Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI) (No Longer Participating per NOT-OD-14-031)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Center for Complementary and Alternative Medicine (NCCAM)
Office of Behavioral and Social Sciences Research (OBSSR)

Funding Opportunity Title

Research on Ethical Issues in Biomedical, Social and Behavioral Research (R01)

Activity Code

R01 Research Project Grant

Announcement Type

 Reissue of PA-07-277

Related Notices

  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • December 13, 2013 - See Notice NOT-OD-14-031. Notice of Extension of Expiration date & the removal of NHLBI's participation.
  • May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

Funding Opportunity Announcement (FOA) Number

PA-11-180

Companion FOA

PA-11-181, R03 Small Grant
PA-11-182, R21 Exploratory/Developmental Grant

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

 93.395, 93.837, 93.838, 93.172, 93.866, 93.273, 93.855, 93.856, 93.286, 93.865, 93.173, 93.279, 93.113, 93.859, 93.242, 93.853, 93.361, 93.213

FOA Purpose

The purpose of this funding opportunity announcement (FOA) is to support investigator-initiated Research Project Grant (R01) applications that propose to study high priority bioethical challenges and issues associated with the types of biomedical, social, and behavioral research supported by the participating NIH Institutes/Centers.  The Office of Behavioral and Social Sciences Research (OBSSR) joins this FOA as part of its efforts to promote research on the behavioral and social aspects of health and illness.  However, only participating ICs will provide direct grant support under this FOA.

Key Dates
Posted Date
Open Date (Earliest Submission Date)
Letter of Intent Due Date

Not applicable

Application Due Date(s)

Standard dates apply , by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Standard dates apply by 5:00 PM local time of applicant organization.

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date(s)

Standard dates apply

Expiration Date

(Extended to May 8, 2015 per NOT-OD-14-031), Originally May 8, 2014

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.


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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

Background:

This funding opportunity announcement and two related announcements (R03, PA-11-181;  R21, PA-11-182) comprise the fourth set in a series of consecutive FOAs published by NIH since 1999 to encourage research on ethical issues related to the conduct of biomedical, social and behavioral research within the NIH mission.  The prior FOA’s in this series focused specifically on ethical issues related to the conduct of human subjects research.  This set of announcements broadens that focus to include ethical issues related to new and emerging biomedical technologies. 

With continuing advances in biomedical, social, and behavioral sciences and technologies and the diversification and expansion of research settings and subjects, researchers face evolving bioethical challenges related to the conduct of research, the management of related data and information, and the application of findings. For example, the NIH has a vested interest in promoting research at the cutting edge of science and technology which has potential benefits, yet risks may be unknown and ethical guidance may be lacking.  Research is needed to anticipate the evolution of bioethical issues, to ensure NIH supported research is conducted in the most ethical manner possible, and to inform policy discussions that may emerge from NIH-supported research.

The NIH is in the process of developing an agency-wide strategic plan for bioethics research and training which will be used to formulate future funding opportunity announcements and guide investments over the next five to ten years.  As part of the planning process, NIH is assessing priority areas for the support of bioethics research.  Future issuances of this FOA may include changes to reflect the outcomes of this assessment.

Research Objectives:

This FOA seeks applications for research projects that propose to analyze and address ethical challenges and issues related to the conduct and output of biomedical, clinical, social and behavioral research within the NIH mission.  The results of projects funded under this program announcement should enhance the ethical conduct and social value of research within the NIH mission, optimize the protection of human research participants, ensure research burdens and benefits are equitably distributed across populations, and contribute to policy development regarding the implementation and oversight of new research discoveries and methods.

Proposals to conduct empirical research as well as those that propose to develop new theoretical and conceptual ethical frameworks will be considered.  Interdisciplinary and collaborative projects utilizing multiple approaches are strongly encouraged. 

