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 Institute of Allergy and Infectious Disease (NIAID), (http://www.niaid.nih.gov)

Title: Global Infectious Disease Research Training Program Award

Announcement Type
This is a re-issue of PA-03-012, which was previously released October 18, 2002.

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

Program Announcement (PA) Number: PAR-05-128

Catalog of Federal Domestic Assistance Number(s)
93.989, 93.856

Key Dates
Release Date: June 23, 2005
Letter of Intent Receipt Date: August 13, 2005; August 14, 2006; August 13, 2007
Application Receipt Date: September 13, 2005; September 13, 2006; September 13, 2007
Peer Review Date: February-March, 2006; February-March, 2007; February-March, 2008
Council Review Date: May 2006; May 2007; May 2008
Earliest Anticipated Start Date: June 1, 2006; June 1, 2007; June 1, 2008
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: September 14, 2007

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

 Section I. Funding Opportunity Description
   1. Research Training Program Objectives

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

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

 Section IV. Application and Submission Information
   1. Address to Request Application Information
   2. Content and Form of Application Submission
   3. Submission Dates and Times
     A. Receipt, 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
   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 Training Program Objectives

Infectious diseases, such as malaria and tuberculosis, continue to impose a tremendous health burden in resource-poor countries throughout the world, claiming millions of lives annually and inflicting severe morbidity that results in significant losses in economic productivity and social progress. Attempts to control infectious diseases endemic to developing countries suffer due to an incomplete understanding of the pathogens, their disease manifestations and transmission mechanisms, inadequate preventive measures and interventions, and inadequate health services and disease control efforts. A major barrier to improved research, treatment and control of infectious diseases is the scarcity of scientists and health professionals in endemic countries with relevant infectious disease research knowledge and expertise.

The purpose of this announcement is to invite applications from U.S. and developing country institutions to train or expand the capabilities of scientists and health professionals from developing countries to engage in infectious diseases research not related directly to HIV/AIDS. Proposals are requested for innovative, collaborative research training programs that would contribute to the long-term goal of building sustainable research capacity in endemic infectious diseases at developing country institutions. The intent is to harness scientific knowledge and skills to enhance prevention, treatment and control of infectious diseases causing major morbidity and mortality in developing countries. Competitive renewal applications for awards made in previous FIC infectious disease research training programs (International Training and Research in Emerging Infectious Diseases (ITREID); Actions for Building Capacity in Support of International Centers for Infectious Disease Research (ABC/ICIDR); Tuberculosis International Training and Research; and International Malaria Research Training), as well as new applications, may be submitted in response to this announcement. Developing country institutions may also apply for one-year planning grants to support the development and submission of research training program proposals in the subsequent year. In addition, ongoing infectious disease research training awardees may apply for competing supplements to their Global Infectious Disease Research Training awards to expand their activities.

FIC will support research-training programs that focus on building sustainable infectious disease research capacity at an institution in an endemic developing country. Sustainable research capacity depends on building a critical mass of scientists and health professionals with in-depth scientific expertise and complementary skills that enable the institution to conduct independent, internationally-recognized infectious disease research relevant to the health priorities of their countries. FIC will support research-training programs that focus on major endemic or life-threatening emerging infectious diseases and are structured to provide an appropriate variety of short- and long-term training opportunities for participants from developing country institutions within the context of ongoing U.S. research collaborations. It is expected that each grant awarded will:

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 (D43) international research training award mechanism that 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 collaborators and any subcontracts. Subcontracts may only request facilities and administrative (F&A) costs of up to eight percent of allowable 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

The Fogarty International Center expects to provide from between $600,000 and $1 million per year to fund a combination of four to six new and competitive renewal awards, one to two planning grants and one to two supplemental awards each year depending on availability of funds. Awards are expected to be made beginning June 1.

Under this PA, an applicant can submit:

An applicant for a Global Infectious Disease Research Training Program award may request a project period of up to five years and a budget for direct costs of up to $138,000 per year maximum.

An applicant for a competing supplement to a current Global Infectious Disease Research Training award may request up to $46,000 per year direct costs for one year.

A developing country applicant for a planning grant may request up to $23,000 direct costs for one year.

