Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Cancer Institute (NCI) National Institute on Dental and Craniofacial Research (NIDCR)
Funding Opportunity Title	Research on Malignancies in the Context of HIV/AIDS (R01)
Activity Code	R01 Research Project Grant
Announcement Type	Reissue of PA-07-455
Related Notices	October 21, 2013 - This PA has been reissued as PA-13-377.
Funding Opportunity Announcement (FOA) Number	PA-10-290
Companion FOA	PA-10-291-, R21 Exploratory/Developmental Grant
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestics Assistance (CFDA) Number(s)	93.393, 93.394, 93.395, 93.396, 93.121
FOA Purpose	This funding opportunity announcement (FOA) issued by NCI and NIDCR, National Institutes of Health, encourages Research Project Grant (R01) applications from institutions/ organizations that propose to continue advancing our understanding of the risks, development, progression, diagnosis, and treatment of malignancies observed in individuals with an underlying Human Immunodeficiency (HIV) infection or Acquired Immune Deficiency Syndrome (AIDS). The NCI and NIDCR seek to encourage research in areas such as the study of the etiologic factors, cofactors, immunopathogenesis, diagnosis, and consequences of both AIDS-defining and non-AIDS defining malignancies in diverse populations in the context of an underlying HIV infection. This FOA invites research efforts that will: (i) provide information on the clinical outcomes of such cancers in the HIV-infected population; and (ii) identify specific contributions resulting from HIV infection and its potential interaction with other pathogens for the development and pathogenesis of these cancers.

Posted Date	September 29, 2010
Open Date (Earliest Submission Date)	December 7, 2010
Letter of Intent Due Date	Not Applicable
Application Due Date(s)	Not Applicable. ONLY AIDS dates apply.
AIDS Application Due Date(s)	Standard dates apply, by 5:00 PM local time of applicant organization.
Scientific Merit Review	Standard dateshttp://grants1.nih.gov/grants/funding/submissionschedule.htm - reviewandaward apply
Advisory Council Review	Standard dateshttp://grants1.nih.gov/grants/funding/submissionschedule.htm - reviewandaward apply
Earliest Start Date(s)	Standard dates apply
Expiration Date	September 8, 2013
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The purpose of this funding opportunity announcement (FOA) is to continue advancing our understanding of the risks, development, progression, diagnosis, and treatment of malignancies observed in individuals with an underlying Human Immunodeficiency (HIV) infection or Acquired Immune Deficiency Syndrome (AIDS). The NCI and NIDCR seek to encourage research in areas such as the study of the etiologic factors, cofactors, immunopathogenesis, diagnosis, and consequences of both AIDS-defining and non-AIDS defining malignancies in diverse populations in the context of an underlying HIV infection. This FOA solicits research efforts that will: (i) provide information on the clinical outcomes of such cancers in the HIV-infected population; and (ii) identify specific contributions resulting from HIV infection and its potential interaction with other pathogens for the development and pathogenesis of these cancers. Ultimately, such efforts could inform screening approaches and therapies targeted to the HIV-infected population.

Biomarkers, Diagnostics, and Therapeutics:

• Discovery of reliable molecular or immunological diagnostic and prognostic biomarkers, or pathogen markers, useful for early detection, progression, or response to treatment of AIDS-defining and non-AIDS-defining malignancies;
• Discovery and development of novel targets and efficacious new therapeutic agents, interventional strategies, or improved delivery systems for the treatment of persons afflicted with AIDS-defining and non-AIDS-defining malignancies;
• Development, and evaluation of novel, selective chemical entities generated by combinatorial chemistry or combinatorial genomics methodologies for therapeutic agents
• Studies to understand the pharmacokinetics of targeted therapies for AIDS-defining and non-AIDS defining malignancies in the context of highly active antiretroviral therapy;

Etiology, Pathogenesis and Immunology:

• Studies to determine pathogenic or immunological mechanisms involved in HCV, HBV, KSHV/HHV8, EBV, HPV, Merkel cell polyomavirus, or other oncogenic infectious agent mediated tumor initiation and promotion of malignancies, concurrent with underlying HIV infections;
• Development of animal and/or cell-based models for AIDS-defining and non-AIDS-defining malignancies;
• Studies to determine the cellular proteome and transcriptome of virally induced tumors in the context of HIV infection;
• Studies to determine the effects of prolonged moderate immunosuppression and/or incomplete or failed responses to combination antiretroviral therapy (cART) on the development of either AIDS-defining or non-AIDS-defining malignancies;
• Studies aimed at identifying the roles of HIV infection in the immunology and pathogenesis of non-AIDS-defining cancers;
• Studies to determine the effects of the concomitant prolonged exposure of HIV-infected patients to antiretroviral therapy and viruses with oncogenic potential on the development of either AIDS-defining or non-AIDS-defining malignancies;

