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)

Title: Framework Programs for Global Health

Announcement Type
New

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

• November 10, 2005 (PAR-06-067) - PAR-05-050 has been reissued.

Program Announcement (PA) Number: PAR-05-050

Catalog of Federal Domestic Assistance Number(s)
93.989

Key Dates
Release Date: February 10, 2005
Letters of Intent Receipt Date(s): March 21, 2005
Application Receipt Dates(s): April 18, 2005
Peer Review Date(s): June/July, 2005
Council Review Date(s): September 13, 2005
Earliest Anticipated Start Date: September 30, 2005
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date : April 19, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Fogarty International Center invites applications for up to three years of support for the creation of new, multidisciplinary programs that will foster Global Health research and teaching within and between institutions, to be called Framework Programs for Global Health. The goals of these Programs will be to encourage greater involvement of NIH-funded researchers in Global Health, to facilitate greater collaboration and interactions among Global Health research and training programs at domestic and foreign sites, to bring new participants into the Global Health discussion, and to engage the next generation of scientists and health workers to choose careers in Global Health. Two core activities will be to create an administrative framework to bring multiple schools (engineering, business, chemistry, biology, communication, public health, medicine, environmental studies, and others) together on the topic of Global Health and to develop multidisciplinary Global Health curricula at the undergraduate and graduate levels. Each program should leverage and enhance currently funded Global Health projects at the institution, supported by NIH and other sponsors, as well as encourage new training opportunities, collaborations and research areas. To ensure that institutions support the Framework at the highest level, letters from the University President, Provost, or other Institutional Director will be required. The Fogarty International Center anticipates funding eight to ten new awards (Framework awards and planning grants) in FY05.

• This award will use the R25 mechanism.
• Eligible organizations include. Non-profit, domestic or foreign, public or private institutions, such as universities, colleges, and research institutions that can link to educational institutions to meet the full requirements of the program. Foreign institutions must be from low- and middle-income countries. To be eligible, institutions must have a pre-requisite number of qualifying active NIH grants, either as direct grant recipients or by having key personnel listed on an award, as described below. Institutions from eligible countries may bring in partners for the purposes of this award, which together must submit a single application.
• Eligible Principal Investigators (PIs) include any individual with the skills, knowledge, and resources necessary to carry out the proposed program. Women and individuals from underrepresented racial and ethnic groups, as well as individuals with disabilities are always encouraged to apply for NIH programs. PIs should be associated with one of the qualifying NIH grants (for example, as a listed investigator) and have demonstrated experience in international training or research programs.
• Only one application may be submitted from a single institution. The term single institution is defined under Eligible Institutions, below.
• The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance, contact Grants Info, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.
• Telecommunications for the hearing impaired is available at: TTY 301-451-5936

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
3. Reporting

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

Section VIII. Other Information - Required Federal Citations

1. Research Objectives

Background

As the world becomes an increasingly global community, there is a need for new, integrated, and multidimensional approaches to Global Health. Health concerns have become the shared concerns of many nations, and health crises can rapidly spread from one country to another. These health threats include infectious diseases such as HIV/AIDS, malaria, and drug-resistant TB, as well as emerging and re-emerging diseases such as SARS and the threat of pandemic influenza. In addition, because of the demographic transition in the developing world, non-communicable diseases and conditions such as those related to trauma and injury, obesity, tobacco use, adverse impacts of the environment, mental health, cancer, and cardiovascular disease represent an increasing disease burden on a global scale. These health challenges encompass biomedical, social, environmental, political and economic dimensions and, consequently, may best be addressed through multi-disciplinary teams and interdisciplinary approaches.

Universities and other institutions of research and teaching in the U.S. and abroad play critical roles in conducting Global Health research and in training the next generation of scientists and professionals in Global Health. To fully harness the expertise in these institutions and include faculties of law, medicine, public health, engineering, journalism and others, new strategies are required. Greater coordination among faculties would energize the Global Health enterprise. At the same time, by bringing multiple schools together around a common concern of Global Health, it would be expected that undergraduates and graduate students would become engaged in this field. An increasing number of institutions have begun to recognize the inherent research interest of Global Health problems and welcome the opportunity to use their substantial creative resources to make a contribution to global welfare by further expansion of Global Health activities.