Areas of Interest:

Applications should address bioethical challenges and ethical issues relevant to the research mission area(s) of the participating NIH Institutes and Centers (ICs).  The participating ICs have identified specific bioethics topics below as the highest priority for consideration.  These are organized into seven categories: 1) ethical considerations of new and emerging technologies; 2) research study design issues; 3) issues associated with therapeutic misconception and the interface between treatment and research; 4) research involving vulnerable populations and urgent situations; 5) research with existing specimens, data, and health information; 6) dissemination and translation of research findings; and 7) oversight of research.  In addition, a description of the research mission areas of the participating ICs is also provided below. Applications that address other bioethical issues directly related to these mission areas will also be considered.

1) Ethical Considerations of New and Emerging Biomedical Technologies

NHGRI; NIA; NIBIB; NIGMS:

NIAAA:

NIDA; NIMH; NCCAM:

NIGMS:

2) Research Study Design Issues (including community engagement; equity in selecting and recruiting study populations; general informed consent issues).

NCI:

NCI; NIA; NIDA; NINDS:

NHGRI:

NIA:

NIA; NICHD; NIDA; NINDS: 

NIAAA; NIDA: 

NIAID; NINDS; NCCAM:   Research on healthy control study participants such as:

NIEHS:

NIMH: 

NCCAM:

3) Therapeutic Misconception and Interface of Treatment and Research (including overlap of clinical and research data; providing clinical care in the context of research).

NHLBI; NCCAM:

NHGRI:

NIA:

NIAAA; NIDA; NINDS; NCCAM:

NIAID; NIBIB; NIDA; NINDS; NINR:

4) Research that involves vulnerable populations (including research in developing countries; disadvantaged and underserved populations; populations with unique challenges to health and well-being), or research in urgent situations (such as emergency research, research during public health emergencies).

NCI:

NHLBI:

NHLBI; NIGMS; NINDS:

NHGRI:

NIA; NIAAA; NIAID; NIDA; NIMH; NINDS; NINR: 

NIA; NIAAA; NIDA; NINDS; NCCAM:

NIA; NIAAA; NIAID; NIDA:

NIA; NICHD; NINDS:

NIA; NINR:

NIGMS:

NINR:

5) Research with Specimens, Data, and/or Health Information (including specimen/data sharing; privacy and confidentiality issues; biobanking).

NCI:

NCI; NIGMS; NINDS:

NHLBI; NINDS:

NHGRI; NIA:

NIA; NINDS:

NIAAA; NIBIB; NIDA; NIGMS; NINDS; NCCAM: 

NICHD; NIDA; NINDS: 

NICHD; NIGMS:

NIEHS:

NINR:

6) Dissemination and Translation of Research Findings (including return of research results; data ownership).

NCI:

NHLBI; NIA; NINDS:

NHGRI:

NIA:

NIA; NINR:

NIEHS:

NINDS; NCCAM:

7) Research Oversight (including IRBs; data and safety monitoring; conflict of interest management).

NCI; NHLBI; NHGRI; NIA; NIAID; NIDA; NIMH; NINDS; NINR:

NHGRI:

NIAAA; NIBIB; NIDA; NIGMS; NINDS; NCCAM: 

NIH IC Mission Areas:

In addition to the high priority topics noted above, applications that address ethical issues which are directly related to the specific research missions of the participating NIH ICs will also be considered.  A brief description of these missions is provided here.

NCI:  The National Cancer Institute coordinates the National Cancer Program, which conducts and supports research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients.

NHLBI:  The National Heart, Lung, and Blood Institute provides leadership for a national program in diseases of the heart, blood vessels, lung, and blood; blood resources; and sleep disorders. Since October 1997, the NHLBI has also had administrative responsibility for the NIH Woman's Health Initiative. The Institute plans, conducts, fosters, and supports an integrated and coordinated program of basic research, clinical investigations and trials, observational studies, and demonstration and education projects.