Molecular Epidemiology and Prevention:

• Studies to characterize the host genetic susceptibility to AIDS-defining and non-AIDS-defining malignancies;
• Assessment of risk factors that impact cancer in the context of HIV infection, in different geographic locations in domestic and international settings;
• Studies to characterize the immunologic, virologic, genetic, and epigenetic differences between those patients on cART who develop pre-neoplastic and neoplastic conditions and those patients who resolve these conditions or do not develop them;
• Studies to identify host and/or life-style factors (e.g., alcohol, drug use, tobacco, energy balance, environment, and nutrition) that may play roles in affecting immunocompetence, enhancing immunosuppression and exacerbating the pathogenesis of either AIDS-defining or non-AIDS-defining malignancies;
• Studies to elucidate the interplay of routes of acquisition of oncogenic viruses and other host cofactors and concomitant pathogens on the molecular epidemiology and natural history of AIDS-defining or non-AIDS-defining malignancies;
• Studies to better determine the role of infectious pathogens in the development and clinical course of AIDS-defining or non-AIDS-defining malignancies;
• Studies that focus on the development of better prevention strategies that may reduce the burden of infectious-related malignancies in diverse HIV/AIDS populations;
• Studies to investigate the effects of smoking on mitochondrial DNA (mtDNA) and mitochondrial toxicity in-utero and its role in AIDS-defining and non-AIDS defining cancers;
• Studies to identify alterations in mitochondrial function and mitochondrial mutations in smokers vs. non-smokers that may play a role in tobacco- related cancer risks in various ethnic populations; and
• Studies to better determine alterations in miRNA profiles in HPV, EBV or KSHV/HHV-8 and HIV co-infected populations which may contribute to viral pathogenesis;

• Studies to characterize the host genetic susceptibility to HIV-associated oral malignancies and other tumors in infected persons;
• Studies to determine the cellular proteome, metabolome, and transcriptome of virally induced tumors of the oral cavity in the context of HIV infection;
• Studies to determine the mode of entry, latency, reactivation, translocation, and transformation of mucosal cells of the oral cavity by oncogenic viruses during HIV infection;
• Studies to determine the immunological, molecular, virological, and pathological mechanisms that are involved in EBV, HPV, KSHV/HHV8, or other oncogenic infectious agent that drive oral malignancies and tumors in the context of HIV infection;
• Studies to determine the effects of prolonged moderate immunosuppression and/or incomplete or failed responses to cART on the development of oral malignancies and tumors;
• Studies to determine the molecular epidemiology of the viral strains that are implicated in the promotion of HIV-associated malignant transformations of the oral cavity;
• Studies that use novel or well-characterized animal-based models for HIV-associated oral malignancies in the research categories described in this FOA;
• Studies to determine the similarities and differences between HIV-associated tumors of the oral mucosa and other anatomical (e.g. vaginal, gastrointestinal, rectal) mucosal surfaces;
• Studies that are geared towards identifying reliable diagnostic and prognostic host biomarkers and oral oncogenic pathogen markers useful for detection of HIV-associated oral malignancies and their progression. Commercial application of host biomarkers in diagnostic assays for HIV-associated oral malignancies and their progression.
• Studies that use novel immunotherapies or combination of novel and standard therapies for modulation of the immune response and controlling oncogenesis of oral pathogens and oral AIDS malignancies through the use of cytokines, chemokines, adjuvants, antibodies, other molecules of the immune system, and other treatment modalities (e.g., chemotherapeutic agents);
• Studies that develop oral topical formulations with potentially combined effects (microbicidal, viricidal, analgesic and anti-inflammatory) to enhance oral mucosal defenses and control or treat oral AIDS malignancies;
• Studies that use metagenomic approaches to characterize the oral virome associated with oral AIDS malignancies and compare it with that of healthy (non-HIV/AIDS cohorts);
• Studies that address oral pathogen translocation with potential interaction with HIV and other infectious agents in the oral cavity of HIV-infected/AIDS subjects to induce exacerbation of inflammation and oral AIDS malignancies.

