Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Human Genome Research Institute (NHGRI)
Funding Opportunity Title	Exploratory Centers of Excellence in ELSI Research (CEER) (P20)
Activity Code	P20 Exploratory Grants
Announcement Type	Reissue of RFA-HG-09-003
Related Notices	None
Funding Opportunity Announcement (FOA) Number	RFA-HG-12-012
Companion Funding Opportunity	RFA-HG-12-005, P50 Specialized Center
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.172
Funding Opportunity Purpose	The National Human Genome Research Institute (NHGRI) is soliciting grant applications for the support of Exploratory Centers (P20) of Excellence in Ethical, Legal and Social Implications (ELSI) Research (CEERs). Exploratory Centers will support expanding or modifying existing resources at an institution for the purpose of developing a Specialized Center (P50) CEER application. The CEER program is designed to develop and support trans-disciplinary research teams that have the expertise and flexibility to anticipate, conduct research on, and respond quickly to a range of ELSI issues related to the rapidly increasing availability and use of genomic approaches and information. CEERs are intended to provide an opportunity to cross disciplinary boundaries and create new research opportunities between and among investigators such as those in the basic genomic and social sciences, clinical and health policy research, ethics, law, the humanities, and various stakeholder communities. In addition, CEERs will play a role in ensuring that relevant ELSI research findings and deliberations are made available to policy makers as appropriate. Finally, CEERs will be responsible for contributing to training the next generation of ELSI researchers, with particular emphasis on training researchers from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds.

Posted Date	April 12, 2012
Letter of Intent Due Date	June, 19, 2012
Application Due Date(s)	July 19, 2012
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	November, 2012
Advisory Council Review	January 2013
Earliest Start Date(s)	April 1, 2013
Expiration Date	July 20, 2012
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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. While some links are provided, 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 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 rapid evolution of genomic technologies and the increasing availability and use of genomic information have the potential to transform how research and medicine are practiced and to reshape the conceptualization of various social norms. New genetic tests and large amounts of detailed personal genomic information are now widely available in research, health care and commercial settings and are being used in a variety of ways. New ethical, legal and social questions are being raised by the availability and use of such information, and the need for coherent and effective policies and practice guidance is increasing. To ensure the usefulness and applicability of these policies, it is essential that they: 1) are informed by reliable data, based on sound theoretical models and rigorous research, and 2) incorporate the perspectives of individuals from diverse racial, ethnic and socioeconomic backgrounds, as well as children, older adults and people with disabilities.

The NHGRI, through its ELSI Research Program, has funded many research projects involving investigators from single or multiple disciplines, using a wide variety of methodologies. While considerable progress has been made on ELSI issues, new issues continue to arise and much remains to be done. As the pace of genomic and genetic breakthroughs continues to increase, the development of research teams that have the multi-disciplinary expertise and flexibility to anticipate and respond rapidly to the large number of emerging and evolving ELSI issues will become increasingly important. The creation and maintenance of research centers with the resources and expertise to design and implement multi-faceted and trans-disciplinary investigations of complex, persistent or rapidly emerging ELSI issues is an important component of the overall NHGRI portfolio in ELSI and genomic research.

The CEER program is designed to support the development of research groups that can anticipate and investigate clearly defined high priority ELSI research questions that can best be approached through intensive and extended collaborations among investigators from multiple disciplines, using diverse methodologies. The investigators in a CEER are encouraged to consider new ways to explore such questions, design innovative research projects that utilize the full range of ELSI research approaches, propose and disseminate research, health, or social policy options based on the results of Center research and, where feasible, facilitate policy development pertinent to specific issues. NHGRI welcomes the involvement of minority-serving institutions and investigators from under-represented minority populations and those with disabilities.

A high priority under this program is the establishment or continuation of strong academic centers in which state-of-the-art ELSI research can be or is being conducted. At some institutions, the nucleus of a well-functioning collaborative research group that could conduct the research described in this FOA may already exist, and such groups will be able to submit suitable P50 applications for this program directly. These groups should submit a Specialized Center (P50) application under RFA-HG-12-005.

However, some groups of investigators may require an opportunity to enhance their collaborative network by establishing or strengthening new multi-investigator or interdisciplinary relationships, demonstrating effective collaborations, exploring organizational concepts, developing courses or curricula, collecting preliminary data, or refining and fully developing their vision for a proposed P50 CEER project. For these groups, this Exploratory Grant (P20) mechanism should be used.