The purpose of this award is to catalyze and support the efforts of universities and other institutions with significant activities in Global Health that are ready to commit to shaping an integrated Program in this area. For the purposes of this PA, "global health activities" are defined as research, teaching, clinical care, prevention, and outreach activities directed towards addressing health concerns that contribute a significant burden of disease in low- and middle-income countries and are of general concern to the international health community. US awards in Global Health are expected to involve partnerships and interactions with institutions in the affected countries. Examples of Global Health areas include HIV/AIDS, malaria, tuberculosis, respiratory and diarrheal diseases, as well as the significant burdens of mental illness and cardiovascular disease in developing countries, among many others. Topics included in FIC programs provide other examples.

Specifically, the objectives of this PA are (1) to increase interactions and joint activities among investigators already engaged in Global Health teaching and research within a campus and among institutions; (2) to encourage new investigators from diverse faculties and disciplines to enter the Global Health field; and (3) to build curricula and develop educational opportunities that will engage the next generation of scientists and health workers to consider careers in Global Health. The activities initiated under this award will create a framework of support for Global Health initiatives. To ensure that institutions support the Framework at the highest level, letters of support from University Presidents, Provosts, or Institutional Directors, and some evidence of institutional commitment, are required. US and developing country institutions are invited to submit applications for Framework Awards. However, recognizing the complexities of putting together the teams necessary to develop a Framework Program, institutions from low- and middle-income countries may choose to submit applications for 2-year Planning Grants, as described below.

Framework Programs

In low- and middle-income institutions only, or in partnerships that include them, once a set of workshops or courses are established that meet these generalized and common needs, the institutions may choose to initially concentrate their advanced curricula in a more focused area that addresses their current strengths, faculty resources, and perceived national public health priorities. The foundational courses will then act as a platform on which additional and more diverse courses might be built in the future. The focus area must still be multidisciplinary and topically broad. For example, "mental health" or "infectious diseases" would be acceptable, while focus on a single disease such as major depression or HIV/AIDS would not be allowable. Applicants should justify the choice of a focus area and provide well-defined capacity building goals in this area for the institution(s) involved. All other institutions should develop a broad curriculum, integrating infectious, chronic, behavioral and environment-related health concerns. The educational opportunities developed under the Framework may take a variety of forms, as appropriate to each institution's strengths and needs.

To foster a culture of multidisciplinary dialogue and teamwork among both students and faculty, at least three departments or schools within the institution must be formal participants in the proposed Framework program. These schools or departments should involve distinct disciplines. That is, three departments within a School of Biological Sciences, such as Microbiology, Genetics, and Biochemistry, would not be sufficient. Instead, innovative programs involving Schools of Medicine, Nursing, Dentistry, Biological Sciences, Public Health, Veterinary Sciences, Chemistry, Ecology and Environmental Studies, Economics, Business, Engineering, Computer Sciences, Mathematics, and others are encouraged. While not every course or activity will bring these disciplines together, a portion of the curricula should specifically address this goal.

Many of the programs sponsored by the Fogarty International Center are by their nature multidisciplinary and provide examples of the types of multidisciplinary approaches that may be developed in a Frameworks curriculum. Examples include the Health, Environment, and Economic Development Program; Ecology of Infectious Diseases Program (which studies ecological and biological mechanisms that govern the relationships between anthropogenic environmental changes and the transmission dynamics of infectious diseases, in many cases generating mathematical models); AIDS International Training and Research Program (biomedical and behavioral science); Stigma (which explores the role of Stigma in Health); Informatics Training for Global Health (informatics as applied to health research); International Training and Research Program in Environmental and Occupational Health(biomedicine, epidemiology, and engineering control technology); International Cooperative Biodiversity Groups (drug discovery, biodiversity conservation, and economic development); and others. Groups studying HIV/AIDS, tuberculosis, malaria, or diarrheal disease may choose to team with groups studying Brain Disorders in developing countries to offer a course on the mental health sequelae of infectious diseases. There are many possible combinations. More information on Fogarty programs can be found at http://www.fic.nih.gov.

