Part I Overview Information

---

Department of Health and Human Services

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

Components of Participating Organizations
Fogarty International Center (FIC) (http://www.fic.nih.gov)
National Cancer Institute (NCI) (http://www.cancer.gov)
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov)
National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.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 Mental Health (NIMH) (http://www.nimh.nih.gov)
National Institute of Nursing Research (NINR) (http://www.ninr.nih.gov)
Office of Research on Women’s Health/Office of the Director (ORWH) (http://orwh.od.nih.gov/)

Title: AIDS International Training and Research Program (D43)

Announcement Type
This is a re-issue of PAR-05-140, which was previously released July 14, 2005.

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

• June 18, 2010 - This PAR has been reissued as (PAR-10-219).
• July 31, 2008 - See Notice (NOT-TW-08-002) Assisting applicants with the new PHS-398 application process.
• February 1, 2008 - This PAR has been reissued as (RFA-TW-08-004).

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. For more information and an initial timeline, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-035.html. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html).

Program Announcement (PA) Number: PAR-07-348

Catalog of Federal Domestic Assistance Number(s)
93.989, 93.398, 93.273, 93.856, 93.121, 93.279, 93.242, 93.361

Key Dates
Release Date: April 2, 2007
Letters of Intent Receipt Date(s): July 13, 2007; July 14, 2008; July 14, 2009
AIDS Application Receipt Date (s): August 14, 2007; August 14, 2008; August 14, 2009
Peer Review Date(s): October-December 2007; October-December 2008; October-December 2009
Council Review Date(s): January 2008; January 2009; January 2010
Earliest Anticipated Start Date(s): April 1, 2008; April 1, 2009; April 1, 2010
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: August 15, 2009

Due Dates for E.O. 12372

Additional Overview Content

Executive Summary

• The purpose of this Funding Opportunity Announcement (FOA) is to invite applications from eligible institutions for innovative, collaborative research training programs that would contribute to the long-term goal of building sustainable research capacity in HIV-related conditions at institutions in low- and middle-income countries.
• Because the nature and scope of the proposed research training will vary from application to application, it is anticipated that the size of each award will also vary. (See guidelines for levels of funding under Funds Available. ) The total amount awarded and the number of awards each year will depend upon the number of applications, the quality of those applications, and the previous duration of re-competing applications.
• This support is available through the D43 mechanism.
• Eligible organizations include: Public/State Controlled Institution of Higher Education; Private Institution of Higher Education; Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education); Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education); Non-domestic (non-U.S.) Entity (Foreign Organization). Eligible U.S. organizations must have ongoing research collaborations in low- and middle-income countries. Foreign institutions in low- and middle-income countries may only apply for planning grants.
• Eligible Principal Investigators include scientists with the skills, knowledge and resources necessary to carry out the proposed research training.
• Only one application may be submitted per institution. Only one award in the AIDS International Training and Research Program (AITRP) will be made to an institution at any given time.
• See Section IV.1 for application materials.
• Telecommunications for the hearing impaired is available at: TTY 301-451-5936.

Table of Contents

---

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(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

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

As the global HIV/AIDS epidemic is well into its third decade, the toll it has taken on individuals' lives is felt around the world. While currently the affected populations are primarily in sub-Saharan Africa, HIV epidemics in China, India and other south Asian countries, and Russia and the Newly Independent States, are increasing. The capacity of institutions in low- and middle-income countries to conduct integrated prevention, care and treatment research across the full range of conditions and issues that relate to HIV/AIDS in their country needs to continue to be strengthened and expanded. In addition to the identification of effective interventions, the ability to evaluate the implementation of these interventions and their social and economic impacts will be crucial to guide policy makers as they develop policies and programs to address the HIV/AIDS epidemic in low- and middle-income countries. Applicants are encouraged to review the annual NIH Plans for HIV-Related Research, available at http://www.nih.gov/od/oar/public/public.htm, for the research interests of NIH.

