Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (

Components of Participating Organizations
National Cancer Institute (NCI)
Fogarty International Center (FIC)

Title: Developing Research Capacity in Africa for Studies on HIV-Associated Malignancies (D43)

Announcement Type

Request For Applications (RFA) Number: RFA-CA-09-016

Catalog of Federal Domestic Assistance Number(s)
93.398, 93.989

Key Dates
Release Date: September 22, 2009
Letters of Intent Receipt Date: November 17, 2009
Application Receipt Date: December 17, 2009
Peer Review Date: February-March 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: July 2010
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: December 18, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
  A. Receipt, Review and Anticipated Start Dates
     1. Letter of Intent
  B. Sending an Application to the NIH
  C. Application Processing
  D. Application Assignment
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. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives


This Funding Opportunity announcement (FOA) solicits grant applications for research training programs aimed at strengthening research capacity in HIV-associated malignancies (particularly viral-associated cancers) at institutions in sub-Saharan Africa. Programs to be proposed must involve international collaboration (a documented partnership) between an academic institution in the United States (U.S.) and a sub-Saharan African institution or institution consortium (institutions must be located in the same country). With the partnership requirement, only eligible U.S. academic institutions and other research institutions with appropriate experience in providing pre-doctoral and/or postdoctoral level training may submit applications in response to this FOA.

Partnering African institutions must be based in one of the sub-Saharan countries listed by the World Bank (,,contentMDK:20421402~pagePK:64133150~piPK:64133175~theSitePK:239419,00.html#Sub_Saharan_Africa).


HIV-associated Cancers in Africa. Up to two thirds of all HIV infected persons live in sub-Saharan Africa, and this region remains the epicenter of the HIV epidemic. Interwoven into the HIV epidemic is the rising cancer incidence in HIV-infected patients. Africa, particularly equatorial Africa, has been the epicenter of various viral related cancers even prior to the HIV epidemic. HIV infected persons are at higher risk of developing these viral associated cancers (e.g., Kaposi’s sarcoma, non-Hodgkin’s lymphoma/Burkitt’s lymphoma and cervical cancer) that signal progression to AIDS. In Africa, combination antiretroviral therapy (cART) remains limited and thus AIDS-defining malignancies continue to be a major problem. Kaposi’s sarcoma is a commonly diagnosed cancer and a leading cause of death in Africa. As cART becomes more available, and HIV-infected people begin to live longer, non-AIDS defining cancers will also have a significant impact on the health resources.

Inadequate Cancer Research Capacity in Africa. The cancer surge in Africa elicits diverse and complex challenges. In many African countries, most of cancers are diagnosed only during the late stages of the disease. Earlier diagnosis as well as cancer care requires multidisciplinary expertise that is often difficult to find in Africa. Importantly, the insufficient numbers of qualified health care providers are paralleled by underdeveloped capacity to conduct cancer research in these countries, even if there might be some research support from abroad.

For these reasons, building research capacity is viewed as one of the critical challenges to be addressed in order to improve the cancer situation in Africa. Specifically, training is needed in a range of disciplines including epidemiology, oncology, pathology, as well as in new diagnostic tools, new treatment regimens, and procedures for the collection, management, analysis and storage of data.

In the past, research capacity-strengthening efforts were supported by the National Cancer Institute (NCI) together with the Fogarty International Center (FIC) through a Revision of Awards to existing AIDS International Training and Research Program (AITRP) grantees (RFA-TW-08-004). However, there is a need to expand these efforts.

Research Objectives and Major Requirements of this FOA

Under this FOA, the NCI in collaboration with FIC will support new research training programs entirely dedicated to strengthening research capacity in HIV-associated malignancies. These programs must involve strategic partnerships between US investigators (from application submitting institution) and African investigators at collaborating institutions in sub-Saharan Africa. Participating institutions must demonstrate active research collaborations in HIV/AIDS or oncology. The proposed training program should be specifically formulated such that the cadre of scientific experts developed will be able to participate fully and efficiently in future research initiatives in HIV-associated malignancies.

Applicants responding to this FOA must outline how the proposed research training program will address the goals and expectations stated below and, specifically, how it will benefit the research needs of the African institution(s) in the field of HIV-associated malignancies.

The main goal for the partnerships (and for the program proposed in response to this FOA) must be to consolidate existing capacity on the African side and develop strategic teams that could become fully efficient and productive as partners to investigators from developed countries in innovative research endeavors oriented on HIV-associated malignancies. Even though these future research endeavors are beyond the scope of this FOA, training programs to be developed must be strongly oriented on facilitating future hypothesis driven studies in HIV-associated malignancies that could compete for support from other funding sources.