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:

Institutions from developing foreign countries that meet the criterion listed below, or domestic U.S. institutions with scientific collaborations with these institutions, are eligible to apply for these awards. U.S. applicants must apply with a developing country institution with which they have a demonstrable history of research collaboration. Developing country applicants should apply in collaboration with U.S. institutions that are capable of enhancing their proposed training opportunities. Eligible developing foreign countries include those that have a Gross National Income per capita (GNI per capita) below $9,000, according to the World Bank classification system (refer only to the GNI per capita ranking in the left column labeled "Atlas Methodology" at http://www.worldbank.org/data/databytopic/GNIPC.pdf).

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed international infectious disease research training 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 programs.

All applicants must be officially listed as the Principal Investigator (not co-Investigator) of at least one active infectious disease research grant (with at least 18 months of support remaining at the time of application), from the NIH or other national or international research support organization, directly relevant to the research training proposed.

An applicant's failure to meet the eligibility criteria by the time of the application deadline will result in the return of the application without review or, if reviewed, will preclude FIC from making an award.

Applications for renewal or supplementation of existing Global Infectious Disease Research Training programs are eligible to compete with applications for new awards.

2. Cost Sharing or Matching

Applicants proposing training that will incur tuition expenses at a U.S. academic institution are encouraged to arrange for the lowest (e.g. in-state) possible tuition scale to be paid.

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

3. Other-Special Eligibility Criteria

Only one application may be submitted per institution proposing research training on a particular infectious disease or working at a particular developing country institution.

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 Grants Info, 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. 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 online 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:

Proposed research should provide unique research training opportunities not available in the U.S.

3. Submission Dates and Times
See Section IV.3.C for details.

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: August 13, 2005; August 14, 2006; August 13, 2007
Application Receipt Date: September 13, 2005; September 13, 2006; September 13, 2007
Peer Review Date: February-March, 2006; February-March, 2007; February-March, 2008
Council Review Date: May 2006; May 2007; May 2008
Earliest Anticipated Start Date: June 1, 2006; June 1, 2007; June 1, 2008

3.A.1. Letter of Intent

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

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

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

The letter of intent should be sent to:

Barbara Sina Ph.D.
Division of International Training and Research
Fogarty International Center
National Institutes of Health
Building 31 Room B2C39
Bethesda, MD 20892-2220
Telephone: (301) 402-9467
FAX: (301) 402-0779
Email: sinab@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 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.

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

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 competing 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/archive/grants/policy/nihgps_2003/index.htm.

Applicants should develop a budget that reflects the resources necessary to implement the components of the comprehensive developing country research-training plan included in their application. The budgets may include costs to support the various types of 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 developing 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 Principal Investigator, other training faculty and administrative staff must be commensurate with the salary structure and benefits at the institution where they are employed.

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 long-term training at the grantee institution. Current NRSA stipend levels may be used as a guide and are described on the web site http://grants.nih.gov/training/nrsa.htm.

Tuition, Fees and Insurance for Trainees: Funds for tuition and academic fees at the U.S. or developing country institution and self-only or family medical insurance may be requested. Programs are encouraged to seek cost-sharing arrangements with the grantee institutions in order to provide reduced tuition trainees.

Network Meetings: Funds to support the attendance of the Principal Investigator and one or two faculty or trainees at the annual network meeting for the program in the U.S. may be requested.

6. Other Submission Requirements

Research Training Plan:
In place of the research plan requested in the PHS 398 application instructions, applicants should follow the instructions regarding research-training plans for NRSA applications.

In addition, the following information should be included:

Needs Assessment:
Applications should present a detailed assessment of the specific needs for infectious disease research training at the developing country institution and a proposed training plan to address those needs during the course of a five-year award. The assessment, conducted jointly by the proposed U.S. and developing country collaborators, should identify specific gaps in laboratory, clinical, epidemiological, vector-related, social science, and operational and health services research expertise, and adjunct skills needed to address the infectious disease focus of the proposal. The relevance of the infectious disease focus of the proposed training to the health of the host endemic country should be explained in detail. The needs assessment should serve as a baseline against which progress can be evaluated in the future.

Types of Training:
The proposed research-training program may focus on one or more emerging or endemic infectious diseases of major health importance to the developing country population focus of the proposal. Mentored trainee research may focus on analyzing the basic mechanisms of host-pathogen interaction, understanding disease transmission and pathology or developing new interventions, prevention measures or diagnostic methods, as well as clinical, operational and health services studies. Trainee research projects may be part of a training faculty member's peer-reviewed infectious disease research grant funded by NIH or other research support agencies.