Institutions must have, or be significantly involved in, a minimum number of active NIH awards in global health areas to be eligible to apply for a Framework grant (see Eligible Institutions, below). It is expected that key personnel on these awards will work together to develop associated curricula. In this way, curricula development may become one means of increasing interactions among these groups, promoting joint training opportunities and allowing for more efficient use of funds to achieve goals common to each of their projects. Under "Core Activities", applicants should address each of the four areas that follow.

A. Purpose and Goals of the Curricula to be Developed: Give an overview of your curriculum plan. What are the specific goals that the institution wishes to address through the curricula to be developed? How will the curricula proposed address those needs? How will the set of proposed offerings contribute to the framework for an integrated program in Global Health? In light of the specific goals of your institution in initiating a Global Health Program, how would the opportunities at the Institution change if the proposed curricula were implemented?

B. Course Content: Applicants should describe the courses to be developed through the Framework award. Examples of activities that might be undertaken under this category include, but are not limited to:

1. Development of a degree program in Global Health, with associated curricula and research requirements. This may be at the undergraduate or graduate level, but should be oriented towards research-relevant training and preparation.
2. Development of a core course in global health for undergraduate or graduate students, to bring together majors in multiple disciplines and teach them how to work across disciplinary boundaries in Global Health research.
3. Development of a program for MDs, nurses, dentists, or other health practitioners who wish to pursue research in Global Health. This may provide educational/research experiences to those in a clinical research track within a clinical training program or form part of the curriculum of a professional school.
4. Design of workshops or courses in foundational skills such as informatics, biostatistics, epidemiology, bioethics, laboratory best practices, research administration, grant and scientific writing, science communication, and mentoring. This might serve as a common training venue for students and faculty participating in all global health research and training awards at the institution, as well as other students within the Framework Program.
5. Leadership training workshops for research scientists to develop skills necessary to promote research, to provide informed advice to policymakers, and to advocate for research resources within their institutions, countries, or wider research networks..
6. Training in evaluation methodologies.
7. Development of courses that address specific Global Health topics through multidisciplinary perspectives. These would most logically be designed to build on the research interests of the participating NIH award groups, participating schools, or areas of collaboration with international partners, including focus areas for low- and middle-income country institution curricula.
8. A course in translation of research into practice. This may bring the research and care communities closer together to explore possibilities in this area, including how to work most effectively with community members to sustain public trust in research.
9. Development of freshman seminars to capture the interest of undergraduates in Global Health research topics.
10. Development of a Global Health intern program to place students from diverse academic fields for short experiences with research groups and organizations involved in Global Health-related activities. Many of these opportunities may be structured short research experiences for students in the program to provide hands-on experiences in Global Health research. This should leverage existing research activities of participating faculty. For applications involving multiple partner institutions, this might involve exchanges of students between sites. However, the host organizations need not be partners on the application. We encourage you to consider the diversity of potential players that contribute to all aspects of Global Health. Examples include community organizations; economic institutions such as the World Bank; drug development alliances such as Medicines for Malaria Venture; departments of private corporations that plan for emergency responses to epidemics; organizations involved in disease detection, monitoring and response including those focused on database design and optimization; U.S. or foreign Government agencies involved in research, policy or technical assistance for Global Health; pharmaceutical and biotech companies; scientific reporting units of local publications that deal with Global Health topics; and many others. These opportunities may offer a larger vision of how the Global Health community operates in scientific, political, and economic arenas, and may provide a useful real-world network of contacts for the students and faculty and for the Framework Program overall. Associated courses may be developed to prepare students for these opportunities and bring them back together at the conclusion of these experiences to share what they have learned. An intern program could be a unifying core for a Framework Program.
11. All programs must include a course in Responsible Conduct of Research and plans to evaluate it.
12. Where appropriate, courses should include education in the importance of inclusion of children, women, and individuals from underrepresented racial and ethnic groups in human subjects research design. The design of training-related research projects should take into account potential sex and gender differences that may affect the questions asked and the analyses performed. These might include different responses to and impacts of health interventions, differences in physiology, and different behavioral bases for disease prevention strategies.

