Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Dental and Craniofacial Research (NIDCR)

Funding Opportunity Title

Epigenomics of Virus-Associated Oral Diseases (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-DE-13-002

Companion Funding Opportunity

RFA-DE-13-003, R21 Exploratory/Developmental Grant

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.121

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) issued by the National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health (NIH), solicits novel, research project grant (R01) applications proposing to investigate the epigenetic basis of virus-associated oral diseases in order to guide the discovery and application of novel epigenomic-based clinical interventions. These studies are expected to: 1) discover and define the mechanisms of action of epigenomic modifications in viral and host epigenomes; and 2) demonstrate how modifications in the host and viral epigenomes cause pathophysiological changes in oral cells and tissues that result in oral diseases and may also cause diseases in other parts of the body.

Key Dates
Posted Date

October 31, 2012

Open Date (Earliest Submission Date)

January 21, 2013

Letter of Intent Due Date(s)

January 21, 2013

Application Due Date(s)

February, 21, 2013, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

May/June, 2013

Advisory Council Review

August, 2013

Earliest Start Date

September, 2013

Expiration Date

February 22, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (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.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The purpose of this FOA is to invite grant applications that seek to determine the epigenetic mechanisms of virus-associated oral diseases in order to guide the discovery and application of novel epigenomic-based clinical interventions. Specifically, studies supported through this FOA are expected to demonstrate how epigenomic modifications in the host and in oral viruses cause pathophysiological changes in oral cells and tissues that result in oral diseases and that may include systemic disease manifestations.

Research Objectives

Basic, translational and preclinical research projects supported through this initiative will address at least one of the following specific objectives:

Research projects that propose genome-wide, biochemical, and/or molecular epigenetic approaches are encouraged. Research projects should focus on oral diseases caused by, but not necessarily limited to Human Immunodeficiency Virus (HIV), Herpes Simplex Virus (HSV), Human Papillomavirus (HPV), Kaposi’s sarcoma Virus (KSHV) or Human Herpesvirus 8 (HHV-8), Epstein Barr Virus (EBV), Polyomaviruses such as BK virus (BKV), Adenovirus, and Cytomegalovirus (CMV). Research grant applications that address the specific objectives of this FOA focusing on an oral disease that establishes epigenomic comparisons in oral cells and tissues derived from both HIV/AIDS infected and non-infected individuals are strongly encouraged.

Background

Epigenetic processes are critical for normal development and functioning of healthy individuals. Epigenomics involves heritable changes in phenotype and gene expression that may be stable over extended time, carry over numerous cell divisions, or may be inherited through many generations without changes to the primary DNA sequence; it refers to external gene and chromatin modifications that affect their transcriptional activation or repression. Epigenomic changes mainly occur at two levels: 1) directly, causing DNA modifications; and 2) indirectly, introducing chromatin epigenetic modifications that alter conformational packaging and define accessibility to the cellular transcriptional machinery. Some of the indirect epigenetic modifications include histone tail changes by acetylation, methylation, sumoylation, ubiquitylation, phosphorylation, and ribosylation. However, epigenomic modifications can also be introduced by other molecules such as non-coding RNAs (i.e., microRNAs [60-70 nucleotides], siRNAs [21-23 nucleotides], piRNAs [26-31 nucleotides], and germ line RNAs [24-29 nucleotides]), histone variants interacting proteins, chromatin or DNA methylation-associated proteins, inter- and intra-chromosomal interactions, molecules of chromatin structure and remodeling, or likely other molecules yet to be discovered.

Virus-induced, host epigenetic perturbations have been reported in human diseases. For instance, viral pathogenicity and life cycle events can induce epigenetic alterations in host genomes and modulate immune responses such as innate immunity, including partial or complete blockage in the production of interferon. The underlying mechanisms of these virus driven epigenetic alterations that cause abnormal cellular processes and may lead to oral diseases are not well understood. Similarly, evidence of epigenetic changes that occur in the genome of oral viruses has been reported, but the nature of these changes remains to be explored further. For example, viral latency, reactivation and lytic replication associated with epigenetic changes and their frequencies are unknown. Therefore, it is fundamental to understand host and viral epigenomic profiles as well as epigenetic marks and mechanisms involved in physiological changes linked to oral diseases. It is expected that these findings will guide the development of novel therapeutic modalities for improving oral health.

Specific Areas of Research Interest

Examples of basic, translational and preclinical research topics supported by this initiative include but are not limited to:

Research projects supported by this FOA must use human primary cells or tissues from the oral mucosa, or established cell lines and explanted tissues derived from the human oral mucosa. In addition to the oral biospecimens, primary or derived human cells and tissues from other human body sites that are also targets of the same virus that causes an oral disease may be utilized, as a minor component, to compare mechanisms of viral and host epigenomic modifications discovered in the oral cavity with those that may be linked to disease manifestations in other parts of the body.

Basic and translational research projects supported by this FOA will include both basic discovery approaches that reveal genome-wide epigenetic characteristics of oral diseases and biochemical or molecular mechanistic approaches by which host and viral epigenomic modifications result in oral diseases. Preclinical research projects proposing to test the safety and toxicity of experimental anti-viral drugs or immunotherapeutic agents, targeting epigenomic modifications in animal models are encouraged. Research grant applications engaging multiple investigators with complementary expertise such as dentist scientists, oral biologists, virologists, immunologists, human geneticists, viral immunologists, and bioinformaticians are strongly encouraged.