The P20 grant mechanism will support planning for a new CEER, expanding or modifying existing resources at an institution for the purpose of developing a P50 CEER application, or conducting feasibility studies to explore various approaches to the development of an interdisciplinary program that offers potential solutions to ELSI problems of special significance to the field of genomics. The application for support of such exploratory studies must explicitly discuss how the proposed planning activities will lead to such a P50 application. It should describe in detail a vision of the research to be conducted under the subsequent P50 grant.

To ensure that the CEERs activities are well organized, integrated and managed, each Exploratory CEER should identify a well-defined, highly significant current research topic, or set of closely related research questions, that are well anchored in genomic and genetic sciences and that will serve as the focus or organizing theme of its exploratory activities. Examples of possible high priority topics are described on the ELSI Research Program s website (http://www.genome.gov/27543732). These topics are based on the broad priority areas identified in the Genomics & Society section of NHGRI’s 2011 strategic plan for the future of human genome research ("Charting a course for genomic medicine: from base pairs to bedside Nature 10 Feb 2011:470;204-13.). They are meant as examples only and should not be considered an exhaustive listing of all possible research areas of focus.

Although aspects of each of these issues can be and are being addressed through Regular (R01), Development/Exploratory (R21) or Small (R03) research grants, the intent of the Exploratory CEER program is to allow researchers to develop the capability to propose more comprehensive, trans-disciplinary approaches to exploring and addressing existing issues and identifying new issues. To accomplish this, each Exploratory CEER will be expected to propose a focused pilot research project that will lay the ground work for the development of a comprehensive research project that uses the full spectrum of ELSI research and policy methodologies and approaches to explore and address the high priority issue they have identified as the theme for their CEER. The research project should develop the trans-discplinary resources that will allow the researchers to integrate data-generating qualitative and quantitative studies, legal and normative analyses, and other analytical or conceptual research methodologies with translational activities that use these conceptual tools and empirical data to inform the development of appropriate public-policy options or professional guidelines. Plans should be described that will support the incorporation of diverse points of view, including, as appropriate, communities that may be particularly vulnerable or disproportionately affected by the issues being addressed.

In addition to describing how the Exploratory CEER will develop the transdisciplinary and translational infrastructure to support the operational core and the comprehensive research project, the CEER application should include a discussion of plans for developing the capability to identify new and emerging issues that are ripe for policy development or need further research and the strategies they will employ to design, review and support new activities that will address these issues. The Exploratory CEER should not propose a training component; however, they should include a description of the types of training activities, particularly for training of investigators from under-represented minority populations, that are envisioned for a subsequent P50 Center.

There is no specific time commitment required of the PI of a P20 project; however, the PI should devote sufficient time to demonstrate that he/she will be able to do the organizational groundwork and planning necessary to develop a competitive P50 center proposal.

An exploratory grant is not required as a precursor to a P50 Center application. In addition, NHGRI’s funding of an exploratory grant does not obligate NHGRI to fund a subsequent P50 Center grant.

Funding Instrument	Grant
Application Types Allowed	New The OER Glossary and the PHS398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NHGRI intends to commit $ 650,000 in FY 2013 to fund up to 2 P20 grants.
Award Budget	Developmental P20 grant applications may request up to $175,000 direct costs per year.
Award Project Period	The maximum period of support for a P20 Development grant is three (3) 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)
• 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 Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant organizations must complete the following registrations as described in the PHS398 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 maintain an active registration, to be renewed at least annually
• eRA Commons

All Program Director(s)/Principal Investigator(s) (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 least4-6 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 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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 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.

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

It is critical that applicants follow the instructions in the PHS398 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.

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:

• Descriptive title of proposed research
• Name, address, and telephone number of the PD(s)/PI(s)
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

The letter of intent should be sent to:

Joy T. Boyer
ELSI Research Program, Division of Extramural Research
National Human Genome Research Institute, NIH
5635 Fishers Lane, Suite 4076
Bethesda, MD 20892
Telephone: (301) 402-4997
FAX: (301) 402-1950
Email: jb40m@nih.gov

Applications must be prepared using the PHS 398 research grant application forms and 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)

At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:

Dr. Rudy Pozzatti
Scientific Review Branch
National Human Genome Research Institute
5635 Fishers Lane, Suite 4076
Bethesda, MD 20892-9305 (for US Postal Service)
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 402-0838
Fax: (301) 435-1580
Email: rp7s@nih.gov

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed.