All trainee research projects should be scientifically reviewed by one of the following processes:

Applicants should also provide training in adjunct skills needed at the host developing country institution to support sustainable independent research such as the use of scientific literature, scientific presentation, grant writing, bioinformatics, bioethics, good clinical practice, biosafety, data management, research administration, the management of intellectual property and English as a second language, if necessary.

Applicants should propose a variety of research training options (degree-related and non-degree training) to match the needs of the trainees and their developing country institution. Long-term research training may include studies leading to an advanced degree or a mentored post-advanced degree experience. Long-term training may include enrollment in academic courses related to infectious disease research. Short-term training in short courses, workshops or practical experience of up to several months in specific research methods or other laboratory, clinical, social science or field skills for infectious disease research may be proposed in addition to long-term training. Participants in short-term training must be involved in research in which the training will be immediately utilized at developing country institutions. Didactic short courses or workshops on broad scientific or medical topics will not be supported.

Training and trainee degrees may be attained at either the U.S. or developing country institution. However, applicants are strongly encouraged to provide support and mentoring by U.S. and developing country faculty for trainees to conduct the research related to their training in the developing country to the greatest extent possible.

Applicants are required to provide all long-term trainees with training in the responsible conduct of research at either the U.S. or developing country institution. For more information on this provision, see the NIH Guide for Grant and Contracts (volume 21, number 43 http://grants.nih.gov/grants/guide/notice-files/not92-236.html). NIH does not require a specific curriculum or format for instruction but the following areas should be included: conflict of interest, responsible authorship and institutional policies for handling scientific misconduct, human subjects, animal studies, data management and data sharing. The inclusion of international perspectives on these topics is strongly encouraged. The following information must be provided in the description of your plan: topics to be covered, format, faculty participating, instructional materials, frequency and duration of training, and how trainee attendance will be monitored.

Types of Trainees:
Applicants should describe the characteristics of the trainees they plan to recruit for each type of training. Training may be offered to a wide range of developing country scientists, including laboratory scientists, clinicians, social scientists, and other health professionals, as well as technical and administrative staff. The intent should be to build a critical mass of researchers and support staff with the combined expertise and skills to conduct independent infectious disease 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.

Trainee Recruitment, Selection and Evaluation:
Training plans should also describe in detail each of the following processes:

Research Training Faculty and Environment:
Applicants should describe the specific roles of U.S. and developing country training faculty who will be directly involved in the proposed training, including their developing country training records, relevant infectious disease research grant support and relevant U.S.-developing country research collaborations. The application should also include letters from participating U.S. and developing country faculty stating agreement with the roles specified in the proposal, as well as their time commitment in the proposed training program. Pertinent infectious disease research resources and the educational environment including the options available for distance learning for the proposed training at the U.S. and developing country institutions should be described.

Training Advisory Group:
A training advisory group composed of expert U.S. and developing country faculty including a majority who are not directly involved in mentoring trainees should be established to assist in trainee selection, scientific review of trainee projects, and evaluation of trainees and training program progress. Applicants should describe the composition and expertise of the proposed training advisory group, the specific responsibilities of the group, and the processes for it to accomplish its responsibilities.

Competitive Renewal Applications:
Competitive renewal applications should contain detailed information about previous FIC-supported research training efforts including: the impact of short- and long-term training experience and a comprehensive list of all trainees; their status before training—including position, country of residence and employment record; type and length of training provided in the U.S.; and developing country and the trainee's current position. Applicants for competitive renewal awards should provide a list of publications in peer-reviewed scientific journals in which trainee research was supported by their previous FIC training award, i.e. publications in which trainees are authors and the FIC award is cited in the acknowledgements. U.S. Principal Investigators proposing competitive renewals are encouraged to prepare to transfer the leadership of the ongoing collaborative training program to the developing country partner in the next renewal application. Such applications should include plans that demonstrate increasing transfer of appropriate training and administrative responsibilities to the collaborating developing country institution during the course of the five-year award.