These future potential studies conducted in collaboration with African partners would be expected to have a major impact on our understanding of the etiology of cancers (particularly viral-associated cancers) and may result in gains in epidemiology and new treatments. Malignancies in the setting of HIV infection provide a unique opportunity to investigate the interplay of viruses, immune deregulation and cancer pathogenesis. In this regard, Dennis Burkitt’s studies conducted in Africa led to the first model of a virus induced human cancer and played a major role in establishing chemotherapy for cancer which benefited people all over the world. It is anticipated that studies originating from this initiative will also have a significant global impact and benefit.

Specific areas of research for which a training program may be proposed may include, but are not limited to:

NOTE: Applications focused only on cancer research (no training program) will be considered non-responsive.

Required Attributes of the Training Programs

Each proposed research training program should address the following specific goals:

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

Section II. Award Information

1. Mechanism of Support

This funding opportunity will use the D43 award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see

2. Funds Available

The estimated total amount of funds available for grants resulting from this FOA is $4.0 million per year, $12.0 million total over three years.

Applicants proposing Research Training Programs in response to this FOA may request a project period of up to three years and a budget (directs costs) of up to $500,000 per year.

The applicant institution may request a Facilities and Administrative (F&A) cost allowance based on eight percent of the total allowable direct costs, exclusive of tuition and related fees and expenditures for equipment. The applicant organization’s administration must provide the necessary management for the transfer of funds and materials to the collaborator(s) and any sub-contracts (consortium). Subcontracts (consortiums) may only charge eight percent F&A costs of applicable direct costs.

Because the nature and scope of the proposed research 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.

NIH grants policies as described in the,,contentMDK:20421402~pagePK:64133150~piPK:64133175~theSitePK:239419,00.html#Sub_Saharan_Africa). An application should focus on only one African country but may include a consortium of institutions/universities within that country. Participating U.S. and African institutions must demonstrate a history of research collaborations in HIV/AIDS or oncology.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her 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 support.

PD/PI must have a strong HIV and cancer research interest and research-training program experience as well as the requisite faculty and facilities to carry out the proposed research training activities.

In addition to the U.S. PD/PI each application must identify one investigator from Africa to serve as Senior Collaborator (if a single African institution is involved in the partnership). If the application involves a consortium of institutions in Africa, up to two African investigators may be identified as Senior Collaborators.

Applicants need to demonstrate the strengths of the partnerships by documenting existing collaborations. Recipients of previous AIDS International Training and Research Program (AITRP) cancer supplemental funding are encouraged to apply; others that meet the eligibility criteria are also encouraged. All applicants should explain their relevant research activities in the field of HIV/AIDS or HIV-associated malignancies.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Number of PDs/PIs. Only single PD/PI may be designated per application. This FOA does not allow multiple PDs/PIs.

Number of Applications. Only one application per U.S. applicant academic institution will be allowed. (Note: if appropriate, an African institution may participate in multiple applications submitted by different U.S. institutions.)

Resubmissions. Resubmission applications are not permitted in response to this FOA.

Renewals. Renewal applications are not permitted in response to this FOA.

Eligible Trainees:   The proposed training program must include a balance of individuals with doctoral level degrees (e.g., M.D., Ph.D., D.V.M, and other doctoral degrees) and individuals with master and bachelor level degrees who are expected to play critical roles in future research projects in HIV-associated malignancies.  In addition, individuals working towards a M.D., Ph.D or equivalent degree at an African institution may receive training if they are expected to play critical roles in future research projects. In exceptional situations, a candidate with less than bachelor degree may be selected, but each such case will have to be strongly justified and such candidate must be indispensable for the team built for the future research needs.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at 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:

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

2. Content and Form of Application Submission

Applications must be prepared using the 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 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 in item (box) 2 only of the face page of the application form and the YES box must be checked.

Supplemental detailed instructions for application preparation noting exceptions from the standard PHS398 instructions are provided in Section IV.6. Other Submission Requirements.

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
Letters of Intent Receipt Date: November 17, 2009
Application Receipt Date: December 17, 2009
Peer Review Date: February-March 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: July 2010

3.A.1. Letter of Intent

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

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

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Geraldina Dominguez Ph.D.
AIDS Malignancy Program

Office of HIV and AIDS Malignancy
National Cancer Institute
31 Center Drive, Room 3A33
Bethesda, MD 20892-2440
Telephone: (301) 496--3204
FAX: 301-480-4137

3.B. Sending an Application to the NIH

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

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

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-3428
FAX: (301) 402-0275

3.C. Application Processing

Applications must be received on or before the application receipt date) described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute Incomplete and/or 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.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at:

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 NIH Grants Policy Statement.