The purpose of this Funding Opportunity Announcement (FOA) is to invite full applications from U.S. institutions and planning grant applications from low- and middle-income country institutions (as defined using the World Bank classification system at http://www.worldbank.org/data/countryclass/classgroups.htm), for innovative, collaborative research training programs that would contribute to the long-term goal of building sustainable HIV-related research capacity at the named low- and middle-income country institutions (herein defined as foreign institutions ).

The Fogarty International Center (FIC), together with partner Institutes, Centers and Offices (ICs) from the National Institutes of Health (NIH), has supported long-term research capacity-strengthening efforts in low- and middle-income country institutions for 20 years through a series of competing five-year awards for the AIDS International Training and Research Program (AITRP). At this time, the FIC, with its partners, will solicit new and competing renewal applications under this FOA. Foreign institutions from low- and middle-income countries may apply for two-year planning grants to support the development and submission of applications for research training program proposals in 2010.

The applications for full awards should describe research-training programs that provide a variety of short-, medium- and long-term training within the context of ongoing collaborations that address the HIV epidemic and response to the epidemic in the country(ies). Applicants are expected to provide support and mentoring for trainees to conduct the research related to their training in their country to the greatest extent possible. U.S. applicants should include a plan that demonstrates the increasing research training options and responsibilities to any collaborating foreign institution during the course of the five-year award. It is expected that each research-training program award supported will:

• Increase the expertise of trainees in relevant biomedical, behavioral, laboratory, clinical, epidemiological, social science, and operational and/or health services research;
• Fill gaps and strengthen the sustainability of HIV-related research within the foreign institution(s);
• Expand and equalize collaborative scientific research interactions between foreign scientists and U.S. researchers;
• Strengthen the capacity of the scientists at the foreign institution(s) to provide the data for evidence-based decision-making related to HIV-related conditions with respect to prevention, care and treatment policies in the foreign country;
• Take advantage of and coordinate with other sources of research and training support at the same foreign institution and in the foreign country;
• Actively work with the foreign institution(s) and their government officials to provide opportunities and positions for all trainees to maximize the use of the knowledge and skills they acquired during their training; and
• Strengthen the scientific and administrative capacity of the foreign institution(s) to compete for current and future NIH and non-NIH research and other grants designed for foreign institutions.

The NINR encourages applications that provide capacity building among professions such as nursing to develop a cadre of nurse scientists at the masters and doctoral levels to conduct independent research, and implement evidence-based findings. To provide additional research training support for specific NIH interests, FIC may solicit applications for competitive supplements to respond to special needs or opportunities on an annual basis. These solicitations are subject to funding availability each year. Funding opportunities, if available, will be announced each year in the NIH Guide and communicated by email to eligible investigators.

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 D43 award mechanism, which limits facilities and administrative (F & A) costs to eight percent of allowable direct costs. The applicant organization's administration must provide the necessary management for the transfer of funds and materials to the collaborator(s) and any sub-contracts (consortium). Subcontracts (consortiums) may only charge eight percent F & A costs of applicable direct costs.

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available

Because the nature and scope of the proposed research training will vary from application to application, and the number and funding level of re-competing applications varies from year to year, it is anticipated that the size of each award will also vary. (See guidelines for levels of funding below.) The total amount awarded and the number of awards each year will depend upon the number of applications, the quality of those applications, and the previous duration of re-competing applications.

FIC expects to award from $500,000 to $5 million to fund up to ten awards annually through this announcement, depending on how many awards are re-competing in a given year. An applicant for a full AITRP award may request a project period of up to five years and a budget for direct costs, according to the following guidelines:

• For re-competing applicants entering their 16th or greater year of funding, $695,000 per year in direct costs;
• For re-competing applicants entering their 11th year of funding, $556,000 per year in direct costs;
• For re-competing applicants entering their sixth year of funding, $417,000 per year in direct costs;
• For new applicants, $278,000 per year in direct costs.

Institutions in low- and middle-income countries may request $23,000 per year direct costs for a two-year planning grant.

Awards are expected to be made by April 1, 2008; April 1, 2009; and April 1, 2010. 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 NOT-OD-05-004.

