The program honors the memory of the late Dr. Irving Selikoff of the Mount Sinai School of Medicine, and Dr. Norton Nelson of New York University, in recognition of their lifelong commitment to the training of health professionals in the occupational and environmental health sciences.

FIC and our partners encourage applications between domestic institutions and Russian institutions. In the event that a meritorious application is funded, it will be considered part of the NIH/DHHS effort to support the International Polar Year which commences in 2007. We also strongly encourage applications from women and individuals from underrepresented racial, ethnic and socially-disadvantaged groups and individuals with disabilities.

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(s). It also uses the just-in-time budget concepts and the non-modular budget format described in PHS398 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 Budget Period is to be submitted with the application.

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

2. Funds Available

Applicants may request a project period of up to five years and a budget for direct costs up to $200,000 per year for competing renewal programs, and up to $150,000 per year for new starts. Consortium institutions may only charge eight percent F & A costs of applicable direct costs. Responsibility for the planning, direction and execution of the proposed activities will be solely that of the applicant in collaboration with their foreign partners. The application should describe research and research training objectives to be pursued, both in the U.S. and at collaborating institutions in the cooperating country or region. Applications may incorporate cooperative activities with scientists from one or several developing countries or regions, based on the research and training objectives of the program. However, applicants are encouraged to focus their efforts on activities that provide maximum national and regional impact.

Continued support during this period depends on satisfactory performance as judged by: annual progress reports, site visits, participation in annual meetings of program directors, career progress of trainees (e.g., positions occupied in home country), research undertaken and research awards received, first author publications and presentations by current and former trainees, and, development of institutional, national or regional capacity for environmental and occupational health research and public health actions including the establishment or strengthening of model environmental and occupational health research centers of excellence in the home countries of trainees and in influencing policies that reduce environmental and occupational health risks. Assessment of performance will be made jointly by FIC, NIEHS, and NIOSH. Special program reviews may be conducted periodically by the FIC, NIEHS, and NIOSH.

Each ITREOH application may contain a request for an additional $50,000 per year for the establishment of a regional resource center for environmental and occupational health. The support will provide for in-country organizational support of facilities, media and staff for regional training activities, conferences, workshops and outreach to both professional and lay communities. The goal is to stimulate the movement of research findings and effective environmental and occupational health practices into the general economic and public health practices in the region.

Applicants should be creative in designing these centers and emphasize how they will operate, their specific goals, and the means to be used to evaluate effectiveness.

These sections will receive an informal priority score, independent of the parent application, which will be used to determine funding. Therefore, an independent budget and cost rationale is required if an application requests funds to establish a resource center.

The grantee institution may request an F & A cost allowance based on eight percent of the total allowable direct costs, exclusive of tuition, insurance, related fees and expenditures for equipment. Applicants should assume a flat budget for the five year budget period. The anticipated award date is on or before May 1, 2007.

The Fogarty International Center, with the National Institute of Environmental Health Sciences, and the National Institute for Occupational Safety and Health, intends to commit approximately $3 million in fiscal year (FY) 2007 to fund 15 new and/or competing continuation grants in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs up to $200,000 per year for competing renewal programs, and up to $150,000 per year for new starts.

Because the nature and scope of the proposed research training will vary from application to application, it is anticipated that the size and duration of each award will also vary. 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

Eligible institutions are U.S. non-profit public or private organizations, such as universities, colleges, hospitals or laboratories, capable of meeting the objectives of this RFA.

1.B. Eligible Individuals

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

The PI should have expertise in the area of environmental and/or occupational health, and a track record in developing, instructing and successfully conducting a training and research program in this area.

The Major Foreign Collaborator(MFC) at the foreign developing country should have the expertise and track record that demonstrates scientific and administrative leadership abilities to conduct the training and research program in country , collaborating with the PI during the training period.

An application for a competing renewal must be at the level at which at least 25% of the funds will be provided for allowable in country expenditures as earlier described.

2. Cost Sharing or Matching

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 per U.S. institution is allowed.

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: [email protected].

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.

3. Submission Dates and Times

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

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: May 22, 2006
Application Receipt Date(s): June 22, 2006
Peer Review Date: October/November 2006
Council Review Date: January 2007
Earliest Anticipated Start Date: April 30, 2007

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
• 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:

Christopher Schonwalder, Ph.D.
Health Science Administrator
Fogarty International Center
National Institutes of Health
111 Alexander Drive
Research Triangle Park, NC 27709
Telephone at NIEHS: (919) 541-4794
Telephone at FIC: (301) 496-1653
FAX: (919) 541-2583
Email: [email protected]

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three 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).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Sally E. Eckert-Tilotta, Ph.D.
Scientific Review Administrator
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-30
Research Triangle Park, NC 27709
(Express/courier address:
79 T. W. Alexander Drive
Building 4401, Room 3173
Research Triangle Park, NC 27709
Telephone: (919) 541-1446
FAX: (919) 541-2503
Email: [email protected]

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the Fogarty International Center and the National Institute of Environmental Health Sciences, both of the National Institutes of Health, and the National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention. Incomplete and non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Annual budget proposals must include the cost of attendance of the program director and any staff, including major foreign collaborator and selected trainees, at an annual ITREOH network meeting in Bethesda, MD, or Research Triangle Park, NC.