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 award if such costs: 1) are necessary to conduct the project, and 2) 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 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

Allowable expenses for Faculty Participation

Appropriate compensation for Collaborators may be requested for their significant activities on the program (such as trainee recruitment and selection) as well as other program-related roles. The administrative, training or teaching responsibilities and time commitment for personnel receiving salary should be thoroughly described and justified.

The salary and fringe benefits for the faculty and program-related staff must not exceed 25 percent of total direct costs.

Review of Progress Meeting: In year two of the funding period, there will be a program network meeting to assess progress and coordinate program activities. The meeting will occur in the U.S., for which the applicant should budget for. The Principal Investigator is expected to attend along with up to two Senior African Collaborators. Applicants may also budget for, other faculty (if appropriate) to attend. In addition, the participation of one long-term trainee who is enrolled at the PD/PI home institution may also be included in the budget.

Allowable expenses for Trainee Participation

Trainee Stipends: Trainees may be paid a stipend comparable to their educational level/professional experience in accordance with NRSA levels or grantee institutional policies while involved in medium- or long-term training at the grantee institution. Current NRSA stipend levels may be used as a guide and are described at Trainees may be paid a stipend while involved in long-term training or conducting long-term training-related research in their home countries at levels comparable with the salary scales for similar professionals in that country, in accordance with the collaborating foreign institution's policies, but not exceeding NRSA stipend levels.

Tuition and Fees for Trainees: Funds for tuition and academic fees at the U.S. or foreign institution may be requested.  The applicant should request full costs.  The awarding IC will apply the appropriate formula at the time of award.

Training Related Expenses: Applicants are encouraged to budget adequate professional development (including, but not limited to, international scientific conference attendance) opportunities for trainees. Training-related expenses (books, computers, and courses for software, English language proficiency, laboratory supplies, etc.) may be included but must be described in the budget justification. Funds for self-only or family medical insurance may be requested, but only to the extent that the same health insurance fees are charged to non-Federally supported individuals.

Non-allowable costs:

Travel funds for faculty and trainees are not allowed (except for moderate funds for travel to scientific meetings that are directly relevant to the project).

6. Other Submission Requirements


In general, applicants responding to this FOA must follow the PHS 398 Instructions for Preparing an Institutional Research Training Application Including Ruth L. Kirschstein-NRSA Applications (, see Section 8). However, various important additions or exceptions to these standard instructions are noted below

Applicants must read the instructions provided in the FOA along with Section 8 of the standard PHS398 instructions that describes the preparation of an institutional research training application.

Table of Content

Use the “Institutional Training Substitute Form Page 3” ( for Table of Content (modified to include additional budget pages as specified below).

Detailed Budget for Initial Budget Period and Budget for Entire Proposed Period of Support

Use the PHS 398 standard budget Form Pages 4 and 5 ( and, respectively) for the complete detailed budget for the initial budget period and for the complete budget for the entire proposed period of support.

Complete these Form Pages by:

(a)   Itemizing the expenses related to faculty participation and program-related costs;

(b)   Entering total (non-itemized) direct costs of the trainee participation costs as "Other Expenses"; and

(c)   Providing appropriate justification.

Respective cost figures from these standard Form Pages 4 and 5 are to be used on the application Face Page (Form Page 1).

In addition to these standard budget Form Pages 4 and 5, all applicants must complete the “Institutional Training Substitute Form Pages 4 and 5” ( and These “Substitute” Form Pages are used to itemize expenses related to trainee participation (in the initial budget period and for the entire period of support, respectively).

Research Training Program Plan

Items 2-5 of the Research Training Program Plan must not exceed 25 pages (excluding tables).

In the preparation of the specific sections (“items” 1-15 in Table of Content) of the Research Training Program Plan follow the PHS 398 instructions for Preparing an Institutional Research Training Application Including Ruth L. Kirschstein-NRSA Applications (, see Section 8) with the additions/modifications defined below.

Re Item 2. Background:

In addition, include the following:

Complete and refer to Table 2 (to be included under Item 14). Do not complete Tables 1 and 3.

Re Item 3a. Program Administration.

In addition, include the following:

Re Item 3b. Program Faculty.

In addition, include the following:

(Do not complete Tables 5 and 6.)

Re Item 3c. Proposed Training.

Replace the standard instructions for this item by the following instructions

Re Item 3d. Training Program Evaluation.

Describe a plan, metrics, and methodology for self-evaluation of the program. Evaluation metrics should eventually encompass both the success of the individual trainees and the impact of the program on research capacity at the foreign institution(s) and the establishment or strengthening of multidisciplinary research training capability in oncology.

Identify benchmarks and a mechanism to be established for periodic review of the progress of trainees and the effectiveness of the program. This aspect may involve regular meetings among faculty participating in the program and periodic review by the TAG and other outside groups of consultants.