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:

• Public/State Controlled Institution of Higher Education
• Private Institution of Higher Education
• Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
• Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education
• Non-domestic (non-U.S.) Entity (Foreign Organization)

Foreign institutions in low- and middle-income countries may only apply for planning grants. Upon successful completion of a planning grant, foreign institutions will be eligible to apply for a full AITRP award, beginning in 2010. (See http://www.worldbank.org/data/countryclass/countryclass.html for World Bank country classification tables to identify the countries considered to low- or middle-income countries.)

Eligible domestic institutions may only apply for full awards, and must demonstrate active research collaborations with institutions in the low- and middle-income countries named in their application.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Women and individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

The applicant Principal Investigator (PI) for full awards and planning grants must have strong HIV-related research and research-training program experience, and the requisite faculty and facilities to carry out the proposed research training activities. The PI and/or key personnel listed on the full award or planning grant application must be designated as the PI of at least one active (with at least 18 months of support remaining at the time of application) HIV-related research award, directly relevant to the research training proposed. The research grants may be funded by the NIH or by other national or international organizations. The research award made to U.S. applicants must involve the foreign collaborating institutions named in the AITRP application, and the applicants need to document this existing research support in their application. All applicants should explain in detail how their relevant research grant support and activities are related to the proposed research training plan. Priority will be given to applicants associated with NIH-funded direct research grants to the foreign institution(s) or with NIH-funded research grants with foreign components at the foreign institution(s).

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

Only one application for an award may be submitted from an institution. Only one AITRP award will be made to an institution at any given time. Planning grant applicant institutions which are named as collaborating foreign institutions on current AITRP awards should take these collaborations into account as they develop their applications to avoid duplication of research training efforts.

The application must demonstrate that the proposed research training will be relevant to and will benefit the HIV-related research needs of the foreign country or countries.

With approval from the FIC Program Officer, research collaborations can also include other industrialized nations linked to U.S. institutions if these collaborations enhance the research training capacity of low- and middle-income countries.

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) 710-0267, 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. 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.

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

• Charge back of customs and import fees is not allowed.
• Format: every effort should be made to comply with the format specifications, which are based upon a standard US paper size of 8.5" x 11."
• Funds for up to 8% administrative costs (excluding equipment) can now be requested (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html)
• Organizations must comply with Federal/NIH policies on human subjects, animals, and biohazards.
• Organizations must comply with Federal/NIH biosafety and biosecurity regulations. See Section VI. 2. Administrative and National Policy Requirements. "
• Additional information regarding foreign grants is available in the NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260).

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): July 13, 2007; July 14, 2008; July 14, 2009
Application Receipt Date(s): August 14, 2007; August 14, 2008; August 14, 2009
Peer Review Date(s): October-December 2007; October-December 2008; October-December 2009
Council Review Date(s): January 2008; January 2009; January 2010
Earliest Anticipated Start Date(s): April 1, 2008; April 1, 2009; April 1, 2010

3.A.1. Letter of Intent

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

• Descriptive title of proposed research training
• Name, address, and telephone number of the Principal Investigator
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

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

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Jeanne McDermott C.N.M., M.P.H., Ph.D.
Division of International Training and Research
Fogarty International Center
31 Center Dr., MSC 2220
Building 31, Room B2C39
Bethesda, MD 20892-2220
Telephone: (301) 496-1492
Fax: (301) 402-0779
Email : mcdermoj@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. 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)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

3.C. Application Processing

Applications must be received on or before the application receipt/submission 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.

Upon receipt applications will be evaluated for completeness by CSR. Incomplete 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 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 a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

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.

Applicants should develop a budget that reflects the resources necessary to implement the components of the comprehensive research-training plan included in their application. The budgets may include costs to support the various types of research training proposed (tuition, stipends, salary, travel, per diem) for trainees and faculty, and costs to support the administration of the program and grant. Adequate resources to meet U.S. government requirements for training and training-related research should be included in the budget.

A detailed budget justification should be provided explaining how requested funds will primarily support low- and middle-income country trainees. All expenses related to trainee participation in the program should be itemized on the PHS Form 398 (NRSA substitute budget pages 4 & 5) in the appropriate categories. All expenses related to faculty participation in the program should be itemized on the PHS Form 398 (budget form pages 4 & 5) in the appropriate categories. The total direct costs of the trainee participation budget should be identified on PHS Form 398 (budget form pages 4 & 5) in the "Other" category. The combining of the budget figures will allow reviewers and FIC staff to review a composite budget of all costs.