C. Course Details: You should be as specific as possible in describing the proposed program, including courses to be offered, length of courses or workshops, frequency of classes, who will teach the courses and under what department or other auspices, selection criteria for participants entering the program, and target enrollment once the program is established. Applicants should attempt to ensure that the courses capture the most qualified individuals and include an adequate representation of men, women, and minority population groups among the student participants. The approval process for new courses at the institution(s) should be described, how this will be navigated for the Framework courses in aggregate, and how this might impact pilot courses and workshops to be implemented during the grant period. Current offerings at the institution may be included in support of the Framework, but simply listing these together would not be sufficient. However, strengthening and supplementing existing curricula and faculty capabilities in this area may be the most effective route to building a Framework Program at many institutions. In such cases, the value added by the Framework Program must be clear. Where distance learning courses are proposed, you must include opportunities for individual mentoring and interaction with students, as well as address infrastructure requirements to access the courses.

D. Administration of the Framework Program: All applications should describe how the Framework Program would be administered in a way that would maximize contributions from three or more schools and any potential partners. As activities must be coordinated across the entire campus or among several institutions, it may be useful to appoint a Program Administrator or develop a Framework Administrative Group. The Framework Administrator may also serve the individual Global Health research and training programs on campus. For example, many training programs, particularly those involving foreign students, have similar needs for an Administrator with experience in contracts, visas, money transfers, helping students assimilate into the University, coordination of travel, language training, and grants administration. Concentrating these functions within a common administrative structure may provide some economy of scale for these programs, freeing funds for other activities. Such a resource may also provide significant added value to new and ongoing research training grant applications, help with preparations for courses and conferences, match potential trainees and opportunities, arrange for lectureships and other activities of the Framework and provide a useful point of contact for those interested in learning more about Global Health.

Supporting Activities
Activities that complement and expand upon the proposed curricula development and provide further collaborative opportunities across multiple schools and research programs should be proposed. They should contribute to creating a Framework identity and more visibility for Global Health on campus, as well as bring new researchers into the Global Health discussion, by increasing activity and interactions in the Global Health area. Possible activities include, but are not limited to:

1. Research related networking activities, such as joint group meetings among research groups working in Global Health, with new participants in business, engineering, law and other schools; scientific conferences to highlight issues in Global Health for the University and associated communities; creation of a website for the Framework Program; and new seminar series in Global Health.
2. Visiting lectureships, which may bring faculty from low- and middle-income countries to the U.S. or vice versa. This may bring fresh perspectives and skills to the Program participants and catalyze the formation of new research collaborations. In this regard, foreign students on campus may also contribute valuable health perspectives from their countries and may be included in Framework activities.
3. Structured opportunities for short research experiences for students in the Program to provide hands-on experiences in Global Health research. This should take advantage of current research activities of participating faculty. For partnering institutions, this might involve exchanges of students between sites.
4. Faculty research development to support needed components of the Program.
5. Formal career advice for students concerning prospects and opportunities in Global Health fields. This may include a website that publishes current opportunities for research and training in Global Health relevant to Framework participants. After the Framework award network is established, the awardees may decide to manage this resource through one Framework group to support all Framework Programs.
6. Networking among Framework Programs funded under this PA or by other sources.

Applications should describe supporting activities in detail and offer specific examples of each activity. For example, if structured opportunities for research or visiting lectureships are proposed, include letters from potential lecturers or from research programs willing to accept students for short research experiences. If conferences are proposed, the potential topics to be addressed and how such a conference would integrate with and further the goals of creating a Framework program should be described. Applicants should describe the relationships of the proposed supporting activities to the proposed curricula. You should also address how these activities will both serve to build a Framework for an integrated program in Global Health, and increase cooperation among ongoing Global Health projects at the institution.

