC 27709
Telephone: (919) 541-4794
FAX: (919) 541-2260
Email: cs64c@nih.gov

NINDS/NIH:
Yuan Liu, PhD
Chief, Office of International Activities
Program Director, Channels, Synapses, and Circuits; Technology Development
NINDS, NIH
Telephone: (301) 496-1917
Email: liuyuan@ninds.nih.gov

OBSSR/OD/NIH:
Virginia Cain, Ph.D.
Office of Behavioral and Social Sciences Research
Office of the Director
National Institutes of Health
Building 1, Room 256
1 Center Drive
Bethesda, MD 20892
Telephone: (301) 402-1146
FAX: (301) 402-1150
Email: virginia_cain@nih.gov

2. Peer Review Contacts:

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

3. Financial or Grants Management Contacts:

Mr. Randolph Williams
Grants Management Specialist
Fogarty International Center
Building 31, Room B2C29
31 Center Drive, MSC 2220
Bethesda , MD 20892-2220
Telephone: (301) 496-5710
FAX: (301) 594-1211
Email: willrand@mail.nih.gov

Section VIII. Other Information

Required Federal Citations

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

Human Subjects Protection:
Federal regulations (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.

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 http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, 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 new PHS Form 398; 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.

Public 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 public 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 PA 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.

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 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 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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