Requested Salary Support: The salary for the PI, other training faculty and administrative staff must be commensurate with the salary structure and benefits at the institution where they are employed and within the limits described at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-033.html. Foreign collaborators may receive appropriate compensation for their significant activities on the program, such as recruitment and selection activities, as well as other program-related roles. The administrative, training or teaching responsibilities and time commitment for personnel receiving salary should be thoroughly described. The salary and fringe benefits for the staff at the grantee institution should not exceed 25 percent of total direct costs.

Travel: Funds may be requested for round-trip economy airfare on U.S. carriers (to the maximum extent possible) and lodging and per diem for U.S. faculty providing training at the foreign site.

Network Meetings: There will be an annual program network meeting to coordinate program activities, normally in the U.S., for which the applicant should budget. Principal Investigators are expected to attend. Applicants may also budget for grant administrators, other faculty, collaborators and trainees to attend.

Trainee Stipends: Trainees may be paid a stipend comparable to their professional experience in accordance with NRSA levels or grantee institutional policies while involved in medium- or long-term training at the grantee institution. Current NRSA stipend levels may be used as a guide and are described at http://grants.nih.gov/training/nrsa.htm.

Tuition and Fees for Trainees: Funds for tuition and academic fees at the U.S. or foreign institution may be requested. Programs are encouraged to seek cost-sharing arrangements with the grantee institutions in order to provide reduced tuition for trainees.

Trainee Travel: Funds may be requested for round-trip economy class airfare on U.S. carriers (to the maximum extent possible). Funds may be requested for lodging and per diem for short-term trainees.

Training Related Expenses: One-time advanced in-country research support of up to $15,000 direct costs for mentored research to be undertaken by a long-term trainee in his/her country upon completion of their training. Applicants are encouraged to budget adequate professional development (including, but not limited to, international scientific conference attendance) opportunities for trainees. Training-related expenses (books, computers, and courses for software, English language proficiency, etc.) may be included but must be described in the budget justification. Funds for self-only or family medical insurance may be requested.

6. Other Submission Requirements

Use the NRSA substitute page for the Table of Contents.

Research Training Plan for Full Award Applications

In place of the research plan requested in the PHS 398 application instructions, please describe the research-training program (25-page limit) that you are proposing and include information related to:

• The priority HIV-related health problems in the country(ies) named in the application and an assessment of the specific needs for research training at the foreign institution(s). The assessment should identify specific gaps in biomedical, behavioral, laboratory, clinical, epidemiological, social science, and operational and health services research expertise, and adjunct skills needed to address the identified HIV-related problems. The needs assessment should serve as a baseline against which progress can be evaluated in the future.
• The proposed research training program to address the gaps and to strengthen the research capacity at the foreign institution(s) to address the HIV-related health priorities in their country(ies). Applicants are requested to describe their plans for coordination with other AITRP grantees, other FIC and/or NIH research and research training programs, and other organizations' activities in the countries in which they collaborate. Specific descriptions of the unique contribution of the proposed research training program to the research capacity of the foreign institution should be included, particularly where multiple FIC HIV-related awardees already provide research training. Provide names, qualifications and research interest of potential mentors.
• The research collaborations between the key personnel at the applicant institution and the collaborating institution, which serve as the research base for the proposed research training program. Include a list of the research grants funded in the last five years in which the PI, major collaborators, and key faculty at the applicant and foreign institution(s) have played a key role. Please include the grant number (if applicable), title, PI, role played by the key personnel, institution, funding period, funding amount and funding agency.
• A plan for meeting the requirements related to the protection of human subjects in all training-related research. The definitions of research and human subjects are included in the Code of Federal Regulations, Title 45, Part 46 (45CFR46) at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Please see http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm for decision trees to determine involvement of human subjects. All training-related research projects in which trainees are involved under this award must be peer-reviewed through a Training Advisory Group (see below), and have written evidence documenting education in the protection of human subjects for the trainee, compliance with the required federal citations, and approval forms from institutional (or ethical) review boards or committees at applicant and collaborating foreign institutions, and from the relevant government authority. (Please see Procedures for Registering Institutional Review Boards and Filing Federal-Wide Assurances of Protection for Human Subjects (FWAs) at http://www.hhs.gov/ohrp/.)
• The Training Advisory Group which should be composed of experts who can provide objective oversight (free of real or perceived conflict of interest) to assist in trainee selection, scientific review of trainee projects, and evaluation of trainee and training program progress. Applicants should describe the composition and expertise of the proposed Training Advisory Group, the responsibilities of the group, and the processes for it to accomplish its responsibilities, including a detailed description of the procedures for scientific review of training-related research.
• Plans to provide education in the responsible conduct of research, including the protection of human subjects, to all long- and medium-term trainees and to short-term trainees involved in research. Applicants must include, as part of their application, plans for obtaining instruction in the responsible conduct of research, including the rationale, subject matter, appropriateness, format, frequency, and duration of instruction. The amount and nature of faculty participation must be described. While NIH does not establish specific curricula or formal requirements, applicants are encouraged to creatively tailor a plan to meet their own needs in relation to the proposed research training. It may include participating in formal activities, such as established courses (credit or non-credit) either as an instructor or a student, or informal activities, such as discussion groups and journal clubs. Possible coverage could include conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, policies for the use of animals and/or human subjects, and organizational (rather than individual) responsibilities for scientific integrity. The inclusion of international perspectives on these topics is required. No award will be made if an application lacks this component.
• Plans to include education on the inclusion of children, women and individuals from underrepresented racial, ethnic and disenfranchised groups in research in their country. Where appropriate, the design of training-related research 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.
• The characteristics of the trainees they plan to recruit for each type of training. The intent should be to build a critical mass of researchers and support staff with the combined expertise and skills to conduct independent HIV-related research. Applicants should provide a description of culturally sensitive strategies to recruit women and members of minority and socially disadvantaged populations in the developing country as trainees.
• Detailed processes for trainee recruitment, trainee candidate evaluation and criteria for selection; any pre-training orientation and preparation; trainee mentorship; and trainee evaluation.
• Plans for post-training integration into the foreign institution's HIV research activities; for dissemination of trainee research results to the relevant international scientific community and the clinical or public health sectors of the country. In-country resources for career development and research opportunities that will be made available for trainees from upper middle-income countries should be described.
• Training program evaluation including tracking of the long-term impact of training on the careers of the trainees and research capacity in the developing country institution.

Competitive Renewal Applications

In addition to the above, re-competing research training applications should also include in the main application a description of the past experience of the grantee in the AITRP program (additional ten-page limit) and include:

• A description of how the research training has addressed the HIV-related health needs and priorities as the HIV epidemic has evolved in the country(ies) and how the training has increased the research capacity of the institution(s) in the collaborating country(ies) to respond to the changing epidemic;
• A description of how the applicant has been able to leverage other NIH or non-NIH program opportunities in the country(ies) as a result of the research training;
• A description of the trainees, including country, training received, any degrees awarded, training-related research and post-training and senior leadership positions, assumed upon completion of training;
• A list of publications in peer-reviewed journals, including local journals, in which a former or current trainee is listed as an author and which was supported through the AITRP grant as evidenced by acknowledgment of support provided by the AITRP grant in the publication;
• A description of how the previous AITRP grant addressed the recruitment and support of women and socially disadvantaged groups within the population of the country(ies);
• A description of the success of the program for the return of long-term trainees (one year or more) to their country of origin following the completion of their training, and a description of the strategies used by the program to maximize the number of trainees who return to their country of origin upon completing their training;
• A description of how the returning trainees are using their skills to strengthen the research capacity of their country. Prior performance through impact will be an important criterion in the re-competition of this program. Examples of such impact include how training received under the program has allowed former trainees to more critically evaluate new and existing interventions and programs, how the training has helped them to assume more responsible positions upon returning home, how continuing collaborations with former trainees resulted in the funding of HIV-related investigators or co-investigators, and publications authored or co-authored by trainees that were based upon support under this program;
• A list of the research grants or other awards received by former trainees or in which former trainees are playing key roles; and
• Examples of health policies that were influenced or implemented by trainees in their home countries.