Structure of the Proposed Framework Program
Applicants should describe the structure of the proposed Framework program. All participating departments, Schools, and partner institutions should be described and plans for how these diverse entities will be coordinated and integrated must be discussed. Will the Framework have a physical office or location on campus, which will coordinate activities and from which information might be obtained, or will all activities be distributed, with information available through some accessible venue such as a website? If partnering between units at distant sites, how will communication between the parts be coordinated and maintained so as to produce integrated curricula and training activities? Are there plans for all the participating groups to meet at regular intervals? If so, what venue will be used? Will travel be required? Will there be a continuing liaison with the university leadership? Are there any practical challenges within the University structure that must be overcome in order to initiate a Framework program, such as credit for junior faculty who participate in the program outside of their departments, distribution of overhead from grants to the Framework program, administrative challenges, and others? How will these be tackled? Coordination, integration, and trans-institutional support are likely to be key elements in the success of any Framework program.

In addition, applicants should describe the relationship of the proposed Framework program to funded Global Health projects at the institution. How will the proposed program leverage and include those projects? How will the curricula and other activities serve to integrate those projects into an interactive, identifiable trans-institutional Program? A list of all funded research and training programs currently at the university in the area of Global Health should be provided. This list will be used for establishing eligibility and determining the richness of the environment as a basis for a Framework Program. Those programs and associated personnel from this list who will specifically work on the Framework award should be indicated.

Evaluation of the design of the Framework Program overall and of individual courses, workshops, and activities should be an important component of the structure of each Program. Benchmarks for the overall program as well as details of the educational goals and skills delivered by each new course to be developed, must be stated and will serve as a baseline for evaluation. An internal and/or external board of advisors should be established to provide advice during the development of the program and to provide counseling and monitoring as it is implemented. Plans for evaluation of the Program should be discussed.

Finally, applicants should describe the long-term vision of the Institution in the area of Global Health. How will the proposed curricula and other activities help attain that vision? How will the Institution sustain and build upon the activities initiated under this award at the conclusion of the award period?

Evidence of Institutional Commitment

As the purpose of this PA is to shape a Framework for Global Health that will catalyze the expansion and coordination of Global Health activities across institutions, it is important that the institutions are fully committed to implementing the products of this grant and sustaining them into the future. Consequently, institutions must provide some evidence of that commitment. This may take the form of in kind contributions, matching funds, or other means, at the discretion of the applicant. For example, salary and fringe benefits associated with the percent effort on this grant for the Program Director and participating faculty may be wholly or partially donated and paid from other grant or institutional sources; release time from teaching or clinical responsibilities may be donated to allow participating faculty to devote attention to curriculum development; multiple Global Health grants on campus may pool their resources to provide a common resource to the program; overhead return from Global Health grants among the partner institutions, or provision of equipment, computers, and space, might similarly be contributed.

Applications must include a letter of commitment from the respective University Presidents or comparable Institution Director in support of the activities proposed, including a commitment to implement the curricula developed under this award, pending approval through established university processes. Where there is more than one institution participating, letters of commitment should be included from each partner institution.

Planning Grants

Applicants from low- and middle-income country institutions may apply for a 2-year planning grant to provide resources needed to develop a more complete Frameworks program. Planning grants provide support to assess needs at the institution and develop institutional support for a Global Health Program; develop collaborations and needed resources; generate preliminary curricula and carry out pilot activities; and organize, plan, prepare, and assemble an application for a Framework award. Planning grants are subject to the same eligibility requirements as Framework Awards. Applicants may only apply for a planning grant)for the April 18, 2005 deadline. This option will not be available in the second year of the PA. Applicants should justify the need for such a program at their institutions and document the expertise and ongoing grants at the institution that this program will build upon. Collaborations among at least three schools at the institution or among partner institutions should be identified, and appropriate letters of commitment from each of these components should be included. The activities to be undertaken in order to solidify those relationships and form a Framework structure should be described.