Re Item 3e. Trainee Candidates.

Replace the standard instructions for this item by the following instructions:

(Do not complete Tables 7A, 7B, 8A, 8B, 9A and 9B.)

Re: Item 4. Recruitment and Retention Plan to Enhance Diversity

In addition, include the following:

Discuss plans to promote diversity relevant to the proposed African country rather than those defined within the U.S. context.

(Do not complete Tables 1, 7A, 7B, and 10.)

Re: Item 5. Plan for Instruction in the Responsible Conduct of Research

In addition, include the following:

Describe plans to ensure that all the trainees to be involved in human subjects research complete the required education in the protection of human subjects. Applicants must also ensure that this education will be properly documented.

Re: Item 7. Human Subjects

Replace the standard instructions for this item by the following instructions:

Re: Item 14. Data Tables

Re: Item 15. Letters of Support

Appendix Materials

All paper PHS 398 applications must provide appendix material on CDs only, and include five identical CDs in the same package with the application (see

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

The following resource sharing policies do not apply to this FOA:

Section V. Application Review Information

1. Criteria

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

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the National Cancer Institute and in accordance with NIH peer review procedures (, using the review criteria stated below.

As part of the scientific peer review, all applications will:

The following will be considered in making funding decisions:

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the program to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the program proposed).

Core Review Criteria. Reviewers will consider each of the five core review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance. How relevant to the goals of this FOA are the areas of research for which the training program is proposed? Is there a clear and measurable outcome of the proposed research training defined in terms of enhancing the ability of the African partners to contribute to new knowledge in HIV-associated malignancy research? How well is the training customized to address research questions of importance common to both the African and American institutions? How significant will be the proposed training program in terms of developing a cadre of researchers at the African institution(s) that will be well equipped to compete for future outside funding?

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the program?  Do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Is the proposed research capacity building taking adequate advantage from the existing partnership between the US PD/PI and the African Senior collaborator(s)?

Innovation. Does the application provide innovative strategies for sustaining research capacity beyond the project period? Do the applicants take advantage of existing expertise to propose original and cost-effective models of training?

Approach. Will the proposed research training program provide an appropriate variety of short-, medium- and long-term training opportunities? How realistic are the plans to complete the proposed research training program in three years? Are the responsibilities of the U.S. applicant institution and responsibilities of the African institution(s) clearly defined? How adequate is the proposed method for monitoring the impact of the research training experience on the careers of the trainees and on the contribution towards building HIV-associated malignancy research at the African institutions? Is there sufficient evidence of developing research independence for African partners?

Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the program benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is there evidence of foreign governmental and institutional support among the relevant institutions for the proposed research training as indicated by the inclusion of letters of support from the participating entities?

In addition to the above review criteria, the following criterion will be applied to applications in the determination of scientific merit and the priority score.

Past Collaborative Training Activities. Does the collaborating US and African institution(s) have a record of past research training program(s) across other disciplines? How successful were former trainees in obtaining individual awards such as fellowships, career awards, and research grants or as significant collaborators on other awards?

Additional Review Criteria. As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Additional Review Considerations. As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Select Agent Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (Not Applicable); 2) Sharing Model Organisms (Not Applicable); and 3) Genome Wide Association Studies (GWAS) (Not Applicable).

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information

1. Award Notices

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

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

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.

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of Award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General ( and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (

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.

3. Reporting

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.The instructions for preparing a progress report for an institutional research training grant should be followed. 

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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:

Geraldina Dominguez, PhD
Office of HIV and AIDS Malignancy
National Cancer Institute
31 Center Drive, Room 3A/33
Bethesda, MD 20892-2440
Telephone: (301) 496-3204
FAX: (301) 480-4137

Jeanne McDermott, CNM, MPH, PhD
Division of International Training and Research
Fogarty International Center
31 Center Drive, Room B2C/39
Bethesda, MD 20892-2220
Telephone: 301-496-1492
Fax: 301-402-0779

2. Peer Review Contacts:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-3428
FAX: (301) 402-0275

3. Financial or Grants Management Contacts:

Carol Perry
Office of Grants Administration
National Cancer Institute
6120 Executive Boulevard, EPS Room 243, MSC 7150
Bethesda, MD 20892-7150 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-7205
FAX: (301) 496-8601

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 ( as mandated by the Health Research Extension Act of 1985 (, and the USDA Animal Welfare Regulations ( 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 (

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,

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 (

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.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see

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 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 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 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 (; a complete copy of the updated Guidelines is available at 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 (

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at and at Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding ( 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.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy ( investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (, to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award. For more information, see the Public Access webpage at

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 ( 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

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at and is not subject to the intergovernmental review requirements of Executive Order 12372. 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

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:

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

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