Planning Grants for Foreign Institutions

Foreign institutions in low- and middle-income countries may apply for two-year planning grants to develop a future HIV research-training program with U.S. collaborators. Planning grants should describe proposed activities to plan a research-training program and to prepare and assemble an application to submit for support of that program in the future.

The planning grant research training application (15-page limit) should include:

• The priority HIV-related health problems in the country and an assessment of the specific needs for research training at the foreign institution. The assessment should describe any current research training efforts that the institution is receiving, with detailed description of efforts funded by FIC.
• Description of the gaps in research training that the applicant is proposing to address in a research training program and a plan for avoiding duplication of research training by others.
• Background of the research and training collaborations which the applicant institution has with proposed collaborators.
• Current and potential future HIV-related research that will serve as the research base for the proposed training program.
• Description of the plan and process that the applicant will use to prepare the application. This process should include developing a relevant transition plan to eliminate duplication of research training with the AITRP awards in which the applicant institution is included.
• Biographical sketches and letters of commitment from the foreign institution, foreign PI, and potential collaborating institution and collaborating PIs, and a list of the recent (within past five years) and active research and research training activities in HIV in which the foreign institution and PI have been involved. Please include grant number (if applicable) and the funding agency.

Planning grant applicants should request budget (up to $23,000 direct costs each year) support for planning grant activities and may include, as necessary:

• Targeted training of foreign institution faculty and administrative staff to fill gaps in expertise directly related to their role in the proposed program or in responsible conduct of research, human subjects education and other research administration areas.
• Training ethical review committee members of foreign institution to obtain certification related to the Office for Human Research Protections (OHRP) Federal-Wide Assurance for the foreign institution.
• Grant writing training for the planning grant program director.

Plan for Sharing Research Data

Not applicable

Sharing Research Resources

Not applicable

Section V. Application Review Information

---

1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

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

2. Review and Selection Process

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

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

• Undergo a selection process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score.
• Receive a written critique
• Receive a second level of review by the Fogarty International Center Advisory Board

The following will be considered in making funding decisions:

• Scientific merit of the proposed project as determined by peer review
• Availability of funds
• Relevance of program priorities

The most important factors to be considered in making funding decisions will be the quality of the proposed project, as determined by peer review, and responsiveness to the review considerations. The proposed instruction in the responsible conduct of research must be rated adequate for an award to be made. In addition, FIC, in consultation with its co-funding partners, will attempt to ensure a reasonable balance of HIV-related scientific issues of the research training, as well as geographic balance.

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Review Criteria for Full Program Applications

Significance: What is the expected contribution of the proposed research training to the ability of the foreign institution(s) to conduct HIV-related research? What is the expected potential of the foreign institution(s) to contribute to addressing the priority HIV-related health problems in the country? Will the proposed research training strengthen the necessary administrative and management skills at the foreign institution(s) and of the trainees to compete for future research support and conduct research? Will the proposed program develop a cadre of multidisciplinary (biomedical, behavioral and social sciences) researchers at the foreign institutions? What is the expected ability of the proposed research training to strengthen the capacity at the foreign institution over the life of the grant to provide opportunities for trainees and junior faculty to rise to scientific leadership positions in this or related programs?

Approach: Will the proposed research training provide the breadth of training opportunities in biomedical, behavioral and social sciences to develop true multidisciplinary research teams at the foreign institution(s)? Does the proposed mix of long-, medium- and short-term training achieve the goals of this FOA, while taking into consideration existing conditions and existing capacity at the foreign institution(s)? Will the trainee recruitment and selection process capture the most qualified individuals and include an adequate representation of men, women and individuals from underrepresented racial, ethnic, or socially disadvantaged groups of the country(ies) among the trainees? What is the expected ability of the proposed training plan to maximize the return and integration of trainees into HIV-related research at the foreign institution(s) to build sustainable research capacity? How adequate is the proposed method to monitor the long-term impact of the HIV/AIDS and HIV-related research training experience on the subsequent careers of the trainees, the HIV-related research capacity at the foreign institution(s), and public health in the country(ies)? How adequate are the proposed plans and systems for scientific peer review of training-related research, for protection of human subjects, for education in the responsible conduct of research, and for inclusion of women, children and disadvantaged groups in research? How well has the Training Advisory Group been constructed to serve the functions defined in this FOA?