Examples of activities include:

1. Meetings among partners to determine roles and to plan joint activities, and the recruitment of additional schools and individuals to introduce needed expertise.
2. Constitution of an advisory group and consultations to lay the groundwork for a Frameworks Program.
3. Faculty strengthening in areas to be emphasized in the Program.
4. Consultations with experts to help develop curricula.
5. Development and deployment of pilot courses and workshops to be further developed in a Framework Program.
6. Development of necessary computational infrastructure.
7. Key personnel may plan to take grant-writing workshops during this period to prepare for writing an application for a Framework award.
8. Planning for and conduct of any of the activities described under Framework awards.

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

1. Mechanism(s) of Support

This funding opportunity will use the NIH Research Education Project Grant (R25) award mechanism. 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

FIC intends to commit up to $1 million in FY05 to fund up to ten new awards in response to this PA. (For a Framework award, an applicant may request a project period of up to three years and a budget of up to $125,000 direct costs per year. For a planning grant, applicants may request a project period of up to two years and a budget of up to $25,000 direct costs per year. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. Facilities and administrative (F & A) costs requested by consortium participants are not included in the direct cost limitation; see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html. F & A costs are limited to eight percent. This PA will be available for two consecutive years for funding beginning in September 2005 and September 2006. We anticipate a limited competition for planning grant awardees in 2007, allowing applicants the opportunity to submit full proposals for Framework awards. The applicant organization's administration must provide the necessary management for the transfer of funds and material to the collaborator(s) and any subcontracts (consortium). Subcontracts (consortiums) may only charge eight percent F & A costs of applicable direct costs.

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

• Non-profit organizations
• Public or private institutions, such as universities, colleges, or research institutions that can link to educations institutions
• Foreign Institutions
• Domestic Institutions

The eligibility criteria for domestic and foreign institutions differ.

U.S. Institutions: Applicant institutions must have a minimum of 5 NIH research grants, training grants, or cooperative agreements in Global Health areas, awarded to one or more of the participating schools or departments within the institution. For this PA, "Global Health awards" are defined as those that address serious health concerns in low- and middle-income countries and must involve international partnerships and activities in those countries. A grant or cooperative agreement may use the R, U, P, or D43 award mechanisms and must be in excess of $100K per year of direct costs. At least one of these qualifying grants must be a FIC International Training Grant, which uses the D43 mechanism. These grants must be active for at least one year beyond the time of expected award (September, 2005).

Foreign Institutions: Foreign institutions must have a minimum of 3 NIH research grants, training grants, or cooperative agreements in Global health areas important to public health concerns in their countries. Allowable award mechanisms, annual minimum direct costs for each grant, and remaining years of activity are as described above. Foreign institutions may be the direct recipients of the NIH award or may be a foreign component/subcontract of a NIH grant awarded to a U.S. institution. Key personnel from the foreign institution must be listed on the grant application. Applicants are strongly encouraged to discuss their potential interest and the eligibility of their institutions with the FIC Program Officer. Eligible foreign countries are defined as low- and middle-income countries according to the World Bank list of economies (http://www.worldbank.org/data/databytopic/CLASS.XLS).

Grants from other funding agencies (such as the United Kingdom Medical Research Council, the French INSERM, the Bill and Melinda Gates Foundation, the Wellcome Trust, and many others) and non-qualifying NIH awards can contribute to the Framework Program and structure but cannot be considered for eligibility purposes Failure to meet the eligibility criteria by the time of peer-review will disqualify the application from consideration.