Research Training Plans

The FIC ITREOH program provides resources for U.S. institutions and collaborating foreign institutions to train scientists from developing countries, including those in Africa, Asia, Latin America, the Middle East, emerging democracies in Eastern Europe and the Newly Independent States of the Former Soviet Union. A developing country is defined by the World Bank as one with an average per capita income of less than $9,000. Research-related training programs in environmental and occupational health sciences for foreign scientists and health professionals may include training plans of varying lengths:

While all three types of training are allowable, emphasis will be on intermediate- to long-term research training, including mid-career training. This approach will accelerate building an enduring research and public health capability at collaborating institutions in participating countries. Justification for the proposed mix of training types must be provided.

Long-term research training would generally take place in the U.S. Short-term research training could take place in the U.S. or in-country. Training-related research and advanced in- country research would generally take place in the trainee’s home country. The research activities will be performed preferentially and predominantly in the trainees home countries or regions in collaboration with the grantee institution scientists. The ultimate goal is collaborative and independent research supported by other mechanisms.

As part of the application, the applicant institution must describe in detail the recruitment and selection procedures for the foreign pre- and post-doctoral scientists and other beneficiaries of the research training program (short- and intermediate-term trainees, workshop participants, etc). To a limited extent, U.S. trainees will be eligible for foreign research experiences under this program, with prior FIC approval, particularly if they are involved in training or research collaboration with developing country scientists.

The ITREOH encourages directors to include women as foreign trainees and, if U.S. trainees are involved, to include women and minorities.

Applicants must address the ability of the trainee recruiting and selection process to capture the most qualified individuals and to include adequate representation of men, women and ethnic minorities, individuals with disabilities, or socially disadvantaged population groups among the developing country trainees.

Agency Goals

Through international research and training efforts, NIH, CDC and other U.S. Government (USG) and non-governmental organizations (NGOs) can play an important role in improving global response and increasing national capacity to identify and address health risks related to environmental change and degradation. The second decade of the U.S. National Occupational Research Agenda (NORA) is sector-based and includes all U.S. employers, workers, public health and research communities (http://www.cdc.gov/niosh/nora). Global collaborations can produce valuable research to address critical sector occupational safety and health problems in sectors and to share implementation of successful practices. To this end, the ITREOH program supports capacity development, including research training and laboratory research, epidemiologic methodologies, environmental and occupational hazard assessment, engineering control, intervention and control research and related policy development designed to facilitate clinical research and support of prevention of environmental health risks. Collaborations established through this program will help to facilitate standardized assessment and monitoring of environmental and occupational health hazards and prepare for the coordinated conduct of scientifically valid and ethically sound studies and interventions worldwide. Most importantly, a new and larger cadre of scientists and public health specialists will understand, evaluate, and help control, mitigate, and prevent the many environmental and occupational dangers that we face globally in the 21^st century.

Research Objectives

Modern technology has provided the means for healthy, productive lives. However, by-products and processes of these technologies present potential health hazards. In both developed and developing countries, better knowledge and understanding of choices and trade-offs make for better health policies. Good science for good decisions is the theme.

The goal of the ITREOH program is to provide the human resources and the collaborative contacts needed to stimulate research that will provide needed understanding of environmental and occupational health issues. The result will be better strategies to reduce any negative impact of useful technologies. The outcomes will be relevant to both the target region and the U.S., as environmental/occupational problems are not constrained by political borders.

There are many issues and solicited grant applications should focus on the most relevant topics in the focus country or region. A needs assessment for the proposed country or region of work should be provided as the basis for the program. Stakeholders from the country/region should be involved in developing the needs assessment.

Whereas impact will be an important evaluation criterion, discussion of how the proposed program will affect public health and policy should be provided. Retaining the benefits of the training program in-country is particularly important. How the proposed program will balance research, training and infrastructure development should be addressed, as well as how the intended outcomes will be sustained.

Emphasis will be placed on collaborative activities in countries and regions where environmental and occupational health conditions adversely impact public health and economic progress.

While applicants may choose from a wide range of activities, they are encouraged to focus on a limited number of scientific and geographic areas so as to make a real impact at collaborating institutions and in collaborating countries.

Examples of some specific environmental and occupational health research and training priorities are:

Special Requirements

Plan for Sharing Research Data (N/A)

Not applicable.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria

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

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, including geographical considerations and special opportunities
• The extent to which the proposed program complements other efforts in environmental and occupational health research supported by the Fogarty International Center and other participating Institutes and Centers.
• The interests and missions specifically identified by the participating funding organizations (FIC and NIEHS of the NIH, and NIOSH of the CDC).
• Program balance between critical research and public health research training areas.