Competing Supplements:
Principal Investigators may apply for one competing one-year supplement annually to an active FIC Global Infectious Disease Research Training Program for the following purposes:

The principal investigator for a supplement application must be the same as the Principal investigator of the parent research training grant. The time period for proposed supplement activities may not exceed the parent research training grant completion date. A supplement application cannot submitted until after parent research training grant is awarded. Competing supplement applications should include:

Planning Grants for Developing Country Institutions:
Developing country institutions may apply for a one-year planning grant to develop a future infectious disease research-training program with U.S. collaborators. Planning grants should propose the following types of activities to organize and plan for a research-training program, and prepare and assemble an application to submit for support of that program the following year:

Plan for Sharing Research Data
Not applicable

Sharing Research Resources
Not applicable

Section V. Application Review Information

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

2. Review and Selection Process

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

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

The following will be considered in making funding decisions:

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

Significance:

  1. The need for the specific infectious disease research training proposed to fill specific gaps in infectious disease research expertise at the developing country institution.
  2. The expected public health benefits and scientific contributions related to the proposed infectious disease research training.
  3. The demonstrated capacity (for competing renewal applications) or expected potential (for new applications) to achieve independent and sustainable laboratory, clinical or public health infectious disease research capacity through the proposed training efforts.

Approach:

  1. The clarity and feasibility of the research training objectives
  2. Adequacy of the research-training plan to achieve the proposed training objectives including:

• A trainee recruitment and selection process that captures the most qualified individuals who could most benefit from the training proposed;
• Culturally sensitive strategies to recruit an adequate representation of women, ethnic minorities and socially disadvantaged groups among the developing country trainees;
• A process for matching trainees to appropriate mentors or instructors and research projects or needed research skills to fill recognized gaps in expertise at the developing country institution;
• A process for scientific peer review of trainee research;
• A plan to provide training in sustainable research enhancing areas such as laboratory safety, responsible conduct of research, scientific writing, grant writing, statistical methods, good clinical practice, medical informatics, data management, management of intellectual property, and English as a second language, if necessary;
• A process for periodic evaluation of trainee progress in acquiring academic and research skills;
• Approaches to support post-training integration into infectious disease research at the developing country institution;
• A method to evaluate the long-term impact of the infectious disease research training program on the subsequent careers of the trainees and the infectious disease research capacity at the developing country institution.

Innovation:

  1. The identification of innovative strategies for trainees to become actively involved in infectious disease laboratory studies, clinical or public health research studies or intervention trials relevant to national health priorities conducted at the developing country institution.
  2. Innovation in training strategies to produce a critical mass of independent infectious disease researchers and sustainable research training by trainees at the developing country institution at the end of the program.
  3. The creativity of plans to use modern information technology to facilitate trainee access to scientific information, distance learning and collaborative interaction.

Investigators:

  1. Qualifications of the program director to lead and the U.S. and developing country faculty to participate as mentors in the proposed research training program.
  2. Adequacy of the ongoing collaboration between the U.S. and developing country investigators and their institutions to provide a suitable framework in which the proposed training will occur.
  3. The extent and the effectiveness of previous research training efforts made by applicants in the proposed developing country.
  4. Relevance of the sources of research support of the program directors and faculty to the research training plan proposed.

Environment:

  1. The adequacy of the infectious disease teaching and research facilities and other resources, and ongoing research support related to the overall training environment at the U.S. and developing country institutions.
  2. The U.S. and developing country institutional commitments to the proposed infectious disease research training.

2.A. Additional Review Criteria:

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
Not applicable

3. Anticipated Announcement and Award Dates

Applicants will be notified of the status of their application by email from the FIC Program Officer after the funding plan is approved by the FIC Director.

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/archive/grants/policy/nihgps_2003/index.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 Notice of Award will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of Award 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 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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.htm).

3. Reporting

Awardees are expected to maintain a trainee tracking system as described above and report trainee publications and significant accomplishments to FIC in a timely manner.

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.

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:

Barbara Sina Ph.D.
Division of International Training and Research
Fogarty International Center
National Institutes of Health
Building 31 Room B2C39
Bethesda, MD 20892-2220
Telephone: (301) 402-9467
FAX: (301) 402-0779
Email: sinab@mail.nih.gov

2. Peer Review Contacts:

Sherry L. Dupere, Ph.D.
Chief, Biology of Development and Aging IRG
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 5136, MSC 7840
Bethesda, MD 20892 (For express mail use ZIP 20817 and remove “MSC 7840”)
Telephone: (301) 435-1021
FAX: (301) 480-3567
Email: duperes@csr.nih.gov

3. Financial or Grants Management Contacts:

Mr. Bruce Butrum
Grants Management Officer
Fogarty International Center
National Institutes of Health
Building 31, Room B2C29
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).

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.

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.

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.


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