NHGRI:   The National Human Genome Research Institute is devoted to advancing health through genome research.  Building on the foundation laid by the sequencing of the human genome, NHGRI’s work now encompasses a broad range of research aimed at expanding understanding of the structure and function of the human genome and its role in health and disease. In addition, a critical part of NHGRI’s mission continues to be the study of the ethical, legal and social implications of genome research.

NIA:  The National Institute on Aging leads a broad scientific effort to understand the nature of aging and to extend the healthy, active years of life.  NIA provides leadership in aging research, training, health information dissemination, and other programs relevant to aging and older people and is the primary Federal agency that supports Alzheimer’s disease research.

NIAAA:  The National Institute on Alcohol Abuse and Alcoholism conducts and supports research to improve the treatment and prevention of alcoholism and alcohol-related problems to reduce the health, social, and economic consequences of this disease.

NIAID:  The National Institute of Allergy and Infectious Diseases conducts and supports basic and applied research to better understand, treat and ultimately prevent infectious, immunologic, and allergic diseases.  Areas of particular interest include prevention, therapeutics, diagnostics, and countermeasures for infectious, immunologic, and allergic diseases both in the US and internationally.

NIBIB:  The National Institute of Biomedical Imaging and Bioengineering improves health by promoting fundamental discoveries, design, development, translation, and assessment of technological capabilities in biomedical imaging and bioengineering.

NICHD: The Eunice Kennedy Shriver National Institute of Child Health and Human Development conducts and supports research on fertility, pregnancy, growth, development and medical rehabilitation to ensure that each child is born healthy and wanted, that women suffer no harmful effects from the reproductive process,  that all children have the chance to fulfill their potential to live healthy and productive lives free from disease or disability, and to ensure the health, productivity, independence, and well-being of all people through optimal rehabilitation.

NIDCD: The National Institute on Deafness and Other Communication Disorders supports and conducts biomedical and behavioral research and research training in normal and disordered conditions of hearing, balance, taste, smell, voice, speech, and language.

NIDA: The National Institute on Drug Abuse leads the nation in bringing the power of science to bear on drug abuse and addiction through support and conduct of research across a broad range of disciplines and rapid and effective dissemination of results of that research to improve drug abuse and addiction prevention, treatment, and policy.

NIEHS:  The National Institute of Environmental Health Sciences reduces the burden of human illness and dysfunction from environmental causes by defining how environmental exposures, genetic susceptibility, and age interact to affect an individual's health.

NIGMS: The National Institute of General Medical Sciences supports basic biomedical research to increase our understanding of life processes and lay the foundation for advances in disease diagnosis, treatment, and prevention.

NIMH:  The mission of the National Institute of Mental Health is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure.

NINDS:  The National Institute of Neurological Disorders and Stroke supports and conducts basic and clinical research on the normal and diseased nervous system to improve the understanding, diagnosis, treatment and prevention of neurological disorders.

NINR:  The mission of the National Institute of Nursing Research is to promote and improve the health of individuals, families, communities, and populations by supporting and conducting clinical and basic research on health and illness across the lifespan. The research focus encompasses health promotion and disease prevention, quality of life, health disparities, and end-of-life care.

NCCAM:  The National Center for Complementary and Alternative Medicine supports rigorous scientific research to explore complementary and alternative medical practices.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal
Resubmission
Revision

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 the proposed project.

Award Project Period

 The scope of the proposed projects 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 (non-U.S.) components of U.S. Organizations are allowed..  

Required Registrations

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.

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.

Eligible Individuals (Project Director/Principal Investigator)

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.

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 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.

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.

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 application submission. 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:  

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.

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 Organizations

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.

3. Submission Dates and Times

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.

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 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.

Requests of $500,000 or more for direct costs in any year

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.

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/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).

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/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?        

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/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.

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/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.

2. Review and Selection Process

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:

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:

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 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.

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 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.