This FOA will not support research projects that propose to: 1) use exclusively animal models to identify host and oral viral epigenomic marks and modifications relevant to oral diseases; 2) use exclusively ex vivo or in vitro systems that do not utilize or that are not derived from human specimens; 3) analyze gene expression profiles without epigenetic profiling or mechanistic epigenetic studies; 4) conduct clinical trials; 5) perform secondary data analysis of primary host and oral viral epigenomics data for oral diseases; and 6) use non-oral primary cells, cell lines, tissues and biospecimens without using human primary cells or tissues from the human oral mucosa, or established cell lines and explanted tissues derived from the human oral mucosa. Applications that propose such projects will be deemed non-responsive and will not be reviewed.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New

The OER Glossary and the SF424 (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. NIDCR intends to support approximately 8-10 R01 applications solicited through this Funding Opportunity Announcement. A companion Funding Opportunity Announcement, RFA-DE-13-003, will support approximately 4-8 R21 additional grant applications. NIDCR intends to commit approximately $5 million in total costs in FY2013 to support meritorious projects solicited through these two announcements.

Award Budget

Application budgets are not limited, but need to reflect actual needs of the 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.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF424 (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.

All Program Directors/Principal Investigators (PD(s)/PI(s)) 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 6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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 SF424 (R&R) Application Guide.

Research Grant Applications including multiple investigators with complementary expertise such as dentist scientists, oral biologists, virologists, immunologists, human geneticists, viral immunologists, and bioinformaticians are strongly encouraged.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

1.            To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;

2.            Of an investigator-initiated application that was originally submitted to an RFA but not paid; or

3.            Of an application with a changed grant activity code.

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

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.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

The letter of intent should be sent to:

Yasaman Shirazi, PhD
Chief, Scientific Review Branch
National Institutes of Health
National Institute of Dental and Craniofacial Research
1DEM, Room 662, MSC 4878
6701 Democracy Boulevard
Bethesda, Maryland 20892 (Courier 20817)
Telephone: (301) 594-5593
Fax: (301) 480-8303
Email: yasaman.shirazi@nih.gov

Required and Optional Components

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 submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

Page Limitations

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

PHS 398 Research Plan Component

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

Research Strategy

Applications responsive to this FOA must have strong potential to advance our understanding of the epigenomic basis of virus-associated oral diseases. The Research Strategy section of the application should clearly address the following:

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

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.

Foreign Institutions

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

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before 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 before the deadline 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.

4. Intergovernmental Review (E.O. 12372)

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.

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

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (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(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(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 System for Award Management (SAM). 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 and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of 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 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).

Scored Review Criteria

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(s)/PI(s), 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?

Has the applicant adequately described the relevance of the epigenomic research proposed to the virus and/or host-related aspects of a virus-associated oral disease? Has the applicant adequately justified the choice of using a specific oral virus or viruses as well as the use of human cells, cell lines, tissues, and biospecimens derived from the human oral mucosa and the relevance to an oral disease? Has the applicant fully justified the use of human cells/tissues from other body sites as applicable? Has the applicant adequately described the relevance of using human cells/tissues from other body sites to an oral disease and addressed the potential systemic disease manifestations? Has the application fully addressed statistical sample size, rationale and calculations, statistical power, and the bioinformatics and data analysis plan of the proposed studies?

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?

Additional Review Criteria

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 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

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable.

Additional Review Considerations

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 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.

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned 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 National Advisory Dental and Craniofacial Research Council. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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.

Section VI. Award Administration Information

1. Award Notices

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’s 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.      

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

Section VII. Agency Contacts

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: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

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: commons@od.nih.gov

Scientific/Research Contact(s)

Isaac R. Rodriguez-Chavez, Ph.D., M.S., M.H.S.
Director, AIDS and Immunosuppression Program
Division of Extramural Research, Integrative Biology and Infectious Diseases Branch
National Institutes of Health
National Institute of Dental and Craniofacial Research
6701 Democracy Blvd., Rm. 614
Bethesda, MD 20892-4878
Telephone: (301) 594-7985
Fax: (301) 480-8319
Email: isaac@nidcr.nih.gov

Peer Review Contact(s)

Yasaman Shirazi, PhD
Chief, Scientific Review Branch
National Institutes of Health
National Institute of Dental and Craniofacial Research
6701 Democracy Boulevard, Suite #662
Bethesda, Maryland 20892 (Courier 20817)
Tel: (301) 594-5593
Fax: (301) 480-8303
Email: yasaman.shirazi@nih.gov

Financial/Grants Management Contact(s)

Diana Rutberg
Grants Management Branch
National Institutes of Health
National Institute of Dental and Craniofacial Research
6701 Democracy Blvd., Room 656
Bethesda, MD 20892-4878
Voice: (301) 594-4798
Fax: (301) 480-3562
Email: rutbergd@mail.nih.gov

Section VIII. Other Information

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.

Authority and Regulations

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.


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