This FOA is not designed to support clinical trials of treatment for HIV-associated malignancies. Nonetheless, some aspects of clinical research may be incorporated in projects proposed in response to this FOA. Depending on a specific project proposed, such aspects may include: analysis of samples and data collected from clinical trials, analysis of identified costs for patient visits, or specimen shipping and handling.

In addition, descriptive research and recruitment or retention of cohorts are not appropriate for this FOA. However, proposed analysis of samples and data acquired from existing cohorts and tissue banks is encouraged. Examples of such cohorts and repositories include the Women s Interagency HIV Study (WIHS) (https://statepiaps.jhsph.edu/wihs/), the Multicenter AIDS Cohort Study (MACS) (http://statepi.jhsph.edu/macs/macs.html), and the AIDS and Cancer Specimen Resource (http://acsr.ucsf.edu). Investigators are encouraged to utilize infrastructure support of the Centers for AIDS Research (http://www.niaid.nih.gov/research/cfar/) or the NCI-designated Cancer Centers if located at those institutions.

Funding Instrument	Grant
Application Types Allowed	New Renewal Resubmission The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.
Award Budget	Application budgets are not limited, but need to reflect actual needs of proposed project.
Award Project Period	Scope of the proposed project should determine the project period. The maximum period is 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions:

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American tribal organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Organizations)

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must be renewed at least annually
• Grants.gov
• eRA Commons

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization 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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

• All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this should be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact (see Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.)

(b) Sharing Model Organisms: Regardless of the amount requested, all applications in which the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible (see Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.)

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for 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. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (NOT-OD-07-088) and http://grants.nih.gov/grants/gwas/.

Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF 424 (R&R) Application Guide.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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

Reviewers will consider each of the review criteria below in the determination of scientific 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

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

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 project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, 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. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

As applicable for the project proposed, reviewers will consider 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.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

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

• Undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review), will be discussed and assigned an overall impact/priority score.
• Receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NGA. 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. More information is provided at Award Conditions and Information for NIH Grants.

When multiple years are involved, 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.

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.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Direct general questions and questions regarding Basic Science to:

Elizabeth Read-Connole Ph.D.
AIDS Malignancies
Cancer Etiology Branch,
Division of Cancer Biology
National Cancer Institute (NCI)
6130 Executive Plaza North Room 5016
Bethesda, MD 20892-7398
Telephone: 301-496-6085
Email: [email protected]

Direct questions regarding to malignant complications of HIV/AIDS to:

Geraldina Dominguez, Ph.D.
AIDS Malignancy Program
Office of HIV and AIDS Malignancy
National Cancer Institute (NCI)
31 Center Drive, Room 3A35
Bethesda, MD 20852
Telephone: 301-496-3204
Email: [email protected]

Direct questions regarding epidemiology of malignant complications of HIV/AIDS to:

Vaurice Starks
Epidemiology and Genetics Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute (NCI)
6130 Executive Boulevard, Room 5100
Bethesda, MD 20892-7324
Telephone: 301-402-9375
Email: [email protected]

Mukesh Verma, Ph.D.
Epidemiology and Genetics Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute (NCI)
National Institutes of Health (NIH)
6130 Executive Boulevard, Room 5100
Bethesda, MD 20892-7324
Telephone: 301-594-7344
Email: [email protected]

Direct questions about oral malignant complications of HIV/AIDS to:

Isaac R. Rodriguez-Chavez, Ph.D., M.S., M.H.S.
AIDS & Immunosuppression Program, IBIDB, DER
National Institute of Dental & Craniofacial Research (NIDCR)
6701 Democracy Boulevard, Room 614
Bethesda, MD 20892-4878
Telephone: 301-594-7985
Email: [email protected]

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Crystal Wolfrey
Chief, Cancer Control and Population Sciences Branch
Office of Grants Administration
National Cancer Institute (NCI)
6120 Executive Boulevard, EPS Room 243, MSC 7150
Bethesda, MD 20892-7150 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS express/courier delivery)
Telephone: 301-496-8634
E-mail: [email protected]

Mary Daley Greenwood
Chief Grants Management Officer
National Institute of Dental
and Craniofacial Research, NIH, HHS
6701 Democracy Boulevard
Room 658, MSC 4878
Bethesda, MD 20892-4878 (Courier 20817)
Phone: 301-594-4808
Email: [email protected]

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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 Part 52 and 45 CFR Parts 74 and 92.