Multiple institutions may be partners on a single application: Institutions that have a history of working together and/or have common goals in the Global Health area may choose to submit an application together for the purposes of developing joint curricula, activities, or degree programs. Every institution to be included must be named (that is, open networks are not allowed) and each institution must submit a letter indicating their commitment to participating in a joint award. A key co-Investigator should be named as the coordinator at each partner institution. The maximum direct costs allowable will remain the same regardless of the number of institutions participating in the application. While the applicant institution (the institution of the Principal Investigator) must be from the US or an eligible foreign country, partners in the application may be any institution(s) in any country selected by the applicant. The applicant institution must be able to fulfill the grant eligibility requirements above (i.e. the requirements cannot be fulfilled as the sum of awards at all partnering institutions). Each additional partner, however, does not need to also fulfill the eligibility requirements. While we encourage interactions between framework programs resulting from separate awards, if the intended outcome of that interaction is a joint curriculum then the institutions must come in on a single application, with one applicant institution and one or more subcontracts. As described under "Core Activities", personnel from three or more schools or departments representing distinct disciplines must be active participants in the design of curricula and other activities. These three schools may be located at separate partner institutions. Applicants must explain why the particular partnerships were chosen and why these partners have the potential to successfully develop a program together. This may be based on a prior history of working together, and evidence of established joint activities, with shared grants, publications, faculty or other interactions should be documented in the application. On the other hand, developing new multidisciplinary programs and programs involving multiple educational levels may bring new groups together who share a common vision but have not previously worked together. A strong justification of why these partnerships add value to the proposed program should be included. The strength of these potential or existing relationships will be a review criterion. Formalizing such linkages by forming a joint program may create expanded research and training opportunities for all partners. Such a program may involve shared curricula, faculty and student exchanges, sharing of research resources, and even joint degrees. In addition, research institutions may need to partner with teaching institutions in order to provide both research and training components for a Framework Program.

As the purpose of this PA is to act as a unifying mechanism for Global Health research related activities across a campus, only one application will be accepted from any single institution. Similarly, institutions may only be partners in one application. However, separate campuses within one university system (for example, the University of California) will be considered separate institutions for the purposes of this PA. Separate campuses in close geographical proximity that belong to one university system, however, are strongly encouraged to submit a joint application, particularly where faculty have joint appointments at both institutions.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Women and individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. Principal Investigators should be associated with one of the qualifying NIH grants (for example, as a listed investigator) and have demonstrated experience in international training or research programs.

2. Cost Sharing or Matching

Not applicable

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
Not applicable

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

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

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

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

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: March 21, 2005
Application Receipt Date(s): April 18, 2005
Peer Review Date: June 2005
Council Review Date: September 13, 2005
Earliest Anticipated Start Date: September 30, 2005

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:

Dr. Flora Katz
Division of International Training and Research
Fogarty International Center
31 Center Drive, MSC 2220
Building 31, Room B2C39
Bethesda, MD 20892-2220
Telephone: (301) 402-9591
FAX: (301) 594-1211
Email: katzf@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. 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)

At the time of submission, two additional copies of the application should be sent to the Scientific Review Administrator :

Dr. Priti Mehrotra
Science Review and Policy Division
DHHS, NIH, NIAID, DEA, SRP
6700-B Rockledge Drive, msc 7616, Rm #3138
Bethesda , MD 20892-7616
Telephone: (301) 301-435-9369, 301-496-2550
Fax: 301-402-2638
Email: pm158b@NIH.GOV

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 CSR and responsiveness by the FIC and the Scientific Review Administrator at NIAID.

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

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

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm (see also Section VI.3. Reporting).

The following restrictions should be observed. Salary support for an administrator to oversee and manage the entire Framework Program is allowable up to 50% salary and fringe benefits. The Program Director may receive salary and fringe benefits compensation for up to 25% professional effort devoted to the Framework Program. Note that tuition and salary support for research fellows to work for an extended period on Global Health research related projects, while recognized as an important component of any institutional program, would not be consistent with the aims of this program, nor would the award size allow for this cost. On the other hand, support of students during short research experiences is allowable, including cost of living, travel, and limited research expenses. FIC will hold a network meeting for Principal Investigators from all Framework Programs (including planning grants) each year on the NIH campus. Funds to travel to this meeting should be included in the budget.

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

Plan for Sharing Research Data

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

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Data sharing should include publications that discuss lessons learned in setting up a Global Health Program in a particular country or context, as institutions throughout the world increasingly consider this option. Investigators on Framework awards will meet once a year to share progress and experiences with each other. After the establishment of the network, investigators may also choose to make some or all of their curricula available to each other or to the general academic community, as consistent with their institutional intellectual policy guidelines. In some cases, it will be desirable to make selected portions of these curricula available over the World Wide Web so that institutions in low- and middle-income countries that do not have these awards might make use of the products of the Framework network in building their own curricula and Global Health Programs.