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the National Institute of Environmental Health Sciences (NIEHS) in consultation with the Fogarty International Center (FIC) and the National Institute for Occupational Safety and Health (NIOSH), 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, generally the top half of applications under review, will be discussed and assigned a priority score.
• Receive a written critique.
• Receive a second level of review by the FIC Advisory Board and other appropriate Advisory Councils

Applications determined to be non-competitive will not be recommended for funding. All applications containing separate requests for resource center funding will receive a separate section of the critique evaluating the resource center proposal. Resource center requests will only be eligible for funding if the parent grant application is successful, and not all resource center requests of successful parent grant applications will be funded.

Review Criteria

Review criteria include those generally applicable to research training programs and research. The scientific evaluation of each application will include assessment of the linkage between proposed training and environmental and occupational health science-related research supported by FIC, NIEHS, and NIOSH. Evidence of support for this program by collaborating institutions and foreign governments must be submitted in writing with the application.

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 training 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 receive a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this research training program address an important problem and do the program priorities reflect the problems of the collaborating country(ies)? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of the training and studies on the concepts or methods that drive this field? What are the expected public health and scientific contributions of the proposed activity at a country and regional level? Are there demonstrated capacity and/or the potential to achieve sustained environmental and occupational health-related research and training efforts, and to build associated clinical and operational research and public health capacity within a country?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the research training? Details of the training plan should be included. Does the applicant recognize potential problem areas and consider alternative tactics? Is there a balance in the proposed training program to provide breadth of training opportunities in academic- or public health-based environmental and occupational health research in biomedical and behavioral sciences? Does the mix of long- and short-term training achieve the goals of this RFA, including focused efforts to build long-term biomedical, behavioral, clinical and operations research, and public health capacity at a model center of research excellence within a collaborating country? Are the proposed procedures and criteria adequate for (a) recruitment, review and selection of trainees, and (b) peer review of research? Does the proposal include concrete plans for trainees to become involved in environmental and occupational health sciences, biomedical and behavioral research, and prevention projects conducted in their home countries?

Innovation: Does the research training program employ novel concepts, approaches, or methods? Are the aims original and innovative? Does the program challenge existing paradigms or develop new methodologies or technologies?

Investigators: Are the investigators in the U.S. and abroad appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the research training team bring complementary and integrated expertise to the project (if applicable)? Are the qualifications of the PI, MFC, and the named faculty adequate to lead and to productively participate in the proposed training and research program? Do the PI, MFC, and participating faculty provide active and adequate research support?

Environment: Does the scientific environment in which the work will be done in the U.S. and abroad contribute to the probability of success? Do the proposed activities take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there firm evidence of institutional support by the U.S. and foreign institutions? Are there adequate mentoring and strength of resources and training environment in-country as evidenced by (a) the quality of teaching and the in-country research facilities and other resources, (b) the availability and history of high-quality candidates chosen on merit, and (c) past history of success of former trainees returning to their home countries and their continued involvement in the program (e.g., participation of past trainees in advanced in-country research and as faculty and mentors for new trainees)?

Those applications that include requests for support of regional resource centers will have these sections reviewed as part of the overall application, but the contents and budgets for this part will receive unofficial but separate merit ratings. The resource center plan will be evaluated based on its potential to affect a permanent and effective center for education, training and outreach in the geographic location and region of activity. Funding of these centers will be integrated into the awards based on the merits and program relevance of both parts of the application.

The initial review group will also examine the adequacy of the process for providing for the protection of human and animal subjects, the safety of the research environment, and plans for including training in the responsible conduct of research and training in the operation of Institutional Review Boards (IRBs), data and safety monitoring boards and community advisory boards as part of the program. IRBs in the home countries of trainees will be responsible for determining the adequacy of inclusion of women, minorities and children in research involving human subjects in their countries.

In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following:

2.A. Additional Review Criteria:

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

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

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

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

2.B. Additional Review Considerations

Budget: 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.

The proposed instruction in the responsible conduct of research must be rated adequate for an award to be made.

2.C. Sharing Research Data (N/A)

Not applicable.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the resource sharing plans with the awardee before recommending funding of an application. The final version of the resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates

Not applicable

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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

A final Progress Report and Financial Status Report are required at the end of the grant project period or upon relinquishment of an award. This report should include an overall summary and impact assessment of the program and any recommendations for the future of the program.

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:

Christopher Schonwalder, Ph.D.
Health Science Administrator
Fogarty International Center
National Institutes of Health
111 Alexander Drive
Research Triangle Park, NC 27709
Telephone at NIEHS: (919) 541-4794
Telephone at FIC: (301) 496-1653
FAX: (919) 541-2583
Email: [email protected]

2. Peer Review Contacts:

Sally E. Eckert-Tilotta, Ph.D.
Scientific Review Administrator
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-30
Research Triangle Park, NC 27709
(Express/courier address:
79 T.W. Alexander Drive
Building 4401, Room 3173
Research Triangle Park, NC 27709)
Telephone: (919) 541-1446
FAX: (919) 541-2503
Email: [email protected]

3. Financial or Grants Management Contacts:

Randolph Williams
Grants Management Specialist
Fogarty International Center
Building 31, Room B2C29
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 496-5710
FAX: (301) 594-1211
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

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

Human Subjects Protection:
Federal regulations (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).

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

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

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

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

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NIH Funding Opportunities and Notices

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