Innovation: How does the proposed research training take advantage of the research infrastructure of the applicant and foreign institutions and of previous and current investments and support from FIC, other NIH ICs, CDC, USAID or other organizations (e.g., President s Emergency Plan for AIDS Relief (PEPFAR), the Bill and Melinda Gates Foundation, the Global Fund for AIDS, TB and Malaria)? Has the applicant described innovative strategies for trainees to become actively involved in HIV-related research relevant to national health priorities conducted at the foreign institution? Does the application describe innovative research training strategies to produce a critical mass of independent HIV researchers and sustainable research training by trainees at the foreign institution at the end of the program? Does the proposed research training program take advantage of modern information technology to facilitate trainee access to scientific information, distance learning and collaborative interaction?

Investigators: Are the applicant PI, the major collaborators, key personnel, and mentors named in the application appropriately trained and well-suited to achieve the goals and implement the activities of the proposed research training program? How strong and successful are the research collaborations between the PI and faculty at the applicant institution with major collaborators and faculty at the collaborating institution(s)?

Environment: Are the mentoring resources and research-training environment at the applicant institution and the collaborating institution(s) adequate to achieve the goals proposed in the application, as evidenced by the quality of teaching and research facilities? Is there evidence of foreign governmental and institutional support among the relevant institutions for the proposed research training?

Additional Criteria for Competitive Renewal Applications

How strong are resources and the research training environment in-country as evidenced by the past history of success of former trainees returning to their home countries and becoming independent researchers?

Do the former trainees remain committed and active in developing the research field in their countries through advanced in-country research and as faculty and mentors for new trainees?

Does the past research training record demonstrate success in terms of the success of former trainees in obtaining individual awards such as fellowships, career awards, and research grants or as significant collaborators on other awards?

Have former trainees been successful in completing the program? Have they returned to their home countries?

Planning Grant Applications

Significance: Does the applicant demonstrate the need for additional HIV-related research training?

Approach: Does the applicant propose a realistic plan for developing a coordinated application for a full AITRP training program?

Innovation: Does the applicant propose creative approaches towards developing a research training program?

Investigator: Do the PI and proposed key personnel have the knowledge, skills and experience to develop and implement a research training program?

Environment: Is there a supportive training environment in-country as demonstrated by adequacy of mentoring resources, institutional support and on-going HIV research projects?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Resubmission Applications (formerly revised/amended applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research training program. 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

Not applicable.

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

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 (designated in item 12 on the Application Face Page). If a grantee is not email-enabled, a hard copy of the NoA will be mailed to the 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 Also 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 (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).

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.

Trainee Tracking System: Awardees are expected to maintain the trainee tracking system and impact criteria as described above. Publications and other significant accomplishments of the program and trainees must be reported and described to the FIC Program Officer in a timely manner.

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:

Jeanne McDermott, C.N.M., M.P.H., Ph.D.
Division of International Training and Research
Fogarty International Center
Building 31, Room B2C39
31 Center Dr., MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 496-1492
Fax: (301) 402-0779
Email: mcdermoj@mail.nih.gov

2. Peer Review Contacts:

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

3. Financial or Grants Management Contacts:

Bruce Butrum
Grants Management Officer
Fogarty International Center
Building 31, Room B2C29
31 Center Dr., MSC 2220
Bethesda , MD 20892-2220
Telephone: (301) 496-1670
Fax: (301) 594-1211
Email: butrumb@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).

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 (http://publicaccess.nih.gov/publicaccess_manual.htm).

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. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for 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 FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 63A 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/.