Sharing Research Resources
Not applicable

1. Criteria

In addition to the criteria below, evidence of institutional commitment to the Framework Program will be an important review criterion. Failure to meet the applicant institution eligibility criteria (i.e. eligible country and pre-requisite number of currently funded NIH grants) by the time of peer-review will disqualify the application from consideration.

2. Review and Selection Process

Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.

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 Fogarty International Center Advisory Board.

The following will be considered in making funding decisions:

• Scientific merit of the proposed project as determined by peer review
• Availability of funds
• Relevance of program priorities, including geographical considerations; the extent to which the proposed program complements other efforts in Global Health research sponsored by the FIC and participating NIH Institutes and Centers; the interests of any co-funding partners; and program balance among critical research and public health research training areas of emphasis among the Framework Programs.

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

The following criteria apply to Framework Awards, and may be applied to Planning Grants, where appropriate. Where Planning Grants would not encompass these activities, do the approaches and activities proposed have the potential to lead to the development of a Framework Program that will meet these criteria?

1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the proposed curricula development and supporting activities address a need at the applicant institution to expand its offerings in the area of Global Health- related research ? Will these activities have a significant impact on the structure and opportunities at the institution? Does the inclusion of any partner institutions add value to the program?

2. Approach. Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Are there adequate plans for the coordination and integration of the ongoing Global Health projects, multiple schools and departments, and institutional partners that will participate in the Framework Program? Are the curricula to be developed likely to achieve the institution's vision for Global Health? In the curriculum plan, is there an adequate balance between didactic and experiential learning opportunities? Is there an adequate evaluation plan? Finally, do the applicants discuss plans to implement the curricula once they are developed and to sustain the activities initiated under this award at the conclusion of the award period?

3. Innovation. Is the project original and innovative? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? Are the multiple scientific disciplines required engaged and integrated in a thoughtful and creative manner?

4. Investigators. Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the Principal Investigator and other participants? Does the Global Health Framework team bring complementary and integrated expertise to the project? Does the faculty identified have the necessary experience in Global Health- related research to lead an effort in this area? For U.S. institutions, do the Principal Investigator and other key personnel have international experience relevant to the teaching goals? Have the key personnel committed adequate time to carry out the goals of this program? For applications involving multiple institutions, do the partnering institutions and personnel have a previous history of successfully working together and/or a strong justification for submitting a joint proposal?

5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed activities benefit from unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? Are the facilities available or proposed adequate to carry out the proposed curricula and support activities once they are developed, including any requirement for information technology infrastructure?

2.A. Additional Review Criteria:

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

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

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

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

2.B. Additional Review Considerations

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

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources
Not applicable

3. Anticipated Announcement and Award Dates
Not applicable

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

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

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

Notices of Grant Award (NGAs) will be sent to the responsible institutional business representative by postal mail or by email.

2. Administrative and National Policy Requirements

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

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

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

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

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:

Dr. Flora Katz
Division of International Training and Research
Fogarty International Center
Building 31, Room B2C39
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 402-9591
FAX: (301) 594-1211
Email: katzf@mail.nih.gov

2. Peer Review Contacts:

Dr. Priti Mehrotra
Science Review and Policy Division
DHHS, NIH, NIAID, DEA, SRP
6700-B Rockledge Drive, MSC 7616, Rm #3138
Bethesda , MD 20892-7616
Telephone: (301) 301-435-9369, 301-496-2550
Fax: 301-402-2638
Email: pm158b@NIH.GOV

3. Financial or Grants Management Contacts:

Mr. Randolph Williams
Grants Management Specialist
Fogarty International Center, NIH
Building 31, Room B2C32
31 Center Drive, MSC 2220
Bethesda , MD 20892-2220
Telephone: (301) 496-5710
FAX: (301) 594-1211
Email: willrand@mail.nih.gov

Required Federal Citations

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

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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

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

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

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

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

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

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

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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

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

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