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. In particular, we encourage questions regarding specific priority topics listed above by participating ICs or about IC-specific research missions to be directed to the Scientific/Research Contacts listed below for the applicable ICs.   

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 301-435-0714
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)

Central NIH Program Contact (for general inquiries):

Ann Hardy
Office of Extramural Programs, OER, OD
Telephone:  301-435-2690
Email: hardyan@od.nih.gov

Kim Witherspoon
National Cancer Institute (NCI)
Telephone: 240-276-6141
Email: kw265c@nih.gov

Donna Dimichele
National Heart Lung and Blood Institute (NHLBI)
Telephone: 301-435-0080
Email: Donna.dimichele@nih.gov

Joy T. Boyer
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-4997
Email: Jb40m@nih.gov

Nina Silverberg
National Institute on Aging (NIA)
Telephone: 301-496-9350
Email: silverbergn@mail.nih.gov

Troy Zarcone
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone:  301-443-1285
Email: troy.zarcone@nih.gov

Larry Prograis
National Institute on Allergy and Infectious Diseases (NIAID)
Telephone:  240-627-3528
Email: lprograis@niaid.nih.gov

Steven Krosnick
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-594-3049
Email: krosnics@mail.nih.gov

Lisa Freund
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone:  301-435-6879
Email: freundl@mail.nih.gov

Gordon Hughes
National Institute on Deafness and Other communication Disorders (NIDCD)
Telephone: 301-435-4085
Email: hughesg@nidcd.nih.gov

Lynda Erinoff
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-1972
Email:  lerinoff@mail.nih.gov

Symma Finn
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-4258
Email: finns@niehs.nih.gov

Donna Krasnewich
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-0943
Email: dkras@nigms.nih.gov

Matthew Rudorfer
National Institute of Mental Health (NIMH)
Telephone: 301-443-1111
Email: mrudorfe@mail.nih.gov

Joanne Odenkirchen
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-3104
Email: odenkirj@ninds.nih.gov

Susan Marden
National Institute of Nursing Research (NINR)
Telephone: (301) 496-9623
Email: mardens@mail.nih.gov

Wendy Weber
National Center for Complementary and Alternative Medicine (NCCAM)
Telephone:  301-402-1272
Email: weberwj@mail.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Shane Woodward
National Cancer Institute (NCI)
Phone: 240-276-6303
Email: woodwards@mail.nih.gov

Ryan Lombardi
National Heart, Lung and Blood Institute (NHLBI)
Telephone: 301-435-0182
Email: lombardr@nhlbi.nin.gov

Cheryl Chick
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-0733
Email: cc149o@nih.gov  

Jeff Ball
National Institute on Aging (NIA)
Telephone: (301) 402-7732
Email: ballj@nia.nih.gov

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: judy.fox@nih.gov

Greg Smith
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: (301) 402-5540
Email: gs225y@nih.gov

Nancy Curling
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Telephone:  301-451-4782
Email:  curlingn@mail.nih.gov

Bryan Clark
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: Bryan.Clark@nih.gov

Christopher Myers
National Institute on Deafness and Communication Disorders (NIDCD)
Telephone: 301-435-0713
Email: myersc@mail.nih.gov 

Pam Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301-253-8729
Email: pfleming@mail.nih.gov

Donald Ellis
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1874
Email: donaldellis@niehs.nih.gov

Lori Burge
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-451-3781
Email: BurgeL@nigms.nih.gov

Rebecca Claycamp
National Institute of Mental Health (NIMH)
Telephone: (301) 443-2811
Email: rc253d@nih.gov

Tijuanna DeCoster
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: decostert@ninds.nih.gov

Lawrence Haller
National Institute of Nursing Research (NINR)
Telephone: 301-402-1878
Email: hallerl@mail.nih.gov

Cornice Martin
National center for Complementary and Alternative Medicine (NCCAM)
Telephone: 301-594-6059
Email: martincor@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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