• For the P20 Exploratory Grant applications, the regular PHS 398 page limitations should be followed, allowing 12 pages for the Research Strategy section.

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

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 PHS398 Application Guide, with the following modification:

• Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan) are expected, but they are not applicable for this FOA.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide

Part I. Overview Information contains information about Key Dates.

Information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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 received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

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.

Consortium participation and collaboration. Annual meetings of investigators from funded Specialized Centers (P50) and Exploratory Center (P20) projects will be held. This will facilitate sharing of information about current and planned research, training, and policy activities, communication of research findings and policy deliberations, and experiences in organizing and operating a CEER. Such meetings will encourage collaboration among CEERs, reduce duplication of effort, and promote more rapid dissemination of knowledge and information. The initial meeting will take place shortly after the grants are funded. Funds for travel to these meetings for up to three investigators (the PDs/PIs and two others) per year should be included in the requested budget. In addition to these meetings, CEER investigators will be expected to participate in and, where appropriate, lead trans-CEER initiatives, such as trainee networking activities, joint workshops and research projects, and trans-CEER publications.

PD/PI commitment and timeline. There is no specific time commitment required of the PD(s)/PI(s) of a P20 project; however, the PD(s)/PI(s) should devote sufficient time to demonstrate that he/she will be able to do the organizational groundwork and planning to develop a successful P50 center application. A timeline should be included in the application that shows how the goals can be met within the timeframe of the P20 CEER grant. This timeline will be used to help assess progress toward the project's goals.

Site visits. Site visits will not be held for the Exploratory P20 grants.

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

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.

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the center 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 center 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 application address an important problem or a critical barrier to progress in the field? If the aims of the CEER 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? Does this application address an important ELSI problem related to genomic and genetic science? Is the research topic clearly defined and is it the primary focus of the Center's activities? If the aims of the application are achieved and a Specialized Center (P50) is established, will our understanding or ability to address the issues surrounding this topic be significantly advanced? Will the proposed Center's activities have an effect on the field of ELSI research? Will they be relevant and useful to the larger research, health, and social policy communities? Does the research problem addressed require investigation by a Center team?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the application? 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(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do the PD(s)/PI(s) have the ability, expertise and experience to lead, coordinate, and manage all of the activities of the Exploratory CEER? Do the PD(s)/PI(s) have sufficient leadership qualities and experience to develop and implement the Exploratory CEER plans for the entire project? Are the other key personnel identified from multiple disciplines? To what degree will the individual and combined expertise of the key personnel contribute to the accomplishment of the overall goals of the Exploratory CEER? Is the level of effort for the key personnel adequate? Is there evidence of effective collaboration among key personnel? Is there evidence that the team has sufficient expertise in both ELSI research and genomic/genetic science?

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 Exploratory CEER? 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 Exploratory CEER 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? Do the plans laid out in the Exploratory CEER build on the multi-disciplinary resources available at the institution?

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

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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

Not Applicable

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 NHGRI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May 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.
• Will receive a written critique.

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 and will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council for Human Genome Research. 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(s)/PI(s) 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’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, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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.

Not Applicable

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 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.

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

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

Ms. Joy T. Boyer
ELSI Research Program, Division of Extramural Research
National Human Genome Research Institute, NIH
5635 Fishers Lane, Suite 4076
Bethesda, MD 20892
Telephone: (301) 402-4997
FAX: (301) 402-1950
Email: jb40m@nih.gov


Dr. Rudy Pozzatti
Scientific Review Branch
National Human Genome Research Institute
5635 Fishers Lane, Suite 4076
Bethesda, MD 20892-9305 (for US Postal Service)
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 402-0838
Fax: (301) 435-1580
Email: rp7s@nih.gov

Ms. Cheryl Chick
Chief, Grants Administration Branch
National Human Genome Research Institute
5635 Fishers Lane, Suite 4076
Bethesda, MD 20892-9306
Telephone: (301) 435-7858
Fax: (301) 451-5434
Email: chickc@mail.nih.gov

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.